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Botensilimab plus balstilimab versus best supportive care for chemo-refractory unresectable colorectal adenocarcinoma

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

Phase 3 Interventional Canadian Cancer Trials Group · NCT07152821

This will test whether two immunotherapy drugs, botensilimab and balstilimab, can help adults with colorectal cancer that cannot be removed by surgery and has stopped responding to other treatments live longer and feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment834 (estimated)
Ages18 Years and up
SexAll
SponsorCanadian Cancer Trials Group Research network
Drugs / interventionschemotherapy, prednisone, botensilimab, balstilimab, immunotherapy
Locations20 sites (Calgary, Alberta and 19 other locations)
Trial IDNCT07152821 on ClinicalTrials.gov

What this trial studies

This is a randomized Phase 3 trial comparing the combination of botensilimab and balstilimab to best supportive care in adults with unresectable, chemo-refractory colorectal adenocarcinoma that is not dMMR/MSI-H. Eligible participants have measurable disease, ECOG performance status 0–1, adequate organ function, and have exhausted available standard therapies. Participants randomized to the investigational arm will receive the two immunotherapies and undergo regular tumor imaging, safety monitoring, and blood/tumor sampling for biomarker and pharmacokinetic studies. Primary and secondary outcomes include overall survival, quality of life, tumor response and growth delay, safety, and identification of predictive biomarkers.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed colorectal adenocarcinoma that is not dMMR/MSI-H, measurable disease, ECOG 0–1, adequate organ and marrow function, life expectancy ≥12 weeks, and who have failed all available standard therapies are the intended participants.

Not a fit: Patients with dMMR/MSI-H tumors, those who still have effective standard treatment options, or those with poor performance status or inadequate organ function are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could extend survival and improve symptoms or quality of life for patients with chemo-refractory, unresectable colorectal cancer.

How similar studies have performed: Single-agent PD-1/PD-L1 therapies have generally not worked well in MSS colorectal cancer, though some combination immunotherapy approaches and early-phase studies have shown limited promising signals.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Must have histologically confirmed colorectal adenocarcinoma that is not deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H).
* Received and failed all prior available therapies, such that the standard of care for the patient would be best supportive care (BSC).
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1.
* Must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
* A life expectancy of ≥ 12 weeks at the time of study entry.
* Must be ≥ 18 years of age.
* Participants must consent to provision of, and investigator must agree to submit, a representative archival formalin fixed paraffin block of tumour tissue for correlative analyses when tumour tissue is available.
* Participants must have adequate organ and marrow function measured within 14 days prior to randomization.
* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French.
* Participant consent must be appropriately obtained in accordance with applicable local and national regulatory requirements.
* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrolment.
* Participants of childbearing potential or partners of participants of childbearing potential must have agreed to use a highly effective contraceptive method

Exclusion Criteria:

* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may be eligible for this trial, however, consultation with CCTG in advance of enrolment is required.
* A history of primary immunodeficiency, solid organ transplant or allogeneic bone marrow transplant.
* Current or prior use of immunosuppressive medication within 7 days before the first dose of study drugs, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease that has required systemic treatment within 2 years of the start of study drug.
* Active or uncontrolled intercurrent illness.
* Active brain metastases or leptomeningeal metastases.
* Receipt of live attenuated vaccination administered within 30 days prior to randomization.
* Lactating women who choose to breast feed.
* Any active disease condition which would render the protocol treatment dangerous or impair the ability of the participant to receive protocol therapy.
* Any condition that does not permit compliance with the protocol.
* Receipt of anti-cancer chemotherapy or biologic therapy within the lesser of i) 21 days, or ii) the usual cycle length of the regimen prior to the first planned dose of study drug.
* Receipt of radiotherapy or investigational agents within four weeks of first planned dose of study drug.
* Any unresolved toxicity (≥ CTCAE grade 2) from previous anti-cancer therapy.
* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
* History of partial or complete bowel obstruction within the last 3 months prior to study enrolment, signs/symptoms of bowel obstruction or known radiologic evidence of impending obstruction.
* Refractory ascites defined as requiring 2 or more therapeutic paracenteses within the last 4 weeks or ≥ 4 times within the last 3 months or ≥ 1 time within the last 2 weeks or requiring diuretics within 2 weeks prior to study enrolment.
* Active or ongoing diarrhea of CTCAE grade 2 or higher.
* Tumour is mismatch repair deficient (dMMR) or microsatellite instability- high (MSI-H) per a standard local testing method.
* Prior exposure to anti-PD-1/PD-L1/CTLA-4 therapy.

Where this trial is running

Calgary, Alberta and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colorectal Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.