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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

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 mCRCparticipants 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 asigned 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
Rogers, Arkansas 72758
Recruiting
City Of Hope
Duarte, California 91010-3012
Withdrawn
USC Norris Comprehensive Cancer Center
Los Angeles, California 90089-1019
Not yet recruiting
Eastern Connecticut Hematology And Oncology Associates
Norwich, Connecticut 06360-2700
Recruiting
Baptist Hospital of Miami
Miami, Florida 33176
Not yet recruiting
Northside Hospital
Atlanta, Georgia 30342
Recruiting
St Lukes Cancer Institute
Boise, Idaho 83712-6267
Not yet recruiting
Rush University Medical Center
Chicago, Illinois 60612-3841
Not yet recruiting
Fort Wayne Medical Oncology & Hematology
Fort Wayne, Indiana 46804
Recruiting
Massachusetts General Hospital,
Boston, Massachusetts 02214
Not yet recruiting
University Of Michigan
Ann Arbor, Michigan 48109-1382
Not yet 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Withdrawn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
Not yet recruiting
Good Samaritan Hospital
Cincinnati, Ohio 45220-2475
Not yet 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 and Solove Research Institute at The Ohio State University Comprehensive C
Columbus, Ohio 43210-1240
Not yet recruiting
University Of Pennsylvania
Philadelphia, Pennsylvania 19104
Not yet recruiting
Thomas Jefferson University - Clinical Trials Office-Medical Oncology
Philadelphia, Pennsylvania 19107
Not yet recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Not yet recruiting
Charleston Hematology Oncology Associates CHOA
Charleston, South Carolina 29414-7710
Recruiting
Sanford Research
Sioux Falls, South Dakota 57104-4663
Not yet recruiting
Chattanooga Oncology & Hematology Associates, Pc
Chattanooga, Tennessee 37404
Not yet recruiting
The Center For Cancer And Blood Disorders
Fort Worth, Texas 76104-4611
Recruiting
VA Commonwealth University - Massey Cancer Center
Richmond, Virginia 23284
Not yet recruiting
University Of Wisconsin - Madison
Madison, Wisconsin 53705-2275
Not yet recruiting
Argentina
Local Institution - 0022
Ciudad Autonoma Buenos Aires, Buenos Aires 1417
Active, not recruiting
Local Institution - 0024
Ciudad Autónoma Buenos Aires, Buenos Aires 1834
Not yet recruiting
Local Institution - 0023
Viedma, RIO Negro 8500
Not yet recruiting
Local Institution - 0028
Buenos Aires C1093AAS
Not yet recruiting
Local Institution - 0026
Buenos Aires C1181ACH
Not yet recruiting
Australia
Local Institution - 0098
Wagga Wagga, New South Wales 2650
Recruiting
Local Institution - 0114
Westmead, New South Wales 2145
Not yet recruiting
Local Institution - 0001
Greenslopes Qld, Queensland 4102
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
Perth, Western Australia 6009
Recruiting
Austria
Local Institution - 0030
Graz 8036
Not yet recruiting
Local Institution - 0078
Klagenfurt 9020
Not yet recruiting
Local Institution - 0131
Salzburg 5020
Not yet recruiting
Belgium
Local Institution - 0133
Liège, WLG 4000
Not yet recruiting
Local Institution - 0070
Edegem 2650
Not yet recruiting
Local Institution - 0068
Gent 9000
Not yet recruiting
Local Institution - 0120
Leuven 3000
Not yet recruiting
Local Institution - 0062
Woluwé-Saint-Lambert 1200
Not yet recruiting
Canada
Local Institution - 0003
Edmonton, Alberta T6G 1Z2
Not yet recruiting
Local Institution - 0007
Toronto, Ontario M5G 2C1
Not yet recruiting
Local Institution - 0019
Montreal, Quebec H2X 3E4
Not yet recruiting
Local Institution - 0104
Montreal, Quebec H4A 3J1
Not yet recruiting
Local Institution - 0014
Ottawa, Quebec K1H 8L6
Not yet recruiting
Local Institution - 0004
Sherbrooke, Quebec J1H 5N4
Not yet recruiting
Chile
Local Institution - 0015
Santiago, Metropolitana 8320000
Not yet recruiting
Local Institution - 0033
Santiago, Metropolitana 8380456
Not yet recruiting
China
Local Institution - 0122
Beijing, Beijing 100142
Not yet recruiting
Local Institution - 0134
Chongqing, Chongqing 400030
Not yet recruiting
Local Institution - 0151
Guangzhou, Guangdong 510655
Not yet recruiting
Local Institution - 0125
Changsha, Hunan 410008
Active, not recruiting
Local Institution - 0138
Changsha, Hunan 410013
Not yet recruiting
Local Institution - 0146
Huaian, Jiangsu 223399
Not yet recruiting
Local Institution - 0149
Shenyang Shi, Liaoning 110042
Not yet recruiting
Local Institution - 0152
Xian, Shaanxi 710038
Not yet recruiting
Local Institution - 0142
Jinan, Shandong 250117
Not yet recruiting
Local Institution - 0153
Shanghai, Shanghai 200032
Not yet recruiting
Local Institution - 0141
Taiyuan, Shanxi 030013
Not yet recruiting
Local Institution - 0144
Chengdu, Sichuan 610074
Not yet recruiting
Local Institution - 0150
Tianjin, Tianjin 300060
Not yet recruiting
Local Institution - 0139
Hangzhou, Zhejiang 310003
Not yet recruiting
Local Institution - 0143
Nanjing City 210008
Not yet recruiting
Local Institution - 0126
Wuhan 430023
Not yet recruiting
Czechia
Local Institution - 0099
Horovice 26801
Not yet recruiting
Local Institution - 0016
Hradec Kralove 500 05
Not yet recruiting
Local Institution - 0100
Olomouc 77900
Not yet recruiting
Local Institution - 0123
Ostrava 708 00
Not yet recruiting
Local Institution - 0064
Prague 5 150 06
Not yet recruiting
France
Local Institution - 0066
Bordeaux 33000
Recruiting
Local Institution - 0017
Caen 14000
Not yet recruiting
Local Institution - 0090
Dijon 21000
Not yet recruiting
Local Institution - 0020
Levallois-Perret 92300
Not yet recruiting
Local Institution - 0036
Lyon 69008
Not yet recruiting
Local Institution - 0089
Paris cedex 12 75571
Not yet recruiting
Local Institution - 0039
Suresnes 92151
Not yet recruiting
Germany
Local Institution - 0055
Berlin 10117
Not yet recruiting
Local Institution - 0101
Essen 45147
Not yet recruiting
Local Institution - 0041
Frankfurt A. Main 60488
Not yet recruiting
Local Institution - 0040
Hamburg 20251
Not yet recruiting
Local Institution - 0054
Mannheim 68167
Not yet recruiting
Local Institution - 0034
Muenchen 81377
Not yet recruiting
Local Institution - 0056
Reutlingen 72764
Not yet recruiting
Local Institution - 0053
Wuerzburg 97080
Not yet recruiting
Italy
Local Institution - 0060
Catania 95124
Not yet recruiting
Local Institution - 0091
Genova 16132
Not yet recruiting
Local Institution - 0045
Milano 20133
Not yet recruiting
Local Institution - 0046
Milano 22162
Not yet recruiting
Local Institution - 0115
Napoli 80131
Not yet recruiting
Local Institution - 0061
Napoli 80138
Not yet recruiting
Local Institution - 0136
Padova 35128
Withdrawn
Local Institution - 0148
Padova 35128
Not yet recruiting
Local Institution - 0059
Reggio Emilia 42123
Not yet recruiting
Japan
Local Institution - 0107
Chiba-shi, Chiba 260-8717
Not yet recruiting
Local Institution - 0084
Kashiwa-shi, Chiba 2778577
Not yet recruiting
Local Institution - 0118
Matsuyama-shi, Ehime 791-0280
Not yet recruiting
Local Institution - 0088
Sapporo-shi, Hokkaido 060-8648
Not yet recruiting
Local Institution - 0086
Kawasaki-shi, Kanagawa 216-8511
Not yet recruiting
Local Institution - 0124
Yokohama-shi, Kanagawa 2418515
Not yet recruiting
Local Institution - 0083
Suita-shi, Osaka 565-0871
Not yet recruiting
Local Institution - 0105
Hidaka-Shi, Saitama 350-1298
Recruiting
Local Institution - 0119
Kitaadachi-gun, Saitama 362-0806
Not yet recruiting
Local Institution - 0085
Sunto-gun, Shizuoka 4118777
Not yet recruiting
Local Institution - 0103
Chuo-ku, Tokyo 104-0045
Not yet recruiting
Local Institution - 0108
Koto-ku, Tokyo 1358550
Not yet recruiting
Local Institution - 0110
Osaka 541-8567
Not yet recruiting
Korea, Republic of
Local Institution - 0073
Goyangsi Ilsandonggu 10408
Not yet recruiting
Local Institution - 0129
Seongnamsi Bundanggu 13620
Not yet recruiting
Local Institution - 0074
Seoul 03080
Not yet recruiting
Local Institution - 0072
Seoul 120-752
Not yet recruiting
Local Institution - 0075
Seoul 135-710
Not yet recruiting
Local Institution - 0092
Songpa-gu, Seoul 138-736
Not yet recruiting
Netherlands
Local Institution - 0050
Amsterdam 1066 CX
Not yet recruiting
Local Institution - 0063
Utrecht 3584 CX
Not yet recruiting
Poland
Local Institution - 0018
Krakow 30-510
Not yet recruiting
Local Institution - 0051
Warszawa 02-507
Not yet recruiting
Local Institution - 0052
Warszawa 02-781
Not yet recruiting
Local Institution - 0037
Warszawa 05400
Not yet recruiting
Puerto Rico
Local Institution - 0106
San Juan 00918
Recruiting
Singapore
Local Institution - 0109
Singapore 169610
Not yet recruiting
Local Institution - 0087
Singapore 329563
Not yet recruiting
Spain
Local Institution - 0112
A Coruña 15009
Not yet recruiting
Local Institution - 0080
Barcelona 08035
Not yet recruiting
Local Institution - 0093
Barcelona 08036
Not yet recruiting
Local Institution - 0029
Barcelona 08916
Not yet recruiting
Local Institution - 0102
Madrid 28041
Not yet recruiting
Local Institution - 0113
Madrid 28046
Not yet recruiting
Local Institution - 0035
Sevilla 41013
Not yet recruiting
Local Institution - 0116
Zaragoza 50009
Not yet recruiting
Sweden
Local Institution - 0067
Goteborg 41346
Not yet recruiting
Local Institution - 0094
Malmo 214 28
Not yet recruiting
Local Institution - 0038
Stockholm 11281
Not yet recruiting
Local Institution - 0135
Stockholm 113 66
Not yet recruiting
Local Institution - 0058
Uppsala 751 85
Not yet recruiting
Switzerland
Local Institution - 0057
Aarau 5000
Not yet recruiting
Local Institution - 0069
Bern 3010
Not yet recruiting
Taiwan
Local Institution - 0128
Changhua City, Changhua 500
Not yet recruiting
Local Institution - 0111
Kao-Hsiung 83301
Not yet recruiting
Local Institution - 0076
Tainan 70403
Not yet recruiting
Local Institution - 0077
Tainan 70403
Not yet recruiting
Local Institution - 0121
Taipei City 10002
Not yet 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), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if KRAS 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

2022-09-29