Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

  • Interventional
  • Recruiting
  • NCT02985957
Eligibility Details Visit Clinicaltrials.gov

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

The purpose of this study is to determine whether nivolumab plus ipilimumab has preliminary evidence of safety and effectiveness in the treatment of participants with metastatic castration-resistant prostate cancer who have progressed after prior docetaxel-containing regimen.

Gender
Male

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

        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 apply

At a Glance

National Government IDNCT02985957

IRB#IRB17-0938

Lead SponsorBristol-Myers Squibb

Lead PhysicianAkash Patnaik

Collaborator(s)N/A

EligibilityMale
18 Years and up
Recruiting