An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer

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 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)

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

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)

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

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)

Number of participants who died due to any cause.

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

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

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