Nivolumab-relatlimab Combo for Colorectal Cancer

(RELATIVITY-123 Trial)

Recruiting at 323 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two drugs, relatlimab and nivolumab, for patients with a certain type of colorectal cancer who haven't responded to other treatments. The drugs help the immune system attack the cancer.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with metastatic colorectal cancer that's not microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR). They must have tried 1-4 standard treatments including specific chemotherapy and targeted drugs, depending on their genetic makeup. People can't join if they've had certain heart issues, untreated brain metastases, prior immunotherapy or the study drugs Regorafenib/TAS-102.

Inclusion Criteria

My cancer worsened within 3 months after my last standard treatment.

My colorectal cancer, which cannot be surgically removed, has returned or spread.

I had severe side effects from previous chemotherapy despite support.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

I do not have uncontrolled high blood pressure, recent heart issues, severe lung disease, or active autoimmune disease.

I have had treatment for brain metastases and my neurological function is back to normal.

Treatment Details

Interventions

• Nivolumab-relatlimab FDC (Checkpoint Inhibitor)
• Regorafenib (Kinase Inhibitor)
• TAS-102 (Chemotherapy)

Trial Overview The study tests a fixed-dose combination of two immune checkpoint inhibitors, Nivolumab-relatlimab FDC (BMS-986213), against either Regorafenib or TAS-102 in patients who have previously treated metastatic colorectal cancer. It aims to see which treatment is more effective after other therapies have failed.

Participant Groups

Group I: Arm A: Nivolumab + Relatlimab Fixed-dose Combination (FDC) Experimental Treatment 1 Intervention

Group II: Arm B: Investigator's Choice Active Control 2 Interventions

Treatment with Regorafenib or TAS-102

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