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Checkpoint Inhibitor

Nivolumab-relatlimab Combo for Colorectal Cancer (RELATIVITY-123 Trial)

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry
Must have sufficient tumor tissue & evaluable PD-L1 expression to meet the study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to follow up visit 2 (approximately 135 days after last dose)
Awards & highlights

RELATIVITY-123 Trial Summary

This trial will test a new drug combination for people with metastatic colorectal cancer who have failed other treatments.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Nivolumab-relatlimab may cause immune-related side effects like inflammation in various organs, skin reactions, hormone gland problems (like thyroid dysfunction), and flu-like symptoms. Regorafenib and TAS-102 might cause fatigue, hand-foot syndrome, diarrhea, liver function changes among others.

RELATIVITY-123 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My colorectal cancer, which cannot be surgically removed, has returned or spread.
Select...
My cancer has enough tissue for testing and shows PD-L1 activity.

RELATIVITY-123 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to follow up visit 2 (approximately 135 days after last dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to follow up visit 2 (approximately 135 days after last dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
OS in all randomized participants
Overall survival (OS) in randomized participants with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥ 1
Secondary outcome measures
DoR by BICR per RECIST v1.1 in all responders
DoR by investigator per RECIST v1.1 in all randomized participants
DoR by investigator per RECIST v1.1 in responders with PD-L1 CPS ≥ 1
+18 more

RELATIVITY-123 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Nivolumab + Relatlimab Fixed-dose Combination (FDC)Experimental Treatment1 Intervention
Group II: Arm B: Investigator's ChoiceActive Control2 Interventions
Treatment with Regorafenib or TAS-102

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,814 Total Patients Enrolled

Media Library

Nivolumab-relatlimab FDC (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05328908 — Phase 3
Colorectal Cancer Research Study Groups: Arm A: Nivolumab + Relatlimab Fixed-dose Combination (FDC), Arm B: Investigator's Choice
Colorectal Cancer Clinical Trial 2023: Nivolumab-relatlimab FDC Highlights & Side Effects. Trial Name: NCT05328908 — Phase 3
Nivolumab-relatlimab FDC (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05328908 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial being conducted at a great number of hospitals in the United States?

"Presently, this study is looking for participants from 52 different sites. Some of these medical centres are in Cincinnati, Boston and Columbus. It would be convenient for enrollees to select a location close to them to reduce travel time and effort."

Answered by AI

Is Nivolumab-relatlimab FDC more likely to cause harm than other treatments?

"Nivolumab-relatlimab FDC is a Phase 3 clinical trial medication, meaning that there is both some efficacy data and multiple rounds of safety data. Consequently, our team has given it a safety score of 3."

Answered by AI

Are there any current openings for eligible participants in this experiment?

"This medical study is currently looking for participants, as detailed on clinicaltrials.gov. The study was first posted on April 28th, 2022 and was last edited on November 1st, 2022."

Answered by AI

Who else is applying?

What state do they live in?
Nova Scotia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer
2022. "A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05328908.
All > Colorectal Cancer Chicago > Bowel Cancer
~191 spots leftby Jan 2025
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