STUDY TITLE: Microsatellite Stable Colorectal Cancer with Radiographic Occult Molecular Residual Disease Treated with Botensilimab (AGEN1181; Bot) plus Balstilimab (AGEN2034, Bal) After Established Definitive Therapy (COMBAT Study)
NCT ID: NCT07551596
This is Phase 2 trial to study the effect of a botensilimab and balstilimab regimen in stage II/III CRC patients with MRD after definitive standard-of-care therapy. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body’s immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab may be an effective combination to remove any remaining microscopic cancer cells in the bloodstream in patients with stage II/III colorectal adenocarcinoma. In addition, clearing the ctDNA from the blood may serve as an early indicator of treatment response.
Status: Active, Recruiting
Key Eligibility Criteria
- Patients with confirmed colorectal adenocarcinoma
- Patients must:
- have undergone a complete surgical resection for stages II and III colon or rectal cancer and completed all planned adjuvant therapies
- have no radiographic evidence of disease within 28 days before or after a positive ctDNA assay
