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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Number of Participants With Treatment Related Adverse Events
Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Time frame: From first dose to 100 days follow up to last dose (Approximately 22 months)
Number of Participants With Treatment Related Serious Adverse Events
Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Time frame: From first dose to 100 days follow up to last dose (Approximately 22 months)
Number of Participants With Dose Limiting Toxicities
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.
Time frame: From first dose to 100 days follow up to last dose (Approximately 22 months)
Number of Participants With AEs Leading to Discontinuation
Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Time frame: From first dose to 100 days follow up to last dose (Approximately 22 months)
Number of Participants Who Died
Number of participant deaths
Time frame: From first dose to 100 days follow up to last dose (Approximately 22 months)
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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
...and 21 more locations
Prostate Specific Antigen Response Rate (PSA-RR)
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.
Time frame: From first dose to 100 days follow up to last dose (Approximately 22 months)
Objective Response Rate
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 frame: From first dose to 100 days follow up to last dose (Approximately 22 months)
Time to Response
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.
Time frame: From first dose to 100 days follow up to last dose (Approximately 22 months)
Duration of Response
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.
Time frame: From first dose to 100 days follow up to last dose (Approximately 22 months)
Overall Survival
OS for all randomized participants is the time between randomization date and the date of death from any cause.
Time frame: From first dose to 100 days follow up to last dose (Approximately 22 months)