A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * Subject or legally authorized representative, is willing and able to provide written informed consent. * Histologically- or cytologically- confirmed colorectal cancer. * ≥ 18 years of age on day of signing informed consent. * Consent for use of archival tissue and blood draws for research purposes. * Performance status of ECOG 0 or 1. * Known non-MSI-H/pMMR by IHC, PCR or NGS testing. MSKCC confirmation of non-MSI-H/pMMR status is not mandatory prior to enrollment and treatment on the study. For patients with outside testing, if sufficient tissue is available testing may be repeated at MSKCC and will not impact initial eligibility. * Consent to undergo MSK IMPACT or NGS, if not previously done * Disease specific criteria: 1. Cohorts 1a and 2a: Undergone a complete surgical resection (R0) 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 ther