New immunotherapy combo aims to extend life in Tough-to-Treat colorectal cancer

NCT ID NCT07152821

First seen Jun 25, 2026 · Last updated Jun 30, 2026 · Updated 4 times

Summary

This Phase 3 trial is testing whether a combination of two immunotherapy drugs, botensilimab and balstilimab, can help people with advanced colorectal cancer that can't be removed by surgery and has stopped responding to chemotherapy. About 834 participants will receive either the drug combo or best supportive care. The main goal is to see if the drugs help people live longer, with additional focus on tumor shrinkage, quality of life, and safety.

What this could mean

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

Active substance

botensilimab and balstilimab (immunotherapy drugs)

What this could lead to

If it works, this could offer a new treatment option for people with advanced colorectal cancer who have run out of standard therapies, potentially helping them live longer and have a better quality of life.

What could go wrong

This is a large Phase 3 trial, but immunotherapy doesn't work for everyone and can cause serious side effects. The cancer type studied (non-MSI-H) is typically less responsive to immunotherapy, so benefits may be modest or not seen at all.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Allan Blair Cancer Centre

    RECRUITING

    Regina, Saskatchewan, S4T 7T1, Canada

    Contact Phone: •••-•••-••••

  • Arthur J.E. Child Comprehensive Cancer Centre

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

    Contact Phone: •••-•••-••••

  • BCCA - Prince George

    RECRUITING

    Prince George, British Columbia, V2M 7E9, Canada

    Contact

  • BCCA - Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

    Contact Phone: •••-•••-••••

  • CHD de Vendée

    NOT_YET_RECRUITING

    La Roche-sur-Yon, France

    Contact

  • CHU Dupuytren

    NOT_YET_RECRUITING

    Limoges, France

    Contact

  • CHU Estaing de Clermont-Ferrand

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

    Contact

  • CHU de Besançon

    NOT_YET_RECRUITING

    Besançon, France

    Contact

  • CHU de Bordeaux - Hôpital Haut Leveque

    NOT_YET_RECRUITING

    Pessac, France

    Contact

  • CHU de Lille

    NOT_YET_RECRUITING

    Lille, France

    Contact

  • CHU de Nantes

    NOT_YET_RECRUITING

    Nantes, France

    Contact

  • CHU de Perpignan

    NOT_YET_RECRUITING

    Perpignan, France

    Contact

  • CHU de Poitiers

    NOT_YET_RECRUITING

    Poitiers, France

    Contact

  • CHU de Reims

    NOT_YET_RECRUITING

    Reims, France

    Contact

  • CHU de Toulouse

    NOT_YET_RECRUITING

    Toulouse, France

    Contact

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

    Contact Phone: •••-•••-••••

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

    NOT_YET_RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

    Contact Phone: •••-•••-••••

  • CIUSSS de l'Estrie - Centre hospitalier

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

    Contact Phone: •••-•••-••••

  • Centre Eugène Marquis

    NOT_YET_RECRUITING

    Rennes, France

    Contact

  • Centre François Baclesse

    NOT_YET_RECRUITING

    Caen, France

    Contact

  • Centre Georges François Leclerc

    NOT_YET_RECRUITING

    Dijon, France

    Contact

  • Centre Hospitalier Privé Saint Grégoire

    NOT_YET_RECRUITING

    Saint-Grégoire, France

    Contact

  • Centre Integre de Sante et de Services Sociaux

    RECRUITING

    Greenfield Park, Quebec, J4V 2H1, Canada

    Contact Phone: •••-•••-••••

  • Centre Jean Perrin

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

    Contact

  • Centre Léon Bérard

    NOT_YET_RECRUITING

    Lyon, France

    Contact

  • Centre Paul Strauss

    NOT_YET_RECRUITING

    Strasbourg, France

    Contact

  • GH Diaconesses Croix Saint Simon

    NOT_YET_RECRUITING

    Paris, France

    Contact

  • GH Mutualiste de Grenoble

    NOT_YET_RECRUITING

    Grenoble, France

    Contact

  • Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, France

    Contact

  • Hotel-Dieu de Quebec

    RECRUITING

    Québec, Quebec, G1R 2J6, Canada

    Contact Phone: •••-•••-••••

  • Hôpital Européen Georges Pompidou

    NOT_YET_RECRUITING

    Paris, France

    Contact

  • Hôpital Foch

    NOT_YET_RECRUITING

    Suresnes, France

    Contact

  • Hôpital Franco-Britannique - fondation Cognacq-Jay

    NOT_YET_RECRUITING

    Levallois-Perret, France

    Contact

  • Hôpital Privé Jean Mermoz

    NOT_YET_RECRUITING

    Lyon, France

    Contact

  • Hôpital Privé du Confluent

    NOT_YET_RECRUITING

    Nantes, France

    Contact

  • ICO Angers

    NOT_YET_RECRUITING

    Angers, France

    Contact

  • ICO Saint Herblain

    NOT_YET_RECRUITING

    Saint-Herblain, France

    Contact

  • Institut Bergonié

    NOT_YET_RECRUITING

    Bordeaux, France

    Contact

  • Institut Paoli Calmettes

    NOT_YET_RECRUITING

    Marseille, France

    Contact

  • Institut Régional du Cancer de Montpellier

    NOT_YET_RECRUITING

    Montpellier, France

    Contact

  • Institut de Cancérologie de Lorraine

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, France

    Contact

  • Institut du Cancer Avignon Sainte Catherine

    NOT_YET_RECRUITING

    Avignon, France

    Contact

  • Juravinski Cancer Centre at Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

    Contact Phone: •••-•••-••••

  • Kingston Health Sciences Centre

    RECRUITING

    Kingston, Ontario, K7L 2V7, Canada

    Contact

  • Lakeridge Health Oshawa

    RECRUITING

    Oshawa, Ontario, L1G 2B9, Canada

    Contact

  • London Health Sciences Centre Research Inc.

    RECRUITING

    London, Ontario, N6A 5W9, Canada

    Contact Phone: •••-•••-••••

  • Niagara Health System

    RECRUITING

    St. Catharines, Ontario, L2S 0A9, Canada

    Contact Phone: •••-•••-••••

  • North York General Hospital

    RECRUITING

    Toronto, Ontario, M2K 1E1, Canada

    Contact Phone: •••-•••-••••

  • Ottawa Hospital Research Institute

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

    Contact Phone: •••-•••-••••

  • Saskatoon Cancer Centre

    RECRUITING

    Saskatoon, Saskatchewan, S7N 4H4, Canada

    Contact Phone: •••-•••-••••

  • Sinai Health System

    RECRUITING

    Toronto, Ontario, M5G 1X5, Canada

    Contact Phone: •••-•••-••••

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

    Contact Phone: •••-•••-••••

  • The Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

    Contact Phone: •••-•••-••••

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

    Contact Phone: •••-•••-••••

  • Waterloo Regional Health Network (WRHN)

    RECRUITING

    Kitchener, Ontario, N2G 1G3, Canada

    Contact Phone: •••-•••-••••