A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- nivolumab
- Conditions
- Prostate Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 292
- Locations
- 66
- Primary Endpoint
- Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
nivolumab + rucaparib
Specified dose on specified days
Intervention: nivolumab
nivolumab + rucaparib
Specified dose on specified days
Intervention: rucaparib
nivolumab + docetaxel + prednisone
Specified dose on specified days
Intervention: nivolumab
nivolumab + docetaxel + prednisone
Specified dose on specified days
Intervention: docetaxel
nivolumab + docetaxel + prednisone
Specified dose on specified days
Intervention: prednisone
nivolumab + enzalutamide
Specified dose on specified days
Intervention: nivolumab
nivolumab + enzalutamide
Specified dose on specified days
Intervention: enzalutamide
Outcomes
Primary Outcomes
Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
Time Frame: 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)
Time Frame: 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 Outcomes
- Radiographic Progression-Free Survival (rPFS)(Up to approximately 84 months)
- Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)(Up to approximately 84 months)
- Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)(Up to approximately 84 months)
- Prostate-Specific Antigen Time to Progression (TTP-PSA)(Up to approximately 84 months)
- Overall Survival (OS)(Up to approximately 84 months)
- Number of Participants With Adverse Events (AEs)(From first dose to up to 30 days post last dose (Up to 82 months))
- Number of Participants Who Died(Up to 84 months)
- Number of Participants With Laboratory Abnormalities in Specific Liver Tests(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(From first dose to up to 30 days post last dose (Up to 82 months))
- Number of Participants With Laboratory Values Change From Baseline(From first dose to up to 30 days post last dose (Up to 82 months))