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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03338790

Run by

Bristol-Myers Squibb

People needed

292

Starts

2017-12-19

Expected to finish

2025-01-10

Last updated by the study team

2026-01-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0010 — Rancho Mirage, California, United States
• Local Institution - 0049 — New Haven, Connecticut, United States
• Local Institution - 0037 — Miami, Florida, United States
• Local Institution - 0009 — Marietta, Georgia, United States
• Local Institution - 0065 — Louisville, Kentucky, United States
• Tulane University — New Orleans, Louisiana, United States
• Local Institution - 0040 — Rockville, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Local Institution - 0012 — Detroit, Michigan, United States
• Local Institution - 0069 — Jackson, Mississippi, United States
• Local Institution - 0011 — St Louis, Missouri, United States
• Local Institution - 0035 — Omaha, Nebraska, United States
• Local Institution - 0038 — Albany, New York, United States
• Local Institution - 0068 — New York, New York, United States
• Local Institution - 0041 — Durham, North Carolina, United States
• Local Institution - 0024 — Portland, Oregon, United States
• Local Institution - 0053 — Allentown, Pennsylvania, United States
• Local Institution - 0039 — Fairfax, Virginia, United States
• Local Institution - 0052 — CABA, Buenos Aires, Argentina
• Local Institution - 0042 — Capital Federal, Buenos Aires, Argentina
• Local Institution - 0062 — Villa Siburu, Córdoba Province, Argentina
• Local Institution - 0044 — Buenos Aires, Distrito Federal, Argentina
• Local Institution - 0043 — CABA, Argentina
• Local Institution - 0015 — Camperdown, New South Wales, Australia
• Local Institution - 0036 — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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