Clinical Trials /

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

NCT02985957

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Nivolumab Plus Ipilimumab, Ipilimumab or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer
  • Official Title: A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: CA209-650
  • SECONDARY ID: 2016-001928-54
  • NCT ID: NCT02985957

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
NivolumabBMS-936558, OpdivoCohort A (Arm A)
IpilimumabBMS-734016, YervoyCohort A (Arm A)
CabazitaxelCohort D (Arm D4)
PrednisoneCohort D (Arm D4)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cohort A (Arm A)Experimental
  • Nivolumab
  • Ipilimumab
Cohort B (Arm B)Experimental
  • Nivolumab
  • Ipilimumab
Cohort C (Arm C)Experimental
  • Nivolumab
  • Ipilimumab
Cohort D (Arm D1)Experimental
  • Nivolumab
  • Ipilimumab
Cohort D (Arm D2)Experimental
  • Nivolumab
  • Ipilimumab
Cohort D (Arm D3)Experimental
  • Ipilimumab
Cohort D (Arm D4)Experimental
  • Cabazitaxel
  • Prednisone

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR) in Cohort B, C, and Cohort D - Part 2 period
Time Frame:Approximately 24 weeks from treatment initiation
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort B, C, and Cohort D - Part 2 period
Time Frame:Approximately 12 months from treatment initiation
Safety Issue:
Description:
Measure:Radiographic/Clinical Progression-Free Survival (rcPFS) in Cohort D - Part 1 period
Time Frame:Approximately 12 months from randomization
Safety Issue:
Description:
Measure:Overall Survival (OS) in Cohort B, C, and Cohort D - Part 2 period
Time Frame:Up to 5 years from treatment initiation
Safety Issue:
Description:
Measure:Overall Survival (OS) in Cohort D - Part 1 period
Time Frame:Up to 5 years from randomization
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs)
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs) leading to discontinuation
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Incidence of Immune-mediated Adverse Events (IMAEs)
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Incidence of deaths
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities: Hematology
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities: Clinical Chemistry
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities: Coagulation
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities: Liver function
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities: Thyroid function
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities: Adrenal function
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities: Renal function
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Number of participants with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF)
Time Frame:Approximately 12 months from treatment initiation
Safety Issue:
Description:
Measure:Estimated changes in health status and health utility as measured by the 3-level EuroQol Five Dimensions (EQ-5D-3L)
Time Frame:Approximately 12 months from treatment initiation
Safety Issue:
Description:
Measure:Changes in cancer related symptoms and quality of life using the Functional Assessment Of Cancer Therapy - Prostate (FACT-P) questionnaire
Time Frame:Approximately 24 months from treatment initiation
Safety Issue:
Description:
Measure:Prostate Specfic Antigen (PSA) Response Rate
Time Frame:Up to 24 weeks from treatment initiation
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

April 23, 2021