A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer

Bristol-Myers Squibb139 sites in 8 countries770 target enrollmentApril 28, 2022

ConditionsColorectal Neoplasms

InterventionsNivolumab-relatlimab FDC Regorafenib TAS-102

DrugsNivolumab-relatlimab FDC Regorafenib TAS-102

Overview

Phase: Phase 3
Intervention: Nivolumab-relatlimab FDC
Conditions: Colorectal Neoplasms
Sponsor: Bristol-Myers Squibb
Enrollment: 770
Locations: 139
Primary Endpoint: Overall survival (OS) in randomized participants with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥ 1
Status: Terminated
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.

Registry

clinicaltrials.gov

Start Date

April 28, 2022

End Date

July 14, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Arm A: Nivolumab + Relatlimab Fixed-dose Combination (FDC)

Intervention: Nivolumab-relatlimab FDC

Arm B: Investigator's Choice

Treatment with Regorafenib or TAS-102

Intervention: Regorafenib

Arm B: Investigator's Choice

Treatment with Regorafenib or TAS-102

Intervention: TAS-102

Outcomes

Primary Outcomes

Overall survival (OS) in randomized participants with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥ 1

Time Frame: Up to 5 years after last participant randomized

OS in all randomized participants

Time Frame: Up to 5 years after last participant randomized

Secondary Outcomes

Objective response rate (ORR) by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in randomized participants with PD-L1 CPS ≥ 1(Up to 5 years after last participant randomized)
ORR by BICR per RECIST v1.1 in all randomized participants(Up to 5 years after last participant randomized)
Progression-free survival (PFS) by BICR per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1(Up to 5 years after last participant randomized)
PFS by BICR per RECIST v1.1 in all randomized participants(Up to 5 years after last participant randomized)
Duration of response (DoR) by BICR per RECIST v1.1 in responders with PD-L1 CPS ≥ 1(Up to 5 years after last participant randomized)
DoR by BICR per RECIST v1.1 in all responders(Up to 5 years after last participant randomized)
Number of participants with adverse events (AEs)(Up to 135 days after participant's last dose)
Number of participants with serious adverse events (SAEs)(Up to 135 days after participant's last dose)
Number of participants with immune-mediated adverse events (IMAEs)(Up to 135 days after participant's last dose)
Number of participants with AEs leading to discontinuation(Up to 135 day's after participant's last dose)
Number of participants with clinical laboratory abnormalities(Up to 135 days after participant's last dose)
Time Until Definitive Deterioration-Physical Function (TUDD-PF): The time from randomization until definitive deterioration in the EORTC QLQ-C30 physical function scale score in randomized participants with PD-L1 CPS ≥ 1(Up to follow up visit 2 (approximately 135 days after last dose))
TUDD-PF: The time from randomization until definitive deterioration in the EORTC QLQ-C30 physical function scale score in all randomized participants(Up to follow up visit 2 (approximately 135 days after last dose))
TUDD-QoL: The time from randomization until definitive deterioration in the EORTC QLQ-C30 global health status/QoL scale score in randomized participants with PD-L1 CPS ≥ 1(Up to follow up visit 2 (approximately 135 days after last dose))
TUDD-QoL: The time from randomization until definitive deterioration in the EORTC QLQ-C30 global health status/QoL scale score in all randomized participants(Up to follow up visit 2 (approximately 135 days after last dose))
PFS by investigator per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1(Up to 5 years after last participant randomized)
PFS by investigator per RECIST v1.1 in all randomized participants(Up to 5 years after last participant randomized)
ORR by investigator per RECIST v1.1 in randomized participants with PD-L1 CPS ≥ 1(Up to 5 years after last participant randomized)
ORR by investigator per RECIST v1.1 in all randomized participants(Up to 5 years after last participant randomized)
DoR by investigator per RECIST v1.1 in responders with PD-L1 CPS ≥ 1(Up to 5 years after last participant randomized)
DoR by investigator per RECIST v1.1 in all randomized participants(Up to 5 years after last participant randomized)