Botensilimab and Balstilimab

This is a Phase 2 trial to study whether the combination of botensilimab and balstilimab, followed by balstilimab alone, is an effective treatment for people with microsatellite stable colorectal cancer or colorectal liver metastases with measurable MRD after standard treatment with surgery and chemotherapy or total neoadjuvant therapy.

Key Eligibility Criteria

• Patients with confirmed colorectal cancer and known non-MSI-H/pMMR by IHC, PCR or NGS testing
• Cohorts 1a and 2a:
  • undergone a complete surgical resection for stage III colon or rectal cancer, followed by adjuvant chemotherapy with FOLFOX or CAPEOX. Post-operative chemotherapy not required if received previous oxaliplatin-based therapy
  • completed Total Neoadjuvant Therapy for rectal cancer with complete clinical and radiographic response is allowed
• Cohorts 1b and 2b:
  • undergone a complete surgical resection for liver metastasis (ablation or stereotactic body radiation therapy [SBRT], but not Y-90, is permitted) and completed standard peri-operative chemotherapy. Peri-operative chemotherapy not required if received previous oxaliplatin-based therapy. Prior floxuridine via Hepatic Arterial Infusion Pump is permitted
  • completed definitive treatment for the primary tumor including resection, or Total Neoadjuvant Therapy for rectal cancer with complete clinical and radiographic response

Treatment

Drug: Botensilimab, a CTLA-4 inhibitor

Drug: Balstilimab, a PD-1 inhibitor

ClinicalTrials.gov ID NCT07227636