An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Purpose
The purpose of this study is to assess the safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.
Condition
- Prostate Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental nivolumab + rucaparib |
Specified dose on specified days |
|
|
Experimental nivolumab + docetaxel + prednisone |
Specified dose on specified days |
|
|
Experimental nivolumab + enzalutamide |
Specified dose on specified days |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Bristol-Myers Squibb