NCT07152821

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 834 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is being done to find out if this approach (taking botensilimab and balstilimab) is better or worse than the usual approach for colorectal adenocarcinoma that cannot be removed by surgery. The usual approach is defined as care most people get for colorectal adenocarcinoma that cannot be removed by surgery and that has become resistant to treatment with available therapies. The usual approach for patients who are not in a study is supportive care with drugs and other treatments that may help to make them feel better or may improve their quality of life. This treatment is known as "best supportive care." Although patients with best supportive care can feel better for some months, the cancer usually continues to grow.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-12-31
• Completion: 2029-06-30
• First posted: 2025-09-03
• Last updated: 2026-04-16

Locations

17 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study