Can a Two-Drug immunotherapy combo outperform standard care in Late-Stage colorectal cancer?

NCT ID NCT05328908

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This clinical trial is testing whether a combination of two immunotherapy drugs, relatlimab and nivolumab, can help people with advanced colorectal cancer that has not responded to previous treatments. The study compares this combination to two standard chemotherapy options (regorafenib or TAS-102). Participants are adults with metastatic colorectal cancer that has progressed after at least one but no more than four prior lines of therapy. The main goal is to see if the immunotherapy combo improves overall survival compared to the standard treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: A fixed-dose combination of two immunotherapy drugs, relatlimab and nivolumab, given as an infusion.
What this could lead to: If effective, this combination could offer a new treatment option for people with advanced colorectal cancer who have run out of standard options, potentially extending survival.
What could go wrong: This is a phase 3 trial, but the outcome is uncertain. The combination may not improve survival compared to existing treatments, and immunotherapy can cause immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

769 people

The number who actually took part.

Started

Apr 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm Spinocerebellar Degenerations

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal neoplasms

Contacts and locations

Locations

Local Institution - 0001

Greenslopes, Queensland, 4120, Australia
Local Institution - 0003

Edmonton, Alberta, T6G 1Z2, Canada
Local Institution - 0004

Sherbrooke, Quebec, J1H 5N4, Canada
Local Institution - 0005

Madison, Wisconsin, 53705-2275, United States
Local Institution - 0007

Toronto, Ontario, M5G 2M9, Canada
Local Institution - 0008

Charleston, South Carolina, 29414, United States
Local Institution - 0009

Durham, North Carolina, 27710, United States
Local Institution - 0010

Clayton, Victoria, 3168, Australia
Local Institution - 0012

Los Angeles, California, 90089-0112, United States
Local Institution - 0014

Ottawa, Ontario, K1H 8L6, Canada
Local Institution - 0015

Santiago, RM, 7560908, Chile
Local Institution - 0016

Hradec Králové, 500 05, Czechia
Local Institution - 0017

Caen, Caen, 14000, France
Local Institution - 0018

Krakow, 30-727, Poland
Local Institution - 0019

Montreal, Quebec, H2X 3E4, Canada
Local Institution - 0020

Levallois-Perret, 92300, France
Local Institution - 0021

Melbourne, Victoria, 3084, Australia
Local Institution - 0022

Ciudad Autónoma Buenos Aires, Buenos Aires, 1425, Argentina
Local Institution - 0023

Rio Grande, 8500, Argentina
Local Institution - 0024

Ciudad Autónoma Buenos Aires, 1834, Argentina
Local Institution - 0025

Miami, Florida, 33176, United States
Local Institution - 0026

Ciudad Autónoma Buenos Aires, B, C1181ACH, Argentina
Local Institution - 0027

Murdoch, Western Australia, 6150, Australia
Local Institution - 0029

Badalona, B, 08916, Spain
Local Institution - 0030

Graz, 6800, Austria
Local Institution - 0031

Atlanta, Georgia, 30342, United States
Local Institution - 0033

Santiago, RM, 8380456, Chile
Local Institution - 0034

München, 81377, Germany
Local Institution - 0035

Seville, 41013, Spain
Local Institution - 0036

Lyon, 69008, France
Local Institution - 0037

Warsaw, Pl-mz, 05-400, Poland
Local Institution - 0038

Stockholm, AB, 112 81, Sweden
Local Institution - 0039

Suresnes, 92151, France
Local Institution - 0040

Hamburg, 20249, Germany
Local Institution - 0041

Frankfurt A. Main, Hesse, 60488, Germany
Local Institution - 0042

Ann Arbor, Michigan, 48109-1382, United States
Local Institution - 0043

East Brunswick, New Jersey, 08816-3340, United States
Local Institution - 0044

Springdale, Arkansas, 72762-5328, United States
Local Institution - 0045

Milan, 20133, Italy
Local Institution - 0046

Milan, MI, 20162, Italy
Local Institution - 0050

Amsterdam, 1066 CX, Netherlands
Local Institution - 0051

Warsaw, Masovian Voivodeship, 02-507, Poland
Local Institution - 0052

Warsaw, 02-781, Poland
Local Institution - 0053

Würzburg, Bavaria, 97080, Germany
Local Institution - 0054

Mannheim, Baden-Wurttemberg, 68167, Germany
Local Institution - 0055

Berlin, State of Berlin, 13353, Germany
Local Institution - 0056

Reutlingen, Baden-Wurttemberg, 72764, Germany
Local Institution - 0057

Aarau, Canton of Aargau, 5000, Switzerland
Local Institution - 0058

Uppsala, C, 751 85, Sweden
Local Institution - 0059

Reggio Emilia, RE, 42123, Italy
Local Institution - 0060

Catania, 95122, Italy
Local Institution - 0061

Naples, 80138, Italy
Local Institution - 0062

Woluwé-Saint-Lambert, BRU, 1200, Belgium
Local Institution - 0064

Prague, 150 06, Czechia
Local Institution - 0066

Bordeaux, 33000, France
Local Institution - 0067

Gothenburg, 413 45, Sweden
Local Institution - 0068

Ghent, VOV, 9000, Belgium
Local Institution - 0069

Bern, 3010, Switzerland
Local Institution - 0070

Edegem, 2650, Belgium
Local Institution - 0071

Boise, Idaho, 83712-6267, United States
Local Institution - 0072

Seoul, Seoul-teukbyeolsi, 03722, South Korea
Local Institution - 0073

Goyang-si, Gyeonggi-do, 10408, South Korea
Local Institution - 0074

Seoul, 110-744, South Korea
Local Institution - 0075

Seoul, 06351, South Korea
Local Institution - 0076

Tainan, TNN, 704, Taiwan
Local Institution - 0077

Tainan, 70403, Taiwan
Local Institution - 0078

Klagenfurt, 9020, Austria
Local Institution - 0080

Barcelona, 08035, Spain
Local Institution - 0081

Fort Wayne, Indiana, 46805, United States
Local Institution - 0082

Cincinnati, Ohio, 45220, United States
Local Institution - 0083

Suita-Shi, 565-0871, Japan
Local Institution - 0084

Kashiwa-Shi, 277-8577, Japan
Local Institution - 0085

Sunto-gun, 411-8777, Japan
Local Institution - 0086

Kawasaki-Shi, 216-8511, Japan
Local Institution - 0087

Singapore, 329563, Singapore
Local Institution - 0088

Sapporo, 060-8648, Japan
Local Institution - 0089

Paris, 75012, France
Local Institution - 0090

Dijon, 21000, France
Local Institution - 0091

Genova, 16132, Italy
Local Institution - 0092

Seoul, 05505, South Korea
Local Institution - 0093

Barcelona, B, 08036, Spain
Local Institution - 0094

Malmö, 214 28, Sweden
Local Institution - 0095

Columbus, Ohio, 43210-1240, United States
Local Institution - 0096

Sioux Falls, South Dakota, 57104, United States
Local Institution - 0097

Fort Worth, Texas, 76104-4611, United States
Local Institution - 0098

Wagga Wagga, New South Wales, 2650, Australia
Local Institution - 0099

Hořovice, 26801, Czechia
Local Institution - 0100

Olomouc, 775 20, Czechia
Local Institution - 0101

Essen, North Rhine-Westphalia, 45147, Germany
Local Institution - 0102

Madrid, M, 28041, Spain
Local Institution - 0103

Chūōku, 104-0045, Japan
Local Institution - 0104

Montreal, Quebec, H4A 3J1, Canada
Local Institution - 0105

Hidaka-shi, 350-1298, Japan
Local Institution - 0106

San Juan, PR, 00927, Puerto Rico
Local Institution - 0107

Chiba, 260-8717, Japan
Local Institution - 0108

Kōtoku, 135-8550, Japan
Local Institution - 0109

Singapore, 169610, Singapore
Local Institution - 0110

Osaka, Osaka, 5418567, Japan
Local Institution - 0111

Kaohsiung City, KHH, 83301, Taiwan
Local Institution - 0112

A Coruña, 15006, Spain
Local Institution - 0113

Madrid, Madrid, 28046, Spain
Local Institution - 0114

Westmead, New South Wales, 2145, Australia
Local Institution - 0115

Naples, 80131, Italy
Local Institution - 0116

Zaragoza, Z, 50009, Spain
Local Institution - 0117

Norwich, Connecticut, 06360-2753, United States
Local Institution - 0118

Matsuyama, 791-0280, Japan
Local Institution - 0119

Kitaadachi-gun, 362-0806, Japan
Local Institution - 0120

Leuven, 3000, Belgium
Local Institution - 0121

Zhongzheng, TPE, 100, Taiwan
Local Institution - 0122

Beijing, 100142, China
Local Institution - 0123

Ostrava, 708 52, Czechia
Local Institution - 0124

Yokohama, 241-8515, Japan
Local Institution - 0126

Wuhan, HB, 430071, China
Local Institution - 0127

Nashville, Tennessee, 37203-2173, United States
Local Institution - 0128

Changhua, CHA, 500, Taiwan
Local Institution - 0129

Seongnamsi Bundanggu, 13620, South Korea
Local Institution - 0131

Salzburg, 5020, Austria
Local Institution - 0132

Richmond, Virginia, 23284, United States
Local Institution - 0134

Chongqing, CQ, 400030, China
Local Institution - 0135

Stockholm, AB, 171 76, Sweden
Local Institution - 0138

Changsha, HN, 410013, China
Local Institution - 0139

Hangzhou, 310003, China
Local Institution - 0141

Taiyuan, SX, 030013, China
Local Institution - 0142

Jinan, SD, 250117, China
Local Institution - 0143

Nanjing, JS, 210008, China
Local Institution - 0144

Chengdu, Sichuan, 610041, China
Local Institution - 0146

Huaian, Jiangsu, 223300, China
Local Institution - 0147

Philadelphia, Pennsylvania, 19111-2434, United States
Local Institution - 0148

Padova, PD, 35128, Italy
Local Institution - 0149

Shenyang, 110042, China
Local Institution - 0150

Tianjin, TJ, 300121, China
Local Institution - 0151

Guangzhou, Guangdong, 510655, China
Local Institution - 0152

Xi'an, SHA, 710038, China
Local Institution - 0153

Shanghai, 200032, China
Local Institution - 0154

Kasama-Shi, 309-1793, Japan
Local Institution - 0158

Changsha, Hunan, 410013, China
Local Institution - 0160

Hangzhou, ZJ, 310022, China
Local Institution - 0164

Wuhan, Hubei, 430079, China
Massachusetts General Hospital,

Boston, Massachusetts, 02214, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.