The purpose of this study is to assess safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
292
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease
Time frame: Up to approximately 36 months
Prostate-Specific Antigen Response Rate (RR-PSA)
Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result
Time frame: Up to approximately 36 months
Radiographic Progression-Free Survival (rPFS)
Radiographic progress-free survival (rPFS) is the time between treatment initiation and the first date of documented progression or death due to any cause, whichever occurs first assessed by the investigator per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Time frame: Up to approximately 84 months
Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)
Time to response per prostate cancer clinical trials working group 3 (TTR-PCWG3) is the time from treatment initiation to the date of the first documented complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Time frame: Up to approximately 84 months
Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)
Duration of response per prostate cancer clinical trials working group 3 (DOR-PCWG3) is the time between the date of first response (complete response/partial response per PCWG3) to the date of first documented radiographic progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) or death due to any cause
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Specified dose on specified days
Specified dose on specified days
Local Institution - 0036
Daphne, Alabama, United States
Local Institution - 0010
Rancho Mirage, California, United States
Local Institution - 0049
New Haven, Connecticut, United States
Local Institution - 0037
Miami, Florida, United States
Local Institution - 0009
Marietta, Georgia, United States
Local Institution - 0065
Louisville, Kentucky, United States
Tulane University
New Orleans, Louisiana, United States
Local Institution - 0040
Rockville, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Local Institution - 0012
Detroit, Michigan, United States
...and 56 more locations
Time frame: Up to approximately 84 months
Prostate-Specific Antigen Time to Progression (TTP-PSA)
Prostate-specific antigen time to progression (TTP-PSA) is the time between treatment initiation to the date of PSA progression per prostate cancer clinical trials working group 3 (PCWG3)
Time frame: Up to approximately 84 months
Overall Survival (OS)
Overall Survival (OS) is the time between treatment initiation and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive. OS will be censored for participants at the date of treatment initiation if they had no follow-up
Time frame: Up to approximately 84 months
Number of Participants With Adverse Events (AEs)
Number of Participants with any grade adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and immune-mediated AEs using the Common Toxicity Criteria Grade for Adverse Events (CTCAE V4)
Time frame: From first dose to up to 30 days post last dose (Up to 82 months)
Number of Participants Who Died
Number of participants who died due to any cause.
Time frame: Up to 84 months
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Number of participants with laboratory abnormalities in specific liver tests based on SI conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * ALP \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
Time frame: From first dose to up to 30 days post last dose (up to 82 months)
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: * TSH value \> ULN and * with baseline TSH value \<= ULN * with at least one FT3/FT4 test value \< LLN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \>= LLN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test. * TSH \< LLN and * with baseline TSH value \>= LLN * with at least one FT3/FT4 test value \> ULN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \<= ULN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test
Time frame: From first dose to up to 30 days post last dose (Up to 82 months)
Number of Participants With Laboratory Values Change From Baseline
Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort
Time frame: From first dose to up to 30 days post last dose (Up to 82 months)