Trials (Vall d'Hebron Barcelona Hospital Campus)
From Beacon
Go back to Vall d'Hebron Barcelona Hospital Campus page
Trials: How to participate[edit | edit source]
Contact information: Click here to access.
NCTID: NCT00036556
Title: Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer Study Summary: This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer. Sponsor: Abbott Intervention: Atrasentan Start Date: 2001-06 Last Updated: 2007-08-15 Number of Patients: 941 Recruitment Status: COMPLETED Condition: Prostatic Neoplasms
NCTID: NCT03606590
Title: Effect of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Sorafenib For Advanced Hepatocellular Carcinoma (HCC) (HEPANOVA) Study Summary: The study is a prospective, phase II trial single arm, historical control aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L(P) System, in combination with sorafenib in patient with advanced HCC. 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. Sponsor: NovoCure GmbH Intervention: NovoTTF-100L(P) device Start Date: 2019-02-15 Last Updated: 2020-07-29 Number of Patients: 25 Recruitment Status: UNKNOWN Condition: Hepatocellular Carcinoma
NCTID: NCT05963997
Title: A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer Study Summary: This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer. Sponsor: Carrick Therapeutics Limited Intervention: Samuraciclib Start Date: 2023-10-09 Last Updated: 2023-10-23 Number of Patients: 48 Recruitment Status: RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT03419897
Title: Study of BGB-A317 in Participants With Previously Treated Unresectable HCC Study Summary: This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma. Sponsor: BeiGene Intervention: Tislelizumab Start Date: 2018-04-09 Last Updated: 2023-07-27 Number of Patients: 249 Recruitment Status: COMPLETED Condition: Hepatocellular Carcinoma (HCC)
NCTID: NCT05210790
Title: A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera Study Summary: The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV. Sponsor: Protagonist Therapeutics, Inc. Intervention: Placebo Start Date: 2022-04-01 Last Updated: 2023-11-09 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Polycythemia Vera
NCTID: NCT05127590
Title: RBN-2397 in Combination With Pembrolizumab in Patients With SCCL Study Summary: RBN-2397 inhibits PARP7, an enzyme that is switched on by cancer stresses, such as the toxins in cigarette smoke. Cancer cells use PARP7 to hide from the immune system by stopping the cell from sending a signal (Type 1 interferon) that tells the immune system that something is wrong and to kill the cell. RBN-2397 has been shown in animal and human studies to inhibit tumor growth and also shuts down the “don’t kill me” signal the tumor is sending to evade the immune system. The purpose of this study is to determine if RBN-2397 in combination with pembrolizumab (a PD-1 inhibitor) has the ability to restore the response to treatment in patients with SCCL that have been previously treated with a PD-1/PD-1 ligand (PD-L1) inhibitor and have had a response followed by disease progression. The Phase 1b portion of the study will assess the safety of RBN-2397 in combination with pembrolizumab (a PD-1 inhibitor) and define the dose of RBN-2397 to be used in combination with pembrolizumab for the Phase 2. The Phase 2 portion of the study will assess the anti-tumor activity of RBN-2397 in combination with pembrolizumab. Sponsor: Ribon Therapeutics, Inc. Intervention: RBN-2397 Start Date: 2022-03-15 Last Updated: 2023-07-03 Number of Patients: 50 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Squamous Non-Small Cell Lung Carcinoma
NCTID: NCT04778397
Title: Study of Magrolimab in Combination With Azacitidine Versus Physician’s Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated Study Summary: The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML). Sponsor: Gilead Sciences Intervention: Magrolimab Start Date: 2021-07-01 Last Updated: 2023-10-11 Number of Patients: 346 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT05171075
Title: A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE Study Summary: This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia) Sponsor: Anthos Therapeutics, Inc. Intervention: Abelacimab Start Date: 2022-09-27 Last Updated: 2023-11-21 Number of Patients: 1020 Recruitment Status: RECRUITING Condition: Venous Thromboembolism
NCTID: NCT03368859
Title: A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab Study Summary: A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum. Sponsor: AbbVie Intervention: Leucovorin Start Date: 2018-03-20 Last Updated: 2021-02-09 Number of Patients: 70 Recruitment Status: TERMINATED Condition: Cancer
NCTID: NCT00523159
Title: IMA901 in Advanced Renal Cell Carcinoma Patients With Measurable Disease Study Summary: This study was conducted in order to evaluate the efficacy and safety of the cancer vaccine IMA901 and GM-CSF as adjuvant in the treatment of advanced renal cell carcinoma. Patients received vaccination with GM-CSF followed by IMA901 during the study period of 9 months. Patients received pre-treatment with a single i.v. infusion of cyclophosphamide prior to the first vaccination. Sponsor: Immatics Biotechnologies GmbH Intervention: Endoxana, IMA901, Leukine Start Date: 2007-05 Last Updated: 2012-07-10 Number of Patients: 68 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma
NCTID: NCT05514054
Title: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer Study Summary: The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Sponsor: Eli Lilly and Company Intervention: Imlunestrant Start Date: 2022-10-04 Last Updated: 2023-10-24 Number of Patients: 6000 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT05317416
Title: Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant Study Summary: The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years Sponsor: Pfizer Intervention: Elranatamab Start Date: 2022-03-25 Last Updated: 2023-11-28 Number of Patients: 760 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT02716116
Title: A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer Study Summary: This study is about a medicine called TAK-788, also known as mobocertinib, given to adults with non-small cell lung cancer. The main aims of this study are to check if there are any side effects from TAK-788, to learn how TAK-788 is processed by the body, and to determine the best dose of TAK-788 to treat this condition. Participants will take TAK-788 capsules with chemotherapy. Participants will continue to take TAK-788 unless they or their doctor decide they should stop this treatment. Participants will take TAK-788 capsules with or without chemotherapy under antidiarrhea prevention to determine the safety of TAK-788 treatment. Non-Asian, non-White participants will take TAK-788 to determine the safety and tolerability of TAK-788 treatment. Sponsor: Takeda Intervention: TAK-788 Start Date: 2016-06-16 Last Updated: 2023-10-18 Number of Patients: 334 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT04042116
Title: A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor Study Summary: This is an open-label, Phase 1b/2 study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (Phase 2) and evaluate the effects of dosing under fasting or fed state (Food Effect) Sponsor: Clovis Oncology, Inc. Intervention: Lucitanib Start Date: 2019-07-29 Last Updated: 2022-12-20 Number of Patients: 227 Recruitment Status: SUSPENDED Condition: Advanced Solid Tumor
NCTID: NCT03268382
Title: p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246 Study Summary: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and PLD chemotherapy regimen in patients with platinum-resistant recurrent high grade serous ovarian cancer (HGSOC) with mutated TP53. In addition, the study aims to assess the safety profile of the combined APR-246 and PLD chemotherapy regimen, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll at least 25 evaluable patients. Sponsor: Aprea Therapeutics Intervention: APR-246 Start Date: 2017-07-31 Last Updated: 2022-07-21 Number of Patients: 36 Recruitment Status: COMPLETED Condition: High-grade Serous Ovarian Cancer
NCTID: NCT04113616
Title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML) Study Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine). Sponsor: Kartos Therapeutics, Inc. Intervention: KRT-232 Start Date: 2019-09-25 Last Updated: 2023-08-02 Number of Patients: 86 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCTID: NCT00004150
Title: High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer. PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer. Sponsor: Robert Roessle Klinik Intervention: fluorouracil Start Date: 1999-03 Last Updated: 2013-11-06 Number of Patients: NA Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT01945775
Title: A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) Study Summary: The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician’s choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations. Sponsor: Pfizer Intervention: talazoparib Start Date: 2013-10-14 Last Updated: 2022-01-20 Number of Patients: 431 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT05508867
Title: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) Study Summary: The purpose of this study is to compare efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) with physician’s choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory, relapsed or refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of coformulated favezelimab/pembrolizumab. The primary study hypotheses are that coformulated favezelimab/pembrolizumab is superior to physician’s choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: favezelimab/pembrolizumab Start Date: 2022-10-18 Last Updated: 2023-11-27 Number of Patients: 360 Recruitment Status: RECRUITING Condition: Hodgkin Lymphoma
NCTID: NCT03430843
Title: A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma Study Summary: The purpose of this study is to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that has progressed during or after first line therapy. Sponsor: BeiGene Intervention: Tislelizumab Start Date: 2018-01-26 Last Updated: 2023-01-18 Number of Patients: 513 Recruitment Status: COMPLETED Condition: Esophageal Squamous Cell Carcinoma (ESCC)
NCTID: NCT03414047
Title: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer Study Summary: The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer. Sponsor: Eli Lilly and Company Intervention: Prexasertib Start Date: 2018-04-10 Last Updated: 2022-08-19 Number of Patients: 172 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT03703466
Title: A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer Study Summary: The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food. Sponsor: Eli Lilly and Company Intervention: Abemaciclib Start Date: 2018-11-28 Last Updated: 2023-05-09 Number of Patients: 72 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT02952586
Title: Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100) Study Summary: This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer. Sponsor: Pfizer Intervention: Avelumab Start Date: 2016-11-28 Last Updated: 2021-09-22 Number of Patients: 697 Recruitment Status: TERMINATED Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT04622319
Title: A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) Study Summary: Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-8201a Start Date: 2020-12-04 Last Updated: 2023-11-07 Number of Patients: 1600 Recruitment Status: RECRUITING Condition: HER2-Positive Primary Breast Cancer
NCTID: NCT04844866
Title: Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients Study Summary: This is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. Sponsor: Miltenyi Biomedicine GmbH Intervention: MB-CART2019.1 Start Date: 2021-08-18 Last Updated: 2023-11-07 Number of Patients: 168 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT00003643
Title: Combination Chemotherapy in Treating Men With Germ Cell Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer. PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 1998-10 Last Updated: 2012-03-06 Number of Patients: 498 Recruitment Status: UNKNOWN Condition: Extragonadal Germ Cell Tumor
NCTID: NCT04832607
Title: Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections Study Summary: Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults. Sponsor: Prof. Tobias Feuchtinger Intervention: Multivirus (CMV, EBV, AdV)-specific T cells Start Date: 2019-08-27 Last Updated: 2023-10-04 Number of Patients: 149 Recruitment Status: RECRUITING Condition: AdV Infection
NCTID: NCT05067283
Title: A Study of MK-1084 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Advanced Solid Tumors (MK-1084-001) Study Summary: This is a study evaluating the efficacy, safety, and pharmacokinetics of MK-1084 in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and MK-1084 plus pembrolizumab in participants with first line (1L) non-small cell lung cancer (NSCLSC) with identified KRAS G12C mutation. Sponsor: Merck Sharp & Dohme LLC Intervention: MK-1084 Start Date: 2021-12-17 Last Updated: 2023-11-24 Number of Patients: 450 Recruitment Status: RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT05254743
Title: A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2022-07-22 Last Updated: 2023-10-12 Number of Patients: 650 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT02098343
Title: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 Study Summary: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients. Sponsor: Aprea Therapeutics Intervention: APR-246 Start Date: 2014-03 Last Updated: 2022-10-13 Number of Patients: 247 Recruitment Status: COMPLETED Condition: Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53
NCTID: NCT01804686
Title: A Long-term Extension Study of PCI-32765 (Ibrutinib) Study Summary: The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment. Sponsor: Janssen Research & Development, LLC Intervention: Ibrutinib Start Date: 2013-09-09 Last Updated: 2023-11-09 Number of Patients: 700 Recruitment Status: ENROLLING_BY_INVITATION Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04404283
Title: Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL Study Summary: Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone. Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is “blinded,” participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL. Sponsor: Seagen Inc. Intervention: Brentuximab vedotin Start Date: 2020-08-20 Last Updated: 2023-11-29 Number of Patients: 225 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT03609047
Title: Adjuvant Palbociclib in Elderly Patients With Breast Cancer Study Summary: Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Palbociclib Start Date: 2019-06-14 Last Updated: 2022-11-17 Number of Patients: 366 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer Stage II
NCTID: NCT03465722
Title: (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST Study Summary: This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs. Sponsor: Blueprint Medicines Corporation Intervention: avapritinib Start Date: 2018-03-26 Last Updated: 2022-10-06 Number of Patients: 476 Recruitment Status: COMPLETED Condition: GIST
NCTID: NCT02654587
Title: Study of OSE2101 Versus Standard Treatment as 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC After Failure of Immune Checkpoint Inhibitor Study Summary: The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment after failure of immune checkpoint-inhibitor regimens. Sponsor: OSE Immunotherapeutics Intervention: OSE2101 Start Date: 2016-02 Last Updated: 2021-03-08 Number of Patients: 363 Recruitment Status: UNKNOWN Condition: Non Small Cell Lung Cancer
NCTID: NCT04211337
Title: A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer Study Summary: The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib. Sponsor: Loxo Oncology, Inc. Intervention: Selpercatinib Start Date: 2020-02-11 Last Updated: 2023-10-30 Number of Patients: 291 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Medullary Thyroid Cancer
NCTID: NCT04821622
Title: Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC Study Summary: The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC. Sponsor: Pfizer Intervention: talazoparib plus enzalutamide Start Date: 2021-05-12 Last Updated: 2023-11-22 Number of Patients: 599 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT04895722
Title: Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) Study Summary: The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-06-25 Last Updated: 2023-11-24 Number of Patients: 320 Recruitment Status: RECRUITING Condition: Colorectal Cancer
NCTID: NCT05208047
Title: (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors Study Summary: This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. Sponsor: Cogent Biosciences, Inc. Intervention: CGT9486 plus sunitinib Start Date: 2022-04-14 Last Updated: 2023-11-28 Number of Patients: 426 Recruitment Status: RECRUITING Condition: Advanced Gastrointestinal Stromal Tumors
NCTID: NCT02155647
Title: Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) Study Summary: This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2014-07-03 Last Updated: 2023-06-05 Number of Patients: 204 Recruitment Status: COMPLETED Condition: Carcinoma, Merkel Cell
NCTID: NCT02872714
Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201) Study Summary: The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations. Sponsor: Incyte Corporation Intervention: pemigatinib Start Date: 2017-01-12 Last Updated: 2023-03-24 Number of Patients: 263 Recruitment Status: COMPLETED Condition: UC (Urothelial Cancer)
NCTID: NCT04833114
Title: Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) Versus R-ICE Alone in Second Line Treatment of Diffuse Large B-cell Lymphoma (DLBCL) Study Summary: An open-label, prospective Phase III clinical study to compare polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) with rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with primary refractory or relapsed diffuse large B-cell lymphoma (DLBCL) Sponsor: GWT-TUD GmbH Intervention: Polatuzumab Vedotin Start Date: 2021-04-30 Last Updated: 2023-10-12 Number of Patients: 334 Recruitment Status: RECRUITING Condition: Relapsed Diffuse Large B-cell Lymphoma
NCTID: NCT02470585
Title: Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Study Summary: The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel <math display="block">C/P</math>) and continued as maintenance therapy compared with chemotherapy alone. Sponsor: AbbVie Intervention: Veliparib Start Date: 2015-06-29 Last Updated: 2023-10-30 Number of Patients: 1140 Recruitment Status: TERMINATED Condition: Ovarian Cancer
NCTID: NCT04910685
Title: (HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis Study Summary: This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of BLU-263 + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. Parts 1 and 2 will enroll patients with ISM. Patients enrolled in Part 1 or Part 2 will roll over onto Part 3 to receive treatment with BLU-263 in an open-label fashion following completion of the earlier Part. Part M will enroll patients with monoclonal mast cell activation syndrome (mMCAS). The study also includes PK groups that will enroll patients with ISM. Sponsor: Blueprint Medicines Corporation Intervention: BLU-263 Start Date: 2021-11-30 Last Updated: 2023-10-23 Number of Patients: 443 Recruitment Status: RECRUITING Condition: Indolent Systemic Mastocytosis
NCTID: NCT05173987
Title: Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) Study Summary: The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2022-02-03 Last Updated: 2023-11-09 Number of Patients: 280 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Neoplasms
NCTID: NCT03533283
Title: An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma Study Summary: This is an open-label, single arm, multicenter, dose finding, Phase Ib study in order to assess the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for this combination treatment and to evaluate the general safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and preliminary anti-tumor activity of this combination treatment in adult patients. This study includes an additional open-label imaging feasibility sub-study using a tracer in adult participants with relpased/refractory B-cell non-Hodgkin’s lymphoma to image CD8+T-cells at baseline and after treatment with glofitamab, including pre-treatment with obinutuzumab. Sponsor: Hoffmann-La Roche Intervention: Glofitamab Start Date: 2018-05-08 Last Updated: 2023-11-02 Number of Patients: 280 Recruitment Status: RECRUITING Condition: Non-Hodgkins Lymphoma
NCTID: NCT04674683
Title: Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma Study Summary: This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by PD-L1 expression and LDH level. Sponsor: HUYABIO International, LLC. Intervention: HBI-8000 in combination with nivolumab Start Date: 2021-08-12 Last Updated: 2023-07-27 Number of Patients: 480 Recruitment Status: RECRUITING Condition: Unresectable or Metastatic Melanoma
NCTID: NCT01966471
Title: A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer Study Summary: This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2014-01-31 Last Updated: 2022-06-14 Number of Patients: 1846 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04620239
Title: ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study Study Summary: This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient’s response to treatment Sponsor: Steba Biotech S.A. Intervention: padeliporfin VTP Start Date: 2021-03-22 Last Updated: 2023-07-18 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Transitional Cell Cancer of Renal Pelvis and Ureter
NCTID: NCT03898791
Title: A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer Study Summary: The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer. Sponsor: Eli Lilly and Company Intervention: LY3295668 Erbumine Start Date: 2019-07-16 Last Updated: 2021-08-05 Number of Patients: 48 Recruitment Status: COMPLETED Condition: Small Cell Lung Cancer
NCTID: NCT02763579
Title: A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC) Study Summary: This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 <math display="block">PD-L1</math> antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Start Date: 2016-06-07 Last Updated: 2023-07-28 Number of Patients: 503 Recruitment Status: COMPLETED Condition: Small Cell Lung Carcinoma
NCTID: NCT05748171
Title: A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL Study Summary: This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization. Sponsor: Pfizer Intervention: Inotuzumab ozogamicin Start Date: 2023-05-17 Last Updated: 2023-11-14 Number of Patients: 100 Recruitment Status: RECRUITING Condition: ACUTE LYMPHOBLASTIC LEUKEMIA
NCTID: NCT05458297
Title: A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006) Study Summary: The purpose of this study is to assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination in participants with select B-cell lymphomas including mantle cell lymphoma (MCL), Richter’s transformation lymphoma (RTL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). This study will also evaluate zilovertamab vedotin as monotherapy and in combination with respect to objective response rate. * Cohort A: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton’s tyrosine kinase inhibition/inhibitor (BTKi), and post therapy chimeric antigen receptor T (CAR-T) cell therapy or ineligible for CAR-T cell therapy * Cohort B: Participants with relapsed or refractory RT disease after at least 1 prior systemic therapy * Cohort C: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi * Cohort D: Participants with relapsed or refractory FL and CLL relapsed or refractory disease after at least 2 prior systemic therapies and have no other available therapy * Cohort E: Participants with relapsed or refractory FL after at least 2 prior systemic therapies and have no other available therapy * Cohort F: Participants with relapsed or refractory CLL after at least 2 prior systemic therapies and have no other available therapy The primary study hypothesis is that zilovertamab vedotin monotherapy has an increased Objective Response Rate (ORR) per Lugano Response Criteria as assessed by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Zilovertamab vedotin Start Date: 2022-07-21 Last Updated: 2023-11-24 Number of Patients: 275 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT03940703
Title: A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2) Study Summary: This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Tepotinib Start Date: 2019-09-19 Last Updated: 2023-08-29 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT02194842
Title: Phase III Radium 223 mCRPC-PEACE III Study Summary: The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) compared to enzalutamide single agent in CRPC patients metastatic to bone Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Ra223 Start Date: 2015-10 Last Updated: 2023-03-30 Number of Patients: 446 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT05775289
Title: A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer Study Summary: The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (RO7247669) in combination with platinum-based chemotherapy compared with pembrolizumab plus platinum-based chemotherapy in participants with previously untreated, locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) non-small-cell lung cancer (NSCLC) who are not eligible to receive curative surgery and/or definitive chemoradiotherapy. Sponsor: Hoffmann-La Roche Intervention: Tobemstomig Start Date: 2023-03-15 Last Updated: 2023-11-02 Number of Patients: 180 Recruitment Status: RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT05050942
Title: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET Study Summary: The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029. Sponsor: Camurus AB Intervention: CAM2029 Start Date: 2021-10-22 Last Updated: 2023-10-06 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Gastro-enteropancreatic Neuroendocrine Tumor
NCTID: NCT01546038
Title: A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Study Summary: This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases. Sponsor: Pfizer Intervention: PF-04449913 Start Date: 2012-06-27 Last Updated: 2020-03-03 Number of Patients: 255 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT02395172
Title: Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200) Study Summary: The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2015-03-24 Last Updated: 2020-08-03 Number of Patients: 792 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT04666038
Title: Study of LOXO-305 Versus Investigator’s Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress. Sponsor: Loxo Oncology, Inc. Intervention: LOXO-305 Start Date: 2021-03-09 Last Updated: 2023-11-01 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00803062
Title: Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer Study Summary: This randomized phase III trial studies the side effects of paclitaxel when given together with cisplatin or topotecan with or without bevacizumab and to compare how well they work in treating patients with stage IVB, cervical cancer that has come back or is persistent. Drugs used in chemotherapy, such as paclitaxel, cisplatin, and topotecan, 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, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether paclitaxel is more effective when given together with cisplatin or topotecan with or without bevacizumab in treating patients with cervical cancer. Sponsor: National Cancer Institute (NCI) Intervention: Bevacizumab Start Date: 2009-04 Last Updated: 2019-07-23 Number of Patients: 452 Recruitment Status: COMPLETED Condition: Cervical Adenocarcinoma
NCTID: NCT01984242
Title: A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma Study Summary: This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody Start Date: 2014-01-08 Last Updated: 2019-12-23 Number of Patients: 305 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma
NCTID: NCT04246489
Title: Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer Study Summary: The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Bintrafusp alfa Start Date: 2020-03-30 Last Updated: 2023-10-23 Number of Patients: 146 Recruitment Status: COMPLETED Condition: Uterine Cervical Neoplasms
NCTID: NCT02291289
Title: A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) Study Summary: This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years. Sponsor: Hoffmann-La Roche Intervention: Cetuximab Start Date: 2015-04-17 Last Updated: 2021-05-26 Number of Patients: 609 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT02205047
Title: Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma Study Summary: The purpose of this study is to find out whether either trastuzumab or the combination of trastuzumab and pertuzumab with standard chemotherapy shows more activity against gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery and it can be safely administered. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Cisplatin Start Date: 2015-07-15 Last Updated: 2023-02-16 Number of Patients: 171 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Malignant Neoplasm of Stomach
NCTID: NCT01265849
Title: Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity Study Summary: The purpose of this study was to determine whether LI administered in combination with cyclophosphamide, indomethacin and zinc in a multivitamin (CIZ) combination prior to standard of care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy) is safe and will increase the overall survival of subjects with previously untreated locally advanced primary squamous cell carcinoma of the oral cavity or soft palate at a median of 3 to 5 years Sponsor: CEL-SCI Corporation Intervention: LI Start Date: 2010-12 Last Updated: 2022-08-19 Number of Patients: 928 Recruitment Status: COMPLETED Condition: Squamous Cell Carcinoma of the Oral Cavity
NCTID: NCT03768063
Title: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study Study Summary: This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-02-28 Last Updated: 2023-11-09 Number of Patients: 1000 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT04728893
Title: Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003) Study Summary: The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter’s transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström’s macroglobulinemia (WM). Sponsor: Merck Sharp & Dohme LLC Intervention: Nemtabrutinib Start Date: 2021-04-05 Last Updated: 2023-11-24 Number of Patients: 450 Recruitment Status: RECRUITING Condition: Hematologic Malignancies
NCTID: NCT01788982
Title: Nintedanib(BIBF1120) in Thyroid Cancer Study Summary: For the treatment of thyroid cancer with the so called targeted therapy the angiogenesis pathway has several potential targets. The Receptors for Vascular endothelial growth factor (VEGF) and especially VEGFR-2 is considered to be crucial for the initiation of the formation as well as the maintenance of tumor vasculature. In thyroid cancer these VEGF receptors (VEGFR-1, VEGFR-2), VEGF itself and receptors of the fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often overexpressed. Other cells as pericytes and smooth muscle cells that are also involved in tumor angiogenesis express these receptors as well. Inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive results. However there is no treatment that is generally considered as standard of care for patients with differentiated thyroid cancer (DTC) or medullar thyroid cancer (MTC) who have progressed on one line of therapy. The classical cytotoxic chemotherapy has not shown a clinically meaningful benefit yet. Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF. Therefore it might act not only on endothelial cells but also on pericytes and smooth muscle cells. Nintedanib also interacts with other kinases such as RET. Because of this multi-kinase activity rationale exists to investigate the effect in MTC and DTC. Because it targets these three major angiogenesis signaling pathways it might prevent further tumor growth and related tumor escape mechanisms. Therefore nintedanib may be active in patients who have progressed on agents that target only one pathway. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nintedanib Start Date: 2014-05 Last Updated: 2020-07-31 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Medullary Thyroid Cancer (MTC)
NCTID: NCT02228382
Title: Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors Study Summary: The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other Tyrosine Kinase Inhibitors). Sponsor: Pfizer Intervention: Bosutinib Start Date: 2014-11-07 Last Updated: 2021-12-30 Number of Patients: 163 Recruitment Status: TERMINATED Condition: Previously Treated PH + CML
NCTID: NCT00057720
Title: TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer Study Summary: The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations. Sponsor: Telik Intervention: TLK286 HCl for injection Start Date: 2003-06 Last Updated: 2011-07-25 Number of Patients: 440 Recruitment Status: COMPLETED Condition: Ovarian Neoplasms
NCTID: NCT03941093
Title: Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced Pancreatic Cancer Study Summary: This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G
P) or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer.
Sponsor: FibroGen Intervention: Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX Start Date: 2019-05-10 Last Updated: 2022-12-27 Number of Patients: 284 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Pancreatic Cancer Non-resectable
NCTID: NCT03456063
Title: A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030) Study Summary: This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Start Date: 2018-04-24 Last Updated: 2023-10-27 Number of Patients: 453 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small-Cell Lung
NCTID: NCT03123393
Title: TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Study Summary: The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL. Sponsor: Calithera Biosciences, Inc Intervention: TAK-659 Start Date: 2017-10-10 Last Updated: 2023-02-08 Number of Patients: 49 Recruitment Status: TERMINATED Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT02725268
Title: A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer Study Summary: The primary purpose of this study is to determine if sapanisertib in combination with weekly paclitaxel improves progression-free survival (PFS) compared to weekly paclitaxel alone. Sponsor: Millennium Pharmaceuticals, Inc. Intervention: Paclitaxel Start Date: 2016-04-01 Last Updated: 2021-11-24 Number of Patients: 241 Recruitment Status: COMPLETED Condition: Endometrial Neoplasms
NCTID: NCT04721015
Title: Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors Study Summary: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed. ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world. In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28-day cycle. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires. Sponsor: AbbVie Intervention: ABBV-637 Start Date: 2021-02-23 Last Updated: 2023-10-17 Number of Patients: 81 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Solid Tumors Cancer
NCTID: NCT03235245
Title: Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib Study Summary: This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nivolumab + Ipilimumab Start Date: 2018-10-30 Last Updated: 2023-11-03 Number of Patients: 271 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Unresectable Stage III Melanoma
NCTID: NCT03410693
Title: Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma Study Summary: This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied. Sponsor: Bayer Intervention: Rogaratinib (BAY1163877) Start Date: 2018-05-31 Last Updated: 2022-09-28 Number of Patients: 175 Recruitment Status: COMPLETED Condition: Carcinoma, Transitional Cell
NCTID: NCT02239120
Title: Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS) Study Summary: 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). Sponsor: Boehringer Ingelheim Intervention: optional ASA as comedication Start Date: 2014-11-27 Last Updated: 2019-09-06 Number of Patients: 5390 Recruitment Status: COMPLETED Condition: Stroke
NCTID: NCT05850520
Title: A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion) Study Summary: Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO). In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema. When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry. The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease. Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg. The main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept and those that received standard of care. To learn how safe the study treatment is in the participants, the researchers will count the number of participants from study start and up to 64 weeks later that have: * adverse events * serious adverse events “Adverse events” are any medical problems that the participants have during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatments. An adverse event is considered “serious” when it leads to death, puts the participants’ lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important. Dependent on the treatment group, the participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study will consist of a test (screening) phase, a treatment phase and an end of study phase. Each participant will be in the study for up to 64 weeks. One visit to the study site is planned during the screening phase, followed by visits approximately every 4 weeks (16 in total) during treatment and one visit at the end of the study. During the study, the study doctors and their team will: * check patients’ eye health using various eye examination techniques * measure patients’ eye vision (BCVA) * take blood and urine samples * do physical examinations * check vital signs * examine heart health using electrocardiogram (ECG) * do pregnancy tests in women of childbearing age In addition, participants will be asked to fill a questionnaire on vision-related quality of life. Sponsor: Bayer Intervention: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose Start Date: 2023-05-15 Last Updated: 2023-11-28 Number of Patients: 822 Recruitment Status: RECRUITING Condition: Macular Edema Secondary to Retinal Vein Occlusion
NCTID: NCT04965493
Title: A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Study Summary: The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2021-09-20 Last Updated: 2023-10-12 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT05132582
Title: A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer Study Summary: This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer. Sponsor: Seagen Inc. Intervention: Tucatinib Start Date: 2022-03-07 Last Updated: 2023-11-29 Number of Patients: 650 Recruitment Status: RECRUITING Condition: HER2 Positive Breast Cancer
NCTID: NCT05283720
Title: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma Study Summary: B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 394 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28-day or 21 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in participants with newly diagnosed treatment-naïve DLBCL; 4: Oral CC-99282 in participants with R/R DLBCL; 5: Oral CC-99282 in participants with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in participants with R/R mantle cell lymphoma (MCL); 6B: Oral ibrutinib, and oral venetoclax in participants with R/R MCL; 7: Oral ibrutinib, and oral venetoclax in participants with newly diagnosed treatment-naïve MCL. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects. Sponsor: AbbVie Intervention: Epcoritamab Start Date: 2022-06-14 Last Updated: 2023-11-24 Number of Patients: 394 Recruitment Status: RECRUITING Condition: Non-Hodgkin Lymphoma
NCTID: NCT04879368
Title: RegoNivo vs Standard of Care Chemotherapy in AGOC Study Summary: To determine if the regorafenib and nivolumab combination (RegoNivo) improves overall survival compared with current standard chemotherapy options in refractory AGOC. Sponsor: Australasian Gastro-Intestinal Trials Group Intervention: Regorafenib Start Date: 2021-06-01 Last Updated: 2023-10-12 Number of Patients: 450 Recruitment Status: RECRUITING Condition: Gastro-Oesophageal Cancer
NCTID: NCT01507168
Title: A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma Study Summary: This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Sponsor: Hoffmann-La Roche Intervention: Placebo Start Date: 2012-02-02 Last Updated: 2020-04-03 Number of Patients: 185 Recruitment Status: COMPLETED Condition: Carcinoma, Hepatocellular
NCTID: NCT04459715
Title: A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) Study Summary: The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Xevinapant (Debio 1143) Start Date: 2020-08-07 Last Updated: 2023-10-24 Number of Patients: 730 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT04589845
Title: Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study Study Summary: TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Entrectinib Start Date: 2021-01-18 Last Updated: 2023-11-13 Number of Patients: 920 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT01853826
Title: An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s) Study Summary: To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI Sponsor: Boehringer Ingelheim Intervention: afatinib Start Date: 2013-07-17 Last Updated: 2023-07-12 Number of Patients: 481 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01483027
Title: Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer Study Summary: The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere. Sponsor: Boston Scientific Corporation Intervention: TheraSphere Start Date: 2012-01 Last Updated: 2022-03-29 Number of Patients: 428 Recruitment Status: COMPLETED Condition: Colorectal Cancer Metastatic
NCTID: NCT03969004
Title: Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma Study Summary: The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: * To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients’ freedom from locoregional recurrence (FFLRR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients’ freedom from distant recurrence (FFDR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT * To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT * To assess cemiplimab pharmacokinetics and immunogenicity in human serum Sponsor: Regeneron Pharmaceuticals Intervention: Cemiplimab Start Date: 2019-06-04 Last Updated: 2023-11-24 Number of Patients: 412 Recruitment Status: RECRUITING Condition: Cutaneous Squamous Cell Carcinoma
NCTID: NCT04052204
Title: Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors Study Summary: Evaluation of the combination of avelumab + bempegaldesleukin (NKTR-214 ) in locally advanced squamous cell carcinoma of the head and neck ( metastatic SCCHN) and avelumab + bempegaldesleukin (NKTR-214) + talazoparib or enzalutamide in metastatic castration resistant prostate cancer (mCRPC). Sponsor: Pfizer Intervention: avelumab Start Date: 2019-12-30 Last Updated: 2021-10-14 Number of Patients: 3 Recruitment Status: TERMINATED Condition: Squamous Cell Carcinoma of the Head and Neck (SCCHN)
NCTID: NCT03178552
Title: A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) Study Summary: This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays. Sponsor: Hoffmann-La Roche Intervention: Alectinib Start Date: 2017-09-22 Last Updated: 2023-11-03 Number of Patients: 1000 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT04464226
Title: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer Study Summary: The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor’s visits as often as they did in the previous study. Sponsor: Bayer Intervention: Darolutamide (Nubeqa, BAY1841788) Start Date: 2020-10-20 Last Updated: 2023-11-18 Number of Patients: 678 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT04656652
Title: Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-1062a Start Date: 2020-12-21 Last Updated: 2023-11-18 Number of Patients: 590 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT03434379
Title: A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma Study Summary: This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2018-03-15 Last Updated: 2023-10-23 Number of Patients: 558 Recruitment Status: COMPLETED Condition: Carcinoma, Hepatocellular
NCTID: NCT04177108
Title: A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer. Study Summary: This study will evaluate the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-11-25 Last Updated: 2023-03-23 Number of Patients: 242 Recruitment Status: COMPLETED Condition: Triple-Negative Breast Cancer
NCTID: NCT05608291
Title: A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery Study Summary: The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS) The secondary objectives of the study are: * To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) * To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by melanoma specific survival (MSS) * To evaluate whether post-operative adjuvant therapy improves distant metastasis-free survival (DMFS), in stage IIC or III patients receiving fianlimab + cemiplimab compared to pembrolizumab * To assess impact of fianlimab + cemiplimab on quality of life as compared to pembrolizumab in adults * To assess safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab * To characterize pharmacokinetics (PK) of fianlimab + cemiplimab using sparse PK sampling in patients 12 years of age and older * To assess immunogenicity of fianlimab and against cemiplimab Sponsor: Regeneron Pharmaceuticals Intervention: Fianlimab Start Date: 2023-01-16 Last Updated: 2023-11-18 Number of Patients: 1530 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT03994627
Title: Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma Study Summary: The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS). Sponsor: Eli Lilly and Company Intervention: Olaratumab Start Date: NA Last Updated: 2023-09-29 Number of Patients: NA Recruitment Status: AVAILABLE Condition: Soft Tissue Sarcoma
NCTID: NCT05696626
Title: Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Study Summary: The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day. Sponsor: Sermonix Pharmaceuticals Inc. Intervention: Lasofoxifene in combination with abemaciclib Start Date: 2023-10-31 Last Updated: 2023-11-14 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT04938817
Title: Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Investigational Agents for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) Study Summary: This study is a rolling arm study of pembrolizumab in combination with investigational agents in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation. Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D. There will be no hypothesis testing in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: coformulation pembrolizumab/quavonlimab Start Date: 2021-08-19 Last Updated: 2023-01-04 Number of Patients: 80 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Carcinoma
NCTID: NCT04498117
Title: Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery Study Summary: Study to compare the safety and efficacy of oregovomab versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who have undergone optimal debulking. Sponsor: CanariaBio Inc. Intervention: Oregovomab Start Date: 2020-08-25 Last Updated: 2023-10-10 Number of Patients: 615 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Ovarian Epithelial
NCTID: NCT03428217
Title: CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma Study Summary: Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC). Sponsor: Calithera Biosciences, Inc Intervention: CB-839 Start Date: 2018-04-24 Last Updated: 2023-03-20 Number of Patients: 444 Recruitment Status: COMPLETED Condition: Advanced Renal Cell Carcinoma
NCTID: NCT01186991
Title: Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Participants With Metastatic, Triple Negative Breast Cancer Study Summary: This is a randomized, Phase II, double-blind, multicenter, placebo-controlled trial designed to preliminarily estimate the efficacy and evaluate the safety and tolerability of onartuzumab (MetMAb) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel versus placebo + bevacizumab + paclitaxel in participants with metastatic or locally recurrent, triple-negative breast cancer who either have not received treatment (first-line) or have progressed after one conventional cytotoxic chemotherapy regimen (second-line). Sponsor: Genentech, Inc. Intervention: Onartuzumab Start Date: 2011-03 Last Updated: 2017-01-20 Number of Patients: 185 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03151408
Title: An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia Study Summary: This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and cytogenetic low-risk AML, who are unfit to receive intensive remission induction chemotherapy due to age ≥ 75 years or comorbidities. Patients will be randomized in a 1:1 ratio to one of two groups: Group A (experimental group) to receive pracinostat plus AZA and Group B (control group) to receive placebo plus AZA. Randomization will be stratified by cytogenetic risk category (intermediate vs. unfavorable-risk, according to SWOG Cytogenetic Risk Category Definitions) and ECOG performance status (0-1 vs. 2). Treatments will be administered based on 28-day cycles, with pracinostat/placebo administered orally once every other day, 3 times a week for 3 weeks, followed by one week of no treatment and AZA administered for 7 days of each cycle. Study treatment should continue until there is documented disease progression, relapse from complete remission (CR), or non-manageable toxicity. A minimum of 6 cycles may be required to achieve a complete remission. Once permanently discontinued from study treatment, patients will enter the Long-term Follow-up phase of the study and will be followed for assessment of disease progression, if applicable, and survival every 3 months (±1 month) until death. The end of this study is defined when 390 events (deaths) have occurred and the study is unblinded for final overall survival analysis. Patients who are receiving study treatment at the end of the study may have the opportunity to continue to receive the study drugs to which they were randomized to (Post- Study Observation Period), until the Sponsor informs the Investigators of the appropriate course of action based on the study results. The Post-Study Observation Period is defined as the period starting from the end of the study for a maximum of 12 months. Sponsor: Helsinn Healthcare SA Intervention: Pracinostat Start Date: 2017-06-23 Last Updated: 2022-03-10 Number of Patients: 406 Recruitment Status: TERMINATED Condition: Acute Myeloid Leukemia
NCTID: NCT03631706
Title: M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC) Study Summary: The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: M7824 Start Date: 2018-10-01 Last Updated: 2023-10-27 Number of Patients: 304 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT04526106
Title: REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Study Summary: This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic cholangiocarcinoma (CCA) and other solid tumors. The study consists of 3 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3). Sponsor: Relay Therapeutics, Inc. Intervention: RLY-4008 Start Date: 2020-09-02 Last Updated: 2023-10-25 Number of Patients: 550 Recruitment Status: RECRUITING Condition: FGFR2 Amplification
NCTID: NCT03485209
Title: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors Study Summary: This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study. * In Part A, the treatment will be given to participants every 3 weeks (3-week cycles). * In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle. * In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part D, participants will be given treatment on Day 1 of every 3-week cycle. Participants in Part D will get tisotumab vedotin with either: ** Pembrolizumab or, ** Pembrolizumab and carboplatin, or ** Pembrolizumab and cisplatin * In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab. * In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin. Sponsor: Seagen Inc. Intervention: tisotumab vedotin Start Date: 2018-06-25 Last Updated: 2023-11-29 Number of Patients: 692 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms
NCTID: NCT01506609
Title: Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer Study Summary: The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer. Sponsor: AbbVie Intervention: Placebo Start Date: 2012-01-23 Last Updated: 2021-10-25 Number of Patients: 294 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT01740427
Title: A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) Study Summary: The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease. Sponsor: Pfizer Intervention: PD-0332991 Start Date: 2013-02-22 Last Updated: 2022-12-08 Number of Patients: 666 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Neoplasms
NCTID: NCT04619004
Title: HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer Study Summary: This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen. Sponsor: Daiichi Sankyo, Inc. Intervention: Patritumab Deruxtecan (Fixed dose) Start Date: 2021-02-02 Last Updated: 2023-11-18 Number of Patients: 420 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer Metastatic
NCTID: NCT00083304
Title: Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer Study Summary: RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy. RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better. This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place. Sponsor: Spectrum Pharmaceuticals, Inc Intervention: Efaproxiral Start Date: 2004-02 Last Updated: 2013-05-10 Number of Patients: 368 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04813627
Title: Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy Study Summary: This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx), during the course of AdCTx and for a period of 630 days thereafter, according to CRC stages and disease characteristics. Participants receive no therapeutic intervention as part of this study. This study will identify participants who might be potential candidates for the clinical trial BNT122-01 (NCT04486378), a study of RO7198457 after completion of standard AdCTx in this patient population. Based on the eligibility criteria for that trial, this study will identify participants with confirmed Stage II (high risk)/III CRC that are positive for ctDNA after resection and are therefore at high risk of disease recurrence to enrich the BNT122-01 study cohort. These participants will have the option to enter screening for BNT122-01 at Screening Visit 2 of that trial if they meet the eligibility criteria of BNT000-001 during screening. Data from the assessments from BNT000-001 will be carried across to the BNT122-01 trial where feasible. Sponsor: BioNTech SE Intervention: Regular blood sample collection for ctDNA assessment Start Date: 2021-07-02 Last Updated: 2023-11-15 Number of Patients: 1500 Recruitment Status: RECRUITING Condition: Colorectal Cancer Stage II
NCTID: NCT04527991
Title: Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician’s Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer Study Summary: The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician’s choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2021-01-13 Last Updated: 2023-06-22 Number of Patients: 696 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced or Metastatic Unresectable Urothelial Cancer
NCTID: NCT04066491
Title: Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC Study Summary: Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: M7824 Start Date: 2019-09-20 Last Updated: 2023-11-14 Number of Patients: 309 Recruitment Status: TERMINATED Condition: Biliary Tract Cancer
NCTID: NCT02425891
Title: A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) Study Summary: This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Start Date: 2015-06-23 Last Updated: 2022-07-19 Number of Patients: 902 Recruitment Status: COMPLETED Condition: Triple Negative Breast Cancer
NCTID: NCT00022191
Title: Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2001-05 Last Updated: 2013-06-12 Number of Patients: 608 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT04657991
Title: A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma Study Summary: The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metastatic (spread to other parts of the body); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day. Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2021-01-15 Last Updated: 2023-11-07 Number of Patients: 624 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT01212991
Title: A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer Study Summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2010-09-16 Last Updated: 2020-03-17 Number of Patients: 1717 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT03906071
Title: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer Study Summary: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy. Sponsor: Mirati Therapeutics Inc. Intervention: Nivolumab Start Date: 2019-07-15 Last Updated: 2023-10-24 Number of Patients: 532 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non-Squamous Non-Small Cell Lung Cancer
NCTID: NCT02005471
Title: A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Study Summary: The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B). Sponsor: Hoffmann-La Roche Intervention: Bendamustine Start Date: 2014-03-17 Last Updated: 2023-10-17 Number of Patients: 389 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT03422679
Title: Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies Study Summary: This is a phase I/II, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of CB-103. Sponsor: Cellestia Biotech AG Intervention: CB-103 Start Date: 2017-12-05 Last Updated: 2023-02-09 Number of Patients: 79 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT02928406
Title: A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract Study Summary: This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2016-11-30 Last Updated: 2022-12-22 Number of Patients: 1005 Recruitment Status: COMPLETED Condition: Urinary Tract Cancer
NCTID: NCT05153239
Title: Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON) Study Summary: Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator’s Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line. Sponsor: PharmaMar Intervention: Irinotecan Start Date: 2022-07-22 Last Updated: 2023-11-27 Number of Patients: 705 Recruitment Status: RECRUITING Condition: Relapsed Small Cell Lung Cancer
NCTID: NCT04950075
Title: Study of INBRX-109 in Conventional Chondrosarcoma Study Summary: Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. Sponsor: Inhibrx, Inc. Intervention: INBRX-109 Start Date: 2021-09-23 Last Updated: 2023-11-08 Number of Patients: 201 Recruitment Status: RECRUITING Condition: Conventional Chondrosarcoma
NCTID: NCT04924075
Title: Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) Study Summary: This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2021-08-12 Last Updated: 2023-11-27 Number of Patients: 322 Recruitment Status: RECRUITING Condition: Pheochromocytoma/Paraganglioma
NCTID: NCT05794906
Title: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies Study Summary: Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen <math display="block">PSMA</math> positron emission tomography <math display="block">PET</math>) /computed tomography <math display="block">CT</math>) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants’ overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Sponsor: Bayer Intervention: Darolutamide (BAY1841788, Nubeqa) Start Date: 2023-04-03 Last Updated: 2023-11-28 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Biochemically Recurrent Prostate Cancer
NCTID: NCT00486759
Title: A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma Study Summary: This 2-arm study was designed to compare the efficacy and safety of bevacizumab (Avastin) in combination with rituximab (MabThera) and CHOP (cyclophosphamide, hydroxydaunorubicin <math display="block">doxorubicin</math>, Oncovin <math display="block">vincristine</math>, prednisone) chemotherapy (R-CHOP) versus rituximab plus CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Patients were randomized to receive 8 cycles of treatment with R-CHOP plus bevacizumab or R-CHOP plus placebo. Treatment with bevacizumab/placebo and R-CHOP was given either on a 2-week or 3-week schedule and bevacizumab was given at a weekly average dose of 5 mg/kg (10 mg/kg for 2-week cycles and 15 mg/kg for 3-week cycles). Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2007-07-26 Last Updated: 2017-07-25 Number of Patients: 787 Recruitment Status: TERMINATED Condition: B-cell Lymphoma
NCTID: NCT02077868
Title: Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment Study Summary: The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal cancer. Sponsor: Mologen AG Intervention: Usual Maintenance Start Date: 2014-09 Last Updated: 2019-09-10 Number of Patients: 540 Recruitment Status: UNKNOWN Condition: Metastatic Colorectal Cancer
NCTID: NCT05386550
Title: Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION) Study Summary: The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Xevinapant (Debio 1143) Start Date: 2022-10-06 Last Updated: 2023-11-02 Number of Patients: 700 Recruitment Status: RECRUITING Condition: Head and Neck Cancer
NCTID: NCT04529850
Title: Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer Study Summary: GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM) Sponsor: Galera Therapeutics, Inc. Intervention: Drug: GC4419 Start Date: 2020-06-30 Last Updated: 2022-08-16 Number of Patients: 38 Recruitment Status: COMPLETED Condition: Head and Neck Cancer
NCTID: NCT02562443
Title: Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients After Failure of an HMA Study Summary: The study’s primary objective <math display="block">in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)</math>, is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk. Sponsor: Onconova Therapeutics, Inc. Intervention: rigosertib Start Date: 2015-12-02 Last Updated: 2022-09-26 Number of Patients: 372 Recruitment Status: TERMINATED Condition: Myelodysplastic Syndrome
NCTID: NCT00849667
Title: Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse Study Summary: This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer. Sponsor: Morphotek Intervention: Farletuzumab Start Date: 2009-04-16 Last Updated: 2022-12-30 Number of Patients: 1100 Recruitment Status: TERMINATED Condition: Ovarian Cancer
NCTID: NCT04740307
Title: Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004) Study Summary: The purpose of this study is to evaluate the safety and efficacy of fixed dose coformulated pembrolizumab/quavonlimab (MK-1308A) plus lenvatinib in a first line (1L) hepatocellular carcinoma (HCC) setting. No hypothesis testing will be performed. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Quavonlimab Start Date: 2021-03-16 Last Updated: 2023-11-13 Number of Patients: 110 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Hepatocellular Carcinoma
NCTID: NCT03395197
Title: Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC Study Summary: This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide. Sponsor: Pfizer Intervention: Talazoparib with enzalutamide Start Date: 2017-12-18 Last Updated: 2023-08-02 Number of Patients: 1125 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: mCRPC
NCTID: NCT00036543
Title: A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer Study Summary: This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer. Sponsor: Abbott Intervention: Atrasentan Start Date: 2001-05 Last Updated: 2006-08-15 Number of Patients: 1000 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT02500043
Title: Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer Study Summary: The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer. Sponsor: Taiho Oncology, Inc. Intervention: TAS-102 Start Date: 2016-02-24 Last Updated: 2021-09-16 Number of Patients: 507 Recruitment Status: COMPLETED Condition: Refractory Metastatic Gastric Cancer
NCTID: NCT02366143
Title: A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Study Summary: This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 <math display="block">PD-L1</math> antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab). Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Start Date: 2015-03-31 Last Updated: 2021-09-23 Number of Patients: 1202 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03155997
Title: Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer Study Summary: The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer. Sponsor: Eli Lilly and Company Intervention: Abemaciclib Start Date: 2017-07-12 Last Updated: 2023-07-14 Number of Patients: 5637 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01307397
Title: A Study of Vemurafenib in Participants With Metastatic Melanoma Study Summary: This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer <math display="block">AJCC</math>) metastatic melanoma. Sponsor: Hoffmann-La Roche Intervention: Vemurafenib Start Date: 2011-03-01 Last Updated: 2017-12-18 Number of Patients: 3219 Recruitment Status: COMPLETED Condition: Malignant Melanoma
NCTID: NCT00715637
Title: Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study Study Summary: Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML. Sponsor: Antisoma Research Intervention: Daunorubicin and Cytarabine Start Date: 2007-06 Last Updated: 2010-10-13 Number of Patients: 420 Recruitment Status: UNKNOWN Condition: Secondary Acute Myeloid Leukemia (Secondary AML, sAML)
NCTID: NCT03317496
Title: Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies Study Summary: This is a Phase 1b/2, open label, multicenter, safety and clinical activity study of avelumab in combination with chemotherapy as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Cohort A1) and in combination with gemcitabine and cisplatin in patients with cisplatin-eligible urothelial (bladder) cancer (UC) (Cohort A2). As more information is learned about other anti-cancer immunotherapy agents, in future portions of the study, avelumab may be combined with chemotherapy and other anti-cancer immunotherapy agents in patients with these same or different tumor types. Sponsor: Pfizer Intervention: Avelumab 800 mg in combination with pemetrexed / carboplatin Start Date: 2017-12-21 Last Updated: 2023-08-29 Number of Patients: 67 Recruitment Status: TERMINATED Condition: Non-small Cell Lung Cancer
NCTID: NCT03148795
Title: A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Study Summary: The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone). Sponsor: Pfizer Intervention: Talazoparib Start Date: 2017-07-04 Last Updated: 2023-05-10 Number of Patients: 128 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT03677596
Title: A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients Study Summary: This study will explore 2 different doses of inotuzumab ozogamicin including the dose that is approved and a lower dose. The main purpose of this study is to evaluate whether a dose of inotuzumab ozogamicin, lower than the approved dose, could be recommended for adult patient with relapsed or refractory ALL who may be at higher risk for severe liver problems after inotuzumab ozogamicin treatment and stem cell transplant (a potentially curative therapy that can replace cancer cells with healthy cells). Efficacy and safety of the 2 doses will be evaluated. Sponsor: Pfizer Intervention: inotuzumab ozogamicin-dose level 2 Start Date: 2019-07-01 Last Updated: 2023-11-22 Number of Patients: 102 Recruitment Status: COMPLETED Condition: Leukemia
NCTID: NCT04644237
Title: Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) Study Summary: This study was designed to evaluate the safety and efficacy of trastuzumab deruxtecan in HER2-mutated metastatic non-small cell lung cancer (NSCLC) participants who had disease recurrence or progression during/after at least one regimen of prior anticancer therapy (second line or later) that must have contained a platinum-based chemotherapy drug. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2021-03-19 Last Updated: 2023-07-27 Number of Patients: 152 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT02785900
Title: Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Study Summary: The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine. Sponsor: Seagen Inc. Intervention: 33A Start Date: 2016-05 Last Updated: 2018-12-12 Number of Patients: 240 Recruitment Status: TERMINATED Condition: Acute Myeloid Leukemia
NCTID: NCT04776148
Title: Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017) Study Summary: The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride). The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival. Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2021-03-29 Last Updated: 2023-11-13 Number of Patients: 480 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Colorectal Neoplasms
NCTID: NCT03767348
Title: Study of RP1 Monotherapy and RP1 in Combination With Nivolumab Study Summary: RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy. Sponsor: Replimune Inc. Intervention: RP1 Start Date: 2017-09-20 Last Updated: 2023-08-02 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT05562830
Title: A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A) Study Summary: This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments. Sponsor: Merck Sharp & Dohme LLC Intervention: Zilovertamab vedotin Start Date: 2022-11-16 Last Updated: 2023-07-03 Number of Patients: 40 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT03906331
Title: Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation Study Summary: Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program. Sponsor: Loxo Oncology, Inc. Intervention: Selpercatinib Start Date: NA Last Updated: 2023-10-02 Number of Patients: NA Recruitment Status: AVAILABLE Condition: Non Small Cell Lung Cancer
NCTID: NCT00069121
Title: A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer Study Summary: This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals. Sponsor: Hoffmann-La Roche Intervention: Capecitabine Start Date: 2003-04-18 Last Updated: 2020-03-06 Number of Patients: 1886 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT02420821
Title: A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC) Study Summary: This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Start Date: 2015-05-20 Last Updated: 2023-01-30 Number of Patients: 915 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma
NCTID: NCT01728155
Title: European Low and Intermediate Risk Neuroblastoma Protocol
Study Summary: The European study, LINES 2009 (Low and Intermediate Risk Neuroblastoma European Study), groups together in a single protocol the treatment of all patients with “non high risk” neuroblastoma (NB), with stratification into two groups: low risk and intermediate risk. These two separate cohorts are included in one single protocol to enable patient data from these two groups to be entered into a common database, as the current prognostic classifications determining treatment may evolve further with subsequent more detailed molecular analysis of the tumours. # LOW RISK STUDY The Low Risk Study is proposed in order to:
minimise the amount of treatment (chemotherapy and surgery) for all appropriate low risk patients, who in previous studies have been shown to have an excellent long-term outcome (as in the SIOPEN 99.1-2 infant neuroblastoma studies where the overall survival was greater than 97%(H. Rubie, JCO).
improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a SCA(Segmental Cromosomal Aberration) genomic profile tumour (presence of any segmental chromosomal change (SCA)) by electively treating these patients with chemotherapy despite the absence of symptoms.
- INTERMEDIATE RISK STUDY
The Intermediate Risk Study is proposed in order to: * reduce the amount of chemotherapy for differentiating histology INRG (International Neuroblastoma Risk Group) stage L2 NB and ganglioneuroblastoma nodular patients who in previous SIOPEN study have been shown to have an excellent long-term outcome; * increase the amount of treatment (radiotherapy and 13-cis-RA (13-cis-Retinoic Acid) for poorly differentiated or undifferentiated histology INRG stage L2 NB or ganglioneuroblastoma nodular patients in order to improve the EFS registered in the previous SIOPEN study; * improve the EFS (Event Free Survival) of MYCN (V-Myc myelocytomatosis viral related oncogene, NB derived ,avian )amplified INSS (International NB Staging System) stage 1 NB patients with the introduction of adjuvant treatment; * maintain the very good results obtained in previous SIOPEN study for INRG stage M infants with a moderate treatment. NEONATAL SUPRARENAL MASSES The incidence of suprarenal tumours/masses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care. The differential diagnosis of these masses ranges from benign (adrenal haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on perinatal suprarenal masses, although based on a relatively large literature, is scattered amongst studies on very few cases with no methodical approach and often short follow up. Therefore, the optimal management of these masses has not been clearly defined. Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases. The SIOPEN Group, based on their results in the first multicenter European Trial for infants with neuroblastoma (INES) and the world-wide experience provided in the literature, is launching this European surveillance study (Multi-centre, non-blinded, one armed prospective trial) for these masses. Treatment: Observation
Sponsor: Instituto de Investigacion Sanitaria La Fe Intervention: chemotherapy Start Date: 2011-01-01 Last Updated: 2023-09-08 Number of Patients: 685 Recruitment Status: COMPLETED Condition: LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES
NCTID: NCT05262530
Title: Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors Study Summary: This trial is an open-label, multicenter, Phase I/IIa, dose escalation, safety, and pharmacokinetics (PK) trial of BNT142 followed by expansion cohorts in patients with Claudin 6 (CLDN6)-positive advanced tumors. Sponsor: BioNTech SE Intervention: BNT142 Start Date: 2022-03-28 Last Updated: 2023-11-21 Number of Patients: 288 Recruitment Status: RECRUITING Condition: Solid Tumor
NCTID: NCT01522612
Title: Colorectal Cancer (CRC) Cetuximab Elderly Frail Study Summary: OBJECTIVE: The principal objective of the trial is to evaluate whether the addition of cetuximab associated with 5-fluorouracil in elderly patients with KRAS wild type advanced colorectal cancer (CRC) prolongs Progression Free Survival, compared with 5-fluorouracil alone. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Cetuximab Start Date: 2013-04 Last Updated: 2016-06-10 Number of Patients: 5 Recruitment Status: TERMINATED Condition: Colorectal Cancer Metastatic
NCTID: NCT04188548
Title: A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer Study Summary: The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer. Sponsor: Eli Lilly and Company Intervention: LY3484356 Start Date: 2019-12-10 Last Updated: 2023-04-13 Number of Patients: 500 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT04401748
Title: Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome Study Summary: Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person’s bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires. Sponsor: AbbVie Intervention: Venetoclax Start Date: 2020-09-10 Last Updated: 2023-04-26 Number of Patients: 531 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelodysplastic Syndrome (MDS)
NCTID: NCT02574455
Title: Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) Study Summary: The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician’s choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline. Sponsor: Gilead Sciences Intervention: Sacituzumab govitecan Start Date: 2017-11-07 Last Updated: 2022-06-15 Number of Patients: 529 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02227251
Title: Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Study Summary: A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit. Sponsor: Karyopharm Therapeutics Inc Intervention: Selinexor Start Date: 2014-11 Last Updated: 2023-08-07 Number of Patients: 244 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT04189614
Title: An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer Study Summary: This study is being done to determine the efficacy and safety of cofetuzumab pelidotin in the PTK7-expressing, recurrent non-small cell lung cancer (NSCLC) population. Sponsor: AbbVie Intervention: Cofetuzumab Pelidotin Start Date: 2020-02-13 Last Updated: 2023-06-27 Number of Patients: 65 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cancer
NCTID: NCT03750786
Title: A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer Study Summary: This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria. Sponsor: Isofol Medical AB Intervention: Arfolitixorin Start Date: 2018-12-18 Last Updated: 2023-10-26 Number of Patients: 490 Recruitment Status: COMPLETED Condition: Colo-rectal Cancer
NCTID: NCT05525286
Title: Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma Study Summary: This trial will assess the MTD and RP2D of SOT102 administered as monotherapy (Part A) and in combination with first-line SoC treatment (mFOLFOX6 with nivolumab and nab-paclitaxel/ gemcitabine; Part B) and efficacy of SOT102 administered as monotherapy (Part C) and in combination with first-line SoC treatment (Part D) in patients with advanced inoperable or metastatic gastric/GEJ adenocarcinoma or inoperable or metastatic pancreatic adenocarcinoma. Sponsor: Sotio Biotech Inc. Intervention: SOT102 Start Date: 2022-03-31 Last Updated: 2023-11-28 Number of Patients: 269 Recruitment Status: SUSPENDED Condition: Gastric Cancer
NCTID: NCT00182819
Title: Radiation Therapy or Temozolomide in Treating Patients With Gliomas Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, 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 whether radiation therapy is more effective than temozolomide in treating gliomas. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: temozolomide Start Date: 2005-07 Last Updated: 2016-10-12 Number of Patients: 709 Recruitment Status: COMPLETED Condition: Brain and Central Nervous System Tumors
NCTID: NCT01964430
Title: Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the “Apact” Study) Study Summary: The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone. Sponsor: Celgene Intervention: nab-Paclitaxel Start Date: 2014-03-28 Last Updated: 2023-06-28 Number of Patients: 866 Recruitment Status: COMPLETED Condition: Pancreatic Neoplasms
NCTID: NCT04597125
Title: Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH Study Summary: Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain. Sponsor: Bayer Intervention: Radium-223 dichloride (Xofigo, BAY88-8223) Start Date: 2020-11-09 Last Updated: 2023-11-14 Number of Patients: 696 Recruitment Status: RECRUITING Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC)
NCTID: NCT01390948
Title: A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma Study Summary: This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be randomly assigned to one of two treatment arms. Upon approval by the Health Authorities/Ethics Committees in the participating countries, an additional young participant cohort (YPC) (children >/= 6 months and < 3 years of age with progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year. Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2011-10-18 Last Updated: 2020-08-06 Number of Patients: 124 Recruitment Status: COMPLETED Condition: High Grade Glioma
NCTID: NCT01383148
Title: Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer Study Summary: This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC). TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen. TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system. Sponsor: Transgene Intervention: TG4010 Start Date: 2012-04 Last Updated: 2017-01-05 Number of Patients: 222 Recruitment Status: TERMINATED Condition: Non-Small-Cell Lung Carcinoma
NCTID: NCT00643565
Title: A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma. Study Summary: This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years. Sponsor: Hoffmann-La Roche Intervention: Standard chemotherapy Start Date: 2008-07-29 Last Updated: 2019-10-22 Number of Patients: 154 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT02242942
Title: Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia Study Summary: This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years. Sponsor: Hoffmann-La Roche Intervention: Chlorambucil Start Date: 2014-12-31 Last Updated: 2023-09-21 Number of Patients: 445 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphocytic Leukemia, Chronic
NCTID: NCT00499265
Title: Gemcitabine With or Without WX-671 in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. WX-671 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with WX-671 may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well gemcitabine works when given together with WX-671 or when given alone in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery. Sponsor: Heidelberg Pharma AG Intervention: gemcitabine hydrochloride Start Date: 2007-04 Last Updated: 2012-03-29 Number of Patients: 95 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT04580121
Title: A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420. Study Summary: This open-label, entry-into-human (EIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of RO7283420. Escalating doses of RO7283420 will be administered to participants with Acute Myeloid Leukemia (AML) in order to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). Sponsor: Hoffmann-La Roche Intervention: RO7283420 Start Date: 2020-11-04 Last Updated: 2023-11-13 Number of Patients: 220 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT04495621
Title: MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) Study Summary: Open-label, dose-confirmation and cohort expansion, multicentre, Phase Ib/II study to assess the anti-tumour activity and safety of MEN1611 in combination with cetuximab for the treatment of patients with PIK3CA mutated metastatic colorectal cancer. Sponsor: Menarini Group Intervention: MEN1611 Start Date: 2020-07-20 Last Updated: 2023-08-30 Number of Patients: 29 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT03386721
Title: Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors Study Summary: This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on participants with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type. Sponsor: Hoffmann-La Roche Intervention: simlukafusp alfa Start Date: 2018-02-19 Last Updated: 2023-02-21 Number of Patients: 256 Recruitment Status: TERMINATED Condition: Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers
NCTID: NCT04607421
Title: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer Study Summary: The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. The study team will monitor how each participant responds to the study treatment for up to about 3 years. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2020-12-21 Last Updated: 2023-09-11 Number of Patients: 815 Recruitment Status: RECRUITING Condition: Neoplasms
NCTID: NCT01982955
Title: Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT) Study Summary: This is a multi-center, open-label, randomized, Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS) of Tepotinib when used in combination with gefitinib in partcipants with T790M negative, MET positive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation and having acquired resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy. This study has 2:1 randomization (Tepotinib/Gefitinib arm versus Chemotherapy arm). Sponsor: Merck KGaA, Darmstadt, Germany Intervention: Tepotinib Start Date: 2013-12-23 Last Updated: 2022-11-08 Number of Patients: 88 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer
NCTID: NCT02102165
Title: AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer. Study Summary: This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe. Eligible patients are those who are 18 or older, either female or male, and who have not received more than 1 type of treatment from the time metastases were discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be collected for central analyses, together with blood, serum and plasma samples. Any samples not analyzed immediately will be stored in an independent bio-repository to enable future (not yet defined) research aimed at better understanding metastatic breast cancer. In summary, the main objectives of AURORA are to better understand the genetic aberrations in metastatic breast cancer and to discover the mechanisms of response or resistance to therapy, in order to ultimately identify the “right therapy for each individual patient”. At the same time, patients with genetic aberrations that are being targeted by new drugs in development will be offered the possibility to participate in clinical trials, when approved and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all patients diagnosed with metastatic breast cancer. Sponsor: Breast International Group Intervention: metastatic lesion biopsy Start Date: 2014-04 Last Updated: 2023-01-18 Number of Patients: 1000 Recruitment Status: SUSPENDED Condition: Metastatic Breast Cancer
NCTID: NCT04979442
Title: Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma Study Summary: Randomized, multicenter, open-label, Phase 3 registration study designed to evaluate the safety and efficacy of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy. Sponsor: Rain Oncology Inc Intervention: RAIN-32 Start Date: 2021-07-14 Last Updated: 2023-10-18 Number of Patients: 175 Recruitment Status: TERMINATED Condition: Dedifferentiated Liposarcoma
NCTID: NCT04586231
Title: A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) Study Summary: This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival. Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2021-02-25 Last Updated: 2023-08-14 Number of Patients: 708 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT06112314
Title: IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) Study Summary: This is a phase 3, randomized, controlled study of IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma. Sponsor: Immunocore Ltd Intervention: IMC-F106C Start Date: 2023-12-01 Last Updated: 2023-11-01 Number of Patients: 680 Recruitment Status: NOT_YET_RECRUITING Condition: Advanced Melanoma
NCTID: NCT02637687
Title: A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children Study Summary: The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb. Sponsor: Bayer Intervention: Larotrectinib (Vitrakvi, BAY2757556) Start Date: 2015-12-16 Last Updated: 2023-10-31 Number of Patients: 155 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors Harboring NTRK Fusion
NCTID: NCT02308085
Title: Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer Study Summary: The best available evidence suggests that pregnancy after breast cancer does not increase a woman’s risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers. Sponsor: ETOP IBCSG Partners Foundation Intervention: Endocrine therapy interruption Start Date: 2014-12-04 Last Updated: 2023-03-16 Number of Patients: 518 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Early Breast Cancer
NCTID: NCT02923921
Title: Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer Study Summary: To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival. Sponsor: Eli Lilly and Company Intervention: Pegilodecakin Start Date: 2017-03-01 Last Updated: 2020-10-19 Number of Patients: 567 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT02450331
Title: A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection Study Summary: This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2015-10-05 Last Updated: 2023-06-18 Number of Patients: 809 Recruitment Status: TERMINATED Condition: Carcinoma, Transitional Cell
NCTID: NCT02164955
Title: A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma. Study Summary: This registry is a prospective, multi-center, observational study and will collect safety data on multiple myeloma adult patients who have received at least two prior therapies and take IMNOVID (pomalidomide) as part of standard care. The registry will remain open until 500 patients will have received at least 3 cycles of pomalidomide. All patients registered will be followed for up to 3 years after the informed consent date or until death or withdrawal of consent. During this time the incidence of second primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed. Sponsor: Celgene Intervention: IMNOVID Start Date: 2014-06-26 Last Updated: 2022-10-20 Number of Patients: 775 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT04662255
Title: Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) Study Summary: This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2021-04-08 Last Updated: 2023-10-04 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Lymphoma, Mantle-Cell
NCTID: NCT04513925
Title: A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) Study Summary: The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2020-08-24 Last Updated: 2023-11-03 Number of Patients: 829 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer (NSCLC)
NCTID: NCT00781612
Title: A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies Study Summary: This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study. Sponsor: Genentech, Inc. Intervention: Docetaxel Start Date: 2008-10-16 Last Updated: 2023-11-13 Number of Patients: 720 Recruitment Status: RECRUITING Condition: Neoplasm Metastasis
NCTID: NCT01508000
Title: Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab in Patients With Resectable Liver Metastases Study Summary: Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases,resection should be considered after limited chemotherapy. There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended. The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome. It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase II study. Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: FOLFOX6 Start Date: 2013-06 Last Updated: 2016-10-12 Number of Patients: 44 Recruitment Status: TERMINATED Condition: Colorectal Cancer Metastatic
NCTID: NCT03523585
Title: DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] Study Summary: This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2018-08-01 Last Updated: 2023-06-26 Number of Patients: 608 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT02399085
Title: Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL Study Summary: This is a Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL). Sponsor: MorphoSys AG Intervention: Tafasitamab Start Date: 2016-03-29 Last Updated: 2023-10-23 Number of Patients: 81 Recruitment Status: COMPLETED Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT01125566
Title: LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment Study Summary: To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment Sponsor: Boehringer Ingelheim Intervention: BIBW 2992 Start Date: 2010-06-22 Last Updated: 2019-07-18 Number of Patients: 508 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT01997229
Title: Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study) Study Summary: The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis. Sponsor: Alexion Pharmaceuticals, Inc. Intervention: Eculizumab Start Date: 2013-12 Last Updated: 2019-07-16 Number of Patients: 125 Recruitment Status: COMPLETED Condition: Refractory Generalized Myasthenia Gravis
NCTID: NCT01949129
Title: Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia Study Summary: The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups. Sponsor: St. Anna Kinderkrebsforschung Intervention: VP16 Start Date: 2013-04 Last Updated: 2020-10-01 Number of Patients: 1000 Recruitment Status: RECRUITING Condition: Acute Lymphoblastic Leukaemia
NCTID: NCT03353753
Title: Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies Study Summary: This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients were randomized in a 2:1 ratio to ripretinib 150 mg QD or placebo Sponsor: Deciphera Pharmaceuticals LLC Intervention: DCC-2618 Start Date: 2018-02-27 Last Updated: 2022-11-21 Number of Patients: 129 Recruitment Status: COMPLETED Condition: Gastrointestinal Stromal Tumors
NCTID: NCT02625610
Title: Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100) Study Summary: The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2015-12-24 Last Updated: 2022-06-09 Number of Patients: 499 Recruitment Status: COMPLETED Condition: Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction
NCTID: NCT01909453
Title: Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma Study Summary: This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms: # LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or # vemurafenib 960 mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms: # LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) Sponsor: Pfizer Intervention: LGX818 Start Date: 2013-12-13 Last Updated: 2023-09-07 Number of Patients: 921 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT05091567
Title: A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer Study Summary: Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-11-18 Last Updated: 2023-11-13 Number of Patients: 690 Recruitment Status: RECRUITING Condition: Small-Cell Lung Cancer
NCTID: NCT01189253
Title: Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma Study Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, 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 whether trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma. PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: doxorubicin hydrochloride Start Date: 2011-05 Last Updated: 2014-08-08 Number of Patients: 133 Recruitment Status: TERMINATED Condition: Sarcoma
NCTID: NCT01739764
Title: An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol Study Summary: This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol’s criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first. Sponsor: Hoffmann-La Roche Intervention: Vemurafenib Start Date: 2013-02-19 Last Updated: 2021-01-07 Number of Patients: 215 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT03547973
Title: Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread Study Summary: The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2018-08-13 Last Updated: 2023-11-13 Number of Patients: 643 Recruitment Status: RECRUITING Condition: Metastatic Urothelial Cancer
NCTID: NCT04393753
Title: Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 Study Summary: This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell Carcinoma that have progressed on a previous therapy with an anti-PD-(L)1 antibody Sponsor: 4SC AG Intervention: domatinostat in combination with avelumab Start Date: 2020-09-01 Last Updated: 2023-07-13 Number of Patients: 19 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Merkel Cell Carcinoma
NCTID: NCT02811861
Title: Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma Study Summary: The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review <math display="block">IIR</math> using Response Evaluation Criteria in Solid Tumors <math display="block">RECIST 1.1</math>) as first-line treatment in participants with advanced renal cell carcinoma (RCC). Sponsor: Eisai Inc. Intervention: Lenvatinib Start Date: 2016-10-13 Last Updated: 2023-07-10 Number of Patients: 1069 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT03734029
Title: Trastuzumab Deruxtecan (DS-8201a) Versus Investigator’s Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] Study Summary: This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants’ cancer: * Cannot be removed by an operation * Has spread to other parts of the body Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan (DS-8201a) Start Date: 2018-12-27 Last Updated: 2023-06-15 Number of Patients: 557 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT05512377
Title: Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder Study Summary: This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants’ health and take note of any unwanted effects. Sponsor: Boehringer Ingelheim Intervention: brigimadlin Start Date: 2022-11-25 Last Updated: 2023-11-28 Number of Patients: 155 Recruitment Status: RECRUITING Condition: Pancreatic Neoplasms
NCTID: NCT03151629
Title: International Registry for Men With Advanced Prostate Cancer (IRONMAN) Study Summary: Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance. Sponsor: Prostate Cancer Clinical Trials Consortium Intervention: Standard of Care Start Date: 2017-07-21 Last Updated: 2023-05-06 Number of Patients: 5000 Recruitment Status: RECRUITING Condition: Prostate Cancer
NCTID: NCT01358877
Title: A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer Study Summary: This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG). Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil Start Date: 2011-11-08 Last Updated: 2023-10-04 Number of Patients: 4804 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03024996
Title: A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy Study Summary: 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. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-01-03 Last Updated: 2023-08-03 Number of Patients: 778 Recruitment Status: TERMINATED Condition: Renal Cell Carcinoma
NCTID: NCT01303796
Title: A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia Study Summary: This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible. Sponsor: Cyclacel Pharmaceuticals, Inc. Intervention: Sapacitabine Start Date: 2011-10-01 Last Updated: 2022-06-22 Number of Patients: 482 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT05298423
Title: Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006) Study Summary: This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following: * progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants. * overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants. Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab/vibostolimab Start Date: 2022-05-03 Last Updated: 2023-11-24 Number of Patients: 784 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT02367794
Title: A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131] Study Summary: This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody Start Date: 2015-06-11 Last Updated: 2022-03-21 Number of Patients: 1021 Recruitment Status: COMPLETED Condition: Squamous Non-Small Cell Lung Cancer
NCTID: NCT04043494
Title: International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma Study Summary: Primary objectives: * Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm) * Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02) Sponsor: University Hospital Muenster Intervention: Cyclophosphamide Start Date: 2019-08-23 Last Updated: 2022-12-16 Number of Patients: 683 Recruitment Status: RECRUITING Condition: Lymphoblastic Lymphoma, Childhood
NCTID: NCT03086369
Title: A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer Study Summary: The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer. Sponsor: Eli Lilly and Company Intervention: Olaratumab Start Date: 2017-06-22 Last Updated: 2022-06-28 Number of Patients: 184 Recruitment Status: COMPLETED Condition: Metastatic Pancreatic Cancer
NCTID: NCT04961996
Title: A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) Study Summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population. Sponsor: Hoffmann-La Roche Intervention: Giredestrant Start Date: 2021-08-27 Last Updated: 2023-11-18 Number of Patients: 4200 Recruitment Status: RECRUITING Condition: Early Breast Cancer
NCTID: NCT04745832
Title: Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL) Study Summary: This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL. Sponsor: MEI Pharma, Inc. Intervention: Zandelisib Start Date: 2021-08-13 Last Updated: 2023-05-09 Number of Patients: 82 Recruitment Status: TERMINATED Condition: Follicular Lymphoma (FL)
NCTID: NCT00553410
Title: Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer Study Summary: RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer. PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer. Sponsor: ETOP IBCSG Partners Foundation Intervention: Letrozole Start Date: 2007-08 Last Updated: 2020-03-11 Number of Patients: 4884 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03075423
Title: Randomized Phase-II Study of Nivolumab Plus Ipilimumab vs. Standard of Care in Untreated and Advanced Non-clear Cell RCC Study Summary: SUNNIFORECAST (Standard of Care vs. Nivolumab + Ipilimumab as First line treatment of renal cell cancer of non-clear cell subtypes) is a Phase II, randomized, open-label investigator initiated trial (IIT) of Nivolumab (BMS-936558) combined with Ipilimumab vs standard of care in subjects with previously untreated and advanced (unresectable or metastatic) non-clear cell renal cell carcinoma (nccRCC). Sponsor: Goethe University Intervention: Ipilimumab plus nivolumab Start Date: 2017-11-01 Last Updated: 2023-10-10 Number of Patients: 316 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Renal Cell Carcinoma
NCTID: NCT03284723
Title: PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors Study Summary: The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer. Sponsor: Pfizer Intervention: PF-06804103 Start Date: 2017-11-01 Last Updated: 2022-03-18 Number of Patients: 95 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT05619172
Title: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer Study Summary: The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa (SOT101) in combination with cetuximab in RAS wild-type colorectal cancer. Sponsor: SOTIO Biotech AG Intervention: Nanrilkefusp alfa Start Date: 2022-12-22 Last Updated: 2023-09-18 Number of Patients: 52 Recruitment Status: RECRUITING Condition: Colorectal Cancer
NCTID: NCT03248492
Title: A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) Study Summary: Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant 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. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-8201a Start Date: 2017-08-25 Last Updated: 2023-11-15 Number of Patients: 253 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT02864992
Title: Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION) Study Summary: This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Tepotinib Start Date: 2016-09-13 Last Updated: 2023-06-09 Number of Patients: 337 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification
NCTID: NCT01808573
Title: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting Study Summary: This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. Sponsor: Puma Biotechnology, Inc. Intervention: neratinib Start Date: 2013-03-29 Last Updated: 2021-06-11 Number of Patients: 621 Recruitment Status: COMPLETED Condition: HER2+ Metastatic Breast Cancer (MBC)
NCTID: NCT05018273
Title: Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors Study Summary: A phase 1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, antigen-specific immune response and preliminary antitumor activity associated with VB10.NEO administered in combination with atezolizumab, and to identify a RP2D for VB10.NEO in combination with atezolizumab, in patients with locally advanced and metastatic tumors that have progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care (SOC). Sponsor: Nykode Therapeutics ASA Intervention: VB10.NEO Start Date: 2021-12-21 Last Updated: 2023-01-31 Number of Patients: 60 Recruitment Status: RECRUITING Condition: Solid Tumors, Adult
NCTID: NCT02273973
Title: A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI) Study Summary: This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks. Sponsor: Genentech, Inc. Intervention: Letrozole Start Date: 2014-11-12 Last Updated: 2018-05-21 Number of Patients: 334 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT05217446
Title: A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer Study Summary: The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: * is metastatic (spread to other parts of the body); * has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR) * has a certain type of abnormal gene called “BRAF” and; * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2022-07-11 Last Updated: 2023-10-25 Number of Patients: 104 Recruitment Status: RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT04053673
Title: Phase 1 Study of RBN-2397, an Oral PARP7 Inhibitor, in Patients With Solid Tumors Study Summary: RBN-2397 inhibits PARP7, an enzyme that is switched on by cancer stresses, such as the toxins in cigarette smoke. Cancer cells use PARP7 to hide from the immune system by stopping the cell from sending a signal (Type 1 interferon) that tells the immune system that something is wrong and to kill the cell. RBN-2397 has been shown in animal studies to inhibit tumor growth and also shuts down the “don’t kill me” signal the tumor is sending to evade the immune system. As a PARP7 inhibitor RBN-2397 is different from drugs inhibiting PARP1, PARP2 and PARP3 enzymes which are approved for the treatment of certain ovarian and breast cancers. The primary purpose of this study is to determine the maximum tolerated dose (MTD) of orally administered RBN-2397 in patients with advanced or metastatic solid tumors. This study will also evaluate the safety and tolerability of RBN-2397, examine the pharmacokinetics (PK) (measure how the body absorbs, breaks down and eliminates RBN-2397) and investigate whether it has antitumor activity in solid tumor cancers. Sponsor: Ribon Therapeutics, Inc. Intervention: RBN-2397 Start Date: 2019-08-01 Last Updated: 2023-03-28 Number of Patients: 130 Recruitment Status: RECRUITING Condition: Solid Tumor, Adult
NCTID: NCT05419388
Title: A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma Study Summary: The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of two dose levels of RO7247669 in participants with unresectable or metastatic melanoma to select the recommended dose for further development. Sponsor: Hoffmann-La Roche Intervention: RO7247669 Start Date: 2022-08-15 Last Updated: 2023-11-03 Number of Patients: 80 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT04222972
Title: A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) Study Summary: This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib. Sponsor: Hoffmann-La Roche Intervention: Pralsetinib Start Date: 2020-07-24 Last Updated: 2023-11-13 Number of Patients: 226 Recruitment Status: RECRUITING Condition: RET-fusion Non Small Cell Lung Cancer
NCTID: NCT05933577
Title: A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) Study Summary: The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid <math display="block">mRNA</math>-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning. Sponsor: Merck Sharp & Dohme LLC Intervention: V940 Start Date: 2023-07-19 Last Updated: 2023-11-24 Number of Patients: 1089 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT02807636
Title: Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Study Summary: A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2016-06-30 Last Updated: 2023-06-09 Number of Patients: 1213 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT03539536
Title: Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer Study Summary: This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3). Sponsor: AbbVie Intervention: Telisotuzumab vedotin Start Date: 2018-10-10 Last Updated: 2023-07-14 Number of Patients: 270 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT02141295
Title: A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer Study Summary: This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in participants with previously untreated metastatic colorectal cancer (mCRC). The study consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized, parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 + bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each 14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic acid plus either vanucizumab or bevacizumab for up to 24 months or until disease progression, unacceptable toxicity, Investigator decision or consent withdrawal, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: 5-FU Start Date: 2014-06-30 Last Updated: 2020-03-25 Number of Patients: 197 Recruitment Status: TERMINATED Condition: Colorectal Cancer
NCTID: NCT03262935
Title: SYD985 vs. Physician’s Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer Study Summary: The purpose of this study is to demonstrate that SYD985 <math display="block">(vic-)trastuzumab duocarmazine</math> is superior to physician’s choice in prolonging progression free survival. Sponsor: Byondis B.V. Intervention: (vic-)trastuzumab duocarmazine Start Date: 2017-12-15 Last Updated: 2023-10-19 Number of Patients: 437 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT00294996
Title: Trial of Myocet in Metastatic Breast Cancer Study Summary: The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer. Sponsor: Sopherion Therapeutics Intervention: Myocet Start Date: 2006-01 Last Updated: 2009-03-31 Number of Patients: 363 Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT01120184
Title: A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE) Study Summary: This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded. Sponsor: Hoffmann-La Roche Intervention: docetaxel Start Date: 2010-07-31 Last Updated: 2017-11-07 Number of Patients: 1095 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04468984
Title: Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis Study Summary: Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF. Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 210 sites across the world. In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires. Sponsor: AbbVie Intervention: Navitoclax Start Date: 2020-08-31 Last Updated: 2023-11-14 Number of Patients: 330 Recruitment Status: RECRUITING Condition: Myelofibrosis (MF)
NCTID: NCT02397928
Title: Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR) Study Summary: The study is a prospective, single arm, non-randomized, open label phase II trial, designed to study the safety and efficacy of a medical device, the NovoTTF-100L concomitant with Pemetrexed and cisplatin or carboplatin in Malignant Pleural Mesothelioma patients. 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. Sponsor: NovoCure Ltd. Intervention: NovoTTF-100L device Start Date: 2015-02 Last Updated: 2018-09-25 Number of Patients: 82 Recruitment Status: COMPLETED Condition: Malignant Pleural Mesothelioma
NCTID: NCT04740918
Title: A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) Study Summary: This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2021-06-07 Last Updated: 2023-11-18 Number of Patients: 96 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT03148418
Title: A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A) Study Summary: This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-09-20 Last Updated: 2023-11-18 Number of Patients: 382 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cancer
NCTID: NCT03138889
Title: Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors Study Summary: This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy. The study is comprised of two groups; dose optimization and dose expansion cohorts. Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC) The dose expansion cohort will include first-line NSCLC patients. Sponsor: Nektar Therapeutics Intervention: NKTR-214 Start Date: 2017-06-09 Last Updated: 2023-03-10 Number of Patients: 162 Recruitment Status: TERMINATED Condition: Non-Small Cell Lung Cancer
NCTID: NCT02908672
Title: A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma Study Summary: This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-01-13 Last Updated: 2023-10-06 Number of Patients: 514 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT04807972
Title: Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis Study Summary: Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of cancer with very poor survival. This study will evaluate adverse events and change in disease activity in participants 18 to 75 years of age with a body weight greater than or equal to 35 kg with Metastatic Pancreatic Cancer Disease treated with Intravenous (IV) infusion of modified FOLFIRINOX (mFFX) combined with IV infusions of ABBV-927 with or without Budigalimab. ABBV-927 and Budigalimab are the investigational drugs being developed for treatment of Metastatic Pancreatic Cancer Disease. In this study, doctors will enroll participants between 18 and 75 years of age with a body weight greater than or equal to 35 kg diagnosed diagnosed with Metastatic Pancreatic Cancer Disease in 4 different groups, called treatment arms. Each group will receive different treatments. Approximately 129 adult participants will be enrolled in the study across approximately 27 sites worldwide. Participants will receive ABBV-927 and Budigalimab as Intravenous (IV) Infusion in Phase 1b and Phase 2 on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b and Phase 2 on Day1 and Day 15 of every 28 day cycle up to maximum of 2 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Sponsor: AbbVie Intervention: ABBV-927 Start Date: 2021-05-28 Last Updated: 2023-08-14 Number of Patients: 40 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Pancreatic Cancer
NCTID: NCT03529110
Title: DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] Study Summary: This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan (T-DXd) Start Date: 2018-08-09 Last Updated: 2023-02-09 Number of Patients: 524 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT05099172
Title: First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) Study Summary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. Two mutations observed in NSCLC are called EGFR- or HER2exon20ins and EGFR C797X. The study treatment, BAY2927088, works by blocking the mutated EGFR protein and also its ex20ins version which are present in NSCLC. It is also believed to work against HER2 and HER2ex20ins mutations. Researchers think this may help stop the further spread of NSCLC cancer. This is the first time that researchers will study BAY2927088 in humans. In this study, the researchers want to learn more about using BAY2927088 in participants who have NSCLC with EGFR and/or HER2 mutations including EGFRex20ins and/or HER2ex20ins mutations. The main aims of this study are to find for BAY2927088 * how safe BAY2927088 is * how it affects the body (also referred to as tolerability) * how BAY2927088 moves into, through and out of the body * the maximum amount of BAY2927088 that the participants can take without too many side effects. The researchers will also study the action of BAY2927088 against the cancer. The study will have three parts: Dose Escalation, Backfill, and Dose Expansion. Each participant of the first, so called dose escalation part, will be assigned to one of specific sequential dose groups for BAY2927088. The amount of BAY2927088 that is given increases stepwise from one group to the next. The second may be initiated at any dose that has already been tested during the first part and found to be safe and to have either reached a predicted efficacious exposure range or to have induced an objective response. The first part and second part will run concurrently. The participants of the third, so called dose expansion part, will receive the most appropriate dose of BAY2927088 found in the first and second parts. The third part may be initiated in parallel with the first and second part based on emerging data. During the study, the participants will take the study treatment in 3 week periods called “cycles”. They will in general take BAY2927088 once daily until their cancer gets worse, until they have medical problems, until they leave the study or until the study is terminated. Participants will have around 5 visits in each cycle. During the study, the study team will: * take blood and urine samples * take regular CT or MRI scans to check if the participants’ cancer has gotten better or worse * check the participants’ overall health and heart health * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. Sponsor: Bayer Intervention: BAY2927088_formulation A Start Date: 2021-10-25 Last Updated: 2023-11-28 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Advanced Non-small Cell Lung Cancer
NCTID: NCT03110562
Title: Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma Study Summary: This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm. Sponsor: Karyopharm Therapeutics Inc Intervention: Selinexor Start Date: 2017-05-24 Last Updated: 2023-01-26 Number of Patients: 402 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT05203172
Title: The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials Study Summary: The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib. All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib. Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years. Sponsor: Pfizer Intervention: Binimetinib only treatment Start Date: 2022-07-05 Last Updated: 2023-11-18 Number of Patients: 46 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT03645928
Title: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors Study Summary: A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy. Sponsor: Iovance Biotherapeutics, Inc. Intervention: Lifileucel Start Date: 2019-05-07 Last Updated: 2023-08-23 Number of Patients: 178 Recruitment Status: RECRUITING Condition: Metastatic Melanoma
NCTID: NCT04697628
Title: Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer Study Summary: This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take. Sponsor: Seagen Inc. Intervention: tisotumab vedotin Start Date: 2021-02-22 Last Updated: 2023-11-14 Number of Patients: 556 Recruitment Status: RECRUITING Condition: Cervical Cancer
NCTID: NCT05618028
Title: Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets Study Summary: B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy. ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 100 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study is up to 64 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans. Sponsor: AbbVie Intervention: ABBV-525 Start Date: 2023-04-04 Last Updated: 2023-04-21 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT05239728
Title: A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) Study Summary: The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS). Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2022-03-15 Last Updated: 2023-11-28 Number of Patients: 1800 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT01461928
Title: A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab Study Summary: This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin’s lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter <math display="block">mg/m\^2</math> intravenously <math display="block">IV</math> in Cycle 1, then 1400 mg subcutaneous <math display="block">SC</math> every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Chemotherapy (Induction Period) Start Date: 2011-12-20 Last Updated: 2019-08-06 Number of Patients: 692 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphoma
NCTID: NCT04178902
Title: A Study of the Safety and Tolerability of ABBV-467 in Adult Participants With Relapsed/Refractory (R/R) Multiple Myeloma Study Summary: This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM). Sponsor: AbbVie Intervention: ABBV-467 Start Date: 2020-05-19 Last Updated: 2021-07-26 Number of Patients: 8 Recruitment Status: TERMINATED Condition: Multiple Myeloma (MM)
NCTID: NCT01684878
Title: Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE) Study Summary: This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine). Sponsor: Hoffmann-La Roche Intervention: Gemcitabine (Chemotherapy) Start Date: 2012-10-22 Last Updated: 2017-05-23 Number of Patients: 208 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT04486378
Title: A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer Study Summary: This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon cancer. Sponsor: BioNTech SE Intervention: RO7198457 intravenous (i.v.) Start Date: 2021-03-08 Last Updated: 2023-11-08 Number of Patients: 201 Recruitment Status: RECRUITING Condition: Colorectal Cancer Stage II
NCTID: NCT04608318
Title: Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) Study Summary: The aim of this study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated CLL. Sponsor: German CLL Study Group Intervention: Ibrutinib Start Date: 2021-03-01 Last Updated: 2023-02-23 Number of Patients: 897 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphoid Leukemia
NCTID: NCT01344018
Title: Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: therapeutic conventional surgery Start Date: 2012-01 Last Updated: 2023-04-24 Number of Patients: 266 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT03460977
Title: PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma Study Summary: A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 In The Treatment Of Adult Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL). Sponsor: Pfizer Intervention: PF-06821497 Start Date: 2018-04-17 Last Updated: 2023-11-18 Number of Patients: 267 Recruitment Status: RECRUITING Condition: Castration Resistant Prostate Cancer (CRPC)
NCTID: NCT02486718
Title: Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010] Study Summary: This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2015-10-31 Last Updated: 2023-11-02 Number of Patients: 1280 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT02603432
Title: A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) Study Summary: The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy. Sponsor: Pfizer Intervention: Avelumab Start Date: 2016-04-25 Last Updated: 2023-06-06 Number of Patients: 700 Recruitment Status: COMPLETED Condition: Urothelial Cancer
NCTID: NCT00061984
Title: Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma Study Summary: RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: pegfilgrastim Start Date: 2003-04 Last Updated: 2014-10-27 Number of Patients: 455 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT02834884
Title: SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access Study Summary: SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: RP-1828 IMMUcan Start Date: 2017-05-03 Last Updated: 2023-11-03 Number of Patients: 4975 Recruitment Status: RECRUITING Condition: All Tumor Types
NCTID: NCT04924101
Title: Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99) Study Summary: The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-07-15 Last Updated: 2023-04-10 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Cancer
NCTID: NCT03673501
Title: A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib Study Summary: This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off). Sponsor: Deciphera Pharmaceuticals LLC Intervention: DCC-2618 Start Date: 2019-02-11 Last Updated: 2021-01-06 Number of Patients: 426 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Gastrointestinal Stromal Tumors
NCTID: NCT01191801
Title: Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML Study Summary: This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine. Sponsor: Sunesis Pharmaceuticals Intervention: vosaroxin + cytarabine Start Date: 2010-12-17 Last Updated: 2018-08-22 Number of Patients: 711 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT04067336
Title: First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Study Summary: This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue in patients with NPM1-m AML. Sponsor: Kura Oncology, Inc. Intervention: Ziftomenib Start Date: 2019-09-12 Last Updated: 2023-10-31 Number of Patients: 199 Recruitment Status: RECRUITING Condition: Advanced Malignant Neoplasm
NCTID: NCT04603495
Title: Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) Study Summary: A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins. Sponsor: Constellation Pharmaceuticals Intervention: Pelabresib Start Date: 2020-11-19 Last Updated: 2023-09-25 Number of Patients: 431 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelofibrosis
NCTID: NCT05206357
Title: Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab Study Summary: The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt’s or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt’s or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally. Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects. Sponsor: AbbVie Intervention: Epcoritamab Start Date: 2022-10-04 Last Updated: 2023-11-28 Number of Patients: 15 Recruitment Status: RECRUITING Condition: Non-hodgkin Lymphoma
NCTID: NCT02517398
Title: MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors Study Summary: The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: MSB0011359C Start Date: 2015-08-31 Last Updated: 2022-06-15 Number of Patients: 600 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT04472598
Title: Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis Study Summary: Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body’s normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis. Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide. Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires. Sponsor: AbbVie Intervention: Navitoclax Start Date: 2020-09-29 Last Updated: 2023-04-27 Number of Patients: 252 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelofibrosis (MF)
NCTID: NCT04770896
Title: A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab Study Summary: This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-04-26 Last Updated: 2023-11-13 Number of Patients: 554 Recruitment Status: RECRUITING Condition: Unresectable Hepatocellular Carcinoma
NCTID: NCT02213744
Title: MM-302 Plus Trastuzumab vs. Chemotherapy of Physician’s Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients Study Summary: This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician’s choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting. Sponsor: Merrimack Pharmaceuticals Intervention: MM-302 Start Date: 2014-07 Last Updated: 2017-01-06 Number of Patients: 113 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT05608044
Title: A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer Study Summary: This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer. Sponsor: Agenus Inc. Intervention: Botensilimab Start Date: 2022-11-30 Last Updated: 2023-09-21 Number of Patients: 230 Recruitment Status: RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT04660344
Title: A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy Study Summary: This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2021-05-03 Last Updated: 2023-10-10 Number of Patients: 520 Recruitment Status: RECRUITING Condition: Muscle-invasive Bladder Cancer
NCTID: NCT03539744
Title: A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma. Study Summary: A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone. Sponsor: AbbVie Intervention: Pomalidomide Start Date: 2018-10-22 Last Updated: 2023-11-28 Number of Patients: 244 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT01957436
Title: A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer Study Summary: This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer. Sponsor: UNICANCER Intervention: abiraterone acetate Start Date: 2013-11-13 Last Updated: 2023-11-08 Number of Patients: 1173 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Prostate Cancer
NCTID: NCT03326674
Title: Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC Study Summary: CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled. Sponsor: Odonate Therapeutics, Inc. Intervention: Tesetaxel and Capecitabine Start Date: 2017-12-21 Last Updated: 2021-07-30 Number of Patients: 685 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT03441113
Title: Extended Access of Momelotinib in Adults With Myelofibrosis Study Summary: The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects. Sponsor: GlaxoSmithKline Intervention: MMB Start Date: 2018-05-03 Last Updated: 2023-06-22 Number of Patients: 237 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Neoplasms
NCTID: NCT01723969
Title: Screening Platform for Clinical Trials in Advanced Colorectal Cancer Study Summary: The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this screening platform is to provide quick access to new drugs to patients by offering a new structure for clinical trials. Currently some of the most challenging clinical questions arise from the molecular sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways in the patients. A major problem for trials in this “personalized medicine” is that the low frequency of the different mutations requires a high effort for screening and identifying the patients. The EORTC CRC screening platform will hopefully offer a feasible and efficient way to characterize the patients on the molecular basis of their tumors and allow to offer them rapid and preferential participation in clinical studies with new drugs targeted to their specific pathway alterations. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Tumour markers testing Start Date: 2013-09 Last Updated: 2022-07-07 Number of Patients: 668 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT02576574
Title: Avelumab in First-line NSCLC (JAVELIN Lung 100) Study Summary: The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Avelumab Start Date: 2015-10-29 Last Updated: 2023-11-07 Number of Patients: 1214 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: First Line Non-Small Cell Lung Cancer
NCTID: NCT03456076
Title: A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer Study Summary: This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. Sponsor: Hoffmann-La Roche Intervention: Alectnib Start Date: 2018-08-16 Last Updated: 2023-09-21 Number of Patients: 257 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT04449874
Title: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation Study Summary: This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation. Sponsor: Genentech, Inc. Intervention: GDC-6036 Start Date: 2020-07-29 Last Updated: 2023-11-13 Number of Patients: 498 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT05578976
Title: A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) Study Summary: B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects. Sponsor: AbbVie Intervention: Epcoritamab Start Date: 2023-02-08 Last Updated: 2023-11-29 Number of Patients: 900 Recruitment Status: RECRUITING Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT05546476
Title: Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15 Study Summary: Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15. Sponsor: Pfizer Intervention: ponsegromab Start Date: 2022-11-21 Last Updated: 2023-11-28 Number of Patients: 168 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT06119581
Title: A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C Study Summary: The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing. Sponsor: Eli Lilly and Company Intervention: LY3537982 Start Date: 2024-01-03 Last Updated: 2023-11-07 Number of Patients: 1016 Recruitment Status: NOT_YET_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01721876
Title: Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2) Study Summary: To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients >= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy Sponsor: Boehringer Ingelheim Intervention: Placebo Start Date: 2013-01-29 Last Updated: 2023-02-08 Number of Patients: 666 Recruitment Status: COMPLETED Condition: Leukemia, Myeloid, Acute
NCTID: NCT00974311
Title: Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy Study Summary: This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy. Sponsor: Pfizer Intervention: Enzalutamide Start Date: 2009-09-30 Last Updated: 2018-12-11 Number of Patients: 1199 Recruitment Status: COMPLETED Condition: Castration-Resistant Prostate Cancer
NCTID: NCT03043313
Title: Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer Study Summary: This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). ‘Metastatic’ means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab. Sponsor: Seagen Inc. Intervention: Trastuzumab Start Date: 2017-06-23 Last Updated: 2023-11-13 Number of Patients: 117 Recruitment Status: COMPLETED Condition: Metastatic Colorectal Adenocarcinoma
NCTID: NCT03709680
Title: Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors Study Summary: A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS). Sponsor: Pfizer Intervention: Palbociclib Start Date: 2019-05-24 Last Updated: 2023-11-22 Number of Patients: 184 Recruitment Status: RECRUITING Condition: Ewing Sarcoma
NCTID: NCT02657434
Title: A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132) Study Summary: This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2016-04-30 Last Updated: 2023-11-21 Number of Patients: 578 Recruitment Status: COMPLETED Condition: Non-Small Cell Lung Cancer
NCTID: NCT02214134
Title: SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access Study Summary: SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the molecular characteristics of their disease. The thoracic tumors include lung cancer, malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular characteristics are identified, there might be the possibility to offer these patients access to targeted clinical trials. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Tumour markers testing Start Date: 2015-05-22 Last Updated: 2022-07-08 Number of Patients: 539 Recruitment Status: COMPLETED Condition: Any Stage of Lung Cancer (Any Histotype)
NCTID: NCT02737501
Title: ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants Study Summary: The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS). Sponsor: Ariad Pharmaceuticals Intervention: Brigatinib Start Date: 2016-05-26 Last Updated: 2021-08-20 Number of Patients: 275 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer
NCTID: NCT05226598
Title: Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007) Study Summary: The primary hypotheses are that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Start Date: 2022-03-24 Last Updated: 2023-05-16 Number of Patients: 700 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non-Small Cell Lung Cancer
NCTID: NCT02075840
Title: A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants Study Summary: This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months. Sponsor: Hoffmann-La Roche Intervention: Alectinib Start Date: 2014-08-19 Last Updated: 2023-11-18 Number of Patients: 303 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT04976634
Title: Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016) Study Summary: The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-08-18 Last Updated: 2023-11-18 Number of Patients: 730 Recruitment Status: RECRUITING Condition: Carcinoma, Hepatocellular
NCTID: NCT01492101
Title: The BEACON Study (Breast Cancer Outcomes With NKTR-102) Study Summary: The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens. The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician’s Choice selected from a list of seven single-agent intravenous therapies. Sponsor: Nektar Therapeutics Intervention: NKTR-102 Start Date: 2011-12 Last Updated: 2021-06-01 Number of Patients: 852 Recruitment Status: COMPLETED Condition: Locally Recurrent Breast Cancer
NCTID: NCT05089734
Title: Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Study Summary: The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy (SG) Start Date: 2021-11-17 Last Updated: 2023-06-29 Number of Patients: 580 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT00375674
Title: A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer Study Summary: To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery. Sponsor: Pfizer Intervention: Sunitinib malate Start Date: 2007-08-01 Last Updated: 2018-09-21 Number of Patients: 674 Recruitment Status: COMPLETED Condition: Kidney Neoplasms
NCTID: NCT01251536
Title: Cetuximab Standard or Dose Escalation in First Line Colorectal Cancer Study Summary: The purposes of this study are to determine whether administering escalating doses of cetuximab in patients with no early skin toxicity could delay the progression of disease in a significant proportion of patients and to study the molecular signatures of response. Sponsor: Universitaire Ziekenhuizen KU Leuven Intervention: Dose escalation of cetuximab Start Date: 2010-12 Last Updated: 2019-10-11 Number of Patients: 108 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT05041257
Title: Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers (PICCOLO) Study Summary: PICCOLO (IMGN853-0419) is a Phase 2 multicenter, open label study designed to evaluate the safety and efficacy of Mirvetuximab Soravtansine in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression. Sponsor: ImmunoGen, Inc. Intervention: Mirvetuximab soravtansine Start Date: 2021-08-31 Last Updated: 2023-10-25 Number of Patients: 79 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Cancer
NCTID: NCT01154140
Title: A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung Study Summary: This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer. Sponsor: Pfizer Intervention: treatment Start Date: 2011-01-13 Last Updated: 2017-11-06 Number of Patients: 343 Recruitment Status: COMPLETED Condition: Non Squamous Lung Cancer
NCTID: NCT02760498
Title: Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma Study Summary: Groups 1 to 4 To estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC Group 6 To provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic <math display="block">nodal or distant</math> or locally advanced treated with cemiplimab Sponsor: Regeneron Pharmaceuticals Intervention: cemiplimab Start Date: 2016-04-07 Last Updated: 2023-11-18 Number of Patients: 432 Recruitment Status: COMPLETED Condition: Advanced Cutaneous Squamous Cell Carcinoma
NCTID: NCT04700124
Title: Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) Study Summary: The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy <math display="block">gemcitabine plus cisplatin</math> and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-04-21 Last Updated: 2023-11-18 Number of Patients: 784 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Muscle Invasive Bladder Cancer
NCTID: NCT02928224
Title: Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer Study Summary: This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator’s choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2016-10-13 Last Updated: 2023-05-06 Number of Patients: 702 Recruitment Status: COMPLETED Condition: BRAF V600E-mutant Metastatic Colorectal Cancer
NCTID: NCT02891824
Title: ATALANTE: Atezolizumab vs Placebo Phase III Study in Late Relapse Ovarian Cancer Treated With Chemotherapy+Bevacizumab Study Summary: This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months). Sponsor: ARCAGY/ GINECO GROUP Intervention: atezolizumab + avastin + platinum-based chemotherapy Start Date: 2016-09-22 Last Updated: 2023-07-21 Number of Patients: 614 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Cancer
NCTID: NCT05215340
Title: Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations Study Summary: This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Sponsor: Daiichi Sankyo, Inc. Intervention: Datopotamab Deruxtecan Start Date: 2022-03-04 Last Updated: 2023-11-18 Number of Patients: 740 Recruitment Status: RECRUITING Condition: Metastatic Non Small Cell Lung Cancer
NCTID: NCT05224141
Title: Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008) Study Summary: This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Co-Formulation Start Date: 2022-03-24 Last Updated: 2023-10-10 Number of Patients: 450 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Carcinoma
NCTID: NCT01287741
Title: A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA) Study Summary: This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks. Sponsor: Hoffmann-La Roche Intervention: Rituximab Start Date: 2011-07-26 Last Updated: 2019-04-12 Number of Patients: 1418 Recruitment Status: TERMINATED Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT05218499
Title: Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma Study Summary: This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants’ health and take note of any unwanted effects. Sponsor: Boehringer Ingelheim Intervention: BI 907828 Start Date: 2022-03-25 Last Updated: 2023-11-07 Number of Patients: 400 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Liposarcoma, Dedifferentiated
NCTID: NCT05605899
Title: Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma Study Summary: The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma. Sponsor: Kite, A Gilead Company Intervention: Axicabtagene Ciloleucel Start Date: 2023-02-10 Last Updated: 2023-11-18 Number of Patients: 300 Recruitment Status: RECRUITING Condition: High-risk Large B-cell Lymphoma (LBCL)
NCTID: NCT00976911
Title: AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer Study Summary: This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals. Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2009-10-29 Last Updated: 2022-06-21 Number of Patients: 361 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT03684811
Title: A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation Study Summary: This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas. The study is divided into two parts: single agent FT-2102 followed by combination therapy. Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored. Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102 + nivolumab (hepatobiliary tumors), and FT-2102 + gemcitabine/cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients. Sponsor: Forma Therapeutics, Inc. Intervention: FT-2102 Start Date: 2018-11-01 Last Updated: 2023-11-18 Number of Patients: 93 Recruitment Status: COMPLETED Condition: Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme)
NCTID: NCT03104699
Title: Study of AGEN2034 in Advanced Tumors and Cervical Cancer Study Summary: This is a 2-part trial: a Phase 1, open-label, dose-escalation study in subjects with metastatic or locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in subjects with recurrent, unresectable, or metastatic (advanced) cervical cancer that has progressed after a platinum-based treatment regimen. Sponsor: Agenus Inc. Intervention: AGEN2034 Start Date: 2017-04-11 Last Updated: 2023-06-05 Number of Patients: 211 Recruitment Status: COMPLETED Condition: Advanced Cancer
NCTID: NCT03069469
Title: Study of DCC-3014 in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor Study Summary: This is a multicenter, open-label Phase 1/2 study of DCC-3014 in patients with malignant solid tumors and tenosynovial giant cell tumor (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumor and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients. Sponsor: Deciphera Pharmaceuticals LLC Intervention: DCC-3014 Start Date: 2017-02-16 Last Updated: 2023-10-06 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Malignant Neoplasm
NCTID: NCT01968213
Title: Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) Study Summary: Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. Sponsor: pharmaand GmbH Intervention: Rucaparib Start Date: 2014-04-07 Last Updated: 2023-06-09 Number of Patients: 564 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT03033511
Title: A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU) Study Summary: 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. Sponsor: AbbVie Intervention: Placebo for dexamethasone Start Date: 2017-02-07 Last Updated: 2021-07-29 Number of Patients: 748 Recruitment Status: TERMINATED Condition: Small Cell Lung Cancer
NCTID: NCT04313881
Title: Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) Study Summary: The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS). Sponsor: Gilead Sciences Intervention: Magrolimab Start Date: 2020-09-09 Last Updated: 2023-09-25 Number of Patients: 539 Recruitment Status: TERMINATED Condition: Myelodysplastic Syndromes
NCTID: NCT05446870
Title: Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002) Study Summary: The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor DNA (ctDNA) at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2022-07-25 Last Updated: 2023-10-26 Number of Patients: 160 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: High-grade Serous Ovarian Carcinoma
NCTID: NCT02492711
Title: Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer Study Summary: The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy. A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy. Sponsor: MacroGenics Intervention: Margetuximab Start Date: 2015-08-24 Last Updated: 2022-11-23 Number of Patients: 624 Recruitment Status: COMPLETED Condition: HER-2 Positive Breast Cancer
