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
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
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.
Inclusion Criteria
Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry.
Participants must have:.
i) 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 in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or;.
ii) been intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures.
Exclusion Criteria
Ciudad Autónoma Buenos Aires, Buenos Aires 1425, Argentina
Ciudad Autónoma Buenos Aires, B C1181ACH, Argentina
Ciudad Autónoma Buenos Aires, 1834, Argentina
Woluwé-Saint-Lambert, BRU 1200, Belgium
Huaian, Jiangsu 223300, China
Frankfurt A. Main, Hesse 60488, Germany
Hidaka-shi, 350-1298, Japan
Kasama-Shi, 309-1793, Japan
Kashiwa-Shi, 277-8577, Japan
Kawasaki-Shi, 216-8511, Japan
Kitaadachi-gun, 362-0806, Japan
Suita-Shi, 565-0871, Japan
Sunto-gun, 411-8777, Japan
Goyang-si, Gyeonggi-do, 10408, South Korea
Seongnamsi Bundanggu, 13620, South Korea