A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer

NCT05328908 | Terminated Phase 3 DMC FDA Drug

• 2 other identifiers: CA224-1232021-004285-35
• Study Type: interventional
• Target: 770
• Locations: 21 countries
• Sites: 136

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.

Conditions

Colorectal Neoplasms

Keywords

Micro-satellite Stable (MSS) Metastatic Colorectal Cancer (mCRC); Relatlimab; Nivolumab; BMS-986213; Regorafenib; Stivarga; Lonsurf

Outcome Measures

Primary Outcomes (2)

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

  Up to 5 years after last participant randomized

• OS in all randomized participants

  Up to 5 years after last participant randomized

Secondary Outcomes (21)

• 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

Study Arms (2)

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

EXPERIMENTAL

Drug: Nivolumab-relatlimab FDC

Arm B: Investigator's Choice

ACTIVE COMPARATOR

Treatment with Regorafenib or TAS-102

Drug: Regorafenib; Drug: TAS-102

Interventions

Nivolumab-relatlimab FDC DRUG

Specified dose on specified days

Also known as: BMS-986213

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

Regorafenib DRUG

Specified dose on specified days

Also known as: Stivarga

Arm B: Investigator's Choice

TAS-102 DRUG

Specified dose on specified days

Also known as: Trifluridine/Tipiracil, Lonsurf

Arm B: Investigator's Choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Must have sufficient tumor tissue \& evaluable PD-L1 expression to meet the study requirements.
• 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.

You may not qualify if:

• Prior treatment with either an immunotherapy or with regorafenib or with TAS-102.
• Untreated central nervous system (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).
• 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.
• Confirmed tumor microsatellite instable high/deficient mismatch repair (MSI-H/dMMR) status as per local standard testing; MSI/MMR test results from initial diagnosis are acceptable.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (139)

Local Institution - 0044

Springdale, Arkansas, 72762-5328, United States

Location

Local Institution - 0012

Los Angeles, California, 90089-0112, United States

Location

Local Institution - 0117

Norwich, Connecticut, 06360-2753, United States

Location

Local Institution - 0025

Miami, Florida, 33176, United States

Location

Local Institution - 0031

Atlanta, Georgia, 30342, United States

Location

Local Institution - 0071

Boise, Idaho, 83712-6267, United States

Location

Local Institution - 0081

Fort Wayne, Indiana, 46805, United States

Location

Massachusetts General Hospital,

Boston, Massachusetts, 02214, United States

Location

Local Institution - 0042

Ann Arbor, Michigan, 48109-1382, United States

Location

Local Institution - 0043

East Brunswick, New Jersey, 08816-3340, United States

Location

Local Institution - 0009

Durham, North Carolina, 27710, United States

Location

Local Institution - 0082

Cincinnati, Ohio, 45220, United States

Location

Local Institution - 0095

Columbus, Ohio, 43210-1240, United States

Location

Local Institution - 0147

Philadelphia, Pennsylvania, 19111-2434, United States

Location

Local Institution - 0008

Charleston, South Carolina, 29414, United States

Location

Local Institution - 0096

Sioux Falls, South Dakota, 57104, United States

Location

Local Institution - 0127

Nashville, Tennessee, 37203-2173, United States

Location

Local Institution - 0097

Fort Worth, Texas, 76104-4611, United States

Location

Local Institution - 0132

Richmond, Virginia, 23284, United States

Location

Local Institution - 0005

Madison, Wisconsin, 53705-2275, United States

Location

Local Institution - 0022

Ciudad Autónoma Buenos Aires, Buenos Aires, 1425, Argentina

Location

Local Institution - 0026

Ciudad Autónoma Buenos Aires, B, C1181ACH, Argentina

Location

Local Institution - 0024

Ciudad Autónoma Buenos Aires, 1834, Argentina

Location

Local Institution - 0023

Río Grande, 8500, Argentina

Location

Local Institution - 0098

Wagga Wagga, New South Wales, 2650, Australia

Location

Local Institution - 0114

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0001

Greenslopes, Queensland, 4120, Australia

Location

Local Institution - 0010

Clayton, Victoria, 3168, Australia

Location

Local Institution - 0021

Melbourne, Victoria, 3084, Australia

Location

Local Institution - 0027

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0030

Graz, 6800, Austria

Location

Local Institution - 0078

Klagenfurt, 9020, Austria

Location

Local Institution - 0131

Salzburg, 5020, Austria

Location

Local Institution - 0062

Woluwé-Saint-Lambert, BRU, 1200, Belgium

Location

Local Institution - 0068

Ghent, VOV, 9000, Belgium

Location

Local Institution - 0070

Edegem, 2650, Belgium

Location

Local Institution - 0120

Leuven, 3000, Belgium

Location

Local Institution - 0003

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0014

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 0007

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0019

Montreal, Quebec, H2X 3E4, Canada

Location

Local Institution - 0104

Montreal, Quebec, H4A 3J1, Canada

Location

Local Institution - 0004

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Local Institution - 0015

Santiago, RM, 7560908, Chile

Location

Local Institution - 0033

Santiago, RM, 8380456, Chile

Location

Local Institution - 0134

Chongqing, CQ, 400030, China

Location

Local Institution - 0151

Guangzhou, Guangdong, 510655, China

Location

Local Institution - 0126

Wuhan, HB, 430071, China

Location

Local Institution - 0138

Changsha, HN, 410013, China

Location

Local Institution - 0164

Wuhan, Hubei, 430079, China

Location

Local Institution - 0158

Changsha, Hunan, 410013, China

Location

Local Institution - 0146

Huaian, Jiangsu, 223300, China

Location

Local Institution - 0143

Nanjing, JS, 210008, China

Location

Local Institution - 0142

Jinan, SD, 250117, China

Location

Local Institution - 0152

Xi'an, SHA, 710038, China

Location

Local Institution - 0144

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0141

Taiyuan, SX, 030013, China

Location

Local Institution - 0150

Tianjin, TJ, 300121, China

Location

Local Institution - 0160

Hangzhou, ZJ, 310022, China

Location

Local Institution - 0122

Beijing, 100142, China

Location

Local Institution - 0139

Hangzhou, 310003, China

Location

Local Institution - 0153

Shanghai, 200032, China

Location

Local Institution - 0149

Shenyang, 110042, China

Location

Local Institution - 0099

Hořovice, 26801, Czechia

Location

Local Institution - 0016

Hradec Králové, 500 05, Czechia

Location

Local Institution - 0100

Olomouc, 775 20, Czechia

Location

Local Institution - 0123

Ostrava, 708 52, Czechia

Location

Local Institution - 0064

Prague, 150 06, Czechia

Location

Local Institution - 0066

Bordeaux, 33000, France

Location

Local Institution - 0017

Caen, 14000, France

Location

Local Institution - 0090

Dijon, 21000, France

Location

Local Institution - 0020

Levallois-Perret, 92300, France

Location

Local Institution - 0036

Lyon, 69008, France

Location

Local Institution - 0089

Paris, 75012, France

Location

Local Institution - 0039

Suresnes, 92151, France

Location

Local Institution - 0054

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Local Institution - 0056

Reutlingen, Baden-Wurttemberg, 72764, Germany

Location

Local Institution - 0053

Würzburg, Bavaria, 97080, Germany

Location

Local Institution - 0041

Frankfurt A. Main, Hesse, 60488, Germany

Location

Local Institution - 0101

Essen, Northwest, 45147, Germany

Location

Local Institution - 0055

Berlin, State of Berlin, 13353, Germany

Location

Local Institution - 0040

Hamburg, 20249, Germany

Location

Local Institution - 0034

München, 81377, Germany

Location

Local Institution - 0046

Milan, MI, 20162, Italy

Location

Local Institution - 0148

Padua, PD, 35128, Italy

Location

Local Institution - 0059

Reggio Emilia, RE, 42123, Italy

Location

Local Institution - 0060

Catania, 95122, Italy

Location

Local Institution - 0091

Genova, 16132, Italy

Location

Local Institution - 0045

Milan, 20133, Italy

Location

Local Institution - 0115

Napoli, 80131, Italy

Location

Local Institution - 0061

Napoli, 80138, Italy

Location

Local Institution - 0110

Osaka, Osaka, 5418567, Japan

Location

Local Institution - 0107

Chiba, 260-8717, Japan

Location

Local Institution - 0103

Chūōku, 104-0045, Japan

Location

Local Institution - 0105

Hidaka-shi, 350-1298, Japan

Location

Local Institution - 0154

Kasama-Shi, 309-1793, Japan

Location

Local Institution - 0084

Kashiwa-Shi, 277-8577, Japan

Location

Local Institution - 0086

Kawasaki-Shi, 216-8511, Japan

Location

Local Institution - 0119

Kitaadachi-gun, 362-0806, Japan

Location

Local Institution - 0108

Kōtoku, 135-8550, Japan

Location

Local Institution - 0118

Matsuyama, 791-0280, Japan

Location

Local Institution - 0088

Sapporo, 060-8648, Japan

Location

Local Institution - 0083

Suita-Shi, 565-0871, Japan

Location

Local Institution - 0085

Sunto-gun, 411-8777, Japan

Location

Local Institution - 0124

Yokohama, 241-8515, Japan

Location

Local Institution - 0050

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 0051

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Local Institution - 0037

Warsaw, Pl-mz, 05-400, Poland

Location

Local Institution - 0018

Krakow, 30-727, Poland

Location

Local Institution - 0052

Warsaw, 02-781, Poland

Location

Local Institution - 0106

San Juan, PR, 00927, Puerto Rico

Location

Local Institution - 0109

Singapore, 169610, Singapore

Location

Local Institution - 0087

Singapore, 329563, Singapore

Location

Local Institution - 0072

Seoul, Seoul-teukbyeolsi, 03722, South Korea

Location

Local Institution - 0073

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Local Institution - 0129

Seongnamsi Bundanggu, 13620, South Korea

Location

Local Institution - 0092

Seoul, 05505, South Korea

Location

Local Institution - 0075

Seoul, 06351, South Korea

Location

Local Institution - 0074

Seoul, 110-744, South Korea

Location

Local Institution - 0029

Badalona, B, 08916, Spain

Location

Local Institution - 0093

Barcelona, B, 08036, Spain

Location

Local Institution - 0102

Madrid, M, 28041, Spain

Location

Local Institution - 0116

Zaragoza, Z, 50009, Spain

Location

Local Institution - 0112

A Coruña, 15006, Spain

Location

Local Institution - 0080

Barcelona, 08035, Spain

Location

Local Institution - 0113

Madrid, 28046, Spain

Location

Local Institution - 0035

Seville, 41013, Spain

Location

Local Institution - 0038

Stockholm, AB, 112 81, Sweden

Location

Local Institution - 0135

Stockholm, AB, 171 76, Sweden

Location

Local Institution - 0058

Uppsala, C, 751 85, Sweden

Location

Local Institution - 0067

Gothenburg, 413 45, Sweden

Location

Local Institution - 0094

Malmo, 214 28, Sweden

Location

Local Institution - 0057

Aarau, Canton of Aargau, 5000, Switzerland

Location

Local Institution - 0069

Bern, 3010, Switzerland

Location

Local Institution - 0128

Changhua, CHA, 500, Taiwan

Location

Local Institution - 0111

Kaohsiung City, KHH, 83301, Taiwan

Location

Local Institution - 0076

Tainan, TNN, 704, Taiwan

Location

Local Institution - 0121

Zhongzheng, TPE, 100, Taiwan

Location

Local Institution - 0077

Tainan, 70403, Taiwan

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Colorectal Neoplasms; Spinocerebellar Degenerations

Interventions

regorafenib; trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 14, 2022
• Study Start: April 28, 2022
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

JP (14); AR (4); AU (6); BE (4); PR (1); SG (2); SE (5); KR (6); TW (5); CL (2); CZ (5); US (20); CA (6); FR (7); CN (18); IT (8); PL (4); ES (8); CH (2); DE (8); NL (1)