Phase 2
N=351
A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02985957 ↗Enrolled (actual)
351
Serious AEs
71.1%
Results posted
Apr 2023
Primary outcome: Primary: Objective Response Rate (ORR) Cohorts B and C Per BICR — 12.5; 20.0 Percent of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Biological); Ipilimumab (Biological); Cabazitaxel (Drug); Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Cohorts B and C Per BICR |
12.5; 20.0 | — |
| PRIMARY Objective Response Rate (ORR) Cohort D |
13.3; 17.4; 8.7; 8.9 | — |
| PRIMARY Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR |
7.59; 5.36 | — |
| PRIMARY Radiographic Progression-Free Survival (rPFS) for Cohort D |
3.70; 3.81; 3.09; 6.34 | — |
| SECONDARY Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C |
4.34; 3.71 | — |
| SECONDARY Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D |
2.53; 3.78; 2.66; 5.85 | — |
| SECONDARY Overall Survival (OS) Cohorts B and C |
19.75; 15.21 | — |
| SECONDARY Overall Survival (OS) Cohort D |
15.9; 14.46; 18.46; 15.15 | — |
| SECONDARY Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C |
17.6; 10.0 | — |
| SECONDARY Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D |
13.6; 18.2; 5.4; 23.9; 30.8; 17.4 | — |
| SECONDARY The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C |
2; 45; 45 | — |
| SECONDARY The Number of Participants Experiencing Adverse Events (AEs) in Cohort D |
69; 71; 37; 69; 11; 27 | — |
| SECONDARY The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C |
1; 17; 33 | — |
| SECONDARY The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D |
38; 44; 15; 32; 7; 18 | — |
| SECONDARY The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C |
1; 17; 18 | — |
| SECONDARY The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D |
16; 27; 7; 13; 3; 6 | — |
| SECONDARY The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C |
1; 3; 2; 0; 15; 17 | — |
| SECONDARY The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D |
1; 4; 0; 0; 1; 2 | — |
| SECONDARY The Number of Participants Who Died in Cohorts A, B and C |
2; 39; 39 | — |
| SECONDARY The Number of Participants Who Died in Cohort D |
14; 15; 4; 13; 2; 9 | — |
| SECONDARY The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C |
0; 6; 23; 0; 3; 8 | — |
| SECONDARY The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D |
26; 35; 14; 42; 10; 8 | — |
| SECONDARY The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C |
0; 2; 5; 0; 2; 2 | — |
| SECONDARY The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D |
6; 8; 0; 1; 3; 5 | — |
| SECONDARY The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C |
0; 5; 13; 0; 3; 7 | — |
| SECONDARY The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D |
13; 20; 1; 11; 10; 16 | — |
| SECONDARY Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C |
0.0; -0.1; -0.5; -0.1; -0.2; -0.1 | — |
| SECONDARY Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D |
-0.3; 0.5; -0.1; -0.5; -0.3; 0.2 | — |
| SECONDARY Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D |
6.73; -4.74; -3.64; -0.28 | — |
| SECONDARY Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C |
0.0083; -0.0074 | — |
| SECONDARY Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D |
0.0032; -0.0328; 0.0113; 0.0219 | — |
Summary
The purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mCRPC).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02985957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.