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Phase 2 N=351 Randomized Treatment

A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)

Prostate Cancer

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

OutcomeResultp-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

View full record on ClinicalTrials.gov →

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.

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