Apply to Trial

Compensation: Varies

Number of Visits: 8

Duration: 6 months

351 Participants Needed

Nivolumab + Ipilimumab for Prostate Cancer
(CheckMate 650 Trial)

Recruiting at 118 trial locations

Overseen ByFirst 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 GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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).

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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.

See 1 more

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.

See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nivolumab followed by ipilimumab or cabazitaxel for metastatic castration-resistant prostate cancer

6 months

Tumor assessments every 8 weeks for 6 months, then every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Follow-up

Participants are monitored for radiographic progression-free survival and overall survival

Up to 61 months

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

7Treatment groups

Experimental Treatment

Group I: Cohort D (Arm D4)Experimental Treatment2 Interventions

Group II: Cohort D (Arm D3)Experimental Treatment1 Intervention

Group III: Cohort D (Arm D2)Experimental Treatment2 Interventions

Group IV: Cohort D (Arm D1)Experimental Treatment2 Interventions

Group V: Cohort C (Arm C)Experimental Treatment2 Interventions

Group VI: Cohort B (Arm B)Experimental Treatment2 Interventions

Group VII: Cohort A (Arm A)Experimental Treatment2 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

Find a Clinic Near You

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

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