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 - RELATIVITY-123

Bristol-Myers Squibb International Corporation0 sites700 target enrollmentMay 23, 2022

DrugsStivarga Lonsurf (15 mg trifluridine and 6.14 mg tipiracil)Lonsurf (20 mg trifluridine and 8.19 mg tipiracil)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Bristol-Myers Squibb International Corporation
Enrollment: 700
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 23, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb International Corporation

Eligibility Criteria

Inclusion Criteria

•\- Histologically confirmed previously treated CRC with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry.
•\- Participants must have:
•a)progressed during or within approximately 3 months following the last administration of approved standard therapies in the metastatic setting (at least 1, but not more than 4 prior lines of therapies), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti\-VEGF therapy, and anti\-EGFR therapy (if RAS wild\-type), if approved in the respective country, or;
•b)been intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures.
•\- Participants must have sufficient tumor tissue \& evaluable PD\-L1 expression to meet the study requirements. Participants with indeterminate PD\-L1 results will be stratified with those participants assessed to be PD\-L1 negative by CPS (see next slide for details).
•\- KRAS mutation status must be documented based on available historical or local testing results as part of medical history prior to study enrollment.
•\- Participants must have measurable disease per RECIST v1\.1\. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately.
•For all Inclusion Criteria please refer to the Protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

Exclusion Criteria

•\- Prior treatment with either an immunotherapy (anti\-LAG\-3, anti\-PD\-1, anti\-PD\-L1, or anti\-CTLA\-4 antibody, or any other antibody or drug specifically targeting T\-cell co\-stimulation or checkpoint pathways) or with regorafenib or with TAS\-102\.
•\- Untreated CNS metastases. Participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment)
•\- Participants with history of refractory hypertension not controlled with anti\-hypertensive therapy, myocarditis (regardless of etiology), uncontrolled arrhythmias, acute coronary syndrome within 6 months prior to dosing, Class II congestive heart failure (as per the New York Heart Association Functional Classification), interstitial lung disease/pneumonitis or an active, known or suspected autoimmune disease.
•\- In the case of prior SARS\-CoV\-2 infection, acute symptoms must have completely resolved and based on investigator assessment in consultation with the clinical trial physician, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.
•\- Participants with historically or locally confirmed tumor MSI\-H/dMMR status
•For all Exclusion Criteria, please refer to the Protocol.