Clinical Trial

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

Study acronym: BATTMAN

Terminated Phase 3

View on ClinicalTrials.gov →

Why the trial stopped

Pharmaceutical Sponsor discontinued trial financial support

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.

Protocol Amendment History 9 changes

critical Trial terminated 2026-07-15

critical Reason stopped changed: — → Pharmaceutical Sponsor discontinued trial financial support 2026-07-15

notable Enrollment reduced: 834 -> 21 participants 2026-07-15

notable Trial sites expanded: 55 -> 67 locations 2026-07-15

notable Primary completion moved earlier: 2028-12-31 -> 2026-07-13 2026-07-15

minor Completion moved earlier: 2029-06-30 -> 2026-07-13 2026-07-15

notable Trial sites expanded: 22 -> 55 locations 2026-06-12

notable Trial sites expanded: 17 -> 20 locations 2026-05-13

notable Trial sites expanded: 12 -> 17 locations 2026-04-15

Trial Details

NCT Number	NCT07152821
Lead Sponsor	Canadian Cancer Trials Group Collaborators: Agenus Inc., Australasian Gastro-Intestinal Trials Group, UNICANCER
Conditions	Colorectal Cancer
Enrollment	21 participants
Start Date	2026-03-31
Primary Completion	2026-07-13 (estimated)
Study Completion	2026-07-13 (estimated)
Updated on ClinicalTrials.gov	2026-07-16