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:

          -  Evidence of Stage IV disease (as defined by American Joint Committee of Cancer
             criteria) on previous bone, CT and/or MRI scan.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  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)

          -  Participants with skeletal system symptoms who are already on medications to
             strengthen bones are allowed if they were started ˃28 days before study treatment

        Exclusion Criteria:

          -  Cancer that has spread to the liver or brain

          -  Active, known, or suspected autoimmune disease or infection

          -  Prior treatment with any drug that targets T cell co-stimulation pathways (such as
             checkpoint inhibitors)

          -  Prior whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow. Bone-directed
             radiotherapy for palliation of painful bone metastases to pelvic region is allowed up
             to 14 days before treatment assignment.

        Other protocol defined inclusion/exclusion criteria could 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)
Time Frame:Approximately 24 weeks from treatment initiation
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Radiographic/Clinical Progression-Free Survival (rcPFS)
Time Frame:Approximately 12 months from treatment initiation
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Up to 5 years from treatment initiation
Safety Issue:
Description:
Measure:Number of participants with adverse events
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Number of participants with serious adverse events
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Number of participants with adverse events leading to discontinuation
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Number of participants with immune-mediated adverse events
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Number of participants with deaths
Time Frame:From first dose up to and including 100 days post last dose
Safety Issue:
Description:
Measure:Number of participants with laboratory abnormalities
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

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