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 Squibb0 sites24 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•\- 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 (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

•\- 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

Not specified