A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.

Key facts

Study ID: NCT04100018
Run by: Bristol-Myers Squibb
People needed: 1030
Starts: 2020-02-06
Expected to finish: 2024-06-25
Last updated by the study team: 2025-06-12

Who can join

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

You may qualify if…

Histologic confirmation of adenocarcinoma of the prostate without small cell features
Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy
Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.
Men must agree to follow specific methods of contraception, if applicable

You may not qualify if…

Active brain metastases
Active, known, or suspected autoimmune disease
Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel
Other protocol-defined inclusion/exclusion criteria apply

Where it is running

Local Institution - 0012 — Anchorage, Alaska, United States
Local Institution - 0293 — Tucson, Arizona, United States
Local Institution - 0269 — Jonesboro, Arkansas, United States
Local Institution - 0179 — Orange, California, United States
Local Institution - 0055 — Rancho Mirage, California, United States
Local Institution - 0260 — Redondo Beach, California, United States
Local Institution - 0081 — Santa Monica, California, United States
Local Institution - 0087 — Denver, Colorado, United States
Local Institution - 0190 — West Haven, Connecticut, United States
Local Institution - 0366 — Washington D.C., District of Columbia, United States
Local Institution - 0196 — Hollywood, Florida, United States
Local Institution - 0397 — Jacksonville, Florida, United States
Local Institution - 0164 — Lakeland, Florida, United States
Local Institution - 0181 — Orlando, Florida, United States
Local Institution - 0285 — Pensacola, Florida, United States
Local Institution - 0177 — Weston, Florida, United States
Local Institution - 0117 — Atlanta, Georgia, United States
Local Institution - 0126 — Marietta, Georgia, United States
Local Institution - 0382 — Thomasville, Georgia, United States
Local Institution - 0287 — Niles, Illinois, United States
Local Institution - 0183 — Fort Wayne, Indiana, United States
Local Institution - 0302 — Louisville, Kentucky, United States
Local Institution - 0150 — Baltimore, Maryland, United States
Local Institution - 0332 — Brandywine, Maryland, United States
Local Institution - 0305 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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