Nivolumab + Ipilimumab for Prostate Cancer

(CheckMate 650 Trial)

Recruiting at 118 trial locations

Overseen By First line of the email MUST contain NCT# and Site #.

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Must be taking: GnRH analogues

Must not be taking: Anti-PD-1, Anti-PD-L1

Disqualifiers: Liver metastases, Brain metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

351 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

Men with advanced prostate cancer that has spread and is resistant to hormone therapy can join. They should be relatively healthy (ECOG 0-1) and on hormone-blocking treatment with low testosterone levels. Men who've had certain recent treatments, active autoimmune diseases, liver metastases, brain tumors, or previous immunotherapy are excluded.

Inclusion Criteria

I am fully active or can carry out light work.

I was previously in Arm D3 or D4 of the trial, have prostate cancer confirmed by tests, and it's stage IV.

My scans show cancer has spread to my bones or soft tissues.

Exclusion Criteria

I have been treated with specific immune system targeting drugs before.

I have received cancer treatment after my last dose of the study medication.

I have an autoimmune disease or a current infection.

Treatment Details

Interventions

• Cabazitaxel
• Ipilimumab
• Nivolumab
• Prednisone

Trial Overview The trial tests the effectiveness of Nivolumab followed by Ipilimumab versus each drug alone or Cabazitaxel in treating metastatic castration-resistant prostate cancer. It aims to see which combination is safer and more tolerable for patients.

Participant Groups

Group I: Cohort D (Arm D4) Experimental Treatment 2 Interventions

Group II: Cohort D (Arm D3) Experimental Treatment 1 Intervention

Group III: Cohort D (Arm D2) Experimental Treatment 2 Interventions

Group IV: Cohort D (Arm D1) Experimental Treatment 2 Interventions

Group V: Cohort C (Arm C) Experimental Treatment 2 Interventions

Group VI: Cohort B (Arm B) Experimental Treatment 2 Interventions

Group VII: Cohort A (Arm A) Experimental Treatment 2 Interventions

Cabazitaxel is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Jevtana for:

• Hormone refractory metastatic prostate cancer

Approved in United States as Jevtana for:

• Metastatic castration-resistant prostate cancer

Approved in Canada as Jevtana for:

• Hormone-refractory metastatic prostate cancer

Approved in Japan as Jevtana for:

• Prostate cancer

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania