RecruitingPhase 3NCT07152821

Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma

Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma: The BATTMAN Trial

Sponsor

Canadian Cancer Trials Group

Enrollment

834 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

Summary

This study is being done to answer the main question of: Do patients with colorectal cancer that cannot be removed by surgery, that is treated with two new immunotherapy drugs, botensilimab and balstilimab, live longer? Other important questions include: Is their quality of life better? Do their tumours slow in growth or possibly shrink in size? Are there markers in their tumour or blood that can predict whether they achieve any of these benefits? In addition, the study is done to confirm the safety of these immunotherapy drugs and to determine how long it takes for the body to metabolize them.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two immunotherapy drugs — botensilimab and balstilimab — versus standard supportive care for people with advanced colorectal cancer that has stopped responding to all available treatments. The cancer in this study is specifically the non-MSI-H (microsatellite stable) type, which typically does not respond to standard immunotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed colorectal adenocarcinoma that is NOT microsatellite instability-high (MSI-H) - You have already tried and failed all standard treatment options - You are reasonably functional (ECOG score 0 or 1) - You have a life expectancy of at least 12 weeks - You can provide tumor tissue for research analysis - You can complete quality-of-life questionnaires in English or French **You may NOT be eligible if...** - You have a history of serious immune deficiency or organ transplant - You have taken immunosuppressive medications recently - You have an active autoimmune or inflammatory condition - You have active brain cancer spread - You have had recent bowel obstruction, severe diarrhea, or need repeated fluid drainage from the abdomen - You have previously received anti-PD-1/PD-L1 or anti-CTLA-4 immunotherapy - You have unresolved serious side effects from prior treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBest Supportive Care

Measures designed to provide palliation of symptoms and improve quality of life as much as possible

DRUGBalstilimab

450mg IV every 3 weeks

DRUGBotensilimab

75mg IV every 6 weeks x 4 doses

Locations(55)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

BCCA - Prince George

Prince George, British Columbia, Canada

BCCA - Vancouver

Vancouver, British Columbia, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Waterloo Regional Health Network (WRHN)

Kitchener, Ontario, Canada

London Health Sciences Centre Research Inc.

London, Ontario, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Niagara Health System

St. Catharines, Ontario, Canada

North York General Hospital

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Sinai Health System

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Centre Integre de Sante et de Services Sociaux

Greenfield Park, Quebec, Canada

CIUSSS de l'Est-de-I'lle-de-Montreal

Montreal, Quebec, Canada

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

The Jewish General Hospital

Montreal, Quebec, Canada

Hotel-Dieu de Quebec

Québec, Quebec, Canada

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

ICO Angers

Angers, France

Institut du Cancer Avignon Sainte Catherine

Avignon, France

CHU de Besançons

Besançon, France

Institut Bergonié

Bordeaux, France

Centre François Baclesse

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

CHU Estaing de Clermont-Ferrand

Clermont-Ferrand, France

Centre Georges François Leclerc

Dijon, France

GH Mutualiste de Grenoble

Grenoble, France

CHD de Vendée

La Roche-sur-Yon, France

Hôpital Franco-Britannique - fondation Cognacq-Jay

Levallois-Perret, France

CHU de Lille

Lille, France

CHU Dupuytren

Limoges, France

Centre Léon Bérard

Lyon, France

Hôpital Privé Jean Mermoz

Lyon, France

Institut Paoli Calmettes

Marseille, France

Institut Régional du Cancer de Montpellier

Montpellier, France

CHU de Nantes

Nantes, France

Hôpital Privé du Confluent

Nantes, France

GH Diaconesses Croix Saint Simon

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

CHU de Perpignan

Perpignan, France

CHU de Bordeaux - Hôpital Haut Leveque

Pessac, France

CHU de Poitiers

Poitiers, France

CHU de Reims

Reims, France

Centre Eugène Marquis

Rennes, France

Centre Hospitalier Privé Saint Grégoire

Saint-Grégoire, France

ICO Saint Herblain

Saint-Herblain, France

Centre Paul Strauss

Strasbourg, France

Hôpital Foch

Suresnes, France

CHU de Toulouse

Toulouse, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT07152821

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