62 results for "Early Phase Trials"

Observational Study Examining Empirically Selected Therapy vs. CANscript™ Recommended Therapy

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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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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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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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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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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DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Some HER-2 breast cancer patients do not respond or build resistance to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.

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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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Intra-arterial Gemcitabine vs. IV Gemcitabine + Nab-Paclitaxel after RT for LAPC (TIGeR-PaC)

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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Resectable Pancreatic Adenocarcinoma and the effects of Fluorouracil vs Gemcitabine Hydrochloride

This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation, 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 more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective than gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating pancreatic cancer.

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment

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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A Phase 1 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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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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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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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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Clear Cell Renal Cell Carcinoma and the effects of CB-839 with Everolimus (CBE)

Phase 2 Study Comparing CB-839 with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic RCC.

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Advanced Refractory Solid Tumors and the effects of CBP501, Cisplatin, and Nivolumab

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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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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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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MIRATI 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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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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D-RVd VS. RVd for Newly Diagnosed Multiple Myeloma

The purpose of this study is to determine if the addition of Daratumumab to Lenalidomide-Bortezomib-Dexamethasone (RVd) will increase the proportion of participants achieving stringent complete response (sCR) by the time of completion of post autologous stem cell transplantation (ASCT) consolidation treatment, compared with RVd alone.

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KEYNOTE-224: Pembrolizumab as Monotherapy for Advanced Hepatocellular Carcinoma

This is an efficacy and safety study of Pembrolizumab (KEYTRUDA®) as monotherapy in participants with HCC in 2 cohorts: participants with advanced HCC and with no curative option after disease progression on Sorafenib or intolerance of Sorafenib (Cohort 1) or who had not received treatment for systemic disease (Cohort 2). Study participants may receive Pembrolizumab once every 3 weeks for up to 35 initial cycles (up to approximately 2 years) and a potential additional 17 cycles in a re-treatment phase (approximately an additional 1 year of treatment).

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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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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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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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Mesothelin Expressing Advanced or Recurrent Malignancies and the effects of Anetumab Ravtansine

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.

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Two Doses of GSK2857916 in Subjects with Multiple Myeloma Who Have Failed Multiple Prior Treatments

Multiple Myeloma (MM) is an incurable malignancy and accounts for 1 percentage of all cancers and for 10% of all hematologic malignancies. Subjects with Relapsed/Refractory Multiple Myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of GSK2857916 monotherapy. Subjects will be treated with GSK2857916 monotherapy until disease progression or unacceptable toxicity and will be followed for Progression Free Survival (PFS) and Overall Survival (OS). The subjects will be randomized to receive either frozen GSK2857916 at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg Intravenous (IV). There will be an independent cohort of subjects who will receive a lyophilized configuration of GSK2857916. Approximately 155 subjects will be enrolled in the study of which 130 subjects will be enrolled to receive frozen GSK2857916 and 25 subjects will be enrolled in the independent lyophilized drug product cohort. The subjects who discontinued from the study other than Progressive Disease (PD), disease evaluation will continue to be performed at 3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of consent, or end of the study whichever occurs first.

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COMET - Communication and Education in Tumor Profiling

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

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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EISAI 222: Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib for uHCC

The primary objective of this study is to assess the safety and tolerability of subsequent Treatment of Physician's Choice (TPC) following the first-line Lenvatinib treatment in Unresectable Hepatocellular Carcinoma (uHCC) participants.

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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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Javelin BRCA/ATM: Avelumab Plus 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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Cisplatin, Intensity-Modulated RT, and Pembrolizumab for Stage III-IV Head and Neck Cancer

This phase I trial studies the side effects and best dose of Pembrolizumab when given together with Cisplatin and intensity-modulated radiation therapy, in treating patients with Stage III-IV Squamous Cell Carcinoma of the Head and Neck. Monoclonal antibodies, such as Pembrolizumab, may block tumor growth in different ways by targeting certain cells. 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. Intensity-modulated radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving Pembrolizumab with Cisplatin and intensity-modulated radiation therapy may work better in treating patients with Squamous Cell Carcinoma of the Head and Neck.

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Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (ATLAS)

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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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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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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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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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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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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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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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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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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Myelofibrosis and the effects of Ruxolitinib in Combination with PU-H71

This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of PU-H71 in subjects taking concomitant ruxolitinib. The first part (Dose Escalation) will employ a standard 3+3 dose escalation design to determine Maximum Tolerated Dose (MTD). The second part of the study (Dose Confirmation) will confirm the recommended Phase 2 dose (RP2D) in an expanded population.

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

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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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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