NCT02985957|CompletedPhase 2ResultsFDA Drug

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

CheckMate 650

A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

CA209-6502016-001928-54

Study Type

interventional

Target

351

Locations

9 countries

Sites

Timeline

RegisteredDec 2016

StartedMar 2017

CompletionJan 2025

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

351

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline

Completed

Started Mar 2017

Longer than P75 for phase_2 prostate-cancer

Geographic Reach

9 countries

58 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.8 years study duration

First Submitted

Initial submission to the registry

November 22, 2016

Completed

15 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed

4 months until next milestone

Study Start

First participant enrolled

March 26, 2017

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2022

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

April 24, 2023

Completed

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2025

Completed

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

November 22, 2016

Results QC Date

March 30, 2023

Last Update Submit

December 19, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

Objective Response Rate (ORR) Cohorts B and C Per BICR
Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment. Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days). Confidence-interval based on Clopper Pearson method.
From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)
Objective Response Rate (ORR) Cohort D
In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment. Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days). Confidence-interval based on Clopper Pearson method.
From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)
Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR
Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first. The following progressive diseases were collected, documented and assessed as below: Radiographic progression per retrospective Blinded Independent Central Review (BICR) assessment 1. Bone disease progression by Prostate Cancer Working Group (PCWG2) 2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Radiographic Progression-Free Survival (rPFS) for Cohort D
Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first. The following progressive diseases were collected, documented and assessed as below: Radiographic progression per BICR assessment 1. Bone disease progression by (Prostate Cancer Working Group) PCWG2 2. Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Based on Kaplan-Meier estimates.
From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)

Secondary Outcomes (27)

Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C
From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D
From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 93 months)
Overall Survival (OS) Cohorts B and C
From first dose to the date of death due to any cause (assessed up to approximately 61 months)
Overall Survival (OS) Cohort D
From randomization to the date of death due to any cause (assessed up to approximately 93 months)
Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C
From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)
+22 more secondary outcomes