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Brief Title: A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer
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
Study ID: NCT05328908
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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 Am Woerthersee, , Austria
Local Institution - 0131, Salzburg, , Austria
Local Institution - 0062, Woluwé-Saint-Lambert, BRU, Belgium
Local Institution - 0068, Gent, 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 - 0164, Wuhan Shi, Hubei, China
Local Institution - 0138, Changsha, Hunan, China
Local Institution - 0158, Changsha, Hunan, China
Local Institution - 0146, Huaian, Jiangsu, China
Local Institution - 0143, Nanjing, Jiangsu, China
Local Institution - 0142, Jinan, Shandong, China
Local Institution - 0141, Taiyuan, Shanxi, China
Local Institution - 0152, Xi'an, SHA, China
Local Institution - 0144, Chengdu, Sichuan, China
Local Institution - 0150, Tianjin, Tianjin, China
Local Institution - 0160, Hangzhou Shi, Zhejiang, China
Local Institution - 0122, Beijing, , China
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Local Institution - 0153, Shanghai, , China
Local Institution - 0149, Shenyang, , China
Local Institution - 0099, Horovice, , Czechia
Local Institution - 0016, Hradec Králové, , Czechia
Local Institution - 0100, Olomouc, , Czechia
Local Institution - 0123, Ostrava, , Czechia
Local Institution - 0064, Praha 5, , Czechia
Local Institution - 0066, Bordeaux, , France
Local Institution - 0017, Caen, , 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 - 0055, Berlin, BE, Germany
Local Institution - 0054, Mannheim, BW, Germany
Local Institution - 0056, Reutlingen, BW, Germany
Local Institution - 0053, Wuerzburg, BY, Germany
Local Institution - 0041, Frankfurt A. Main, HE, Germany
Local Institution - 0101, Essen, Northwest, Germany
Local Institution - 0040, Hamburg, , Germany
Local Institution - 0034, Munchen, , Germany
Local Institution - 0046, Milano, 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, Napoli, , Italy
Local Institution - 0061, Napoli, , Italy
Local Institution - 0110, Osaka-shi, Osaka, Japan
Local Institution - 0107, Chiba-Shi, , Japan
Local Institution - 0103, Chuo-Ku, , 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, Koto-Ku, , Japan
Local Institution - 0118, Matsuyama City, , Japan
Local Institution - 0088, Sapporo-shi, , Japan
Local Institution - 0083, Suita-Shi, , Japan
Local Institution - 0085, Sunto-gun, , Japan
Local Institution - 0124, Yokohama-Shi, , Japan
Local Institution - 0072, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Local Institution - 0073, Goyang-si, Gyeonggi-do, , Korea, Republic of
Local Institution - 0129, Seongnamsi Bundanggu, , Korea, Republic of
Local Institution - 0092, Seoul, , Korea, Republic of
Local Institution - 0075, Seoul, , Korea, Republic of
Local Institution - 0074, Seoul, , Korea, Republic of
Local Institution - 0050, Amsterdam, , Netherlands
Local Institution - 0051, Warsaw, MZ, Poland
Local Institution - 0037, Warszawa, Pl-mz, Poland
Local Institution - 0018, Kraków, , Poland
Local Institution - 0052, Warszawa, , Poland
Local Institution - 0106, San Juan, , Puerto Rico
Local Institution - 0109, Singapore, , Singapore
Local Institution - 0087, Singapore, , Singapore
Local Institution - 0029, Badalona, B, Spain
Local Institution - 0093, Barcelona, B, Spain
Local Institution - 0102, Madrid, M, Spain
Local Institution - 0116, Zaragoza, Z, Spain
Local Institution - 0080, Barcelona, , Spain
Local Institution - 0112, La Coruña, , Spain
Local Institution - 0113, Madrid, , Spain
Local Institution - 0035, Sevilla, , Spain
Local Institution - 0038, Stockholm, AB, Sweden
Local Institution - 0135, Stockholm, AB, Sweden
Local Institution - 0058, Uppsala, C, Sweden
Local Institution - 0067, Goteborg, , Sweden
Local Institution - 0094, Malmö, , Sweden
Local Institution - 0057, Aarau, AG, Switzerland
Local Institution - 0069, Bern, , Switzerland
Local Institution - 0128, Changhua, CHA, Taiwan
Local Institution - 0111, Kaohsiung, KHH, Taiwan
Local Institution - 0076, Tainan, TNN, Taiwan
Local Institution - 0121, Zhongzheng, TPE, Taiwan
Local Institution - 0077, Tainan, , Taiwan
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR