A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer
NCT ID: NCT05328908
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
770 participants
INTERVENTIONAL
2022-04-28
2025-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Nivolumab + Relatlimab Fixed-dose Combination (FDC)
Nivolumab-relatlimab FDC
Specified dose on specified days
Arm B: Investigator's Choice
Treatment with Regorafenib or TAS-102
Regorafenib
Specified dose on specified days
TAS-102
Specified dose on specified days
Interventions
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Nivolumab-relatlimab FDC
Specified dose on specified days
Regorafenib
Specified dose on specified days
TAS-102
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Río 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 - 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 - 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, Northwest, 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
Padua, 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, 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 - 0102
Madrid, M, Spain
Local Institution - 0116
Zaragoza, Z, Spain
Local Institution - 0112
A Coruña, , Spain
Local Institution - 0080
Barcelona, , Spain
Local Institution - 0113
Madrid, , 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
Malmo, , 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 City, TNN, Taiwan
Local Institution - 0121
Zhongzheng, TPE, Taiwan
Local Institution - 0077
Tainan City, , Taiwan
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2021-004285-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA224-123
Identifier Type: -
Identifier Source: org_study_id
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