arrow copy Created with Sketch. FightCRC Logo fcc-logo-light
A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer

Program Status

Recruiting

Phase

Phase 3

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Nivolumab-relatlimab FDC, Regorafenib, TAS-102, Lonsurf, Opdivo, Stivarga

Tags

MSS/ pMMR

Comments

Phase III trial for MSS CRC that includes immunotherapy in one of the arms.
Relatlimab (anti-LAG-3 antibody, immunotherapy) in combination with nivolumab (anti PD-1, immunotherapy, Opdivo) for the treatment of late-line MSS mCRC participants who failed at least 1 but no more than 4 prior lines of therapy, versus standard of care (Stivarga or Lonsurf).
Trial is randomized (patients may be assigned to any of the two arms).
No prior treatment with either an immunotherapy or with regorafenib or with TAS-102 are allowed.

Anti-LAG-3 antibody relatlimab, combined with anti PD-1, has resulted in clinical activity for melanoma patients who were resistant to anti PD-1 monotherapy.

 

Location Location Status
United States
Highlands Oncology Group - Springdale
Springdale, Arkansas 72762-5328
Recruiting
City Of Hope
Duarte, California 91010-3012
Withdrawn
USC Norris Comprehensive Cancer Center
Los Angeles, California 90089-1019
Recruiting
Local Institution - 0117
Norwich, Connecticut 06360-2753
Completed
Local Institution - 0025
Miami, Florida 33176
Completed
Northside Hospital - Atlanta
Atlanta, Georgia 30342
Recruiting
Local Institution - 0071
Boise, Idaho 83712-6267
Completed
Rush University Medical Center
Chicago, Illinois 60612-3841
Withdrawn
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46805
Recruiting
Massachusetts General Hospital,
Boston, Massachusetts 02214
Not yet recruiting
University of Michigan - Rogel Cancer Center
Ann Arbor, Michigan 48109-5000
Recruiting
Mayo Clinic in Arizona - Phoenix
Rochester, Minnesota 55905-0001
Withdrawn
Astera Cancer Care
East Brunswick, New Jersey 08816
Recruiting
Duke University Medical Center
Durham, North Carolina 27710-0001
Recruiting
Good Samaritan Hospital
Cincinnati, Ohio 45220-2475
Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Columbus, Ohio 43210-1240
Not yet recruiting
The James Cancer Hospital
Columbus, Ohio 43210-1240
Not yet recruiting
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Withdrawn
Thomas Jefferson University - Clinical Trials Office-Medical Oncology
Philadelphia, Pennsylvania 19107
Withdrawn
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Recruiting
Roper Hospital
Charleston, South Carolina 29414
Recruiting
Sanford Research
Sioux Falls, South Dakota 57104-4663
Recruiting
Tennessee Oncology
Nashville, Tennessee 37203-2173
Recruiting
Sydney Children'S Hospital
Fort Worth, Texas 76104-4611
Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia 23284
Recruiting
University of Wisconsin-Madison - Wisconsin Institutes for Medical Research (WIMR)
Madison, Wisconsin 53705-2275
Recruiting
Argentina
Local Institution - 0028
Buenos Aires, BA 1264
Withdrawn
Local Institution - 0022
Ciudad Autónoma Buenos Aires, Buenos Aires 1425
Recruiting
Local Institution - 0026
Ciudad Autónoma Buenos Aires, B C1181ACH
Recruiting
Local Institution - 0023
Viedma, RIO Negro 8500
Recruiting
Local Institution - 0024
Ciudad Autónoma Buenos Aires 1834
Recruiting
Australia
Local Institution - 0098
Wagga Wagga, New South Wales 2650
Recruiting
Local Institution - 0114
Westmead, New South Wales 2145
Recruiting
Local Institution - 0001
Greenslopes, Queensland 4120
Recruiting
Local Institution - 0002
Woodville South, South Australia 5011
Withdrawn
Local Institution - 0010
Clayton, Victoria 3168
Recruiting
Local Institution - 0021
Melbourne, Victoria 3084
Recruiting
Local Institution - 0027
Murdoch, Western Australia 6150
Recruiting
Austria
Local Institution - 0030
Graz 6800
Completed
Local Institution - 0078
Klagenfurt Am Woerthersee 9020
Completed
Local Institution - 0131
Salzburg 5020
Recruiting
Belgium
Local Institution - 0062
Woluwé-Saint-Lambert, BRU 1200
Recruiting
Local Institution - 0068
Gent, VOV 9000
Recruiting
Local Institution - 0133
Liège, WLG 4000
Withdrawn
Local Institution - 0070
Edegem 2650
Completed
Local Institution - 0120
Leuven 3000
Recruiting
Canada
Local Institution - 0003
Edmonton, Alberta T6G 1Z2
Recruiting
Local Institution - 0014
Ottawa, Ontario K1H 8L6
Recruiting
Local Institution - 0007
Toronto, Ontario M5G 2M9
Recruiting
Local Institution - 0019
Montreal, Quebec H2X 3E4
Recruiting
Local Institution - 0104
Montreal, Quebec H4A 3J1
Recruiting
Local Institution - 0004
Sherbrooke, Quebec J1H 5N4
Recruiting
Chile
Local Institution - 0015
Santiago, RM 7560908
Recruiting
Local Institution - 0033
Santiago, RM 8380456
Recruiting
China
Local Institution - 0134
Chongqing, CQ 400030
Recruiting
Local Institution - 0151
Guangzhou, Guangdong 510655
Recruiting
Local Institution - 0126
Wuhan, HB 430071
Recruiting
Local Institution - 0164
Wuhan Shi, Hubei 430079
Active, not recruiting
Local Institution - 0125
Changsha, Hunan 410008
Withdrawn
Local Institution - 0138
Changsha, Hunan 410013
Recruiting
Local Institution - 0158
Changsha, Hunan 410013
Active, not recruiting
Local Institution - 0146
Huaian, Jiangsu 223300
Recruiting
Local Institution - 0143
Nanjing, Jiangsu 210008
Active, not recruiting
Local Institution - 0142
Jinan, Shandong 250117
Recruiting
Local Institution - 0141
Taiyuan, Shanxi 030013
Recruiting
Local Institution - 0152
Xi'an, SHA 710038
Recruiting
Local Institution - 0144
Chengdu, Sichuan 610074
Recruiting
Local Institution - 0156
Singapore, Singapore 150081
Withdrawn
Local Institution - 0150
Tianjin, Tianjin 300121
Completed
Local Institution - 0160
Hangzhou Shi, Zhejiang 310022
Active, not recruiting
Local Institution - 0122
Beijing 100142
Recruiting
Local Institution - 0163
Changchun 130021
Withdrawn
Local Institution - 0159
Chengdu Shi 610610
Withdrawn
Local Institution - 0162
Fuzhou 350014
Withdrawn
Local Institution - 0157
Guangzhou 510080
Withdrawn
Local Institution - 0139
Hangzhou 310003
Recruiting
Local Institution - 0161
Nanning Shi 530021
Withdrawn
Local Institution - 0153
Shanghai 200032
Recruiting
Local Institution - 0155
Shanghai 200032
Withdrawn
Local Institution - 0149
Shenyang 110042
Completed
Czechia
Local Institution - 0099
Horovice 26801
Recruiting
Local Institution - 0016
Hradec Králové 500 05
Recruiting
Local Institution - 0123
Ostrava 708 52
Recruiting
Local Institution - 0064
Praha 5 150 06
Recruiting
Local Institution - 0100
Uherske Hradiste - Sady 686 01
Recruiting
France
Local Institution - 0066
Bordeaux 33000
Recruiting
Local Institution - 0017
Caen 14000
Recruiting
Local Institution - 0090
Dijon 21000
Recruiting
Local Institution - 0020
Levallois-Perret 92300
Recruiting
Local Institution - 0036
Lyon 69008
Recruiting
Local Institution - 0089
Paris 75012
Recruiting
Local Institution - 0039
Suresnes 92151
Recruiting
Germany
Local Institution - 0055
Berlin, BE 13353
Recruiting
Local Institution - 0054
Mannheim, BW 68167
Recruiting
Local Institution - 0056
Reutlingen, BW 72764
Recruiting
Local Institution - 0034
Muenchen, BY 81377
Recruiting
Local Institution - 0053
Wuerzburg, BY 97080
Completed
Local Institution - 0041
Frankfurt A. Main, HE 60488
Recruiting
Local Institution - 0101
Essen, Northwest 45147
Recruiting
Local Institution - 0040
Hamburg 20251
Recruiting
Italy
Local Institution - 0091
Genova, GE 16132
Recruiting
Local Institution - 0148
Padova, PD 35128
Recruiting
Local Institution - 0059
Reggio Emilia, RE 42123
Recruiting
Local Institution - 0060
Catania 95124
Recruiting
Local Institution - 0046
Milano 22162
Recruiting
Local Institution - 0045
Milan 20133
Recruiting
Local Institution - 0115
Napoli 80131
Recruiting
Local Institution - 0061
Napoli 80138
Not yet recruiting
Local Institution - 0136
Padova 35128
Withdrawn
Japan
Local Institution - 0107
Chiba-shi, Chiba 260-8717
Recruiting
Local Institution - 0088
Sapporo-shi, Hokkaido 060-8648
Recruiting
Local Institution - 0086
Kawasaki-shi, Kanagawa 216-8511
Recruiting
Local Institution - 0124
Yokohama-Shi, Kanagawa 241-8515
Recruiting
Local Institution - 0083
Suita-shi, Osaka 565-0871
Recruiting
Local Institution - 0105
Hidaka-Shi, Saitama 3501298
Recruiting
Local Institution - 0085
Sunto-gun, Shizuoka 4118777
Recruiting
Local Institution - 0103
Chuo-Ku 104-0045
Recruiting
Local Institution - 0084
Kashiwa-Shi 277-8577
Recruiting
Local Institution - 0119
Kitaadachi-gun 362-0806
Recruiting
Local Institution - 0108
Koto-Ku 135-8550
Recruiting
Local Institution - 0118
Matsuyama City 791-0280
Recruiting
Local Institution - 0110
Osaka-shi 541-8567
Recruiting
Korea, Republic of
Local Institution - 0072
Seoul, Seoul-teukbyeolsi 03722
Recruiting
Local Institution - 0073
Goyang-si, Gyeonggi-do 10408
Recruiting
Local Institution - 0129
Seongnamsi Bundanggu 13620
Recruiting
Local Institution - 0092
Seoul 05505
Recruiting
Local Institution - 0075
Seoul 06351
Recruiting
Local Institution - 0074
Seoul 110-744
Recruiting
Netherlands
Local Institution - 0063
Utrecht, UT 3584 EA
Withdrawn
Local Institution - 0050
Amsterdam 1066 CX
Recruiting
Poland
Local Institution - 0051
Warsaw, MZ 02-507
Recruiting
Local Institution - 0037
Warszawa, Pl-mz 05-400
Recruiting
Local Institution - 0018
Krakow 30-510
Recruiting
Local Institution - 0052
Warszawa 02-781
Recruiting
Puerto Rico
Local Institution - 0106
San Juan 00927
Completed
Singapore
Local Institution - 0109
Singapore 169610
Recruiting
Local Institution - 0087
Singapore 329563
Active, not recruiting
Spain
Local Institution - 0029
Badalona, B 08916
Recruiting
Local Institution - 0093
Barcelona, B 08036
Recruiting
Local Institution - 0102
Madrid, M 28041
Recruiting
Local Institution - 0116
Zaragoza, Z 50009
Recruiting
Local Institution - 0080
Barcelona 08035
Not yet recruiting
Local Institution - 0112
La Coruña 15006
Completed
Local Institution - 0113
Madrid 28046
Recruiting
Local Institution - 0035
Sevilla 41013
Recruiting
Sweden
Local Institution - 0038
Stockholm, AB 112 81
Recruiting
Local Institution - 0067
Goteborg 41346
Recruiting
Local Institution - 0094
Malmö 214 28
Recruiting
Local Institution - 0135
Stockholm 113 66
Not yet recruiting
Local Institution - 0058
Uppsala 751 85
Recruiting
Switzerland
Local Institution - 0057
Aarau, AG 5000
Recruiting
Local Institution - 0069
Bern 3010
Recruiting
Taiwan
Local Institution - 0111
Kaohsiung, KHH 83301
Recruiting
Local Institution - 0128
Changhua City, Changhua 500
Recruiting
Local Institution - 0076
Tainan 70403
Recruiting
Local Institution - 0077
Tainan 70403
Recruiting
Local Institution - 0121
Taipei City 10002
Recruiting

Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com
Contact
855-907-3286 Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
Contact

Inclusion Criteria

Inclusion Criteria:

Histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry

Participants must have:

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;
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

Exclusion Criteria:

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.

Other protocol-defined inclusion/exclusion criteria apply

NCT ID

NCT05328908

Date Trial Added

2022-04-14

Updated Date

2023-11-30