Nivolumab + Relatlimab + Ipilimumab for Renal Cell Carcinoma

Recruiting in Palo Alto (17 mi)

Overseen by Eric Jonasch, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.

Research Team

Eric Jonasch, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with advanced kidney cancer (Renal Cell Carcinoma) who haven't had treatment before. Participants should be fit enough for the treatments and not have any health conditions that could interfere with the study or their safety.

Inclusion Criteria

Women must not be breastfeeding while taking the study drug and for up to five months after the last dose of study drug

I am 18 years old or older.

Willing and able to provide a signed and dated written informed consent

Exclusion Criteria

I have or had cancer spread to my brain or spinal cord.

Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation

I haven't taken steroids or immunosuppressants in the last 14 days.

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)
• Nivolumab (Checkpoint Inhibitor)
• Relatlimab (Monoclonal Antibodies)

Trial Overview The study compares two approaches: one group receives a combination of Nivolumab, Relatlimab, and Ipilimumab (triplet), while another gets just Nivolumab and Ipilimumab (doublet). The drugs are given intravenously on different schedules to see which works better against kidney cancer.

Participant Groups

Group I: Treatment with Nivolumab + Relatlimab + Ipilimumab Experimental Treatment 2 Interventions

Participants will randonmized to study and treatment will be administered on an outpatient basis.

Group II: Treatment with Nivolumab + Ipilimumab Experimental Treatment 2 Interventions

Participants will randonmized to study and treatment will be administered on an outpatient basis.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Bristol-Myers Squibb

Industry 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