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

Status
Completed
Cancer Type
Bone Tumor
Trial Phase
Phase III
Eligibility
18 Years and older, Male
Study Type
Treatment
NCT ID
NCT04100018
Protocol IDs
CA209-7DX (primary)
NCI-2019-08322
2019-002030-36
Study Sponsor
Bristol-Myers Squibb

Summary

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.

Eligibility

  1. Histologic confirmation of adenocarcinoma of the prostate without small cell features
  2. 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)
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  4. Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
  5. Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
  6. 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
  7. 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.
  8. Men must agree to follow specific methods of contraception, if applicable
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