277 results for "Patients "

AREN03B2: Study of Kidney Tumors in Younger Patients

This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

APEC14B1: Project - Every Child for Younger Patients with Cancer

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Observational Cohort Study of Patients with Castration-Resistant Prostate Cancer (CRPC)

The purpose of this study is to describe patterns of care in CRPC patients, as well as health-related quality of life (HRQoL) outcomes associated with CRPC and its management.

This study will also describe factors influencing treatment decisions including reason(s) for treatment choices and triggers for treatment changes for CRPC as well as describe clinical outcomes based on patient characteristics.

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Collecting and Storing Tissue from Young Patients with Cancer

Collecting and storing samples of tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. This laboratory study is collecting and storing tissue, blood, and bone marrow samples from young patients with cancer.

Denosumab in Treating Patients with Recurrent or Refractory Osteosarcoma

This phase II trial studies how well denosumab works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as denosumab, may block tumor growth in different ways by targeting certain cells.

S1417CD: Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer

This clinical trial studies the use of the financial impact assessment tool in patients with colorectal cancer that has spread from the primary site to other places in the body. Gathering information about patients with colorectal cancer over time may help doctors better understand the financial impact of cancer and help patients avoid financial problems during treatment.

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Observational Study to evaluate patients receiving Transarterial Chemoembolization (TACE) Therapy

The purpose of this study is to determine if there is a link between liver cancer recurrences after liver transplant, in a specific population of patients who have received TACE therapy.

Cisplatin/Carboplatin & Etoposide +/- Nivolumab in Patients with Extensive Stage Lung Cancer

This randomized phase II clinical trial studies how well cisplatin, carboplatin, and etoposide work when given together with nivolumab in treating patients with extensive stage lung cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving cisplatin, carboplatin, and etoposide together with nivolumab may work better in treating patients with extensive stage lung cancer.

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ATLAS: Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

The purpose of the ATLAS study is to determine how patients with locally advanced or metastatic urothelial carcinoma respond to treatment with rucaparib.

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MIRATI 516-001: Study of MGCD516 in Patients with Advanced Cancer

MGCD516 is a Receptor Tyrosine Kinase (RTK) Inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles.

Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, Non-Small Cell Lung Cancer and Head and Neck Cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene.

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S1702: Isatuximab in Treating Patients with Relapsed or Refractory Primary Amyloidosis

This phase II trial studies how well Isatuximab works in treating patients with Primary Amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as Isatuximab, may interfere with the ability of cancer cells to grow and spread.

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ABTR04B1: Collecting and Storing Tissue from Young Patients with Cancer

This laboratory study is collecting and storing tissue, blood, and bone marrow samples from young patients with cancer. Collecting and storing samples of tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

A031501: Pembrolizumab in Treating Patients with Locally Advanced Bladder Cancer

This randomized phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

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AEWS1221: Combination Chemotherapy +/- Ganitumab in Treating Patients with Metastatic Ewing Sarcoma

This randomized phase III trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination chemotherapy is more effective with or without ganitumab in treating patients with newly diagnosed Ewing sarcoma.

Assessing Compliance with Mercaptopurine Treatment in Younger Patients with ALL in First Remission

This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia in remission. Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.

A211401: Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes

This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline [tobacco cessation service available through a toll-free telephone number] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.

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Risk-Based Classification System of Patients with Newly Diagnosed Acute Lymphoblastic Leukemia

This research trial studies a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.

Observation of Kidney Transplant Patients to evaluation the T-SPOT response

The purpose of this study is to determine the usefulness of the T-SPOT.CMV lab test and the T-SPOT.PRT lab test during the 12 months following kidney transplantation. These lab tests monitor your body’s responses to specific T-cell markers that help identify the existence of infection and/or identify body changes that may suggest a rejection of the transplant.

CMV infections are actually very common in our population, however our immune systems keep them from ever being an issue. They become a problem for transplant patients because of the immunosuppressive drugs they must take during their recovery period post-transplant.

Non-Small Cell Lung Cancer and the effects of BIO 300 in Patients Receiving Chemoradiation


The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral Suspension when used in combination with standard dose radiation therapy and chemotherapy in patients with non-small cell lung cancer. Based on preclinical data the investigators hypothesize that BIO 300 Oral Suspension will reduce the incidence of radiation-induced pneumonitis and pulmonary fibrosis.

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S1400F: Durvalumab and Tremelimumab in Treating Patients with Recurrent Stage IV Lung Cancer

This phase II trial studies how well Durvalumab and Tremelimumab works in treating patients with Stage IV Lung Cancer that has come back after previous treatment. Monoclonal antibodies, such as Durvalumab and Tremelimumab, may interfere with the ability of tumor cells to grow and spread.

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A191402CD: Decision Aids in Improving Knowledge in Patients with Newly Diagnosed Prostate Cancer

This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

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BLU-554-1101: Phase I Study of BLU-554 in Patients with Hepatocellular Carcinoma

This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of BLU- 554 administered orally in patients with FGF19 IHC+ hepatocellular carcinoma (HCC). The study consists of 3 parts, a dose-escalation part (Part 1), an expansion part (Part 2) exploring a once daily (qd) dosing schedule at the recommended Phase 2 dose (RP2D), and a Part 3 expansion of the qd dosing schedule at the RP2D in TKI naive patients.

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EA8143: Renal Cell Carcinoma and the Effects of Perioperative Nivolumab vs. Observation in Patients

This randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.

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EAQ162CD: Financial Burden Assessment in Patients with Stage I-III Colon or Rectal Cancer Undergoing Treatment

This research trial studies the financial burden in patients with Stage I-III Colon or Rectal Cancer who are undergoing treatment. Collecting data from patients about their cost and quality of life may help doctors to better understand the impact of cancer treatment on a patient’s employment and finances.

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Patients with HCC waiting for Liver Transplantation and the effects of Everolimus and Tacrolimus

Sorafenib is approved by the FDA for treatment of patients with advanced kidney cancer and advanced unresectable HCC. It is not known whether sorafenib, the study medication, is effective in preventing cancer recurrence in high risk patients following liver transplantation. This study’s purpose is to see if sorafenib is safe and effective in these high risk patients.

EA9161: Ibrutinib and Obinutuzumab with or without Venetoclax in Patients with Chronic Lymphocytic Leukemia

This phase III trial studies how well Ibrutinib and Obinutuzumab with or without Venetoclax work in treating patients with Chronic Lymphocytic Leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as Obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as Venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Ibrutinib, Obinutuzumab and Venetoclax may work better in treating patients with Chronic Lymphocytic Leukemia.

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Javelin BRCA/ATM: Avelumab + Talazoparib in Patients with BRCA or ATM Mutant Solid Tumors

Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect. Avelumab is a human immunoglobulin (Ig)G1 monoclonal antibody (mAb) directed against programmed death ligand 1 (PD-L1). Avelumab selectively binds to PD-L1 and competitively blocks its interaction with programmed death receptor 1 (PD-1), thereby interfering with this key immune checkpoint inhibition pathway. Avelumab is currently being investigated as single agent and in combination with other anti cancer therapies in patients with locally advanced or metastatic solid tumors and various hematological malignancies. Talazoparib is a potent, orally bioavailable poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, which is cytotoxic to human cancer cell lines harboring gene mutations that compromise deoxyribonucleic acid (DNA) repair, an effect referred to as synthetic lethality, and by trapping PARP protein on DNA thereby preventing DNA repair, replication, and transcription. Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors with a BReast CAncer susceptibility gene (BRCA)1, or BRCA2, or ataxia telangiectasia mutated (ATM) gene defect.

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TPI-ALV-201: Refractory or Relapsed AML Patients and the Effects of Alvocidib, Cytarabine and Mitoxantrone

The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) to FLAM compared to AM treatment in refractory or relapsed AML patients with demonstrated NOXA BH3 priming of ≥ 40% by mitochondrial profiling in bone marrow.

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S1501: Carvedilol in Preventing Cardiac Toxicity in Patients with Metastatic HER-2-Positive Breast Cancer

This phase III trial studies how well carvedilol works in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may prevent the heart from side effects of chemotherapy.

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Diabetes Patients with Cardiac Events and the effects of edetate disodium-based (EDTA) chelation

We are trying to find out if chelation treatments given through the vein (which removes heavy metals and/or minerals from the body) and vitamins and minerals by mouth lower the risk of new heart problems.

A151216: Genetic Testing in Screening Patients with Stage IB-IIIA Non-Small Cell Lung Cancer

This phase III ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

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AALL1131: Chemotherapy in Treating Young Patients with High-Risk B ALL and Ph-like Sensitive Mutations

This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.

STR-001-001: Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment (STRATA)

Many patients are treated for advanced cancer without knowledge of underlying molecular features that might indicate FDA approved therapies or potential eligibility for biomarker-selected clinical trials. Strata Oncology is initiating the Strata Trial with the primary goal of understanding the proportion of subjects available for clinical trials and approved targeted therapies in advanced cancer while assessing the feasibility of using a large-scale NGS screening program to match subjects for eligibility assessments in clinical trials and/or for approved targeted therapies.

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PUMA-NER-5201: Patients with Malignant Solid Tumor Harboring Somatic ERBB and the Effects of Neratinib

This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating ERBB (EGFR, ERBB2, ERBB3) mutations or with EGFR gene amplification. The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti -cancer therapy. Treatment will consist of neratinib alone 240 mg daily in all ERBB2 mutated cancers (solid tumors (NOS), ovarian, gastroesophageal, endometrial, and biliary tract) excluding hormone positive breast cancers.

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Collecting and Storing Samples of Bone Marrow and Blood from Patients with Relapsed ALL or NHL

This research study is collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma. Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and help predict the recurrence of cancer.

AALL1231: Chemotherapy +/- Bortezomib in Treating Younger Patients with T-Cell ALL or T-Cell Lymphoma

This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

ALTE05N1: Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

AG013-ODOM-201: Oral Mucositis in Head & Neck Cancer Patients and the Effects of Topically-applied AG013

The purpose of the study is to evaluate, safety and tolerability administered AG013 compared to placebo for reducing Oral Mucositis in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time and development, and overall incidence of Om during the active treatment phase, beginning from the start of radiation therapy until 2 weeks following its completion.

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LOXO-EXT-17005: Phase 1/2 Study of LOXO-195 in Patients with Previously Treated NTRK Fusion Cancers

This is a Phase 1/2, multi-center, open-label study designed to evaluate the safety and efficacy of LOXO-195 when administered orally to patients age ≥ 1 month and older with NTRK fusion cancers treated with a prior TRK inhibitor.

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Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients with Recurrent Stage IV Squamous Cell Lung Cancer

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid "Master Protocol" (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

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ELITE (Eliminate Thombroembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Pati

This study is a 2 year research project to assess warfarin management issues faced by atrial fibrillation patients in ambulatory settings.

CALGB-30610: Radiation Therapy Regimens for Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

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EARLY TAVR (Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patien

The purpose of this study is to evaluate the TAVR compared to surveillance for patients with asymptomatic severe aortic stenosis.

S1207: Hormone-Positive Breast Cancer and the Effects of Everolimus with Endocrine Therapy

Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.

This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

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THAOS

THAOS is a global, multi-center, longitudinal observational survey open to all patients with Transthyretin-associated amyloidosis, including both inherited and wild-type disease and participants with TTR mutations without a diagnosis of ATTR.

Short Bowel Syndrome - A Multi-center Registry

This study is just observing patients who have short bowel syndrome for 10 years to learn more about this condition. There is no change in treatment if you participate in this study.

A011202: Node Positive Breast Cancer and the effects of Axillary Lymph Node Dissection Vs. Axillary Radiation

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

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MARINER

The purpose of this study is to determine the safety & efficacy of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.

OPUS Registry

Opsumit is a newly available endothelin receptor antagonist (ERA) in the US. Evaluating the safety profile of Opsumit in the post-marketing setting will provide further characterization of its use from clinical practice. This study is a prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

NCT02126943

EA1131: Breast Cancer and the Effects of Platinum Based Chemotherapy

This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to observation in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than observation in treating patients with residual triple negative basal-like breast cancer.

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GENETIC-AF

This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic receptor.

Colon Cancer and the Microenvironment of Stem Cells

This study is collecting specimens from patients who have cancer and from patients who do not have cancer to use in our cancer research lab.

ANBL1232: Response and Biology-Based Risk Factor-Guided Therapy in Treating Non-High-Risk Neuroblastoma

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

Partner 3

This study is being conducted in order to assess the safety & efficacy of the SAPIEN 3 transcatheter heart valve in low risk patients requiring aortic valve replacement who have severe, calcific, symptomatic aortic stenosis.

A091401: Metastatic or Unresectable Sarcoma and the Effects of Nivolumab with or without Ipilimumab

This randomized phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with sarcoma that has spread from the primary site to other parts of the body or cannot be removed by surgery. Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with metastatic or unresectable sarcoma.

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HIMALAYA: Durvalumab + Tremelimumab as 1st-line Treatment for Unresectable Hepatocellular Carcinoma

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of Durvalumab plus Tremelimumab combination therapy and Durvalumab monotherapy versus Sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy.

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Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) Registry

The Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) registry is designed to provide important and timely insight into the management of acute stroke patients who are on novel oral anticoagulants in community practice.

EA5162: Osimertinib for Stage IIIB-IV or Recurrent NSCLC with EGFR Exon 20 Insertion Mutations

This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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CX-839-007: Advanced Triple Negative Breast Cancer (TNBC) and the Effects of the Glutaminase Inhibitor, CB-839

CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with Paclitaxel in patients of African ancestry and non-African ancestry with advanced Triple Negative Breast Cancer. Multiple single-arm cohorts will be enrolled in which 800 mg BID CB-839 will be administered in combination with the full approved dose of Paclitaxel.

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Pediatric Type 2 Diabetes Mellitus and the effects of Sitagliptin

For the treatment of pediatric patients (10 to 17 years of age, inclusive) with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.

ACNS1422: Reduced Craniospinal RT and Chemotherapy for Newly Diagnosed WNT-Driven Medulloblastoma

This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

Pediatric Type 2 Diabetes Mellitus and the effects of Sitagliptin (5 year observational follow up)

Patients previously enrolled in Merck 0431-083 can participate in this 5-year follow-up observational, non-interventional, multinational study.

CBP17-01: Advanced Refractory Solid Tumors and the Effects of CBP501, Cisplatin, and Nivolumab (CanBas)

This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors. The first part of the study involves dose-escalation, in which successive cohorts of three patients will receive escalating doses of CBP501 and/or cisplatin until the maximum tolerated dose (MTD) is reached, based on tolerability observed during the first 21 days of treatment. The second part of the study involves treatment of expansion cohorts of 9 to 12 patients each in specific indications to confirm the tolerability of treatment at the RD and evaluate evidence of anti-tumor activity in specific indication.

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NSABP B-51: Early Stage Breast Cancer and the Effects of Standard vs. Comprehensive Radiation

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.

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TRITON2: Rucaparib for Metastatic CR Prostate Cancer & Homologous Recombination Gene Deficiency

The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.

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FEN-T14: Intravenous Fenretinide Emulsion for Relapsed/Refractory Peripheral T-Cell Lymphomas

This is an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior system therapy.

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NSABP B-55: Breast Cancer, BRCA1/2 Mutation and the Effects of Olaparib

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

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PREVENT II

PREVENT II is a prospective study of subjects receiving the HM II LVAD as per the current FDA approved indications for use that will investigate if subjects in the Treatment Arm (Warfarin + placebo) experience a reduced incidence of non-surgical bleeding without an increased risk of thromboembolic events.

UNTOUCHED

This is a study that aims to assess the 18 month incidence of inappropriate shocks implanted with the EMBLEM S-ICD system for primary prevention of sudden cardiac death

RENAVIV: Pazopanib With or Without Abexinostat for Locally Advanced or Metastatic Renal Cell Carcinoma

In this randomized, Phase 3, double-blind, placebo-controlled study, patients will be randomized 2:1 to receive either a combination of pazopanib plus abexinostat or pazopanib plus placebo. At the time of disease progression, patient treatment assignment will be unblinded, and those patients randomized to the pazopanib plus placebo treatment arm will have the option of crossing over to receive treatment with a combination of pazopanib plus abexinostat. Patients may continue to receive study drug until any of the following events: the development of IRC-verified radiographic progression, clinical disease progression, unacceptable toxicity, another discontinuation criterion is met, withdrawal of consent, or closure of the study by the sponsor. No maximum duration of therapy has been set.

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DCL-16-001: Select B-Cell Malignancies and the Effects of CLR 131

This study evaluates CLR 131 in patients with select B Cell Malignancies, including Multiple Myeloma (MM), Indolent Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL), Lymphoplasmacytic Lymphoma (LPL), Marginal Zone Lymphoma (MZL), Mantle Cell Lymphoma (MCL), and Diffuse Large B Cell Lymphoma (DLBCL) who have been previously treated with standard therapy for their underlying malignancy.

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RTOG-0924: Prostate Cancer and the Effects of Androgen-Deprivation Therapy and Radiation Therapy

Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy X-Rays to kill tumor cells. This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

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COLO-007: ABI-009 (Nab-rapamycin) + FOLFOX & Bevacizumab as First-line Therapy for Advanced or Metastatic CRC

A phase 1/2 multi-center investigation of ABI-009 (nab-rapamycin) in combination with mFOLFOX6 and Bevacizumab as first-line therapy in patients with advanced or metastatic colorectal cancer.

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A081105: Erlotinib Hydrochloride for Stage IB-IIIA Non-Small Cell Lung Cancer

This phase III ALCHEMIST treatment trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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ACNS0831: Ependymoma and Effects of Maintenance Chemotherapy vs. Observation After Induction Chemoradiation


This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

A031701: Gemcitabine and Cisplatin in Treating Participants with Invasive Bladder Urothelial Cancer

This phase II trial studies how well Gemcitabine hydrochloride and Cisplatin work in treating participants with invasive bladder urothelial cancer.

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Liver Transplant - A Prospective, Observational Study of Donor and Recipient Factors

This study is intended to evaluate if there is injury to the liver in liver transplant patients.

Untreated Acute Myeloid Leukemia and the effects of Lintuzumab-Ac225 with Cytarabine

The study is a multicenter, open label Phase I/II trial. The goal of the Phase I part of this study is to find the highest tolerable dose of Lintuzumab-Ac225 that can be given with cytarabine to patients with AML. The goal of the Phase II part of this study is to learn if Lintuzumab-Ac225 and cytarabine can control AML. The safety of this drug combination will also be studied. Lintuzumab-Ac225 is designed to deliver radiation therapy directly inside leukemia cells without giving any radiation to the surrounding normal cells. Cytarabine is designed to insert itself into DNA (genetic material) of cancer cells and stop the DNA from repairing itself.

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Tracon 253PC101: TRC253, an Androgen Receptor Antagonist, in Metastatic Castration-Resistant Prostate Cancer

This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will receive oral doses of TRC253. The study will be conducted in 2 parts: part 1 (dose escalation) and part 2 (dose expansion).

The objective of Part 2 is to gather additional information on the safety, pharmacokinetics (PK) and pharmacodynamic (PD) characteristics, and the clinical efficacy of TRC253 in a pre-defined population of patients with metastatic castrate-resistant prostate cancer (mCRPC). Patients enrolled into Part 2 will have received prior treatment with enzalutamide or apalutamide and showed characteristics of acquired resistance based on changes in PSA serum levels. Patients will be centrally screened for the presence of the AR F876L (androgen receptor F876L) mutation from a plasma sample and enrolled into Cohort 1 (AR F876L positive) or Cohort 2 (AR F876L negative). Cohort 2 may be expanded if a specific molecular mechanism sensitizing the mCRPC to TRC253 therapy can be identified retrospectively. Additional patients may be prospectively selected for this specific molecular resistance mechanism and added to Cohort 2 upon recommendation by the medical monitor and Principal Investigators.

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EA2142: Gastroenteropancreatic Neuroendocrine Carcinoma and the Effects of Cisplatin and Etoposide

This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.

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E4512: Resected Early Stage Non-Small Cell Lung Cancer and the Effects of Crizotinib

This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.

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JAZZ 402: A Post-Marketing Observational Study of VYXEOS™

The purpose of this observational study is to provide data on the incidence and severity of infusion-related reactions during and immediately following each infusion of VYXEOS during the first induction.

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A021502: Colon Cancer and the Effects of Standard Chemotherapy +/- Atezolizumab as Adjuvant Therapy

This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.

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EA6141: Melanoma, Stage 3 or 4 and the Effects of Nivolumab + Ipilimumab + Sargramostim

This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.

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AAML1331: Acute Promyelocytic Leukemia and the Effects of Arsenic Trioxide and All-trans Retinoic Acid

This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.

Rucaparib vs. Physician's Choice in Metastatic CRPC & Homologous Recombination Gene Deficiency

The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

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Systemic Embolism/Stroke and the effects of Rivaroxaban with Aspirin

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

Idiopathic Generalized Epilepsy and the effects of Vimpat, Lacosamide

This study allows patients with uncontrolled seizures and a specific type of epilepsy access to an on-market drug to control seizures. This study is currently only available for patients who have enrolled in the SP0982 study.

A051301: Diffuse Large B-Cell Lymphoma of Activated B-Cell Subtype and the Effects of Ibrutinib vs. Placebo

This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.

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Ischemic Stroke and the Rate of Atrial Fibrillation Through 12 Months

The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF) through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™ Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC) medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known origin.

AALL1621: Acute Lymphocytic Leukemia and the Effects of Low Dose Inotuzumab Ozogamicin

The goal of this clinical research study is to learn if inotuzumab ozogamycin can help to control the disease in participants with acute lymphocytic leukemia (ALL). The safety of this treatment will also be studied.

Epilepsy and the effects of SAGE-547 (Allopregnanolone with Captisol)

Medication trial for patients suffering from super-refractory status epilepticus (life-threatening, continuous seizures) that has failed traditional treatment.

EA5152: Nivolumab, Cabozantinib S-Malate, & Ipilimumab for Recurrent Stage IV NSCLC

This partially randomized phase II trial studies how well nivolumab, cabozantinib s-malate, and ipilimumab work in treating patients with stage IV non-small cell lung cancer that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab, cabozantinib s-malate, and ipilimumab may work better in treating patient with stage IV non-small cell lung cancer.

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NKTR 16-214-05: NKTR-214 with Anti-PD-1 OR Anti-PD-L1 for Select Advanced or Metastatic Solid Tumors (PROPEL)

This study is to assess the safety and tolerability, define the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) and to assess the preliminary clinical benefit of NKTR-214 when combined with Pembrolizumab (Keytruda®) or Atezolizumab (Tecentriq®). Up to 30 patients will be enrolled concurrently in each combination arm. NKTR-214 in combination with Pembrolizumab will be evaluated in select patients with metastatic Melanoma, Urothelial Bladder Cancer or Non-Small Cell Lung Cancer (NSCLC). NKTR-214 in combination with Atezolizumab will be evaluated in select patients with Urothelial Bladder Cancer or NSCLC. Both drugs target the immune system and may act synergistically to promote anticancer effects.

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S1400: A Biomarker-Driven Master Protocol for Squamous Cell Lung Cancer

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid "Master Protocol" (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

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ATHENA: Rucaparib & Nivolumab as Maintenance following response to 1st-Line Platinum Chemo for Ovarian Cancer

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

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NET-001: ABI-009 in Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors

The purpose of this study is to determine whether ABI-009 will make advanced, malignant neuroendocrine tumor(s) of the lung, gastrointestinal tract and/or pancreas that cannot be removed by surgery smaller and slow the spread of your cancer in patients who have progressed or been intolerant to everolimus. All eligible participants will receive ABI-009, the study drug.

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EA6134: BRAFV600 Mutant Melanoma and the Effects of Dabrafenib, Trametinib, Ipilimumab and Nivolumab

This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

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ANBL00B1: Biomarkers in Tumor Tissue Samples for Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

LOXO-RET-17001: Study of LOXO-292 in Advanced Solid Tumors, RET Fusion+ Solid Tumors, and Medullary Thyroid Cancer

This is a Phase 1/2, open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

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FIGHT: Bemarituzumab (FPA144) Combined with Modified FOLFOX6 in Gastric/Gastroesophageal Junction Cancer

This is a global, randomized, double-blind, controlled study to evaluate the efficacy of Bemarituzumab (FPA144) + mFOLFOX6 versus Placebo + mFOLFOX6 in patients with FGFR2 selected Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA blood assay demonstrating FGFR2 gene amplification).

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A171601: Palbociclib and Letrozole or Fulvestrant for ER Positive, HER2 Negative Metastatic Breast Cancer

This phase II trial studies the side effects and how well Palbociclib and Letrozole or Fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as Letrozole or Fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Palbociclib and Letrozole or Fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

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EAQ152: Communication and Education in Tumor Profiling (COMET)

This research trial studies how well pre-test genetic education and remote genetic counseling works in communicating tumor profiling results to patients with advanced cancer. Web-based genetic education before receiving tumor profiling results and remote genetic counseling for patients with potential germline mutations may increase genetic knowledge and reduce distress for patients with advanced cancer.

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Open Posterior Spinal Fusion Procedures and the effects of the SA4AG Vaccine

The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.

AGCT1531: Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Germ Cell Tumors

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

S0820: Adenomas and Second Primary Colorectal Cancers and the Effects of Eflornithine and Sulindac

The investigators hypothesize that the combination of Eflornithine and Sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.

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Recurrent Osteosarcoma and the effects of Dinutuximab with Sargramostim

This phase II trial studies how well dinutuximab works when given with sargramostim in treating patients with osteosarcoma that has come back after treatment (recurrent). Dinutuximab is a type of drug called a monoclonal antibody. It is designed to recognize a specific target on the surface of cancer cells. It then attaches to the cancer cells and kills them, without harming normal cells. Sargramostim may help the body increase the amount of white blood cells it produces, which help the body fight off infections. Giving sargramostim with dinutuximab may help the dinutuximab work better and kill more cancer cells.

ARST1431: Combination Chemotherapy with or without Temsirolimus for Intermediate-Risk Rhabdomyosarcoma

This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy or combination chemotherapy plus temsirolimus is more effective in treating patients with intermediate-risk rhabdomyosarcoma.

Soprano

The purpose of this study is to evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation.

Squamous Cell Carcinoma (SCC) of the Lung and the effects of Glembatumumab Vedotin

The purpose of this study is to see whether glembatumumab vedotin is effective in treating people who have advanced or metastatic squamous cell lung cancer that contains gpNMB, to examine how the body handles the drug and the side effects associated with glembatumumab vedotin.

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cVAD Registry (Previously USPella)

The USpella Registry is a multi-site retrospective, observational registry for collection of data for patients who have been supported with the Impella 2.5, Impella 5.0/LD or Impella CP cardiac assist device and treated per the institution’s standard of care. The data collection involves medical chart reviews and transcription of de-identified data onto a set of case report forms.

NRG-GY007: Ruxolitinib, Paclitaxel, & Carboplatin for Stage III-IV Epithelial Ovarian Cancer

This phase I/II partially randomized trial studies the side effects and the best dose of Ruxolitinib Phosphate when given together with Paclitaxel and Carboplatin and to see how well they work in treating patients with Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Ruxolitinib Phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as Paclitaxel and Carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Ruxolitinib Phosphate together with Paclitaxel and Carboplatin may be a better treatment for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

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Embolic Stroke and the effects of dabigatran etexilate vs acetylsalicylic acid

This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

Recurrent Primary Sclerosing Cholangitis and the effects of Vancomycin

This study is testing the use of an antibiotic called Vancomycin to treat the recurrence of primary sclerosing cholangitis in liver transplant patients.

NRG-GI004: Combination Chemotherapy, Bevacizumab, and/or Atezolizumab for dMMR Metastatic Colorectal Cancer

This randomized phase III trial studies how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating patients with deficient DNA mismatch repair colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab and atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with colorectal cancer.

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CREST-2

This trial is testing that intensive medical management differs from the combination of CEA and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis and to test that intensive medical management differs from the combination of CAS and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis.

RU011501I: Breast Cancer and of Effects Folate Receptor Alpha Peptide Vaccine, Sargramostim, & Cyclophosphamide

This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide may work better in treating patients with triple negative breast cancer.

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ANHL12P1: Brentuximab Vedotin or Crizotinib and Chemotherapy in Treating Anaplastic Large Cell Lymphoma

This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether brentuximab vedotin and combination chemotherapy is more effective than crizotinib and combination chemotherapy in treating anaplastic large cell lymphoma.

CardioMEMS HF System Post Approval Study

The purpose of this Post Approval study is to evaluate the CardioMEMS HF System in patients with Class III Heart Failure in a clinical setting.

DCP-001: Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCORP

Screening tool used to collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials.

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RTOG-1216: Head and Neck Cancer and the Effects of Radiation Therapy with Cisplatin, Docetaxel

This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer.

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SYNCARDIA 50cc (TAH-T)

The objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probably benefit to, transplant-eligible pediatric patients (aged 10-18 years) and adult patients (aged 19-75 years) at imminent risks of death from biventricular failure without experiencing permanent disabling, stroke-related deficits.

Epilepsy and the effects of Vimpat, Lacosamide

This study is exploring a medication (currently on the market) for its effectiveness in controlling “grand-mal” seizures in patients with a specific type of epilepsy.

Leadless II

Nanostim’s safety and effectiveness trial for a leadless cardiac pacemaker.

**This study is not accepting new participants at this time.

EAY131: Molecular Analysis for Therapy Choice (MATCH)

This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

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APEC1621: Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders and Targeted Therapy

This screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

SPHERE (Uptravi® (SelixiPag): The Users Drug Registry)

This registry is being conducted in order to further outline the clinical characteristics, outcomes and dosing/titration regiments of patients treated with Uptravi in routine clinical practice.

Colon and Rectal Surgery and the effects of E-101

This study is testing a new medicine to see if it helps prevent infections in the incision after colon or rectal surgery.

Medial meniscus deficiency and the effects of the NUsurface Meniscus Implant

The purpose of this study is to evaluate the safety and clinical benefit of a new artificial meniscus implant to treat patients with knee pain after meniscus surgery.

ALTE11C2: Effects of Dexrazoxane on Biomarkers Associated with Cardiomyopathy After Cancer Treatment (HEART)

This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

S1612: Azacitidine +/- Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone for AML or MDS

This randomized phase II/III trial studies how well azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone work in treating older patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as azacitidine, decitabine, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone may kill more cancer cells.

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Multiple Sclerosis and the effects of MD1003

The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.

NSABP B-59: Neoadjuvant Chemotherapy with Atezolizumab or Placebo for TNBC Followed After Surgery by Atezolizumab or Placebo

The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, Atezolizumab, is better than the usual chemotherapy plus a placebo. The usual chemotherapy in this study is Paclitaxel (WP) and Carboplatin followed by Doxorubicin and Cyclophosphamide (AC) or Epirubicin and Cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for Triple Negative Breast Cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with Atezolizumab or the placebo. To be better, Atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery.

Another purpose of this study is to test the good and bad effects of Atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.

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Amulet™ (AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE))

The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.

HALO

The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.

Pediatric Type 2 Diabetes Mellitus and the effects of Lixisenatide

This study is to establish a safe dose for lixisenatide in children and adolescents of different age-groups and to understand whether lixisenatide has beneficial effects on Type 2 Diabetes Mellitus in children and adolescents.

At present, metformin and insulin are the only drugs with regulatory approval in most countries for the treatment of pediatric diabetes. Because approximately half of youth with Type 2 Diabetes Mellitus fail to maintain glycemic control when treated with metformin either alone or in conjunction with lifestyle interventions, insulin therapy is often required soon after diagnosis. Thus, there is a need for more treatment options for children and adolescents with Type 2 Diabetes Mellitus.

STU 022015-069: Stage 1 NSCLC and the Effects of Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (STABLE-MATES Trial)

To Determine if Stereotactic Ablative Radiotherapy improves survival over Sublobar Resection in High Risk Operable Stage I NSCLC.

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Multiple Sclerosis and the effects of Ocrelizumab

This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.

WO39210: Renal Cell Carcinoma and the Effects of Atezolizumab as Adjuvant Therapy

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

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invested

INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons.

Please note: we only enroll/recruit patients between the months of August & December.

AAML1531: AML in Down Syndrome and the Effects of Cytaribine, Daunorubicin Hydrochloride, Thioguanine

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

S1609: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART)

This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.

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JAZZ 201: Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

This is a study comparing the Defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

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A011502: Node Positive HER2 Negative Breast Cancer and the Effects of Placebo vs. Aspirin as Adjuvant Therapy

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

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BEST - CLI

The BEST-CLI Trial is a multicenter randomized trial of best endovascular (EVT) or best open surgical (OPEN) revascularization in patients with CLI (Critical Limb Ischemia) and infrainguinal arterial occlusive disease who are candidates for both open and endovascular treatment.

GlIadeL WAfer ImplaNT (VIGILANT) Registry

This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care. Data will be collected on the safety and effectiveness of treatment with Gliadel Wafer perioperatively and ongoing during regular office visits up to 3-years. Patients enrolled in this registry will be asked to complete a questionnaire (Functional Assessment of Cancer Therapy-Brain [FACT-Br]) about their well-being and clinicians will complete the Karnofsky Performance Status (KPS) during office visits.

GO39942: Comparing Efficacy & Safety of Polatuzumab Vedotin with R-CHP vs R-CHOP for DLBCL (POLARIX)

This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of Polatuzumab Vedotin plus R-CHP versus R-CHOP in participants with previously untreated Diffuse Large B-Cell Lymphoma (DLBCL).

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RTOG-1008: RT +/- Chemotherapy for High-Risk Malignant Salivary Gland Tumors that have been Surgically Removed

This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

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Symptomatic Chondral or Osteochondral Defects of the Knee and the effects of MACI

The purpose of this study is to evaluate the safety and performance of MACI compared to microfracture in children aged 10-16years old.

MACI is an experimental product that contains your child’s own cells. MACI contains cells which have been grown from your child’s own knee cartilage cells. This study hopes to show that these cells can be safely given back to a child who has a knee cartilage injury and can improve the child’s knee symptoms and function.

AdaptResponse Clinical Trial

This study is testing the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices that contain the AdativCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) condition and left bundle branch block (LBBB).

VICCGI1523: Liver Cancer and the Effect of SIR-Spheres

This research trial studies Yttrium Y 90 resin microspheres in collecting data from patients with liver cancer not capable of being removed by surgery (unresectable) for the radiation-emitting Selective Internal Radiation-Spheres (SIR-spheres) in non-resectable (RESIN) liver tumor registry. The information generated will help doctors better understand treatment patterns involving Y90 therapy, gain additional insights in the long-term outcomes for patients, as well as guide future research for using Y90 therapy, especially for those conditions where data is currently very limited or lacking.

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AALL1631: Imatinib Mesylate and Combination Chemotherapy in Newly Diagnosed Philadelphia Chromosome + ALL

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

LIFE Study/HFN-LIFE

This study’s primary objective is to determine whether, in patients with symptomatic, advanced heart failure due to left ventricular systolic dysfunction, treatment with LCZ696 for 24 weeks will improve Pro-B-type Natriuretic Peptide (NT-proBNP) levels, which reflect hemodynamic and clinical status, compared to treatment with valsartan.

USA-MCI GON-1.01: Ovarian Cancer and the Effects of Screening Using Gynecologic Fluids and Mucus

In this Phase II biomarker validation study we will further refine and validate these biomarkers using a new collection of samples from at least 200 ovarian cancer cases with epithelial ovarian cancer (endometroid and papillary serous histology, most common) and comparing these against 600 patients with a diagnosis of a benign adnexal mass that enter the clinics during the same time period. Patient samples will be collected on their first visit to the gynecologic oncologist at a number of collaborating clinics. Final processing of all of the samples will be performed within the proteomics research facilities of the Mitchell Cancer Institute using Selected Reaction Monitoring (SRM, with mass spectrometry) based on the refined set of makers statistically selected within the first aim. Biomarkers validated within this study will be compared with the well accepted CA-125 data for the patients. The research involves a three year validation and may allow detection of this cancer at a very early stage when the survival is as high as 90%. One aim examines a self-taken test that could allow its use in medically underrepresented and rural areas.

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Knee cartilage injuries and the effects of NeoCart Investigational tissue implant

Dr. Jones is looking for patients between the ages of 18-59 with certain knee cartilage injuries to evaluate NeoCart®, an investigational cartilage tissue implant grown from a patient’s own cells. The procedure uses regenerative medicine technology that could provide an alternative to the standard-of-care microfracture surgery.

If knee pain is stopping you from living your best life OR stopping a loved one from being active, then this clinical trial may be right for you. To learn more visit www.NeoCartImplant.com, call (504) 265-9090 or Text knee1 to 87888. Std. Msg. & Data rates apply

CA209-901: Nivolumab + Ipilimumab or SOC Chemotherapy VS SOC Chemotherapy Alone for Urothelial Cancer

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating patients with previously untreated inoperable or metastatic urothelial cancer.

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Multiple Sclerosis and documentation of the drug utilization of Tecfidera (Dimethyl Fumarate)

The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF).

A091605: Pembrolizumab +/- Stereotactic Body Radiation Therapy for Advanced Merkel Cell Cancer

This randomized phase II trial studies how well Pembrolizumab with or without stereotactic body radiation therapy works in treating patients with Merkel Cell Cancer that has spread to other places in the body. Monoclonal antibodies, such as Pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy is a specialized radiation therapy that sends X-Rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving Pembrolizumab with stereotactic body radiation therapy may work better in treating patients with Merkel Cell Cancer.

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Hypofractionated Radiation or Conventional Radiation after Surgery for Prostate Cancer

This randomized phase III trial studies how well hypofractionated radiation therapy works compared to conventional radiation therapy after surgery in treating patients with prostate cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Conventional radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. It is not yet known whether giving hypofractionated radiation therapy or conventional radiation therapy after surgery may work better in treating patients with prostate cancer.

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E1910: BCR-ABL Negative B Lineage ALL and the Effects of Blinatumomab

This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.

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NRG-GY006: Vaginal Cancer and/or Cervical Cancer and the Effects of Radiation and Cisplatin +/- IV Triapine

This randomized phase II trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer.

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EA5142: Non-Small Cell Lung Cancers and the Effects of Nivolumab (ANVIL)

This randomized phase III trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and kill tumor cells remaining after surgery and standard of care chemotherapy.

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NRG-GY009: Pegylated Liposomal Doxorubicin + Atezolizumab and/or Bevacizumab for Recurrent Ovarian Cancer

This randomized phase II/III trial studies how well Pegylated Liposomal Doxorubicin Hydrochloride with Atezolizumab and/or Bevacizumab work in treating patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer that has come back. Drugs used in chemotherapy, such as Pegylated Liposomal Doxorubicin Hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal Antibodies, such as Atezolizumab and Bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

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S1416: Breast Cancer and the Effects of Cisplatin With or Without ABT-888 (Veliparib)

This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with stage IV triple-negative breast cancer and/or breast cancer (BRCA) mutation-associated breast cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin is more effective with or without veliparib in treating patients with triple-negative and/or BRCA mutation-associated breast cancer.

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A221505: Hypofractionated RT After Mastectomy in Preventing Recurrence in Stage IIa-IIIa Breast Cancer

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with Stage IIa-IIIa Breast Cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

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S1613: Trastuzumab + Pertuzumab or Cetuximab + Irinotecan for HER2/Neu Amplified Colorectal Cancer

This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.

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Liver Transplantation and the effects of Everolimus Immunosuppression Treatment

When receiving a liver transplant, patients are required to take numerous immunosuppressive drugs. This study will look at the safety and effectiveness of taking everolimus with tacrolimus (another immunosuppressive drug) to see if these two drugs help lower your chances of getting cancer in your new liver versus taking tacrolimus and mycophenolic acid (Myfortic®), mycophenolate mofetil (CellCept®), or azathioprine (Imuran®) after having a liver transplant.

Stenting and the effects of the Wingspan Stent System with Gateway PTA Balloon Catheter

The Wingspan Stent System with Gateway PTA Balloon Catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries prior to stenting for the purpose of improving intracranial perfusion. This device is authorized by federal law for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, intracranial vessels with ≥50% stenosis that are accessible to the system.

Hodgkin Lymphoma and the effects of Nivolumab + Brentuximab Vedotin vs. Brentuximab Vedotin Alone

The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant.

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NRG-GY012: Olaparib, Cediranib, and Wee1 Inhibitor for Recurrent, Refractory, or Metastatic Endometrial Cancer

This randomized phase II trial studies how well Olaparib, Cediranib maleate, and Wee1 Inhibitor, AZD1775, work in treating patients with endometrial cancer that has come back, does not respond to treatment, or has spread to other places in the body. Olaparib, Cediranib maleate, and Wee1 Inhibitor AZD1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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U01: Early Detection of Pancreatic Cancer

This project is innovative as it will use Next-Generation Sequencing (NGS)-based miRNA-Sequencing for discovery of cell-free and exosomal miRNA biomarkers in matched tissue and plasma samples, and validate these in multiple, well-characterized cohorts of patients with PNs and PDAC vs. controls. If successful, this proposal will profoundly transform early detection of pancreatic cancer using a non-invasive, robust and inexpensive clinical assay.

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Non-Small Cell Lung Cancer (NSCLC) and the effects of Tumor Treating Fields (TTFields) - METIS

The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

S1500: Renal Cell Carcinoma and the Effects of Multiple MET Kinase Inhibitors

This randomized phase II trial studies how well cabozantinib-s-malate, crizotinib, volitinib, or sunitinib malate work in treating patients with kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate, crizotinib, volitinib, and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Diabetic Foot Ulcers and the effects of NEOX® CORD 1K

A randomized, multi-center, cross-over study, in which, the efficacy and safety of NEOX® CORD 1K will be evaluated in patients suffering from difficult to heal and non-healing diabetic foot ulcers. NEOX® CORD 1K is a cryopreserved human Amniotic Membrane and Umbilical Cord (AM/UC) matrix intended for use as a wound covering for dermal ulcers and defects. It is a FDA approved and designated Human Cell & Tissue Product (HCT/P) by the U.S. FDA.

EAE161: CT Perfusion in Predicting Outcomes in Ovarian Cancer Receiving Bevacizumab

This phase II trial studies how well computed tomography perfusion imaging works in predicting outcomes in patients with ovarian, fallopian tube, or primary peritoneal cancer who are receiving bevacizumab. Computed tomography perfusion imaging monitors the effects of the drug treatment on the blood flow to the tumor and may help to predict whether a certain drug therapy is likely be successful in a patient with ovarian, fallopian tube, or primary peritoneal cancer.

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AALL1331: Pediatric B-Cell Acute Lymphoblastic Leukemia and the Effects of Blinatumomab

This randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, can block cancer growth by finding cancer cells and helping to kill them or carrying cancer-killing substances to them. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

MIT-201701: Observational Study Examining Empirically Selected Therapy vs. CANscript Recommended Therapy (CANscript)

The purpose of this study is to test the CANscript™ sensitivity assay, which is a new and different assay developed to test the sensitivity of different cancer types to physician selected therapies (both drugs and/or drug combinations) indicated for the stage and type of cancer for treatment. CANscript™ tests how a patients specific tumor reacts to the therapies being considered by the treating physician. CANscript™ test results have been shown to closely correspond with actual clinical results, providing physicians with information that may help him/her develop a more personalized cancer treatment and care plan based on the patients specific condition. The researchers want to see if CANscript™ test results are helpful in selecting the treatments prescribed and provided. There will be about 800 people taking part in this study, across 5 different tumor types. The study is designed to assess the decision impact of the CANscript™ test results in informing physicians in therapy selection.

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ALTE1621: Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors

This randomized phase IIb trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much greater risk for developing heart failure compared to survivors who didn't get any anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and can't pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular complications.

EA8134: International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study) [InPACT]

This is an international phase III trial, with a Bayesian design, incorporating two sequential randomizations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomization for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions.

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PARADISE-MI (Prospective ARNI vs ACE Inhibitor Trial to Determine Superiority in Reducing Heart Fail

The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF.

Brain tumors and the effects of EVICEL® Fibrin Sealant (Human) vs a Hydrogel Sealant

Patients undergoing brain surgery (craiectomy or craniotomy) will be enrolled in the trial. Upon completion of the sutured dural repair, the closure will be evaluated for intraoperative cerebrospinal fluid (CSF) leakage. Subjects who have a CSF leak will be stratified by surgical procedure, posterior fossa or supratentorial approach and then randomized to either EVICEL Fibrin Sealant or DuraSeal™ Dural Sealant System in a 1:1 allocation ratio. Subjects will be followed post-operatively through discharge and again at 30 (-/+7) days and 60 (-/+14) days post-surgery.

S1602: Bladder Cancer and the effects of Intravesical Therapy

This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.

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RTOG-1112: Hepatocellular Carcinoma and the Effects of Sorafenib vs SBRT + Sorafenib

This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation therapy to see how well they work compared to sorafenib tosylate alone in treating patients with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send the radiation dose directly to the tumor and cause less damage to normal tissue. Giving sorafenib tosylate together with stereotactic body radiation therapy may kill more tumor cells.

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S1608: Follicular Lymphoma and effects of Obinutuzumab +/- PI3K-delta Inhibitor TGR-1202, Lenalidomide, or Combination Chemotherapy

This randomized phase II trial studies how well obinutuzumab with or without PI3K-delta inhibitor TGR-1202, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back or does not respond to treatment. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. PI3K-delta inhibitor TGR-1202 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without PI3K-delta inhibitor TGR-1202, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.

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NRG-BR003: Breast Cancer and the Effects of Doxorubicin + Cyclophosphamide, then Paclitaxel +/- Carboplatin

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

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WF 97116: Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil

This study is to compare the safety and effects of Donepezil (Aricept) or if it decreases memory loss after receiving chemotherapy for breast cancer. A randomized, placebo controlled, double-blind, parallel group Phase 3 design will be used to assess the effect of 24 Weeks of Donepezil on cognitive function (memory) in breast cancer survivors who report having cognitive dysfunction and demonstrate memory impairment 1-5 Year post chemotherapy. Patients who meet the eligibility criteria will be stratified by age (<50, 50-59, 60-69, ≥70) and randomized to Donepezil or placebo with equal probability.

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Glioblastoma and the effects of adjuvant temozolomide with radiation and Veliparib

This randomized phase II/III trial studies how well temozolomide and veliparib work and compare them to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.

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A041501: Inotuzumab Ozogamicin & Frontline Chemotherapy in Treating Young Adults with Newly Diagnosed B-Cell ALL

This partially randomized phase III trial studies the side effects of Inotuzumab Ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B Acute Lymphoblastic Leukemia. Monoclonal antibodies, such as Inotuzumab Ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Inotuzumab Ozogamicin with chemotherapy may work better in treating young adults with B Acute Lymphoblastic Leukemia.

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GOG-0279: Cisplatin + Gemcitabine & Radiation Therapy for Squamous Cell Carcinoma of the Vulva

This phase II trial studies how well radiation therapy works when given with gemcitabine hydrochloride and cisplatin work in treating patients with squamous cell cancer of the vulva that has spread from where it started to nearby tissue or lymph nodes. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.

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NRG-GU002: Prostate Cancer and the Effects of Anti-Androgen Therapy and Radiation Therapy +/- Docetaxel

This randomized phase II / III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

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S1619: Atezolizumab, Pemetrexed, Cisplatin, and Surgery +/- RT for Stage I-III Malignant Mesothelioma

This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and surgery with or without radiation therapy in treating patients with stage I-III pleural malignant mesothelioma. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab, pemetrexed disodium, and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving atezolizumab after surgery may kill any remaining tumor cells.

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NRG-GY005: Ovarian, Fallopian Tube, or Peritoneal Cancer and the Effects of Cediranib + / - Olaparib

This randomized phase II/III trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.

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NRG-GI002: Rectal Cancer and the Effects of Veliparib and Combination Chemotherapy

This randomized phase II trial studies how well veliparib works with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving veliparib with combination chemotherapy and radiation therapy may kill more tumor cells and giving it before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

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Respond CAS

The objective of the Continued Access study is to gather confirmatory evidence on the safety of the SonRtip lead and performance of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in a patient population that is reflective of current heart failure treatment practice.

BMT CTN 1503: Bone Marrow Transplantation vs SOC for Severe Sickle Cell Disease (STRIDE2)

This is a clinical trial that will compare survival and sickle related outcomes in adolescents and young adults with severe sickle cell disease after bone marrow transplantation and standard of care. The primary outcome is 2-year overall survival.

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Parkinson's disease and the effects of urate-elevating inosine treatment

A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial to determine whether oral inosine dosed to moderately elevate serum urate (from ≤5.7 mg/dL to 7.1-8.0 mg/dL) over 2 years slows clinical decline in early PD.

Abdominal Aortic Aneurysms and the effects of the GORE® EXCLUDER® Conformable AAA Endoprosthesis

The purpose of this research study is to assess the safety and effectiveness of the GORE®EXCLUDER® Conformable AAA Endoprosthesis when used for the treatment of Abdominal Aortic Aneurysms (AAA). In this research study, the Study Device will be placed inside your abdominal aorta (in the approximate area of the belly button) and the Study Device will extend into both leg arteries. The Study Device will block the aneurysm (the weakened and bulging part of the artery) in the abdominal aorta from blood flow while maintaining blood flow to the arteries in the legs.

Pediatric Seizures and the effects of Perampanel Oral Suspension

This is an open-label, multicenter study with an extension phase to evaluate the safety and tolerability of an perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to <12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic seizures (PGTC).

Epilepsy and the effects of NRL-1

This study evaluates the pharmacokinetic and safety of NRL-1 in epilepsy subjects. Subjects will receive a single intranasal dose of NRL-1 of either 5 mg, 10 mg, 15 mg or 20 mg and will be based on the subject's body weight.

Lennox-Gastaut Syndrome and the effects of Perampanel

This study is being conducted to demonstrate that perampanel given as adjunctive anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS).

AREN1721: Axitinib and Nivolumab in Treating Unresectable or Metastatic TFE/Translocation Renal Cell Carcinoma

This phase II trial studies how well axitinib and nivolumab works in treating participants with TFE/translocation renal cell carcinoma that cannot be removed by surgery or has spread to other places in the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving axitinib and nivolumab may work better in treating participants with TFE/translocation renal cell carcinoma.

Premature Infants at Risk of Bronchopulmonary Dysplasia and the effects of Sildenafil

This study is testing a medication to learn more about the safety, potential side effects, dosing, and effectiveness when given to premature infants who are at risk for developing a condition called Bronchopulmonary Dysplasia (BPD). Additionally, this study is testing the medication to reduce the risk of developing BPD in premature infants.

While some doctors may use this medication to treat infants with BPD, the Food and Drug Administration (FDA) has not approved it for this use because the ability of the medication to effectively treat BPD has not been demonstrated in this population. The medication is approved, by the FDA, for use in adults to treat a disease that causes high blood pressure in the lungs. However, whether this medication helps premature infants at risk for BPD is not known. The results of this study could help us find the safest and most helpful doses of the medication to give to premature infants to prevent BPD.

RAPID (Registry of Angiovac Procedures in Detail Outcomes Database)

The primary objective of this registry is to determine the procedure related mortality associated with the use of the AngioVac device, which is an FDA approved device that is being used in clinical practice for the removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

TrialNet Pathway to Prevention

This study will help us learn more about how type 1 diabetes occurs and provides monitoring to individuals at risk. In addition, the study will help us identify people who may be eligible for prevention trials.

TrialNet is a research group dedicated to the study, prevention, and early treatment of type 1 diabetes. Type 1 diabetes is now understood as a disease that develops over time in stages. Stage 1 starts with the appearance of two or more autoantibodies. This is followed by Stage 2, which is the development of abnormal blood glucose levels. Stage 3 is the diagnosis of type 1 diabetes.

AHOD1331: Brentuximab Vedotin and Chemotherapy in Treating Stage IIB or Stage IIIB-IVB Hodgkin Lymphoma

This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB or stage IIIB-IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating Hodgkin lymphoma.

Articular Cartilage Defects and the effects of NOVOCART 3D vs Microfracture

NOVOCART 3D is a surgical procedure completed in two steps. This procedure utilizes your own cartilage in the repair of your knee. Microfracture is a surgical procedure for treatment of cartilage damage of the knee.

Learn more about Aesculap

AG120-C-009: AG-120 (Ivosidenib) vs. Placebo with Azacitidine for Previously Untreated AML with IDH1 Mutation

Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (Ivosidenib) + Azacitidine vs Placebo + Azacitidine in adult subjects with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is Overall Survival (OS). The key secondary efficacy endpoints are Event free Survival (EFS), rate of complete remission (CR), Rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Subjects eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) Azacitidine. An estimated 392 subjects will participate in the study.

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ADXS-NEO-02: Expressing Personalized Tumor Antigens Study (NEO)

This is a Phase 1, open-label, uncontrolled, multicenter study in 3 distinct solid tumors. The study design is dose-escalation/de-escalation using a standard 3 + 3 design to evaluate the safety profile of ADXS-NEO, to select a recommended phase 2 dose (RP2D), and identify initial signs of clinical activity in each of the 3 tumor-specific cohorts.

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ALTE16C1: Biospecimen Analysis in Determining Effects of Chemotherapy on Fertility in Osteosarcoma Survivors

This research trial studies saliva, semen, and blood samples to determine effects of chemotherapy on fertility in osteosarcoma survivors. Study biospecimen samples from osteosarcoma survivors in the laboratory may help doctors learn whether chemotherapy causes fertility problems and to learn more about the long term effects.

AFT-25: Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS

This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC.

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Agenus C-550: AGEN1884 + AGEN2034 for Metastatic or Locally Advanced Solid Tumors, and Expansion into Select Solid Tumors (Cervical)

This is a Phase 1/2, open-label, multi-arm study, of AGEN1884 in combination with AGEN2034 in subjects with advanced solid tumors including cervical cancer. AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) antibody, designed to block program cell death-1 (PD-1). AGEN1884 is a novel, fully human monoclonal immunoglobulin G1 (IgG1) antibody, designed to block cytotoxic T lymphocyte antigen-4 (CTLA-4).

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Astellas EV-301: Enfortumab vs Chemotherapy for Metastatic Urothelial Cancer

The purpose of this study is to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy.

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RETNET: Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver

The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary hypothesis is that chemoembolization will be nearly twice as durable as bland embolization; thatis, the hazard ratio for HPFS will be 1.76 or better.

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ALS and the effects of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA)

AMX0035 is a combination therapy designed to reduce neuronal death through blockade of key cellular death pathways originating in the mitochondria and endoplasmic reticulum (ER). This clinical trial is designed to demonstrate that treatment is safe, tolerable, and able to slow decline in function as measured by the ALSFRS-R. The trial will also assess the effects of AMX0035 on muscle strength, vital capacity, and biomarkers of ALS including markers of neuronal death and neuroinflammation.

ALS and the effects of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA)

AMX0035 is a combination therapy designed to reduce neuronal death through blockade of key cellular death pathways originating in the mitochondria and endoplasmic reticulum (ER). This clinical trial is designed to demonstrate that treatment is safe, tolerable, and able to slow decline in function as measured by the ALSFRS-R. The trial will also assess the effects of AMX0035 on muscle strength, vital capacity, and biomarkers of ALS including markers of neuronal death and neuroinflammation.

PANOVA-3: Gemcitabine & Nab-Paclitaxel +/- TTFields as Front-Line Treatment for Pancreatic Cancer

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with Gemcitabine and Nab-Paclitaxel, for front line treatment of locally-advanced Pancreatic Adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

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Urinary Tract Infections and the effects of Probiotics

This pilot study is a double blinded placebo-controlled study in females with recurrent multi-drug resistant (MDR) urinary tract infections (UTI). Our study hypothesizes that a novel probiotic strain improves antibiotic sensitivity patterns in these former MDR UTIs.

Peripheral Artery Disease and the effects of Metformin (The PERMET Trial)

This study is testing an FDA-approved medicine to see whether and how it helps people with blockages in their leg arteries who do not have diabetes to have fewer leg symptoms while walking.

Peripheral Artery Disease and the effects of Telmisartan Plus Exercise (The TELEX Trial)

This study is testing an FDA-approved medicine to see whether and how it helps people with blockages in their leg arteries to have fewer leg symptoms while walking. The study is also testing whether the medicine works best alone, or when combined with walking for exercise.

Migraines and the effects of the nVNS as prophylactic treatment

This study collects clinical data related to the safety and efficacy of the nVNS for the prophylactic treatment of migraine.

Endometriosis-Associated Pain and the effects of Elagolix with Estradiol/Norethindron Acetate

This study evaluates the safety and efficacy of Elagolix in combination with concomitant hormonal add-back therapy (E2/NETA) in the management of endometriosis-associated pain (EAP) in premenopausal women.

Migraine attacks and the effects of lasmiditan

This study will assess the efficacy, consistency of response, and safety of lasmiditan in acute treatment of 4 migraine attacks with or without aura.

Migraine Treatment and management Electronic Diary (M-TED)

A non-interventional, prospective, study assessing the burden of migraine using a smartphone-based tracker app

Premenopausal Uterine Fibroids and the effects of Elagolix with Estradiol/Norethindrone Acetate

This study assesses the safety and efficacy of Elagolix 300 mg BID in combination with E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg QD) compared to placebo in reducing heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

M14-064: ABT-165 + FOLFIRI vs Bevacizumab + FOLFIRI for Metastatic Colorectal Cancer

A study to evaluate the efficacy and tolerability of ABT-165 + FOLFIRI compared to Bevacizumab + FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.

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Pediatric Type 2 Diabetes Mellitus and the effects of Alogliptin

This study is evaluating effectiveness and safety of a medication in children and teenagers diagnosed with Type 2 Diabetes who are experiencing poor glucose and HbA1c control.

E7080-G000-307: Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone for Advanced RCC (CLEAR)

This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma.

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Premenopausal Women with Uterine Fibroids and the effects of Elagolix

This study evaluates the long-term efficacy and safety of Elagolix administered alone and in combination with add-back therapy (estradiol/norethindrone acetate or E2/NETA) to reduce heavy menstrual bleeding (HMB) associated with uterine fibroids.

Exploratory Digital Assessment of Cognition and Function with Alzheimer's Disease

Exploratory Digital Assessment of Cognition and Function in Healthy Controls and Subjects with Alzheimer's Disease

Optune Prescription

Optune Prescription

Medtronic Product Surveillance Registry (PSR)

The purpose of this Registry is to provide continuing evaluation and periodic reporting of safety & effectiveness of Medtronic market-released products.

Liver Transplantation and the effect of the OrganOx metra® device vs standard care

The OrganOx metra® device may be a new way of storing (preserving) the liver prior to transplantation. Currently this machine is only intended for investigational use and is not commercially available in the United States. The device uses a method to store the liver at normal body temperature during transport after it has been removed from the donor. The goal is to determine if this method may improve the outcome of transplant over the traditional “cold storage” method.

ECLIPSE

The purpose of this study is to evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique prior to stent implantation for treatment of severely calcified coronary artery lesions.

Kidney Transplantation and the effects of Sanguinate

This study is looking at the effect of the drug on the kidney function after transplantation.

Kidney Transplantation and the effects of QPI-1002

This study is looking at the effect of the drug on the kidney function after transplantation.

Lung Transplantation with RSV infection and the effects of Presatovir (GS-5806)

This study is looking at the effect of the drug on the RSV infection after lung transplantation.

Brady MRI PAS (SJM Brady MRI Post Approval Study)

The purpose of this study is to evaluate the long-term safety of the FDA approved St. Jude Medical Tendril MRI lead implanted with a SJM Brady MRI implantable pulse generator in subjects with a standard bradycardia pacing indication.

MOMENTUM 3 (Momentum 3 CAP Continued Access Protocol)

The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the MOMENTUM 3 IDE Study.

Barostim Therapy for Heart Failure (BeAT-HF)

The objective of this study is to demonstrate that treatment with the Barostim neo system, relative to medical management, reduces the rate of cardiovascular mortality or worsening heart failure that leads to hospitalization, cardiac assist device or heart transplant.

aMAZE Study

This study is evaluating the safety & effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.

MPP PMS (MultiPoint Pacing Post Market Study)

This is a study that aims to understand the use of the MPP technology in real world clinical practice and its impact on the rate of CRT response, programming timing, workflow, rates of heart failure hospitalizations, reduction in heart failure related healthcare utilizations and all –cause mortality.

Diabetic Foot Ulcers and the effects of Single-Use, Negative Pressure Wound Therapy System (PICO)

The aim of this study is to compare the clinical efficacy of a portable, single-use type of Negative Pressure Wound Therapy canister, commonly called a “wound vac,” which draws swelling, infectious material, and fluid away from the wound in order to facilitate healing.

Vest Registry

The purpose of VEST trial is to test the hypothesis that a non-invasive wearable cardioverter defibrillator (WCD) will reduce sudden death and death due to ventricular arrhythmia in the first 90 days following an MI in participants with left ventricular dysfunction (EF≤35%).

GRAHF-2 (Genomic Response Analysis of Heart Failure Therapy in African Americans)

The purpose of this study is to evaluate the response to therapy when a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts.

FMD Registry

Data registry to determine the natural course of fibromuscular dysplasia and to determine which procedures are more effective to relieve symptoms and reduce adverse outcomes.

Outcome Allomap Registry (OAR)

The objective of this registry is to observe short and long term clinical outcomes in heart transplant recipients who receive AlloMap testing as part of allograft rejection surveillance.

Moderately to Severely Active Crohn’s Disease and the effects of Filgotinib

The purpose of this study is to see if Filgotnib, oral JAK-1 inhibitor, is effective and safe in treating people with moderate to severe Crohn’s Disease, which is an inflammatory disease of the gastrointestinal tract (digestive tract).

This is a randomized study in which the patient will be assigned to treatment 1 or treatment 2 of the study medication or a placebo. This is also a blinded study which means that the physician (principal investigator), staff, or pharmacy will not know which treatment the patient is assigned to. If by week 10 the patient does not respond to their assigned treatment he/she will have the option to be randomized into the long term extension study in one of the study medication treatments.

DREAM HF-1

The primary objective of this study is to determine the efficacy and safety of using Allogeneic Mesenchymal Precursor Cells in chronic heart failure due to left ventricle systolic dysfunction.

VICTORIA

VICTORIA will test the hypothesis that vericiguat is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF.

WISE LE Study (Evaluation of WIRION™ EPS in Lower Extremities Arteries)

The purpose of this study is to demonstrate the safety & performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)

Portico™ (Re-sheathable transcatheter Aortic Valve System US IDE Trial)

The PORTICO clinical trial is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery.

ACCL1333/CV185-155: ALL or Lymphoma (T or B Cell) and the Effects of Apixaban for Thromboembolism Prevention

To compare the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on the composite endpoint of adjudicated non-fatal deep vein thrombosis (DVT, including asymptomatic and symptomatic), pulmonary embolism (PE), and cerebral venous sinus thrombosis (CSVT); and venous thrombosis (VTE) -related-death during 25-28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed ALL or lymphoma (T or B cell), a functioning Central Venous Access Device(CVAD) and receiving pegylated L-asparaginase during chemotherapy induction and to assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on adjudicated major bleeding events during 25-28 days of open-label treatment.

Rectal Cancer and the effects of Pinpoint, Fluorescence

This study is testing new imaging technology that is used during surgery.

Cancer and the effects of intravenous 4-demethyl-4-cholesteryloxycarbonylpenclomedine (dm-choc-pen)

4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not transported out of the brain via Pgp (p-glycoprotein) (1). DM-CHOC-PEN has completed Phase I/II trials in humans with primary and secondary tumors involving the brain with success. Complete remissions in both primary (astrocytomas, GBM) and metastatic lung cancers.

A021501: Pancreatic Cancer and the Effects of Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation

The purpose of this study is to compare any good and bad effects of using chemotherapy compared to chemotherapy and radiation prior to surgery. This study will allow the researchers to know whether which approach is better, the same, or worse than the other.

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Plegridy Real World Effectiveness and Safety Observational Program

The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice.

Ischemic Stroke and the effects of HT-3951 on Upper Extremity Motor Function

This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following ischemic stroke.

M16-298: Small Cell Lung Cancer (SCLC) and the Effects of Rovalpituzumab Tesirine / Dexamethasone (MERU)

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

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RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension)

This clinical trials is designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.

Supranuclear Palsy and the effects of Intravenously Administered BMS-986168

The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory abnormalities.

Neuromuscular Blockade and the effects of Sugammadex

This is a randomized, active comparator-controlled, parallel-group, multi-site, double-blind safety trial of sugammadex (MK-8616) for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium in adult ASA Physical Status Class 3 and 4 participants. The first primary objective of this study is to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex.

ALTE1631: Web-Based Physical Activity Intervention in Children and Adolescents with ALL in First Remission

This randomized clinical trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with newly diagnosed Acute Lymphoblastic Leukemia that shows a decrease in or disappearance of signs and symptoms. Regular physical activity after receiving treatment for cancer may help to maintain a healthy weight and improve energy levels and overall health.

AFT-38: Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA)

The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

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Non-Small Cell Lung Cancer and the effects of Atezolizumab Alone vs with Daratumumab

The purpose of the study is to compare the overall response rate in Non-Small Cell Lung Cancer (NSCLC) participants treated with Daratumumab in combination with Atezolizumab versus Atezolizumab alone.

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HALO-109-3-1: Stage IV Pancreatic Cancer and the Effects of Nab-Paclitaxel + Gemcitabine +/- PEGPH20

The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with Nab-Paclitaxel plus Gemcitabine (PAG treatment), compared with placebo combined with Nab-Paclitaxel plus Gemcitabine (AG treatment), in participants with Hyaluronan (HA)-High Stage IV previously untreated Pancreatic Ductal Adenocarcinoma (PDA). Participants will be randomized in a 2:1 ratio to PAG or AG treatment.

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AALL15P1: Azacitidine and Combination Chemotherapy in Treating Infants with ALL and KMT2A Gene Rearrangement

This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug may kill more cancer cells.

TIGeR-PaC: Intra-arterial Gemcitabine vs. IV Gemcitabine + Nab-Paclitaxel after RT for Locally Advanced Pancreatic Cancer

The study is a multi-center, un-blinded, randomized control study of subjects with locally advanced pancreatic adenocarcinoma which is unresectable.

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A011401: Breast Cancer and the Effects of Weight Loss in Overweight and Obese Women

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

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S1418: Triple Negative Breast Cancer and the Effects of MK3475 (Pembrolizumab) as Adjuvant Therapy

This randomized phase III trial studies how well pembrolizumab works in treating triple negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

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WF-10217: Work Ability in Young Adult Survivors (WAYS)

To document levels of labor force participation, occupation, educational attainment, and financial toxicity following cancer treatment in YA cancer survivors aged 25-34 years. This observational, cross-sectional study will recruit 200 YA survivors through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base (WF NCORP RB). Data will be collected using a web-based interface and will capture physical, psychosocial and cognitive late effects; work ability; work-related outcomes, including labor force participation, occupation, work place characteristics, and educational attainment; survivor characteristics; and cancer diagnosis/treatment information (from clinical records). We will evaluate the relationships among these measures using the theoretical framework to guide statistical analysis.

Free Perforations and the effects of the JOSTENT Graft Master

The JOSTENT Graft Master is indicated only for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts ≥ 2.75 mm in diameter.

Aneurysms and the effects of the CODMAN ENTERPRISE Vascular Reconstruction Device

The CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System is a type of intracranial stent. It is made of a flexible metal material called nitinol and is self-expanding. This device is authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of ≥2.5 mm and ≤4 mm. Wide-neck is defined as having a neck width ≥4 mm or a dome-to-neck ratio ‹2. The effectiveness of this device for this use has not been demonstrated.

Preterm Labor and the effect of the Cervilenze Device

Currently, it is difficult to predict which pregnant women with symptoms of preterm (early) labor will actually experience preterm delivery of the baby. Length of the cervix (the opening to the uterus or womb) in pregnant women has been shown to be one of the risk factors associated with delivering a baby preterm. CerviLenz is a simple, single use device approved by the FDA to measure cervical length. The purpose of the study is to see how well the Cervilenz measurement of cervical length correlates with preterm delivery.

Preterm Preeclampsia and the effects of Recombinant Human Antithrombin (Atryn)

The purpose of this study is to evaluate the safety and effectiveness of ATryn in subjects with preterm preeclampsia. This study involves research to assess if ATryn can:

  • increase the time the baby stays in the womb
  • decrease problems the mother may experience
  • improve the health and well-being of the baby

GSK 201973: ER Positive Breast Cancer and the Effects of GSK525762 with Fulvestrant

This is a combination Phase I and II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with advanced or metastatic ER+ breast cancer, who has disease that has progressed after prior treatment with at least one line of endocrine therapy.

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Heart Failure and the effects of the OPTIMIZER® System

Evaluation of the Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%: FIX-HF-5C

**This study is not accepting new participants at this time.