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

• Status: Active, not recruiting
• Trial end date: 2021-11-18
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborators: Astellas Pharma Inc; Clovis Oncology; Clovis Oncology, Inc.
• Treatments: Antibodies, Monoclonal; Docetaxel; Nivolumab; Prednisone; Rucaparib

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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