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A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer
Sponsor: Bristol-Myers Squibb
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
769
Start Date
2022-04-28
Completion Date
2025-07-14
Last Updated
2026-08-26
Healthy Volunteers
No
Conditions
Interventions
Nivolumab-relatlimab FDC
Specified dose on specified days
Regorafenib
Specified dose on specified days
TAS-102
Specified dose on specified days
Locations (139)
Local Institution - 0044
Springdale, Arkansas, United States
Local Institution - 0012
Los Angeles, California, United States
Local Institution - 0117
Norwich, Connecticut, United States
Local Institution - 0025
Miami, Florida, United States
Local Institution - 0031
Atlanta, Georgia, United States
Local Institution - 0071
Boise, Idaho, United States
Local Institution - 0081
Fort Wayne, Indiana, United States
Massachusetts General Hospital,
Boston, Massachusetts, United States
Local Institution - 0042
Ann Arbor, Michigan, United States
Local Institution - 0043
East Brunswick, New Jersey, United States
Local Institution - 0009
Durham, North Carolina, United States
Local Institution - 0082
Cincinnati, Ohio, United States
Local Institution - 0095
Columbus, Ohio, United States
Local Institution - 0147
Philadelphia, Pennsylvania, United States
Local Institution - 0008
Charleston, South Carolina, United States
Local Institution - 0096
Sioux Falls, South Dakota, United States
Local Institution - 0127
Nashville, Tennessee, United States
Local Institution - 0097
Fort Worth, Texas, United States
Local Institution - 0132
Richmond, Virginia, United States
Local Institution - 0005
Madison, Wisconsin, United States
Local Institution - 0022
Ciudad Autónoma Buenos Aires, Buenos Aires, Argentina
Local Institution - 0026
Ciudad Autónoma Buenos Aires, B, Argentina
Local Institution - 0024
Ciudad Autónoma Buenos Aires, Argentina
Local Institution - 0023
Rio Grande, Argentina
Local Institution - 0098
Wagga Wagga, New South Wales, Australia
Local Institution - 0114
Westmead, New South Wales, Australia
Local Institution - 0001
Greenslopes, Queensland, Australia
Local Institution - 0010
Clayton, Victoria, Australia
Local Institution - 0021
Melbourne, Victoria, Australia
Local Institution - 0027
Murdoch, Western Australia, Australia
Local Institution - 0030
Graz, Austria
Local Institution - 0078
Klagenfurt, Austria
Local Institution - 0131
Salzburg, Austria
Local Institution - 0062
Woluwé-Saint-Lambert, BRU, Belgium
Local Institution - 0068
Ghent, VOV, Belgium
Local Institution - 0070
Edegem, Belgium
Local Institution - 0120
Leuven, Belgium
Local Institution - 0003
Edmonton, Alberta, Canada
Local Institution - 0014
Ottawa, Ontario, Canada
Local Institution - 0007
Toronto, Ontario, Canada
Local Institution - 0019
Montreal, Quebec, Canada
Local Institution - 0104
Montreal, Quebec, Canada
Local Institution - 0004
Sherbrooke, Quebec, Canada
Local Institution - 0015
Santiago, RM, Chile
Local Institution - 0033
Santiago, RM, Chile
Local Institution - 0134
Chongqing, CQ, China
Local Institution - 0151
Guangzhou, Guangdong, China
Local Institution - 0126
Wuhan, HB, China
Local Institution - 0138
Changsha, HN, China
Local Institution - 0164
Wuhan, Hubei, China
Local Institution - 0158
Changsha, Hunan, China
Local Institution - 0146
Huaian, Jiangsu, China
Local Institution - 0143
Nanjing, JS, China
Local Institution - 0142
Jinan, SD, China
Local Institution - 0152
Xi'an, SHA, China
Local Institution - 0144
Chengdu, Sichuan, China
Local Institution - 0141
Taiyuan, SX, China
Local Institution - 0150
Tianjin, TJ, China
Local Institution - 0160
Hangzhou, ZJ, China
Local Institution - 0122
Beijing, China
Local Institution - 0139
Hangzhou, China
Local Institution - 0153
Shanghai, China
Local Institution - 0149
Shenyang, China
Local Institution - 0099
Hořovice, Czechia
Local Institution - 0016
Hradec Králové, Czechia
Local Institution - 0100
Olomouc, Czechia
Local Institution - 0123
Ostrava, Czechia
Local Institution - 0064
Prague, Czechia
Local Institution - 0017
Caen, Caen, France
Local Institution - 0066
Bordeaux, France
Local Institution - 0090
Dijon, France
Local Institution - 0020
Levallois-Perret, France
Local Institution - 0036
Lyon, France
Local Institution - 0089
Paris, France
Local Institution - 0039
Suresnes, France
Local Institution - 0054
Mannheim, Baden-Wurttemberg, Germany
Local Institution - 0056
Reutlingen, Baden-Wurttemberg, Germany
Local Institution - 0053
Würzburg, Bavaria, Germany
Local Institution - 0041
Frankfurt A. Main, Hesse, Germany
Local Institution - 0101
Essen, North Rhine-Westphalia, Germany
Local Institution - 0055
Berlin, State of Berlin, Germany
Local Institution - 0040
Hamburg, Germany
Local Institution - 0034
München, Germany
Local Institution - 0046
Milan, MI, Italy
Local Institution - 0148
Padova, PD, Italy
Local Institution - 0059
Reggio Emilia, RE, Italy
Local Institution - 0060
Catania, Italy
Local Institution - 0091
Genova, Italy
Local Institution - 0045
Milan, Italy
Local Institution - 0115
Naples, Italy
Local Institution - 0061
Naples, Italy
Local Institution - 0110
Osaka, Osaka, Japan
Local Institution - 0107
Chiba, Japan
Local Institution - 0103
Chūōku, Japan
Local Institution - 0105
Hidaka-shi, Japan
Local Institution - 0154
Kasama-Shi, Japan
Local Institution - 0084
Kashiwa-Shi, Japan
Local Institution - 0086
Kawasaki-Shi, Japan
Local Institution - 0119
Kitaadachi-gun, Japan
Local Institution - 0108
Kōtoku, Japan
Local Institution - 0118
Matsuyama, Japan
Local Institution - 0088
Sapporo, Japan
Local Institution - 0083
Suita-Shi, Japan
Local Institution - 0085
Sunto-gun, Japan
Local Institution - 0124
Yokohama, Japan
Local Institution - 0050
Amsterdam, Netherlands
Local Institution - 0051
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0037
Warsaw, Pl-mz, Poland
Local Institution - 0018
Krakow, Poland
Local Institution - 0052
Warsaw, Poland
Local Institution - 0106
San Juan, PR, Puerto Rico
Local Institution - 0109
Singapore, Singapore
Local Institution - 0087
Singapore, Singapore
Local Institution - 0072
Seoul, Seoul-teukbyeolsi, South Korea
Local Institution - 0073
Goyang-si, Gyeonggi-do, South Korea
Local Institution - 0129
Seongnamsi Bundanggu, South Korea
Local Institution - 0092
Seoul, South Korea
Local Institution - 0075
Seoul, South Korea
Local Institution - 0074
Seoul, South Korea
Local Institution - 0029
Badalona, B, Spain
Local Institution - 0093
Barcelona, B, Spain
Local Institution - 0113
Madrid, Madrid, Spain
Local Institution - 0102
Madrid, M, Spain
Local Institution - 0116
Zaragoza, Z, Spain
Local Institution - 0112
A Coruña, Spain
Local Institution - 0080
Barcelona, Spain
Local Institution - 0035
Seville, Spain
Local Institution - 0038
Stockholm, AB, Sweden
Local Institution - 0135
Stockholm, AB, Sweden
Local Institution - 0058
Uppsala, C, Sweden
Local Institution - 0067
Gothenburg, Sweden
Local Institution - 0094
Malmö, Sweden
Local Institution - 0057
Aarau, Canton of Aargau, Switzerland
Local Institution - 0069
Bern, Switzerland
Local Institution - 0128
Changhua, CHA, Taiwan
Local Institution - 0111
Kaohsiung City, KHH, Taiwan
Local Institution - 0076
Tainan, TNN, Taiwan
Local Institution - 0121
Zhongzheng, TPE, Taiwan
Local Institution - 0077
Tainan, Taiwan