Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer

Keywords

Prostate Cancer Prostatic Neoplasms Prednisone Docetaxel Nivolumab

Eligibility

For males ages 18 years and up

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

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-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
  • 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

Locations

  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Local Institution not yet accepting patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting Investigator Inquiry Form FDA Safety Alerts and Recalls
ID
NCT04100018
Phase
Phase 3
Study Type
Interventional
Last Updated