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.
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
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | BMS-936558, Opdivo | Cohort A (Arm A) |
Ipilimumab | BMS-734016, Yervoy | Cohort A (Arm A) |
Cabazitaxel | | Cohort D (Arm D4) |
Prednisone | | Cohort 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
Name | Type | Description | Interventions |
---|
Cohort A (Arm A) | Experimental | | |
Cohort B (Arm B) | Experimental | | |
Cohort C (Arm C) | Experimental | | |
Cohort D (Arm D1) | Experimental | | |
Cohort D (Arm D2) | Experimental | | |
Cohort D (Arm D3) | Experimental | | |
Cohort D (Arm D4) | Experimental | | |
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