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RECRUITING
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

834

Start Date

2026-03-31

Completion Date

2029-06-30

Last Updated

2026-04-02

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 (12)

BCCA - Prince George

Prince George, British Columbia, Canada

BCCA - Vancouver

Vancouver, British Columbia, Canada

Kingston Health Sciences Centre

Kingston, 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

Sinai Health System

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Centre Integre de Sante et de Services Sociaux

Greenfield Park, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada