An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT03338790
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 292
- Histologic confirmation of adenocarcinoma of the prostate
- Evidence of stage IV disease on previous bone, CT, and/or MRI scan
- Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
- Mandatory plasma and fresh or archival tumor tissue must be submitted
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast
- Participants with active brain metastases
- Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment
Other protocol defined inclusion/exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description nivolumab + docetaxel + prednisone nivolumab Specified dose on specified days nivolumab + rucaparib nivolumab Specified dose on specified days nivolumab + rucaparib rucaparib Specified dose on specified days nivolumab + docetaxel + prednisone docetaxel Specified dose on specified days nivolumab + docetaxel + prednisone prednisone Specified dose on specified days nivolumab + enzalutamide enzalutamide Specified dose on specified days nivolumab + enzalutamide nivolumab Specified dose on specified days
- Primary Outcome Measures
Name Time Method Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) Up to approximately 36 months 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
Prostate-Specific Antigen Response Rate (RR-PSA) Up to approximately 36 months 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
- Secondary Outcome Measures
Name Time Method Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3) Up to approximately 36 months 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 PCWG3 or death due to any cause
Overall Survival (OS) Up to approximately 36 months 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
Radiographic Progression-Free Survival (rPFS) Up to approximately 36 months 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 PCWG3
Number of Participants With Adverse Events (AEs) From first dose to up to 30 days post last dose (Up to 34 months) 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 to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3) Up to approximately 36 months 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 PCWG3
Prostate-Specific Antigen Time to Progression (TTP-PSA) Up to approximately 36 months Prostate-specific antigen time to progression (TTP-PSA) is the time between treatment initiation to the date of PSA progression per prostate cancer clinical trails working group 3
Number of Participants With Laboratory Abnormalities in Specific Liver Tests From first dose to up to 30 days post last dose (up to 34 months) 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 ULNNumber of Participants With Laboratory Values Change From Baseline From first dose to up to 30 days post last dose (Up to 34 months) 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
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests From first dose to up to 30 days post last dose (Up to 34 months) 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 testNumber of Deaths Up to 36 months Number of deaths in all treated participants
Trial Locations
- Locations (66)
Local Institution - 0037
🇺🇸Miami, Florida, United States
Local Institution - 0009
🇺🇸Marietta, Georgia, United States
Local Institution - 0012
🇺🇸Detroit, Michigan, United States
Local Institution - 0035
🇺🇸Omaha, Nebraska, United States
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 - 0065
🇺🇸Louisville, Kentucky, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Local Institution - 0040
🇺🇸Rockville, Maryland, United States
Scroll for more (56 remaining)Local Institution - 0037🇺🇸Miami, Florida, United States