Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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-na├»ve 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 - Sufficient tumor samples from either a fresh biopsy (obtained during screening) or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides - Men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria

  • Prior malignancy active within the previous 3 years (i.e. participants with a history of prior malignancy are eligible if treatment was completed at least 3 years before enrollment) 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 - 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Nivolumab + docetaxel + prednisone
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • OPDIVO,
    • BMS-936558-01
  • Drug: Prednisone
    Specified dose on specified days
  • Drug: Docetaxel
    Specified dose on specified days
Placebo Comparator
Arm B: Placebo + docetaxel + prednisone
  • Drug: Prednisone
    Specified dose on specified days
  • Drug: Docetaxel
    Specified dose on specified days
  • Other: Placebo
    Specified dose on specified days

Recruiting Locations

University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Arif Hussain, Site 0150
800-888-8823

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
please email:
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.