RecruitingPhase 2NCT07227636

A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy

Phase II Study of Adjuvant Botensilimab in Combination With Balstilimab in Patients With Colorectal Cancer and Persistent Circulating Tumor DNA Following Surgery and Chemotherapy

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

284 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Rectal Cancer

Summary

The researchers are doing this study to find out whether the combination of botensilimab and balstilimab (BOT/BAL), followed by balstilimab alone, is an effective treatment for people with microsatellite stable (MSS) colorectal cancer or colorectal liver metastases (CRLM) who have measurable residual disease (MRD) after standard treatment with surgery and chemotherapy or total neoadjuvant therapy (TNT).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two immunotherapy drugs — botensilimab and balstilimab — in people with colorectal cancer whose tumor is not MSI-H (meaning standard immunotherapy typically does not work well for them) and who still have detectable cancer DNA in the blood (ctDNA+) after surgery and chemotherapy. **You may be eligible if...** - You are 18 or older with confirmed colorectal cancer - Your tumor has been tested and is NOT microsatellite instability-high (non-MSI-H/pMMR) - You have had complete surgical removal of your colorectal cancer or liver metastases - You have completed standard chemotherapy (FOLFOX or CAPEOX) after surgery - You still have detectable cancer DNA in the blood (ctDNA positive) **You may NOT be eligible if...** - Your tumor is MSI-H (standard immunotherapy may be considered instead) - You have not had complete surgical removal of the cancer - You are not able to provide tissue or blood samples for testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBotensilimab

All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses

DRUGBalstilimab

All patients will receive balstilimab IV on days 1, 15, and 29 of the 42 day cyclePatient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle.

OTHERPlacebo

Placebo