A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02985957

Sponsor: Bristol-Myers Squibb

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • 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).
  • Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL) For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
  • Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization Exclusion Criteria:
  • Presence of visceral metastases in the liver
  • Active brain metastases or leptomeningeal metastases
  • Active, known, or suspected autoimmune disease or infection
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
  • Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab
  • Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel) Other protocol-defined inclusion/

Exclusion Criteria:

  • Presence of visceral metastases in the liver
  • Active brain metastases or leptomeningeal metastases
  • Active, known, or suspected autoimmune disease or infection
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:
  • Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab
  • Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel) Other protocol-defined inclusion/exclusion criteria apply

View trial on ClinicalTrials.gov