A Phase 2, Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- BMS-986218
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 10
- Locations
- 30
- Primary Endpoint
- Number of Participants With Treatment Related Adverse Events
- Status
- Terminated
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
Arm 1A: Docetaxel + BMS-986218
Intervention: BMS-986218
Arm 1A: Docetaxel + BMS-986218
Intervention: Docetaxel
Arm 2B: Docetaxel + BMS-986218
Intervention: BMS-986218
Arm 1B: Docetaxel + BMS-986218 + Nivolumab
Intervention: BMS-986218
Arm 1B: Docetaxel + BMS-986218 + Nivolumab
Intervention: Docetaxel
Arm 1B: Docetaxel + BMS-986218 + Nivolumab
Intervention: Nivolumab
Arm 2A: Docetaxel
Intervention: Docetaxel
Arm 2B: Docetaxel + BMS-986218
Intervention: Docetaxel
Arm 2C: Docetaxel + BMS-986218 + Nivolumab
Intervention: BMS-986218
Arm 2C: Docetaxel + BMS-986218 + Nivolumab
Intervention: Docetaxel
Arm 2C: Docetaxel + BMS-986218 + Nivolumab
Intervention: Nivolumab
Arm 2D (Optional Crossover): BMS-986218 + Nivolumab
Intervention: BMS-986218
Arm 2D (Optional Crossover): BMS-986218 + Nivolumab
Intervention: Nivolumab
Outcomes
Primary Outcomes
Number of Participants With Treatment Related Adverse Events
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: From first dose to 100 days follow up to last dose (Approximately 22 months)
Number of participant deaths
Secondary Outcomes
- Prostate Specific Antigen Response Rate (PSA-RR)(From first dose to 100 days follow up to last dose (Approximately 22 months))
- Objective Response Rate(From first dose to 100 days follow up to last dose (Approximately 22 months))
- Time to Response(From first dose to 100 days follow up to last dose (Approximately 22 months))
- Duration of Response(From first dose to 100 days follow up to last dose (Approximately 22 months))
- Overall Survival(From first dose to 100 days follow up to last dose (Approximately 22 months))