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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

Terminated

Phase

Phase 3

Prior Immunotherapy Allowed

CRC-directed Trial

Yes

Drugs

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

Tags

MSS/ MMRp

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.

Helpful Links

Futility Analysis Ends Nivolumab and Relatlimab Evaluation in Pretreated MSS mCRC

Location	Location Status
United States
Local Institution - 0044 Springdale, Arkansas 72762-5328	Terminated
Local Institution - 0012 Los Angeles, California 90089-0112	Terminated
Local Institution - 0117 Norwich, Connecticut 06360-2753	Terminated
Local Institution - 0025 Miami, Florida 33176	Terminated
Local Institution - 0031 Atlanta, Georgia 30342	Terminated
Local Institution - 0071 Boise, Idaho 83712-6267	Terminated
Local Institution - 0081 Fort Wayne, Indiana 46805	Terminated
Massachusetts General Hospital, Boston, Massachusetts 02214	Terminated
Local Institution - 0042 Ann Arbor, Michigan 48109-1382	Terminated
Local Institution - 0043 East Brunswick, New Jersey 08816-3340	Terminated
Local Institution - 0009 Durham, North Carolina 27710	Terminated
Local Institution - 0082 Cincinnati, Ohio 45220	Terminated
Local Institution - 0095 Columbus, Ohio 43210-1240	Terminated
Local Institution - 0147 Philadelphia, Pennsylvania 19111-2434	Terminated
Local Institution - 0008 Charleston, South Carolina 29414	Terminated
Local Institution - 0096 Sioux Falls, South Dakota 57104	Terminated
Local Institution - 0127 Nashville, Tennessee 37203-2173	Terminated
Local Institution - 0097 Fort Worth, Texas 76104-4611	Terminated
Local Institution - 0132 Richmond, Virginia 23284	Terminated
Local Institution - 0005 Madison, Wisconsin 53705-2275	Terminated
Argentina
Local Institution - 0022 Ciudad Autónoma Buenos Aires, Buenos Aires 1425	Terminated
Local Institution - 0026 Ciudad Autónoma Buenos Aires, B C1181ACH	Terminated
Local Institution - 0024 Ciudad Autónoma Buenos Aires 1834	Terminated
Local Institution - 0023 Rio Grande 8500	Terminated
Australia
Local Institution - 0098 Wagga Wagga, New South Wales 2650	Terminated
Local Institution - 0114 Westmead, New South Wales 2145	Terminated
Local Institution - 0001 Greenslopes, Queensland 4120	Terminated
Local Institution - 0010 Clayton, Victoria 3168	Terminated
Local Institution - 0021 Melbourne, Victoria 3084	Terminated
Local Institution - 0027 Murdoch, Western Australia 6150	Terminated
Austria
Local Institution - 0030 Graz 6800	Terminated
Local Institution - 0078 Klagenfurt Am Woerthersee 9020	Terminated
Local Institution - 0131 Salzburg 5020	Terminated
Belgium
Local Institution - 0062 Woluwé-Saint-Lambert, BRU 1200	Terminated
Local Institution - 0068 Gent, VOV 9000	Terminated
Local Institution - 0070 Edegem 2650	Terminated
Local Institution - 0120 Leuven 3000	Terminated
Canada
Local Institution - 0003 Edmonton, Alberta T6G 1Z2	Terminated
Local Institution - 0014 Ottawa, Ontario K1H 8L6	Terminated
Local Institution - 0007 Toronto, Ontario M5G 2M9	Terminated
Local Institution - 0019 Montreal, Quebec H2X 3E4	Terminated
Local Institution - 0104 Montreal, Quebec H4A 3J1	Terminated
Local Institution - 0004 Sherbrooke, Quebec J1H 5N4	Terminated
Chile
Local Institution - 0015 Santiago, RM 7560908	Terminated
Local Institution - 0033 Santiago, RM 8380456	Terminated
China
Local Institution - 0134 Chongqing, CQ 400030	Terminated
Local Institution - 0151 Guangzhou, Guangdong 510655	Terminated
Local Institution - 0126 Wuhan, HB 430071	Terminated
Local Institution - 0164 Wuhan Shi, Hubei 430079	Terminated
Local Institution - 0138 Changsha, Hunan 410013	Terminated
Local Institution - 0158 Changsha, Hunan 410013	Terminated
Local Institution - 0146 Huaian, Jiangsu 223300	Terminated
Local Institution - 0143 Nanjing, Jiangsu 210008	Terminated
Local Institution - 0142 Jinan, Shandong 250117	Terminated
Local Institution - 0141 Taiyuan, Shanxi 030013	Terminated
Local Institution - 0152 Xi'an, SHA 710038	Terminated
Local Institution - 0144 Chengdu, Sichuan 610041	Terminated
Local Institution - 0150 Tianjin, Tianjin 300121	Terminated
Local Institution - 0160 Hangzhou Shi, Zhejiang 310022	Terminated
Local Institution - 0122 Beijing 100142	Terminated
Local Institution - 0139 Hangzhou 310003	Terminated
Local Institution - 0153 Shanghai 200032	Terminated
Local Institution - 0149 Shenyang 110042	Terminated
Czechia
Local Institution - 0099 Horovice 26801	Terminated
Local Institution - 0016 Hradec Králové 500 05	Terminated
Local Institution - 0100 Olomouc 775 20	Terminated
Local Institution - 0123 Ostrava 708 52	Terminated
Local Institution - 0064 Praha 5 150 06	Terminated
France
Local Institution - 0066 Bordeaux 33000	Terminated
Local Institution - 0017 Caen 14000	Terminated
Local Institution - 0090 Dijon 21000	Terminated
Local Institution - 0020 Levallois-Perret 92300	Terminated
Local Institution - 0036 Lyon 69008	Terminated
Local Institution - 0089 Paris 75012	Terminated
Local Institution - 0039 Suresnes 92151	Terminated
Germany
Local Institution - 0055 Berlin, BE 13353	Terminated
Local Institution - 0054 Mannheim, BW 68167	Terminated
Local Institution - 0056 Reutlingen, BW 72764	Terminated
Local Institution - 0053 Wuerzburg, BY 97080	Terminated
Local Institution - 0041 Frankfurt A. Main, HE 60488	Terminated
Local Institution - 0101 Essen, Northwest 45147	Terminated
Local Institution - 0040 Hamburg 20249	Terminated
Local Institution - 0034 Munchen 81377	Terminated
Italy
Local Institution - 0046 Milano, MI 20162	Terminated
Local Institution - 0148 Padova, PD 35128	Terminated
Local Institution - 0059 Reggio Emilia, RE 42123	Terminated
Local Institution - 0060 Catania 95122	Terminated
Local Institution - 0091 Genova 16132	Terminated
Local Institution - 0045 Milan 20133	Terminated
Local Institution - 0115 Napoli 80131	Terminated
Local Institution - 0061 Napoli 80138	Terminated
Japan
Local Institution - 0110 Osaka-shi, Osaka 5418567	Terminated
Local Institution - 0107 Chiba-Shi 260-8717	Terminated
Local Institution - 0103 Chuo-Ku 104-0045	Terminated
Local Institution - 0105 Hidaka-shi 350-1298	Terminated
Local Institution - 0154 Kasama-Shi 309-1793	Terminated
Local Institution - 0084 Kashiwa-Shi 277-8577	Terminated
Local Institution - 0086 Kawasaki-Shi 216-8511	Terminated
Local Institution - 0119 Kitaadachi-gun 362-0806	Terminated
Local Institution - 0108 Koto-Ku 135-8550	Terminated
Local Institution - 0118 Matsuyama City 791-0280	Terminated
Local Institution - 0088 Sapporo-shi 060-8648	Terminated
Local Institution - 0083 Suita-Shi 565-0871	Terminated
Local Institution - 0085 Sunto-gun 411-8777	Terminated
Local Institution - 0124 Yokohama-Shi 241-8515	Terminated
Korea, Republic of
Local Institution - 0072 Seoul, Seoul-teukbyeolsi 03722	Terminated
Local Institution - 0073 Goyang-si, Gyeonggi-do 10408	Terminated
Local Institution - 0129 Seongnamsi Bundanggu 13620	Terminated
Local Institution - 0092 Seoul 05505	Terminated
Local Institution - 0075 Seoul 06351	Terminated
Local Institution - 0074 Seoul 110-744	Terminated
Netherlands
Local Institution - 0050 Amsterdam 1066 CX	Terminated
Poland
Local Institution - 0051 Warsaw, MZ 02-507	Terminated
Local Institution - 0037 Warszawa, Pl-mz 05-400	Terminated
Local Institution - 0018 Kraków 30-727	Terminated
Local Institution - 0052 Warszawa 02-781	Terminated
Puerto Rico
Local Institution - 0106 San Juan 00927	Terminated
Singapore
Local Institution - 0109 Singapore 169610	Terminated
Local Institution - 0087 Singapore 329563	Terminated
Spain
Local Institution - 0029 Badalona, B 08916	Terminated
Local Institution - 0093 Barcelona, B 08036	Terminated
Local Institution - 0102 Madrid, M 28041	Terminated
Local Institution - 0116 Zaragoza, Z 50009	Terminated
Local Institution - 0080 Barcelona 08035	Terminated
Local Institution - 0112 La Coruña 15006	Terminated
Local Institution - 0113 Madrid 28046	Terminated
Local Institution - 0035 Sevilla 41013	Terminated
Sweden
Local Institution - 0038 Stockholm, AB 112 81	Terminated
Local Institution - 0135 Stockholm, AB 171 76	Terminated
Local Institution - 0058 Uppsala, C 751 85	Terminated
Local Institution - 0067 Goteborg 413 45	Terminated
Local Institution - 0094 Malmö 214 28	Terminated
Switzerland
Local Institution - 0057 Aarau, AG 5000	Terminated
Local Institution - 0069 Bern 3010	Terminated
Taiwan
Local Institution - 0128 Changhua, CHA 500	Terminated
Local Institution - 0111 Kaohsiung, KHH 83301	Terminated
Local Institution - 0076 Tainan, TNN 704	Terminated
Local Institution - 0121 Zhongzheng, TPE 100	Terminated
Local Institution - 0077 Tainan 70403	Terminated

Inclusion Criteria

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

* 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

2025-08-13