Trials (University Cancer Institute Toulouse-Oncopole): Difference between revisions
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(Created page with "{{forpatients}} {{forproviders}} {{forresearchers}} Go back to University Cancer Institute Toulouse-Oncopole page '''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 mel...") |
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Go back to [[University Cancer Institute Toulouse-Oncopole]] page | Go back to [[University Cancer Institute Toulouse-Oncopole]] page | ||
=== Trials: How to participate === | |||
'''Contact information:''' [https://www.iuct-oncopole.fr/en/clinical-research Click here to access]. | |||
'''NCTID''': NCT06112314 | '''NCTID''': NCT06112314 | ||
'''Title''': IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) | '''Title''': [[hasTrialTitle::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. | '''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 | '''Sponsor''': Immunocore Ltd | ||
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'''Condition''': Advanced Melanoma | '''Condition''': Advanced Melanoma | ||
'''NCTID''': NCT04717414 | '''NCTID''': NCT04717414 | ||
'''Title''': An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions | '''Title''': [[hasTrialTitle::An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions]] | ||
'''Study Summary''': The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept. | '''Study Summary''': The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept. | ||
'''Sponsor''': Celgene | '''Sponsor''': Celgene | ||
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'''Condition''': Myeloproliferative Disorders | '''Condition''': Myeloproliferative Disorders | ||
'''NCTID''': NCT05572515 | '''NCTID''': NCT05572515 | ||
'''Title''': A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma | '''Title''': [[hasTrialTitle::A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma]] | ||
'''Study Summary''': The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd. | '''Study Summary''': The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd. | ||
'''Sponsor''': Janssen Research & Development, LLC | '''Sponsor''': Janssen Research & Development, LLC | ||
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'''Condition''': Relapsed or Refractory Multiple Myeloma | '''Condition''': Relapsed or Refractory Multiple Myeloma | ||
'''NCTID''': NCT05508867 | '''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) | '''Title''': [[hasTrialTitle::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). | '''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 | '''Sponsor''': Merck Sharp & Dohme LLC | ||
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'''Condition''': Hodgkin Lymphoma | '''Condition''': Hodgkin Lymphoma | ||
'''NCTID''': NCT02824159 | '''NCTID''': NCT02824159 | ||
'''Title''': Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib | '''Title''': [[hasTrialTitle::Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib]] | ||
'''Study Summary''': Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib. Clinical trials for ibrutinib and idelalisib were performed with a small number of patients (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this study is to determine the association between clinically significant side effects occurrence during the first year of treatment and plasma mean concentration of the steady state of ibrutinib or idelalisib at 1 month. | '''Study Summary''': Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib. Clinical trials for ibrutinib and idelalisib were performed with a small number of patients (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this study is to determine the association between clinically significant side effects occurrence during the first year of treatment and plasma mean concentration of the steady state of ibrutinib or idelalisib at 1 month. | ||
'''Sponsor''': University Hospital, Toulouse | '''Sponsor''': University Hospital, Toulouse | ||
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'''Condition''': Hematological Malignancies | '''Condition''': Hematological Malignancies | ||
'''NCTID''': NCT04172675 | '''NCTID''': NCT04172675 | ||
'''Title''': A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) | '''Title''': [[hasTrialTitle::A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)]] | ||
'''Study Summary''': The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator’s Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy. | '''Study Summary''': The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator’s Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy. | ||
'''Sponsor''': Janssen Research & Development, LLC | '''Sponsor''': Janssen Research & Development, LLC | ||
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'''Condition''': Urinary Bladder Neoplasms | '''Condition''': Urinary Bladder Neoplasms | ||
'''NCTID''': NCT05050097 | '''NCTID''': NCT05050097 | ||
'''Title''': A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma | '''Title''': [[hasTrialTitle::A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma]] | ||
'''Study Summary''': The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens. | '''Study Summary''': The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens. | ||
'''Sponsor''': Janssen Research & Development, LLC | '''Sponsor''': Janssen Research & Development, LLC | ||
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'''Condition''': Multiple Myeloma | '''Condition''': Multiple Myeloma | ||
'''NCTID''': NCT03762447 | '''NCTID''': NCT03762447 | ||
'''Title''': A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors | '''Title''': [[hasTrialTitle::A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors]] | ||
'''Study Summary''': The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments. | '''Study Summary''': The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments. | ||
'''Sponsor''': Incyte Corporation | '''Sponsor''': Incyte Corporation | ||
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'''Condition''': Solid Tumors | '''Condition''': Solid Tumors | ||
'''NCTID''': NCT03333655 | '''NCTID''': NCT03333655 | ||
'''Title''': Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy | '''Title''': [[hasTrialTitle::Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy]] | ||
'''Study Summary''': The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies. | '''Study Summary''': The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies. | ||
'''Sponsor''': Hoffmann-La Roche | '''Sponsor''': Hoffmann-La Roche | ||
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'''Condition''': Neoplasms | '''Condition''': Neoplasms | ||
'''NCTID''': NCT03662126 | '''NCTID''': NCT03662126 | ||
'''Title''': KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment | '''Title''': [[hasTrialTitle::KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment]] | ||
'''Study Summary''': This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to “cross-over” to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time. | '''Study Summary''': This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to “cross-over” to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time. | ||
'''Sponsor''': Kartos Therapeutics, Inc. | '''Sponsor''': Kartos Therapeutics, Inc. | ||
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'''Condition''': Primary Myelofibrosis (PMF) | '''Condition''': Primary Myelofibrosis (PMF) | ||
'''NCTID''': NCT05317416 | '''NCTID''': NCT05317416 | ||
'''Title''': Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant | '''Title''': [[hasTrialTitle::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 | '''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 | '''Sponsor''': Pfizer | ||
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'''Condition''': Multiple Myeloma | '''Condition''': Multiple Myeloma | ||
'''NCTID''': NCT04589845 | '''NCTID''': NCT04589845 | ||
'''Title''': Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study | '''Title''': [[hasTrialTitle::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. | '''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 | '''Sponsor''': Hoffmann-La Roche | ||
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'''Condition''': Solid Tumors | '''Condition''': Solid Tumors | ||
'''NCTID''': NCT03859427 | '''NCTID''': NCT03859427 | ||
'''Title''': A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma | '''Title''': [[hasTrialTitle::A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma]] | ||
'''Study Summary''': Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy. | '''Study Summary''': Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy. | ||
'''Sponsor''': Amgen | '''Sponsor''': Amgen | ||
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'''Condition''': Relapsed or Refractory Multiple Myeloma | '''Condition''': Relapsed or Refractory Multiple Myeloma | ||
'''NCTID''': NCT06045806 | '''NCTID''': NCT06045806 | ||
'''Title''': A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation | '''Title''': [[hasTrialTitle::A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation]] | ||
'''Study Summary''': The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT). | '''Study Summary''': The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT). | ||
'''Sponsor''': Bristol-Myers Squibb | '''Sponsor''': Bristol-Myers Squibb | ||
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'''Condition''': Multiple Myeloma | '''Condition''': Multiple Myeloma | ||
'''NCTID''': NCT04181827 | '''NCTID''': NCT04181827 | ||
'''Title''': A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma | '''Title''': [[hasTrialTitle::A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma]] | ||
'''Study Summary''': The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel <math display="block">cilta-cel</math>) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd). | '''Study Summary''': The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel <math display="block">cilta-cel</math>) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd). | ||
'''Sponsor''': Janssen Research & Development, LLC | '''Sponsor''': Janssen Research & Development, LLC | ||
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'''Condition''': Multiple Myeloma | '''Condition''': Multiple Myeloma | ||
'''NCTID''': NCT04691804 | '''NCTID''': NCT04691804 | ||
'''Title''': A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer | '''Title''': [[hasTrialTitle::A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer]] | ||
'''Study Summary''': To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2). | '''Study Summary''': To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2). | ||
'''Sponsor''': Jiangsu HengRui Medicine Co., Ltd. | '''Sponsor''': Jiangsu HengRui Medicine Co., Ltd. | ||
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'''Condition''': Metastatic Castration-Resistant Prostate Cancer (mCRPC) | '''Condition''': Metastatic Castration-Resistant Prostate Cancer (mCRPC) | ||
'''NCTID''': NCT03424005 | '''NCTID''': NCT03424005 | ||
'''Title''': A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer | '''Title''': [[hasTrialTitle::A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer]] | ||
'''Study Summary''': This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study: Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line <math display="block">1L</math> PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line <math display="block">2L</math> CIT-naive cohort). Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort). Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment. | '''Study Summary''': This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study: Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line <math display="block">1L</math> PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line <math display="block">2L</math> CIT-naive cohort). Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort). Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment. | ||
'''Sponsor''': Hoffmann-La Roche | '''Sponsor''': Hoffmann-La Roche | ||
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'''Condition''': Breast Cancer | '''Condition''': Breast Cancer | ||
'''NCTID''': NCT02034916 | '''NCTID''': NCT02034916 | ||
'''Title''': A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) | '''Title''': [[hasTrialTitle::A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)]] | ||
'''Study Summary''': The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease: * Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or * Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease | '''Study Summary''': The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease: * Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or * Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease | ||
'''Sponsor''': Pfizer | '''Sponsor''': Pfizer | ||
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'''Condition''': Breast Neoplasms | '''Condition''': Breast Neoplasms | ||
'''NCTID''': NCT03589326 | '''NCTID''': NCT03589326 | ||
'''Title''': A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia | '''Title''': [[hasTrialTitle::A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia]] | ||
'''Study Summary''': In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study. | '''Study Summary''': In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study. | ||
'''Sponsor''': Takeda | '''Sponsor''': Takeda | ||
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'''Condition''': Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL) | '''Condition''': Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL) | ||
'''NCTID''': NCT04919226 | '''NCTID''': NCT04919226 | ||
'''Title''': Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE | '''Title''': [[hasTrialTitle::Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE]] | ||
'''Study Summary''': The purpose of the study is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin. | '''Study Summary''': The purpose of the study is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin. | ||
'''Sponsor''': ITM Solucin GmbH | '''Sponsor''': ITM Solucin GmbH | ||
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'''Condition''': Neuroendocrine Tumors | '''Condition''': Neuroendocrine Tumors | ||
'''NCTID''': NCT04023526 | '''NCTID''': NCT04023526 | ||
'''Title''': A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy | '''Title''': [[hasTrialTitle::A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy]] | ||
'''Study Summary''': The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy. | '''Study Summary''': The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy. | ||
'''Sponsor''': OncoVerity, Inc. | '''Sponsor''': OncoVerity, Inc. | ||
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'''Condition''': Leukemia, Myeloid, Acute | '''Condition''': Leukemia, Myeloid, Acute | ||
'''NCTID''': NCT03822117 | '''NCTID''': NCT03822117 | ||
'''Title''': Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) | '''Title''': [[hasTrialTitle::Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)]] | ||
'''Study Summary''': The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations. | '''Study Summary''': The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations. | ||
'''Sponsor''': Incyte Corporation | '''Sponsor''': Incyte Corporation | ||
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'''Condition''': Solid Tumor Malignancy | '''Condition''': Solid Tumor Malignancy | ||
'''NCTID''': NCT04923893 | '''NCTID''': NCT04923893 | ||
'''Title''': A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy | '''Title''': [[hasTrialTitle::A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy]] | ||
'''Study Summary''': The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS). | '''Study Summary''': The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS). | ||
'''Sponsor''': Janssen Research & Development, LLC | '''Sponsor''': Janssen Research & Development, LLC | ||
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'''Condition''': Multiple Myeloma | '''Condition''': Multiple Myeloma | ||
'''NCTID''': NCT05455320 | '''NCTID''': NCT05455320 | ||
'''Title''': A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment | '''Title''': [[hasTrialTitle::A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment]] | ||
'''Study Summary''': The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). | '''Study Summary''': The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). | ||
'''Sponsor''': Janssen Research & Development, LLC | '''Sponsor''': Janssen Research & Development, LLC | ||
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'''Condition''': Relapsed or Refractory Multiple Myeloma | '''Condition''': Relapsed or Refractory Multiple Myeloma | ||
'''NCTID''': NCT01080391 | '''NCTID''': NCT01080391 | ||
'''Title''': Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma | '''Title''': [[hasTrialTitle::Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma]] | ||
'''Study Summary''': The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting. | '''Study Summary''': The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting. | ||
'''Sponsor''': Amgen | '''Sponsor''': Amgen | ||
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'''Condition''': Relapsed Multiple Myeloma | '''Condition''': Relapsed Multiple Myeloma | ||
'''NCTID''': NCT02920008 | '''NCTID''': NCT02920008 | ||
'''Title''': Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia | '''Title''': [[hasTrialTitle::Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia]] | ||
'''Study Summary''': Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: * High intensity (intermediate or high dose cytarabine <math display="block">HiDAC</math>; mitoxantrone, etoposide, and cytarabine <math display="block">MEC</math>; or fludarabine, cytarabine, granulocyte colony stimulating factor <math display="block">G-CSF</math>, +/- idarubicin <math display="block">FLAG/FLAG-Ida</math>). * Low intensity (low dose cytarabine <math display="block">LDAC</math>, decitabine, or azacitidine). * BSC. | '''Study Summary''': Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: * High intensity (intermediate or high dose cytarabine <math display="block">HiDAC</math>; mitoxantrone, etoposide, and cytarabine <math display="block">MEC</math>; or fludarabine, cytarabine, granulocyte colony stimulating factor <math display="block">G-CSF</math>, +/- idarubicin <math display="block">FLAG/FLAG-Ida</math>). * Low intensity (low dose cytarabine <math display="block">LDAC</math>, decitabine, or azacitidine). * BSC. | ||
'''Sponsor''': Astex Pharmaceuticals, Inc. | '''Sponsor''': Astex Pharmaceuticals, Inc. | ||
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'''Condition''': Acute Myeloid Leukemia | '''Condition''': Acute Myeloid Leukemia | ||
'''NCTID''': NCT02005471 | '''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) | '''Title''': [[hasTrialTitle::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). | '''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 | '''Sponsor''': Hoffmann-La Roche | ||
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'''Condition''': Chronic Lymphocytic Leukemia | '''Condition''': Chronic Lymphocytic Leukemia | ||
'''NCTID''': NCT01945775 | '''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) | '''Title''': [[hasTrialTitle::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. | '''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 | '''Sponsor''': Pfizer | ||
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'''Condition''': Breast Neoplasms | '''Condition''': Breast Neoplasms | ||
'''NCTID''': NCT05267106 | '''NCTID''': NCT05267106 | ||
'''Title''': Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations | '''Title''': [[hasTrialTitle::Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations]] | ||
'''Study Summary''': This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal. | '''Study Summary''': This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal. | ||
'''Sponsor''': Incyte Corporation | '''Sponsor''': Incyte Corporation | ||
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'''Condition''': Glioblastoma | '''Condition''': Glioblastoma | ||
'''NCTID''': NCT04722146 | '''NCTID''': NCT04722146 | ||
'''Title''': A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma | '''Title''': [[hasTrialTitle::A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma]] | ||
'''Study Summary''': The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens. | '''Study Summary''': The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens. | ||
'''Sponsor''': Janssen Research & Development, LLC | '''Sponsor''': Janssen Research & Development, LLC | ||
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'''Condition''': Multiple Myeloma | '''Condition''': Multiple Myeloma | ||
'''NCTID''': NCT05238922 | '''NCTID''': NCT05238922 | ||
'''Title''': Study of INCB123667 in Subjects With Advanced Solid Tumors | '''Title''': [[hasTrialTitle::Study of INCB123667 in Subjects With Advanced Solid Tumors]] | ||
'''Study Summary''': This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A. | '''Study Summary''': This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A. | ||
'''Sponsor''': Incyte Corporation | '''Sponsor''': Incyte Corporation | ||
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'''Condition''': Solid Tumors | '''Condition''': Solid Tumors | ||
'''NCTID''': NCT05800964 | '''NCTID''': NCT05800964 | ||
'''Title''': Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors. | '''Title''': [[hasTrialTitle::Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors]]. | ||
'''Study Summary''': The primary objective of this study is to: * Evaluate the safety and tolerability of AMG 305 in adult participants * Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose * Determine the recommended phase 2 dose (RP2D) | '''Study Summary''': The primary objective of this study is to: * Evaluate the safety and tolerability of AMG 305 in adult participants * Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose * Determine the recommended phase 2 dose (RP2D) | ||
'''Sponsor''': Amgen | '''Sponsor''': Amgen | ||
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'''Condition''': Advanced Solid Tumors | '''Condition''': Advanced Solid Tumors | ||
'''NCTID''': NCT04551053 | '''NCTID''': NCT04551053 | ||
'''Title''': To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304) | '''Title''': [[hasTrialTitle::To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)]] | ||
'''Study Summary''': The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy. | '''Study Summary''': The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy. | ||
'''Sponsor''': Incyte Corporation | '''Sponsor''': Incyte Corporation | ||
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'''Condition''': Myelofibrosis | '''Condition''': Myelofibrosis | ||
'''NCTID''': NCT04634877 | '''NCTID''': NCT04634877 | ||
'''Title''': Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) | '''Title''': [[hasTrialTitle::Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)]] | ||
'''Study Summary''': The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS. | '''Study Summary''': The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS. | ||
'''Sponsor''': Merck Sharp & Dohme LLC | '''Sponsor''': Merck Sharp & Dohme LLC | ||
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'''Condition''': Endometrial Neoplasms | '''Condition''': Endometrial Neoplasms | ||
'''NCTID''': NCT04221035 | '''NCTID''': NCT04221035 | ||
'''Title''': High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) | '''Title''': [[hasTrialTitle::High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)]] | ||
'''Study Summary''': This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma. | '''Study Summary''': This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma. | ||
'''Sponsor''': Gustave Roussy, Cancer Campus, Grand Paris | '''Sponsor''': Gustave Roussy, Cancer Campus, Grand Paris | ||
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'''Condition''': High-Risk Neuroblastoma | '''Condition''': High-Risk Neuroblastoma | ||
'''NCTID''': NCT03850535 | '''NCTID''': NCT03850535 | ||
'''Title''': A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission | '''Title''': [[hasTrialTitle::A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission]] | ||
'''Study Summary''': This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML). | '''Study Summary''': This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML). | ||
'''Sponsor''': Hoffmann-La Roche | '''Sponsor''': Hoffmann-La Roche | ||
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'''Condition''': Acute Myeloid Leukemia | '''Condition''': Acute Myeloid Leukemia | ||
'''NCTID''': NCT05079230 | '''NCTID''': NCT05079230 | ||
'''Title''': Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia | '''Title''': [[hasTrialTitle::Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia]] | ||
'''Study Summary''': The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy. | '''Study Summary''': The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy. | ||
'''Sponsor''': Gilead Sciences | '''Sponsor''': Gilead Sciences | ||
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'''Condition''': Acute Myeloid Leukemia | '''Condition''': Acute Myeloid Leukemia | ||
'''NCTID''': NCT04003610 | '''NCTID''': NCT04003610 | ||
'''Title''': Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) | '''Title''': [[hasTrialTitle::Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)]] | ||
'''Study Summary''': The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment. | '''Study Summary''': The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment. | ||
'''Sponsor''': Incyte Corporation | '''Sponsor''': Incyte Corporation | ||
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'''Condition''': Metastatic Urothelial Carcinoma | '''Condition''': Metastatic Urothelial Carcinoma | ||
'''NCTID''': NCT03652064 | '''NCTID''': NCT03652064 | ||
'''Title''': A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy | '''Title''': [[hasTrialTitle::A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy]] | ||
'''Study Summary''': The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone. | '''Study Summary''': The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone. | ||
'''Sponsor''': Janssen Research & Development, LLC | '''Sponsor''': Janssen Research & Development, LLC | ||
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'''Condition''': Multiple Myeloma | '''Condition''': Multiple Myeloma | ||
'''NCTID''': NCT03011372 | '''NCTID''': NCT03011372 | ||
'''Title''': A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) | '''Title''': [[hasTrialTitle::A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)]] | ||
'''Study Summary''': The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement. | '''Study Summary''': The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement. | ||
'''Sponsor''': Incyte Corporation | '''Sponsor''': Incyte Corporation | ||
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'''Condition''': MPN (Myeloproliferative Neoplasms) | '''Condition''': MPN (Myeloproliferative Neoplasms) | ||
'''NCTID''': NCT03462719 | '''NCTID''': NCT03462719 | ||
'''Title''': A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | '''Title''': [[hasTrialTitle::A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)]] | ||
'''Study Summary''': The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC). | '''Study Summary''': The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC). | ||
'''Sponsor''': Janssen Research & Development, LLC | '''Sponsor''': Janssen Research & Development, LLC | ||
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'''Condition''': Leukemia, Lymphocytic, Chronic, B-Cell | '''Condition''': Leukemia, Lymphocytic, Chronic, B-Cell | ||
'''NCTID''': NCT04580485 | '''NCTID''': NCT04580485 | ||
'''Title''': INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors | '''Title''': [[hasTrialTitle::INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors]] | ||
'''Study Summary''': This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) | '''Study Summary''': This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) | ||
'''Sponsor''': Incyte Corporation | '''Sponsor''': Incyte Corporation | ||
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'''Condition''': Ovarian Cancer | '''Condition''': Ovarian Cancer | ||
'''NCTID''': NCT04122625 | '''NCTID''': NCT04122625 | ||
'''Title''': Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143 | '''Title''': [[hasTrialTitle::Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143]] | ||
'''Study Summary''': Part A (dose-optimization)- to determine the recommended phase 2 dose (RP2D) taking into account dose-limiting toxicity (DLT/s) in Cycle 1, overall safety/tolerability and pharmacokinetic (PK), by optimizing doses of Debio 1143 when combined with the standard dose of nivolumab, as well as treatment compliance in participants with advanced solid malignancies who failed prior systemic standard treatments. Part B (basket trial)- to evaluate the preliminary anti-tumor activity of Debio 1143 at the RP2D in combination with nivolumab at the standard dose, overall and in each participant cohort (Cohort 1: small cell lung cancer <math display="block">SCLC</math>; Cohort 2: squamous cell carcinoma of the head and neck <math display="block">SCCHN</math>; Cohort 3: gastrointestinal (GI) cancers with known microsatellite instability-high/mismatch repair deficiency (MSI-H/MMRd) or other deoxyribonucleic acid (DNA) damage repair (DDR) abnormalities, including homologous recombination deficiency (HRD); Cohort 4: platinum-resistant epithelial ovarian cancer <math display="block">EOC</math>, endometrial cancer, primary peritoneal cancer (PPC) or cervical cancer, with known MSIH/MMRd, hereditary/somatic mutations of the breast cancer 1 (BRCA1) and BRCA2 genes or other DNA DDR abnormalities (incl. HRD). | '''Study Summary''': Part A (dose-optimization)- to determine the recommended phase 2 dose (RP2D) taking into account dose-limiting toxicity (DLT/s) in Cycle 1, overall safety/tolerability and pharmacokinetic (PK), by optimizing doses of Debio 1143 when combined with the standard dose of nivolumab, as well as treatment compliance in participants with advanced solid malignancies who failed prior systemic standard treatments. Part B (basket trial)- to evaluate the preliminary anti-tumor activity of Debio 1143 at the RP2D in combination with nivolumab at the standard dose, overall and in each participant cohort (Cohort 1: small cell lung cancer <math display="block">SCLC</math>; Cohort 2: squamous cell carcinoma of the head and neck <math display="block">SCCHN</math>; Cohort 3: gastrointestinal (GI) cancers with known microsatellite instability-high/mismatch repair deficiency (MSI-H/MMRd) or other deoxyribonucleic acid (DNA) damage repair (DDR) abnormalities, including homologous recombination deficiency (HRD); Cohort 4: platinum-resistant epithelial ovarian cancer <math display="block">EOC</math>, endometrial cancer, primary peritoneal cancer (PPC) or cervical cancer, with known MSIH/MMRd, hereditary/somatic mutations of the breast cancer 1 (BRCA1) and BRCA2 genes or other DNA DDR abnormalities (incl. HRD). | ||
'''Sponsor''': Debiopharm International SA | '''Sponsor''': Debiopharm International SA | ||
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'''Condition''': Solid Tumor | '''Condition''': Solid Tumor | ||
'''NCTID''': NCT04703192 | '''NCTID''': NCT04703192 | ||
'''Title''': Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01) | '''Title''': [[hasTrialTitle::Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)]] | ||
'''Study Summary''': This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma. | '''Study Summary''': This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma. | ||
'''Sponsor''': Daiichi Sankyo, Inc. | '''Sponsor''': Daiichi Sankyo, Inc. | ||
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'''Condition''': Relapsed/Refractory Peripheral T-Cell Lymphoma | '''Condition''': Relapsed/Refractory Peripheral T-Cell Lymphoma | ||
'''NCTID''': NCT03274492 | '''NCTID''': NCT03274492 | ||
'''Title''': A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma | '''Title''': [[hasTrialTitle::A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma]] | ||
'''Study Summary''': This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL). | '''Study Summary''': This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL). | ||
'''Sponsor''': Hoffmann-La Roche | '''Sponsor''': Hoffmann-La Roche | ||
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'''Condition''': Diffuse Large B-Cell Lymphoma | '''Condition''': Diffuse Large B-Cell Lymphoma | ||
'''NCTID''': NCT03273153 | '''NCTID''': NCT03273153 | ||
'''Title''': A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma | '''Title''': [[hasTrialTitle::A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma]] | ||
'''Study Summary''': This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma. | '''Study Summary''': This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma. | ||
'''Sponsor''': Hoffmann-La Roche | '''Sponsor''': Hoffmann-La Roche | ||
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'''Condition''': Advanced BRAFV600 Wild-type Melanoma | '''Condition''': Advanced BRAFV600 Wild-type Melanoma | ||
'''NCTID''': NCT03397394 | '''NCTID''': NCT03397394 | ||
'''Title''': Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma | '''Title''': [[hasTrialTitle::Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma]] | ||
'''Study Summary''': The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib. | '''Study Summary''': The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib. | ||
'''Sponsor''': pharmaand GmbH | '''Sponsor''': pharmaand GmbH | ||
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'''Condition''': Bladder Cancer | '''Condition''': Bladder Cancer | ||
'''NCTID''': NCT01969578 | '''NCTID''': NCT01969578 | ||
'''Title''': Androgen Deprivation Therapy in Advanced Salivary Gland Cancer | '''Title''': [[hasTrialTitle::Androgen Deprivation Therapy in Advanced Salivary Gland Cancer]] | ||
'''Study Summary''': Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs. The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients. | '''Study Summary''': Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs. The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients. | ||
'''Sponsor''': European Organisation for Research and Treatment of Cancer - EORTC | '''Sponsor''': European Organisation for Research and Treatment of Cancer - EORTC | ||
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'''Condition''': Salivary Gland Cancer | '''Condition''': Salivary Gland Cancer | ||
'''NCTID''': NCT03059823 | '''NCTID''': NCT03059823 | ||
'''Title''': A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors | '''Title''': [[hasTrialTitle::A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors]] | ||
'''Study Summary''': The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed. The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort. | '''Study Summary''': The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed. The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort. | ||
'''Sponsor''': Incyte Corporation | '''Sponsor''': Incyte Corporation | ||
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'''Condition''': Locally Advanced Solid Tumors | '''Condition''': Locally Advanced Solid Tumors | ||
'''NCTID''': NCT06039384 | '''NCTID''': NCT06039384 | ||
'''Title''': A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation | '''Title''': [[hasTrialTitle::A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation]] | ||
'''Study Summary''': The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib. | '''Study Summary''': The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib. | ||
'''Sponsor''': Incyte Corporation | '''Sponsor''': Incyte Corporation | ||
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'''Condition''': Advanced Solid Tumors | '''Condition''': Advanced Solid Tumors | ||
'''NCTID''': NCT04740918 | '''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) | '''Title''': [[hasTrialTitle::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. | '''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 | '''Sponsor''': Hoffmann-La Roche | ||
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'''Condition''': Metastatic Breast Cancer | '''Condition''': Metastatic Breast Cancer | ||
'''NCTID''': NCT05949684 | '''NCTID''': NCT05949684 | ||
'''Title''': ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions | '''Title''': [[hasTrialTitle::ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions]] | ||
'''Study Summary''': The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD). | '''Study Summary''': The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD). | ||
'''Sponsor''': Bristol-Myers Squibb | '''Sponsor''': Bristol-Myers Squibb | ||
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'''Condition''': Myelodysplastic Syndromes | '''Condition''': Myelodysplastic Syndromes | ||
'''NCTID''': NCT05651932 | '''NCTID''': NCT05651932 | ||
'''Title''': A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma | '''Title''': [[hasTrialTitle::A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma]] | ||
'''Study Summary''': A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM). | '''Study Summary''': A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM). | ||
'''Sponsor''': K36 Therapeutics, Inc. | '''Sponsor''': K36 Therapeutics, Inc. | ||
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'''Condition''': Multiple Myeloma | '''Condition''': Multiple Myeloma | ||
'''NCTID''': NCT02924402 | '''NCTID''': NCT02924402 | ||
'''Title''': Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies | '''Title''': [[hasTrialTitle::Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies]] | ||
'''Study Summary''': The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD). | '''Study Summary''': The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD). | ||
'''Sponsor''': Xencor, Inc. | '''Sponsor''': Xencor, Inc. | ||
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'''Condition''': B-cell Non-Hodgkins Lymphoma | '''Condition''': B-cell Non-Hodgkins Lymphoma | ||
'''NCTID''': NCT03772028 | '''NCTID''': NCT03772028 | ||
'''Title''': Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) | '''Title''': [[hasTrialTitle::Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)]] | ||
'''Study Summary''': stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy | '''Study Summary''': stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy | ||
'''Sponsor''': The Netherlands Cancer Institute | '''Sponsor''': The Netherlands Cancer Institute | ||
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'''Condition''': Ovarian Cancer | '''Condition''': Ovarian Cancer | ||
'''NCTID''': NCT04811560 | '''NCTID''': NCT04811560 | ||
'''Title''': A Study of JNJ-75276617 in Participants With Acute Leukemia | '''Title''': [[hasTrialTitle::A Study of JNJ-75276617 in Participants With Acute Leukemia]] | ||
'''Study Summary''': The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D<math display="block">s</math>) of JNJ-75276617 in Part 1 (Dose Escalation) and to determine safety and tolerability at the RP2D(s) in Part 2 (Dose Expansion). | '''Study Summary''': The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D<math display="block">s</math>) of JNJ-75276617 in Part 1 (Dose Escalation) and to determine safety and tolerability at the RP2D(s) in Part 2 (Dose Expansion). | ||
'''Sponsor''': Janssen Research & Development, LLC | '''Sponsor''': Janssen Research & Development, LLC | ||
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'''Condition''': Acute Leukemias | '''Condition''': Acute Leukemias | ||
'''NCTID''': NCT04700124 | '''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) | '''Title''': [[hasTrialTitle::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). | '''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 | '''Sponsor''': Merck Sharp & Dohme LLC | ||
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'''Condition''': Muscle Invasive Bladder Cancer | '''Condition''': Muscle Invasive Bladder Cancer | ||
'''NCTID''': NCT02130557 | '''NCTID''': NCT02130557 | ||
'''Title''': A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia | '''Title''': [[hasTrialTitle::A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia]] | ||
'''Study Summary''': Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study. | '''Study Summary''': Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study. | ||
'''Sponsor''': Pfizer | '''Sponsor''': Pfizer | ||
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'''Condition''': Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive | '''Condition''': Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive | ||
'''NCTID''': NCT04471844 | '''NCTID''': NCT04471844 | ||
'''Title''': Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM | '''Title''': [[hasTrialTitle::Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM]] | ||
'''Study Summary''': To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy. | '''Study Summary''': To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy. | ||
'''Sponsor''': NovoCure GmbH | '''Sponsor''': NovoCure GmbH | ||
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'''Condition''': Glioblastoma Multiforme | '''Condition''': Glioblastoma Multiforme | ||
'''NCTID''': NCT02719574 | '''NCTID''': NCT02719574 | ||
'''Title''': Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation | '''Title''': [[hasTrialTitle::Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation]] | ||
'''Study Summary''': This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states. | '''Study Summary''': This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states. | ||
'''Sponsor''': Forma Therapeutics, Inc. | '''Sponsor''': Forma Therapeutics, Inc. | ||
| Line 605: | Line 610: | ||
'''Condition''': Acute Myeloid Leukemia | '''Condition''': Acute Myeloid Leukemia | ||
'''NCTID''': NCT02467270 | '''NCTID''': NCT02467270 | ||
'''Title''': Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses | '''Title''': [[hasTrialTitle::Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses]] | ||
'''Study Summary''': The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as measured by <=1 % Breakpoint Cluster Region-Abelson Transcript Level using International Scale (BCR-ABL1IS) at 12 months. | '''Study Summary''': The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as measured by <=1 % Breakpoint Cluster Region-Abelson Transcript Level using International Scale (BCR-ABL1IS) at 12 months. | ||
'''Sponsor''': Takeda | '''Sponsor''': Takeda | ||
| Line 615: | Line 620: | ||
'''Condition''': Myeloid Leukemia, Chronic, Chronic Phase | '''Condition''': Myeloid Leukemia, Chronic, Chronic Phase | ||
'''NCTID''': NCT02631070 | '''NCTID''': NCT02631070 | ||
'''Title''': A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes | '''Title''': [[hasTrialTitle::A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes]] | ||
'''Study Summary''': The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions. | '''Study Summary''': The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions. | ||
'''Sponsor''': Celgene | '''Sponsor''': Celgene | ||
| Line 625: | Line 630: | ||
'''Condition''': Myelodysplastic Syndromes | '''Condition''': Myelodysplastic Syndromes | ||
'''NCTID''': NCT03309111 | '''NCTID''': NCT03309111 | ||
'''Title''': Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma | '''Title''': [[hasTrialTitle::Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma]] | ||
'''Study Summary''': The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma. | '''Study Summary''': The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma. | ||
'''Sponsor''': Ichnos Sciences SA | '''Sponsor''': Ichnos Sciences SA | ||
| Line 634: | Line 639: | ||
'''Recruitment Status''': RECRUITING | '''Recruitment Status''': RECRUITING | ||
'''Condition''': Relapsed/Refractory Multiple Myeloma | '''Condition''': Relapsed/Refractory Multiple Myeloma | ||
<span style="display:none">hasTrialTitle::IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)</span> | |||
<span style="display:none">hasTrialTitle::An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions</span> | |||
<span style="display:none">hasTrialTitle::A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma</span> | |||
<span style="display:none">hasTrialTitle::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)</span> | |||
<span style="display:none">hasTrialTitle::Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib</span> | |||
<span style="display:none">hasTrialTitle::A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)</span> | |||
<span style="display:none">hasTrialTitle::A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma</span> | |||
<span style="display:none">hasTrialTitle::A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors</span> | |||
<span style="display:none">hasTrialTitle::Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy</span> | |||
<span style="display:none">hasTrialTitle::KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment</span> | |||
<span style="display:none">hasTrialTitle::Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant</span> | |||
<span style="display:none">hasTrialTitle::Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study</span> | |||
<span style="display:none">hasTrialTitle::A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma</span> | |||
<span style="display:none">hasTrialTitle::A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation</span> | |||
<span style="display:none">hasTrialTitle::A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma</span> | |||
<span style="display:none">hasTrialTitle::A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer</span> | |||
<span style="display:none">hasTrialTitle::A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer</span> | |||
<span style="display:none">hasTrialTitle::A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)</span> | |||
<span style="display:none">hasTrialTitle::A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia</span> | |||
<span style="display:none">hasTrialTitle::Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE</span> | |||
<span style="display:none">hasTrialTitle::A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy</span> | |||
<span style="display:none">hasTrialTitle::Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)</span> | |||
<span style="display:none">hasTrialTitle::A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy</span> | |||
<span style="display:none">hasTrialTitle::A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment</span> | |||
<span style="display:none">hasTrialTitle::Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma</span> | |||
<span style="display:none">hasTrialTitle::Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia</span> | |||
<span style="display:none">hasTrialTitle::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)</span> | |||
<span style="display:none">hasTrialTitle::A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)</span> | |||
<span style="display:none">hasTrialTitle::Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations</span> | |||
<span style="display:none">hasTrialTitle::A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma</span> | |||
<span style="display:none">hasTrialTitle::Study of INCB123667 in Subjects With Advanced Solid Tumors</span> | |||
<span style="display:none">hasTrialTitle::Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors</span> | |||
<span style="display:none">hasTrialTitle::To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)</span> | |||
<span style="display:none">hasTrialTitle::Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)</span> | |||
<span style="display:none">hasTrialTitle::High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)</span> | |||
<span style="display:none">hasTrialTitle::A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission</span> | |||
<span style="display:none">hasTrialTitle::Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia</span> | |||
<span style="display:none">hasTrialTitle::Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)</span> | |||
<span style="display:none">hasTrialTitle::A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy</span> | |||
<span style="display:none">hasTrialTitle::A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)</span> | |||
<span style="display:none">hasTrialTitle::A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)</span> | |||
<span style="display:none">hasTrialTitle::INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors</span> | |||
<span style="display:none">hasTrialTitle::Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143</span> | |||
<span style="display:none">hasTrialTitle::Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)</span> | |||
<span style="display:none">hasTrialTitle::A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma</span> | |||
<span style="display:none">hasTrialTitle::A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma</span> | |||
<span style="display:none">hasTrialTitle::Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma</span> | |||
<span style="display:none">hasTrialTitle::Androgen Deprivation Therapy in Advanced Salivary Gland Cancer</span> | |||
<span style="display:none">hasTrialTitle::A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors</span> | |||
<span style="display:none">hasTrialTitle::A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation</span> | |||
<span style="display:none">hasTrialTitle::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)</span> | |||
<span style="display:none">hasTrialTitle::ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions</span> | |||
<span style="display:none">hasTrialTitle::A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma</span> | |||
<span style="display:none">hasTrialTitle::Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies</span> | |||
<span style="display:none">hasTrialTitle::Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)</span> | |||
<span style="display:none">hasTrialTitle::A Study of JNJ-75276617 in Participants With Acute Leukemia</span> | |||
<span style="display:none">hasTrialTitle::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)</span> | |||
<span style="display:none">hasTrialTitle::A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia</span> | |||
<span style="display:none">hasTrialTitle::Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM</span> | |||
<span style="display:none">hasTrialTitle::Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation</span> | |||
<span style="display:none">hasTrialTitle::Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses</span> | |||
<span style="display:none">hasTrialTitle::A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes</span> | |||
<span style="display:none">hasTrialTitle::Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma</span> | |||
<span style="display:none">hasCancerType::C00-D48: All neoplasms</span> | |||
<span style="display:none">hasCancerType::C00-C97: All cancer types</span> | |||
<span style="display:none">hasCancerType::C00-C14: Mouth/throat cancers</span> | |||
<span style="display:none">hasCancerType::C15-C26: Digestive system cancers</span> | |||
<span style="display:none">hasCancerType::C30-C39: Lung/chest cancers</span> | |||
<span style="display:none">hasCancerType::C40-C41: Bone cancers</span> | |||
<span style="display:none">hasCancerType::C43-C44: Skin cancers/melanoma</span> | |||
<span style="display:none">hasCancerType::C45-C49: Soft tissue cancer</span> | |||
<span style="display:none">hasCancerType::C50: Breast cancer</span> | |||
<span style="display:none">hasCancerType::C51-C58: Female genitalia cancers</span> | |||
<span style="display:none">hasCancerType::C60-C63: Male genitalia cancer</span> | |||
<span style="display:none">hasCancerType::C64-C68: Urinary system cancers</span> | |||
<span style="display:none">hasCancerType::C69-C72: Eye and brain cancer</span> | |||
<span style="display:none">hasCancerType::C73-C75: Thyroid and other gland cancers</span> | |||
<span style="display:none">hasCancerType::C76-C80: Cancers of unknown or unspecified areas</span> | |||
<span style="display:none">hasCancerType::C81-C96: Cancers of the blood and immune system</span> | |||
<span style="display:none">hasCancerType::C97-C97: Cancers in multiple locations from the start</span> | |||
<span style="display:none">hasCancerType::D00-D09: Early-stage cancers not yet spread</span> | |||
<span style="display:none">hasCancerType::D10-D36: Benign tumour</span> | |||
<span style="display:none">hasCancerType::D37-D48: Growths of uncertain nature</span> | |||
<span style="display:none">hasCancerType::unknown</span> | |||
<span style="display:none">isTrial</span> | |||
Latest revision as of 18:42, 14 December 2025
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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: NCT04717414
Title: An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions Study Summary: The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept. Sponsor: Celgene Intervention: ACE-536 Start Date: 2021-02-25 Last Updated: 2023-11-14 Number of Patients: 309 Recruitment Status: RECRUITING Condition: Myeloproliferative Disorders
NCTID: NCT05572515
Title: A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Study Summary: The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd. Sponsor: Janssen Research & Development, LLC Intervention: Teclistamab Start Date: 2023-03-29 Last Updated: 2023-09-13 Number of Patients: 590 Recruitment Status: RECRUITING Condition: Relapsed or Refractory Multiple Myeloma
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: NCT02824159
Title: Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib Study Summary: Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib. Clinical trials for ibrutinib and idelalisib were performed with a small number of patients (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this study is to determine the association between clinically significant side effects occurrence during the first year of treatment and plasma mean concentration of the steady state of ibrutinib or idelalisib at 1 month. Sponsor: University Hospital, Toulouse Intervention: Blood samples for pharmacokinetics exploration Start Date: 2016-04 Last Updated: 2020-12-28 Number of Patients: 121 Recruitment Status: COMPLETED Condition: Hematological Malignancies
NCTID: NCT04172675
Title: A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Study Summary: The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator’s Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy. Sponsor: Janssen Research & Development, LLC Intervention: Erdafitinib Start Date: 2020-02-28 Last Updated: 2023-11-13 Number of Patients: 107 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urinary Bladder Neoplasms
NCTID: NCT05050097
Title: A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma Study Summary: The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens. Sponsor: Janssen Research & Development, LLC Intervention: Talquetamab Start Date: 2021-09-22 Last Updated: 2023-11-08 Number of Patients: 182 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT03762447
Title: A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors Study Summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments. Sponsor: Incyte Corporation Intervention: INCB086550 Start Date: 2018-12-10 Last Updated: 2023-11-02 Number of Patients: 138 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors
NCTID: NCT03333655
Title: Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer Progressing on CPI Therapy Study Summary: The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies. Sponsor: Hoffmann-La Roche Intervention: Biopsy Start Date: 2018-02-16 Last Updated: 2022-08-12 Number of Patients: 15 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT03662126
Title: KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment Study Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to “cross-over” to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time. Sponsor: Kartos Therapeutics, Inc. Intervention: KRT-232 Start Date: 2019-01-15 Last Updated: 2023-04-28 Number of Patients: 385 Recruitment Status: RECRUITING Condition: Primary Myelofibrosis (PMF)
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: 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: NCT03859427
Title: A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Study Summary: Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy. Sponsor: Amgen Intervention: Carfilzomib Start Date: 2019-05-08 Last Updated: 2023-10-27 Number of Patients: 454 Recruitment Status: COMPLETED Condition: Relapsed or Refractory Multiple Myeloma
NCTID: NCT06045806
Title: A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation Study Summary: The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT). Sponsor: Bristol-Myers Squibb Intervention: idecabtagene vicleucel Start Date: 2023-10-16 Last Updated: 2023-11-07 Number of Patients: 618 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT04181827
Title: A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma Study Summary: The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel <math display="block">cilta-cel</math>) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd). Sponsor: Janssen Research & Development, LLC Intervention: JNJ-68284528 Start Date: 2020-06-12 Last Updated: 2023-11-09 Number of Patients: 419 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT04691804
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer Study Summary: To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2). Sponsor: Jiangsu HengRui Medicine Co., Ltd. Intervention: Fuzuloparib , Abiraterone acetate and Prednisone Start Date: 2021-03-18 Last Updated: 2022-08-01 Number of Patients: 804 Recruitment Status: RECRUITING Condition: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NCTID: NCT03424005
Title: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer Study Summary: This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study: Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line <math display="block">1L</math> PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line <math display="block">2L</math> CIT-naive cohort). Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort). Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment. Sponsor: Hoffmann-La Roche Intervention: Capecitabine Start Date: 2018-04-02 Last Updated: 2023-11-07 Number of Patients: 242 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT02034916
Title: A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) Study Summary: The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease: * Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or * Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease Sponsor: Pfizer Intervention: talazoparib Start Date: 2013-12-13 Last Updated: 2019-10-14 Number of Patients: 84 Recruitment Status: TERMINATED Condition: Breast Neoplasms
NCTID: NCT03589326
Title: A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia Study Summary: In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study. Sponsor: Takeda Intervention: Ponatinib Start Date: 2018-10-04 Last Updated: 2023-10-27 Number of Patients: 245 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
NCTID: NCT04919226
Title: Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE Study Summary: The purpose of the study is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin. Sponsor: ITM Solucin GmbH Intervention: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT Start Date: 2021-12-21 Last Updated: 2023-09-13 Number of Patients: 202 Recruitment Status: RECRUITING Condition: Neuroendocrine Tumors
NCTID: NCT04023526
Title: A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy Study Summary: The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy. Sponsor: OncoVerity, Inc. Intervention: Azacitidine Start Date: 2019-07-29 Last Updated: 2023-08-09 Number of Patients: 103 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Leukemia, Myeloid, Acute
NCTID: NCT03822117
Title: Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations. Sponsor: Incyte Corporation Intervention: Pemigatinib Start Date: 2019-10-17 Last Updated: 2023-03-20 Number of Patients: 111 Recruitment Status: TERMINATED Condition: Solid Tumor Malignancy
NCTID: NCT04923893
Title: A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy Study Summary: The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS). Sponsor: Janssen Research & Development, LLC Intervention: Bortezomib Start Date: 2021-08-19 Last Updated: 2023-11-09 Number of Patients: 650 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT05455320
Title: A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment Study Summary: The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). Sponsor: Janssen Research & Development, LLC Intervention: Talquetamab Start Date: 2022-10-13 Last Updated: 2023-11-08 Number of Patients: 810 Recruitment Status: RECRUITING Condition: Relapsed or Refractory Multiple Myeloma
NCTID: NCT01080391
Title: Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma Study Summary: The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting. Sponsor: Amgen Intervention: Dexamethasone Start Date: 2010-07-14 Last Updated: 2022-09-21 Number of Patients: 792 Recruitment Status: COMPLETED Condition: Relapsed Multiple Myeloma
NCTID: NCT02920008
Title: Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia Study Summary: Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: * High intensity (intermediate or high dose cytarabine <math display="block">HiDAC</math>; mitoxantrone, etoposide, and cytarabine <math display="block">MEC</math>; or fludarabine, cytarabine, granulocyte colony stimulating factor <math display="block">G-CSF</math>, +/- idarubicin <math display="block">FLAG/FLAG-Ida</math>). * Low intensity (low dose cytarabine <math display="block">LDAC</math>, decitabine, or azacitidine). * BSC. Sponsor: Astex Pharmaceuticals, Inc. Intervention: guadecitabine Start Date: 2017-03-16 Last Updated: 2023-05-25 Number of Patients: 302 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
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: 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: NCT05267106
Title: Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations Study Summary: This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal. Sponsor: Incyte Corporation Intervention: Pemigatinib Start Date: 2022-05-20 Last Updated: 2023-11-15 Number of Patients: 164 Recruitment Status: RECRUITING Condition: Glioblastoma
NCTID: NCT04722146
Title: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma Study Summary: The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens. Sponsor: Janssen Research & Development, LLC Intervention: Teclistamab Start Date: 2021-03-12 Last Updated: 2023-11-09 Number of Patients: 140 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT05238922
Title: Study of INCB123667 in Subjects With Advanced Solid Tumors Study Summary: This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A. Sponsor: Incyte Corporation Intervention: INCB0123667 Start Date: 2022-07-05 Last Updated: 2023-11-03 Number of Patients: 340 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT05800964
Title: Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors. Study Summary: The primary objective of this study is to: * Evaluate the safety and tolerability of AMG 305 in adult participants * Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose * Determine the recommended phase 2 dose (RP2D) Sponsor: Amgen Intervention: AMG 305 Start Date: 2023-06-13 Last Updated: 2023-11-27 Number of Patients: 260 Recruitment Status: RECRUITING Condition: Advanced Solid Tumors
NCTID: NCT04551053
Title: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304) Study Summary: The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy. Sponsor: Incyte Corporation Intervention: parsaclisib Start Date: 2021-05-26 Last Updated: 2023-10-18 Number of Patients: 177 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelofibrosis
NCTID: NCT04634877
Title: Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) Study Summary: The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-01-10 Last Updated: 2023-11-21 Number of Patients: 990 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Neoplasms
NCTID: NCT04221035
Title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) Study Summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: Vincristine Start Date: 2019-11-05 Last Updated: 2023-02-13 Number of Patients: 800 Recruitment Status: RECRUITING Condition: High-Risk Neuroblastoma
NCTID: NCT03850535
Title: A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission Study Summary: This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML). Sponsor: Hoffmann-La Roche Intervention: Idasanutlin Start Date: 2019-03-25 Last Updated: 2022-06-21 Number of Patients: 24 Recruitment Status: TERMINATED Condition: Acute Myeloid Leukemia
NCTID: NCT05079230
Title: Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia Study Summary: The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy. Sponsor: Gilead Sciences Intervention: Magrolimab Start Date: 2022-07-07 Last Updated: 2023-10-30 Number of Patients: 432 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT04003610
Title: Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) Study Summary: The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment. Sponsor: Incyte Corporation Intervention: Pemigatinib Start Date: 2020-05-14 Last Updated: 2022-05-26 Number of Patients: 7 Recruitment Status: TERMINATED Condition: Metastatic Urothelial Carcinoma
NCTID: NCT03652064
Title: A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy Study Summary: The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone. Sponsor: Janssen Research & Development, LLC Intervention: Daratumumab Start Date: 2018-11-06 Last Updated: 2023-11-09 Number of Patients: 395 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT03011372
Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement. Sponsor: Incyte Corporation Intervention: Pemigatinib Start Date: 2017-04-25 Last Updated: 2023-07-03 Number of Patients: 47 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: MPN (Myeloproliferative Neoplasms)
NCTID: NCT03462719
Title: A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC). Sponsor: Janssen Research & Development, LLC Intervention: Ibrutinib Start Date: 2018-04-17 Last Updated: 2023-11-09 Number of Patients: 211 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Leukemia, Lymphocytic, Chronic, B-Cell
NCTID: NCT04580485
Title: INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors Study Summary: This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) Sponsor: Incyte Corporation Intervention: INCB106385 Start Date: 2021-02-03 Last Updated: 2023-11-09 Number of Patients: 54 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Cancer
NCTID: NCT04122625
Title: Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143 Study Summary: Part A (dose-optimization)- to determine the recommended phase 2 dose (RP2D) taking into account dose-limiting toxicity (DLT/s) in Cycle 1, overall safety/tolerability and pharmacokinetic (PK), by optimizing doses of Debio 1143 when combined with the standard dose of nivolumab, as well as treatment compliance in participants with advanced solid malignancies who failed prior systemic standard treatments. Part B (basket trial)- to evaluate the preliminary anti-tumor activity of Debio 1143 at the RP2D in combination with nivolumab at the standard dose, overall and in each participant cohort (Cohort 1: small cell lung cancer <math display="block">SCLC</math>; Cohort 2: squamous cell carcinoma of the head and neck <math display="block">SCCHN</math>; Cohort 3: gastrointestinal (GI) cancers with known microsatellite instability-high/mismatch repair deficiency (MSI-H/MMRd) or other deoxyribonucleic acid (DNA) damage repair (DDR) abnormalities, including homologous recombination deficiency (HRD); Cohort 4: platinum-resistant epithelial ovarian cancer <math display="block">EOC</math>, endometrial cancer, primary peritoneal cancer (PPC) or cervical cancer, with known MSIH/MMRd, hereditary/somatic mutations of the breast cancer 1 (BRCA1) and BRCA2 genes or other DNA DDR abnormalities (incl. HRD). Sponsor: Debiopharm International SA Intervention: Debio 1143 Start Date: 2019-04-26 Last Updated: 2023-06-12 Number of Patients: 46 Recruitment Status: COMPLETED Condition: Solid Tumor
NCTID: NCT04703192
Title: Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01) Study Summary: This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma. Sponsor: Daiichi Sankyo, Inc. Intervention: Valemetostat Tosylate Start Date: 2021-06-03 Last Updated: 2023-05-26 Number of Patients: 148 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed/Refractory Peripheral T-Cell Lymphoma
NCTID: NCT03274492
Title: A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma Study Summary: This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL). Sponsor: Hoffmann-La Roche Intervention: Polatuzumab Vedotin Start Date: 2017-11-16 Last Updated: 2023-11-24 Number of Patients: 1000 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT03273153
Title: A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma Study Summary: This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma. Sponsor: Hoffmann-La Roche Intervention: Cobimetinib Start Date: 2017-12-11 Last Updated: 2022-09-21 Number of Patients: 446 Recruitment Status: TERMINATED Condition: Advanced BRAFV600 Wild-type Melanoma
NCTID: NCT03397394
Title: Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Study Summary: The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib. Sponsor: pharmaand GmbH Intervention: Rucaparib Start Date: 2018-06-01 Last Updated: 2023-06-09 Number of Patients: 97 Recruitment Status: TERMINATED Condition: Bladder Cancer
NCTID: NCT01969578
Title: Androgen Deprivation Therapy in Advanced Salivary Gland Cancer Study Summary: Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs. The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bicalutamide + triptorelin Start Date: 2015-09-24 Last Updated: 2023-09-11 Number of Patients: 149 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Salivary Gland Cancer
NCTID: NCT03059823
Title: A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors Study Summary: The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed. The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort. Sponsor: Incyte Corporation Intervention: retifanlimab Start Date: 2016-11-15 Last Updated: 2023-07-12 Number of Patients: 325 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced Solid Tumors
NCTID: NCT06039384
Title: A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation Study Summary: The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib. Sponsor: Incyte Corporation Intervention: INCB099280 Start Date: 2024-01-10 Last Updated: 2023-11-24 Number of Patients: 125 Recruitment Status: RECRUITING Condition: Advanced Solid Tumors
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: NCT05949684
Title: ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions Study Summary: The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD). Sponsor: Bristol-Myers Squibb Intervention: Luspatercept Start Date: 2023-10-24 Last Updated: 2023-11-18 Number of Patients: 360 Recruitment Status: RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT05651932
Title: A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma Study Summary: A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM). Sponsor: K36 Therapeutics, Inc. Intervention: KTX-1001 Start Date: 2023-02-22 Last Updated: 2023-10-24 Number of Patients: 60 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT02924402
Title: Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies Study Summary: The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD). Sponsor: Xencor, Inc. Intervention: XmAb13676 Start Date: 2016-10 Last Updated: 2023-03-01 Number of Patients: 270 Recruitment Status: RECRUITING Condition: B-cell Non-Hodgkins Lymphoma
NCTID: NCT03772028
Title: Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Study Summary: stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy Sponsor: The Netherlands Cancer Institute Intervention: cisplatin Start Date: 2020-01-01 Last Updated: 2023-09-08 Number of Patients: 538 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT04811560
Title: A Study of JNJ-75276617 in Participants With Acute Leukemia Study Summary: The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D<math display="block">s</math>) of JNJ-75276617 in Part 1 (Dose Escalation) and to determine safety and tolerability at the RP2D(s) in Part 2 (Dose Expansion). Sponsor: Janssen Research & Development, LLC Intervention: JNJ-75276617 Start Date: 2021-05-19 Last Updated: 2023-11-09 Number of Patients: 110 Recruitment Status: RECRUITING Condition: Acute Leukemias
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: NCT02130557
Title: A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia Study Summary: Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study. Sponsor: Pfizer Intervention: Bosutinib Start Date: 2014-07-15 Last Updated: 2021-05-18 Number of Patients: 536 Recruitment Status: COMPLETED Condition: Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
NCTID: NCT04471844
Title: Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM Study Summary: To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy. Sponsor: NovoCure GmbH Intervention: Optune® Start Date: 2020-12-08 Last Updated: 2023-11-01 Number of Patients: 950 Recruitment Status: RECRUITING Condition: Glioblastoma Multiforme
NCTID: NCT02719574
Title: Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation Study Summary: This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states. Sponsor: Forma Therapeutics, Inc. Intervention: FT-2102 (olutasidenib) Start Date: 2016-04 Last Updated: 2023-11-18 Number of Patients: 336 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT02467270
Title: Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses Study Summary: The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as measured by <=1 % Breakpoint Cluster Region-Abelson Transcript Level using International Scale (BCR-ABL1IS) at 12 months. Sponsor: Takeda Intervention: Ponatinib Start Date: 2015-06-30 Last Updated: 2023-01-25 Number of Patients: 283 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myeloid Leukemia, Chronic, Chronic Phase
NCTID: NCT02631070
Title: A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes Study Summary: The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions. Sponsor: Celgene Intervention: Luspatercept Start Date: 2016-02-09 Last Updated: 2021-12-17 Number of Patients: 229 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT03309111
Title: Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma Study Summary: The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma. Sponsor: Ichnos Sciences SA Intervention: ISB 1342 Start Date: 2017-10-25 Last Updated: 2022-05-16 Number of Patients: 245 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Multiple Myeloma
