NCT07227636

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a 2-part, 2-cohort each. Part-1 will be a non-randomized study of 54 subjects to assess ctDNA clearance, including 2 cohorts. Cohort 1a includes 27 patients with stage III non-MSI-H/pMMR colorectal cancer following surgery and adjuvant chemotherapy or total neoadjuvant therapy (TNT), with persistent MRD. Cohort 1b includes 27 patients with non-MSI-H/pMMR CRLM following surgery and peri-operative chemotherapy, with persistent MRD. Part-2 will be a randomized, placebo-controlled, double-blind study of 230 patients with non- MSI-H/pMMR CRC with MRD, to assess RFS. Cohort 2a includes 113 patients with stage III non-MSI-H/pMMR colorectal cancer following surgery and adjuvant chemotherapy or TNT with persistent MRD, randomized 2:1 to treatment versus placebo.

Conditions

• Colorectal Cancer
• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Botensilimab	All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses
DRUG	Balstilimab	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.
OTHER	Placebo	Placebo

Timeline

• Start date: 2025-11-07
• Primary completion: 2030-11-01
• Completion: 2030-11-01
• First posted: 2025-11-13
• Last updated: 2026-02-06

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study