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TERMINATED
NCT07152821
PHASE3

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

Sponsor: Canadian Cancer Trials Group

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2026-03-31

Completion Date

2026-07-13

Last Updated

2026-07-14

Healthy Volunteers

No

Interventions

OTHER

Best Supportive Care

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

DRUG

Balstilimab

450mg IV every 3 weeks

DRUG

Botensilimab

75mg IV every 6 weeks x 4 doses

Locations (67)

Gosford Hospital

Gosford, New South Wales, Australia

Tamworth Rural Referral Hospital

North Tamworth, New South Wales, Australia

Redcliffe Hospital

Redcliffe, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Grampians Health

Ballarat, Victoria, Australia

Monash Health

Clayton, Victoria, Australia

Goulburn Valley Health

Shepparton, Victoria, Australia

Sir Charles Gairnder Hospital

Nedlands, Western Australia, Australia

Flinders Medical Center

Adelaide, Australia

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

BCCA - Prince George

Prince George, British Columbia, Canada

BCCA - Vancouver

Vancouver, British Columbia, Canada

BCCA - Victoria

Victoria, 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

Thunder Bay Regional Health Sciences Centre/

Thunder Bay, 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

Centre François Baclesse

Caen, Cedex 5, France

Institut Régional du Cancer de Montpellier

Montpellier, Cedex 5, France

Centre Léon Bérard

Léon, Cedex 8, France

Institut du Cancer Avignon Sainte Catherine

Avignon, Cedex 9, France

Institut Paoli Calmettes

Marseille, Cedex 9, France

Institut Bergonié

Bordeaux, Cedex, France

Rue Michel Polonowski

Lille, Cedex, France

ICO Angers

Angers, France

CHU de Besançon

Besançon, 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 Dupuytren

Limoges, France

Hôpital Privé Jean Mermoz

Lyon, 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

Auckland City Hospital

Auckland, New Zealand