A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- Registration Number
- NCT05169684
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 10
- Histologic confirmation of carcinoma of the prostate without small cell features
- Documented prostate cancer progression by Prostate Cancer Working Group 3 (PCWG3) criteria while castrate
- Evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography (CT)/magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the screening visit
- Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC) and have received at least one novel antiandrogen therapy (NAT)
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment in Part 1 or randomization in Part 2
- Untreated central nervous system (CNS) metastases
- Leptomeningeal metastases
- Active, known or suspected autoimmune disease
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm 1A: Docetaxel + BMS-986218 BMS-986218 - Arm 1B: Docetaxel + BMS-986218 + Nivolumab BMS-986218 - Arm 2B: Docetaxel + BMS-986218 Docetaxel - Arm 2C: Docetaxel + BMS-986218 + Nivolumab BMS-986218 - Arm 2C: Docetaxel + BMS-986218 + Nivolumab Docetaxel - Arm 2C: Docetaxel + BMS-986218 + Nivolumab Nivolumab - Arm 2D (Optional Crossover): BMS-986218 + Nivolumab BMS-986218 - Arm 2D (Optional Crossover): BMS-986218 + Nivolumab Nivolumab - Arm 1B: Docetaxel + BMS-986218 + Nivolumab Nivolumab - Arm 2B: Docetaxel + BMS-986218 BMS-986218 - Arm 1A: Docetaxel + BMS-986218 Docetaxel - Arm 1B: Docetaxel + BMS-986218 + Nivolumab Docetaxel - Arm 2A: Docetaxel Docetaxel -
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Related Adverse Events From first dose to 100 days follow up to last dose (Approximately 22 months) Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Number of Participants With Treatment Related Serious Adverse Events From first dose to 100 days follow up to last dose (Approximately 22 months) Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Number of Participants With Dose Limiting Toxicities From first dose to 100 days follow up to last dose (Approximately 22 months) DLTs will be defined as:
Any treatment-related AEs for which a participant permanently discontinues a study treatment (other than daily prednisone) and that occurs during the first 2 cycles of treatment.
Any death not clearly due to the underlying disease or extraneous causes and that occurs during the first 2 cycles of treatment Greater than or equal to Grade 2 pneumonitis lasting greater than 5 days despite appropriate medical therapy and that occurs during the first 2 cycles of treatment Any neutropenic fever as well as Grade 4 neutropenia or thrombocytopenia for \> 7 days that occurs during the first 2 cycles of treatment Any treatment-related AE that delays initiation of Cycle 2 or Cycle 3 of treatment by greater than 2 consecutive weeks.Number of Participants With AEs Leading to Discontinuation From first dose to 100 days follow up to last dose (Approximately 22 months) Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Number of Participants Who Died From first dose to 100 days follow up to last dose (Approximately 22 months) Number of participant deaths
- Secondary Outcome Measures
Name Time Method Objective Response Rate From first dose to 100 days follow up to last dose (Approximately 22 months) Objective response rate per PCWG3 (ORR-PCWG3) is the proportion of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. The BOR is defined as the best response designation, as determined by the BICR, recorded between the date of randomization and the date of objectively documented radiographic progression, or last tumor measurement, whichever occurs first.
Time to Response From first dose to 100 days follow up to last dose (Approximately 22 months) Time to response per PCWG3 (TTR-PCWG3) is the time from randomization date to the date of the first documented CR or PR per PCWG3, as determined by BICR.
Duration of Response From first dose to 100 days follow up to last dose (Approximately 22 months) Duration of response per PCWG3 (DOR-PCWG3) is the time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3 (as determined by BICR), or death due to any cause.
Overall Survival From first dose to 100 days follow up to last dose (Approximately 22 months) OS for all randomized participants is the time between randomization date and the date of death from any cause.
Prostate Specific Antigen Response Rate (PSA-RR) From first dose to 100 days follow up to last dose (Approximately 22 months) PSA-RR is the proportion of randomized participants with a 50% or greater decrease in PSA from baseline to any post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response.
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Trial Locations
- Locations (30)
Arizona Oncology - Tucson - Wilmot Road Location
🇺🇸Tucson, Arizona, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Rocky Mountain Cancer Centers - Littleton
🇺🇸Littleton, Colorado, United States
Yale School Of Medicine
🇺🇸New Haven, Connecticut, United States
Medical Oncology Hematology Consultants - Newark
🇺🇸Newark, Delaware, United States
The Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Local Institution - 0004
🇺🇸Marietta, Georgia, United States
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
🇺🇸Chicago, Illinois, United States
University Of Iowa Hospitals And Clinics
🇺🇸Iowa City, Iowa, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Scroll for more (20 remaining)Arizona Oncology - Tucson - Wilmot Road Location🇺🇸Tucson, Arizona, United States