A Phase 2 interventional study of nivolumab and docetaxel in Prostate Cancer, sponsored by Bristol-Myers Squibb. Completed at 66 sites in 11 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 292 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Specified dose on specified days
Biological: nivolumab · Drug: rucaparib
Specified dose on specified days
Biological: nivolumab · Drug: docetaxel · Drug: prednisone
Specified dose on specified days
Biological: nivolumab · Drug: enzalutamide
Specified dose on specified days
Also known as: BMS-936558, Opdivo
Specified dose on specified days
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
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)
| Milestone | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Started | 88 | 71 | 84 | 49 |
| Completed | 0 | 3 | 1 | 0 |
| Not completed | 88 | 68 | 83 | 49 |
| Withdrew: Disease progression | 65 | 46 | 54 | 42 |
| Withdrew: Study drug toxicity | 12 | 8 | 14 | 0 |
| Withdrew: Death | 2 | 1 | 1 | 0 |
| Withdrew: Adverse event unrelated to study drug | 4 | 4 | 6 | 4 |
| Withdrew: Participant request to discontinue study treatment | 4 | 3 | 3 | 1 |
| Withdrew: Poor/non-compliance | 0 | 1 | 0 | 0 |
| Withdrew: Participant withdrew consent | 1 | 0 | 1 | 1 |
| Withdrew: Other reasons | 0 | 5 | 1 | 1 |
| Withdrew: Maximum clinical benefit | 0 | 0 | 1 | 0 |
| Withdrew: Administrative reason by sponsor | 0 | 0 | 1 | 0 |
| Withdrew: Participant no longer meets study criteria | 0 | 0 | 1 | 0 |
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
| Percentage of participants | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Overall | 10.3 (3.9 to 21.2) | 15.4 (5.9 to 30.5) | 40.0 (25.7 to 55.7) | 11.1 (1.4 to 34.7) |
| Homologous Recombination Deficiency (HRD+) | 17.2 (5.8 to 35.8) | 25.0 (8.7 to 49.1) | 36.8 (16.3 to 61.6) | 20.0 (0.5 to 71.6) |
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
| Percentage of participants | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Overall | 11.9 (5.9 to 20.8) | 27.3 (17.0 to 39.6) | 46.9 (35.7 to 58.3) | 34.1 (20.5 to 49.9) |
| Homologous Recombination Deficiency (HRD+) | 18.2 (8.2 to 32.7) | 41.9 (24.5 to 60.9) | 50.0 (32.4 to 67.6) | 50.0 (18.7 to 81.3) |
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)
| Months | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Overall | 4.60 (3.68 to 5.72) | 8.15 (5.59 to 10.97) | 9.20 (8.25 to 11.47) | 5.75 (3.81 to 9.33) |
| Homologous Recombination Deficiency (HRD+) | 5.59 (3.68 to 8.08) | 11.01 (6.74 to 12.02) | 10.45 (8.44 to 12.88) | 8.48 (3.78 to NA) |
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)
| Months | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Overall | 1.94 (1.6 to 5.1) | 1.95 (1.8 to 11.0) | 1.94 (1.6 to 8.3) | 1.9 (1.9 to 1.9) |
| Homologous Recombination Deficiency (HRD+) | 2.76 (1.6 to 5.1) | 2.07 (1.8 to 11.0) | 2.04 (1.8 to 8.3) | 1.9 (1.9 to 1.9) |
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
| Months | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Overall | NA (3.45 to NA) | 7.10 (3.78 to NA) | 7.21 (6.47 to 12.35) | NA (9.23 to NA) |
| Homologous Recombination Deficiency (HRD+) | NA (3.45 to NA) | 7.10 (3.78 to NA) | 7.43 (6.44 to 13.86) | NA (NA to NA) |
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)
| Months | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Overall | 3.78 (2.83 to 6.47) | 3.45 (2.83 to 6.21) | 8.67 (7.16 to 10.35) | 3.09 (2.79 to 6.37) |
| Homologous Recombination Deficiency (HRD+) | 6.47 (3.78 to 9.63) | 10.25 (4.63 to 13.77) | 8.64 (7.16 to 10.58) | 5.55 (2.73 to 8.28) |
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
| Months | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Overall | 13.96 (10.35 to 15.77) | 20.24 (13.54 to 22.90) | 18.17 (15.15 to 25.49) | 17.41 (12.98 to 24.15) |
| Homologous Recombination Deficiency (HRD+) | 15.15 (11.40 to 18.20) | 23.00 (13.54 to 29.27) | 19.35 (13.54 to 27.20) | 24.97 (9.10 to 45.50) |
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)
| Participants | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Adverse Events (AEs) | 88 | 71 | 83 | 49 |
| Serious Adverse Events (SAEs) | 49 | 37 | 41 | 20 |
| AEs leading to discontinuation | 47 | 31 | 37 | 17 |
| Immune-mediated AEs (Pneumonitis) | 1 | 2 | 9 | 0 |
| Immune-mediated AEs (Diarrhea/Colitis) | 3 | 4 | 2 | 0 |
| Immune-mediated AEs (Hepatitis) | 8 | 6 | 1 | 2 |
| Immune-mediated AEs (Nephritis/Renal Dysfunction) | 0 | 3 | 0 | 0 |
| Immune-mediated AEs (Rash) | 6 | 5 | 7 | 10 |
| Immune-mediated AEs (Hypersensitivity) | 0 | 0 | 0 | 3 |
| Immune-mediated AEs (Adrenal insufficiency) | 1 | 0 | 0 | 0 |
| Immune-mediated AEs (Hypothyroidism/Thyroiditis) | 7 | 6 | 3 | 5 |
| Immune-mediated AEs (Hyperthyroidism) | 2 | 1 | 2 | 0 |
| Immune-mediated AEs (Hypophysitis) | 0 | 0 | 1 | 0 |
| Immune-mediated AEs (Diabetes Mellitus) | 0 | 1 | 0 | 1 |
Number of participants who died due to any cause.
| Participants | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Number of Participants Who Died | 79 | 66 | 76 | 47 |
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
| Participants | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| ALT or AST > 3xULN | 19 | 23 | 6 | 4 |
| ALT or AST > 5xULN | 11 | 15 | 3 | 3 |
| ALT or AST > 10xULN | 2 | 5 | 1 | 0 |
| ALT or AST > 20xULN | 0 | 1 | 1 | 0 |
| TOTAL BILIRUBIN > 2xULN | 3 | 1 | 1 | 0 |
| ALP > 1.5xULN | 49 | 34 | 35 | 22 |
| Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 1.5xULN within one day | 3 | 1 | 0 | 1 |
| Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 1.5xULN within 30 days | 4 | 1 | 0 | 1 |
| Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 2xULN within one day | 2 | 1 | 0 | 0 |
| Concurrent ALT or AST elevation > 3xULN with total Bilirubin > 2xULN within 30 days | 2 | 1 | 0 | 0 |
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
| Participants | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| TSH > ULN | 23 | 17 | 12 | 17 |
| TSH > ULN with TSH <= ULN at baseline | 18 | 12 | 7 | 12 |
| TSH > ULN with at least one FT3/FT4 test value < LLN | 10 | 6 | 7 | 5 |
| TSH > ULN with all other FT3/FT4 test values >= LLN | 11 | 9 | 3 | 9 |
| TSH > ULN with FT3/FT4 test missing | 2 | 2 | 2 | 3 |
| TSH < LLN | 17 | 12 | 25 | 8 |
| TSH < LLN with TSH >= LLN at baseline | 14 | 11 | 19 | 8 |
| TSH < LLN with at least one FT3/FT4 test value > ULN | 6 | 5 | 2 | 7 |
| TSH < LLN with all other FT3/FT4 test values <= ULN | 8 | 4 | 11 | 0 |
| TSH < LLN with FT3/FT4 test missing | 3 | 3 | 12 | 1 |
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
| Participants | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Hemoglobin Grade 0 | 23 | 21 | 30 | 8 |
| Hemoglobin Grade 1 | 38 | 28 | 23 | 13 |
| Hemoglobin Grade 2 | 8 | 3 | 2 | 2 |
| Platelet Grade 0 | 34 | 32 | 10 | 13 |
| Platelet Grade 1 | 4 | 1 | 0 | 0 |
| Leukocytes Grade 0 | 39 | 35 | 30 | 13 |
| Leukocytes Grade 1 | 10 | 6 | 3 | 3 |
| Leukocytes Grade 2 | 1 | 0 | 1 | — |
| Lymphocytes Grade 0 | 24 | 30 | 28 | 14 |
| Lymphocytes Grade 1 | 11 | 8 | 1 | 2 |
| Lymphocytes Grade 2 | 3 | 3 | 6 | 3 |
| Lymphocytes Grade 3 | 1 | 0 | 0 | — |
| Neutrophil Grade 0 | 35 | 26 | 38 | 7 |
| Neutrophil Grade 1 | 3 | 4 | 1 | — |
| Neutrophil Grade 2 | 1 | — | — | 1 |
| Alkaline Phosphatase Grade 0 | 25 | 34 | 13 | 8 |
| Alkaline Phosphatase Grade 1 | 14 | 4 | 13 | 6 |
| Alkaline Phosphatase Grade 2 | 9 | 1 | 3 | 0 |
| Alkaline Phosphatase Grade 3 | 1 | 3 | 0 | 0 |
| Aspartate Aminotransferase Grade 0 | 52 | 49 | 16 | 9 |
| Aspartate Aminotransferase Grade 1 | 5 | 4 | 6 | 4 |
| Alanine Aminotransferase Grade 0 | 48 | 48 | 13 | 4 |
| Alanine Aminotransferase Grade 1 | 4 | 3 | 3 | 1 |
| Bilirubin Grade 0 | 16 | 12 | 2 | 3 |
| Bilirubin Grade 1 | 1 | — | — | 0 |
| Creatinine Grade 0 | 31 | 30 | 13 | 3 |
| Creatinine Grade 1 | 7 | 5 | 5 | 2 |
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
| Percentage of participants | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Overall | 12.1 (5.0 to 23.3) | 15.4 (5.9 to 30.5) | 40.0 (25.7 to 55.7) | 11.1 (1.4 to 34.7) |
| Homologous Recombination Deficiency (HRD+) | 20.7 (8.0 to 39.7) | 25.0 (8.7 to 49.1) | 36.8 (16.3 to 61.6) | 20.0 (0.5 to 71.6) |
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
| Percentage of participants | Arm A1 | Arm A2 | Arm B | Arm C |
|---|---|---|---|---|
| Overall | 11.8 (5.8 to 20.6) | 28.8 (18.3 to 41.3) | 46.9 (35.7 to 58.3) | 34.1 (20.5 to 49.9) |
| Homologous Recombination Deficiency (HRD+) | 18.2 (8.2 to 32.7) | 43.8 (26.4 to 62.3) | 50.0 (32.4 to 67.6) | 50.0 (18.7 to 81.3) |
Collected over Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 84 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 84 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A1: Nivolumab 480 mg and Rucaparib 600 mg | 79/88 (89.8%) | 53/88 (60.2%) | 87/88 (98.9%) |
| Arm A2: Nivolumab 480 mg and Rucaparib 600 mg | 66/71 (93%) | 45/71 (63.4%) | 70/71 (98.6%) |
| Arm B: Nivolumab 360 mg and Docetaxel 75 mg/m2 | 76/84 (90.5%) | 50/84 (59.5%) | 83/84 (98.8%) |
| Arm C: Nivolumab 480 mg and Enzalutamide 160 mg | 47/49 (95.9%) | 25/49 (51%) | 48/49 (98%) |
| Event | Arm A1: Nivolumab 480 mg and Rucaparib 600 mg | Arm A2: Nivolumab 480 mg and Rucaparib 600 mg | Arm B: Nivolumab 360 mg and Docetaxel 75 mg/m2 | Arm C: Nivolumab 480 mg and Enzalutamide 160 mg |
|---|---|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 14/88 | 9/71 | 8/84 | 7/49 |
| PneumoniaInfections and infestations | 2/88 | 9/71 | 6/84 | 2/49 |
| AnaemiaBlood and lymphatic system disorders | 8/88 | 4/71 | 0/84 | 2/49 |
| Acute kidney injuryRenal and urinary disorders | 7/88 | 2/71 | 1/84 | 1/49 |
| SepsisInfections and infestations | 2/88 | 4/71 | 3/84 | 1/49 |
| Febrile neutropeniaBlood and lymphatic system disorders | 4/88 | 1/71 | 4/84 | 0/49 |
| NeutropeniaBlood and lymphatic system disorders | 4/88 | 1/71 | 4/84 | 0/49 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/88 | 0/71 | 4/84 | 0/49 |
| Urinary tract infectionInfections and infestations | 2/88 | 3/71 | 1/84 | 1/49 |
| Aspartate aminotransferase increasedInvestigations | 0/88 | 3/71 | 1/84 | 0/49 |
| Event | Arm A1: Nivolumab 480 mg and Rucaparib 600 mg | Arm A2: Nivolumab 480 mg and Rucaparib 600 mg | Arm B: Nivolumab 360 mg and Docetaxel 75 mg/m2 | Arm C: Nivolumab 480 mg and Enzalutamide 160 mg |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 46/88 | 35/71 | 36/84 | 17/49 |
| DiarrhoeaGastrointestinal disorders | 29/88 | 21/71 | 42/84 | 9/49 |
| FatigueGeneral disorders and administration site conditions | 36/88 | 26/71 | 41/84 | 21/49 |
| AnaemiaBlood and lymphatic system disorders | 32/88 | 30/71 | 25/84 | 15/49 |
| VomitingGastrointestinal disorders | 30/88 | 18/71 | 14/84 | 5/49 |
| AlopeciaSkin and subcutaneous tissue disorders | 0/88 | 2/71 | 28/84 | 1/49 |
| Decreased appetiteMetabolism and nutrition disorders | 29/88 | 21/71 | 25/84 | 14/49 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 17/88 | 11/71 | 20/84 | 16/49 |
| Back painMusculoskeletal and connective tissue disorders | 20/88 | 11/71 | 25/84 | 12/49 |
| Alanine aminotransferase increasedInvestigations | 16/88 | 21/71 | 5/84 | 4/49 |
| Age, Continuous(Years) | Arm A1 | Arm A2 | Arm B | Arm C | Total |
|---|---|---|---|---|---|
| Mean | 66.6 ± 8.3 | 70.7 ± 9.7 | 70.3 ± 7.6 | 69.8 ± 8.0 | 69.4 ± 8.4 |
| Sex: Female, Male(Participants) | Arm A1 | Arm A2 | Arm B | Arm C | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 88 | 71 | 84 | 49 | 292 |
| Race (NIH/OMB)(Participants) | Arm A1 | Arm A2 | Arm B | Arm C | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 1 | 1 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 1 | 8 | 2 | 15 |
| White | 72 | 64 | 70 | 42 | 248 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 10 | 5 | 5 | 5 | 25 |
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Studies of the drugs tested here: Nivolumab · Docetaxel · Enzalutamide · Rucaparib