OncoMatch/Clinical Trials/NCT07227636
A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy
Is NCT07227636 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Botensilimab and Balstilimab for colorectal cancer.
Treatment: Botensilimab · Balstilimab — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Excluded: POLD1 activating mutation
Excluded: POLE activating mutation
Disease stage
Required: Stage III
Undergone a complete surgical resection (R0) for stage III colon or rectal cancer, followed by adjuvant chemotherapy with FOLFOX or CAPEOX. ... Undergone a complete surgical resection (R0) for liver metastasis ... Completed definitive treatment for the primary tumor including (R0) resection, or Total Neoadjuvant Therapy for rectal cancer with complete clinical and radiographic response.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy (FOLFOX, CAPEOX, oxaliplatin-based therapy) — adjuvant or peri-operative
adjuvant chemotherapy with FOLFOX or CAPEOX. Post-operative chemotherapy not required if received previous oxaliplatin-based therapy. ... completed standard peri-operative chemotherapy. Peri-operative chemotherapy not required if received previous oxaliplatin-based therapy.
Must have received: surgery — R0 resection for stage III colon or rectal cancer or for liver metastasis
Undergone a complete surgical resection (R0) for stage III colon or rectal cancer ... Undergone a complete surgical resection (R0) for liver metastasis
Cannot have received: anti-PD-1 therapy
Prior therapy with an anti-PD-1 ... agent.
Cannot have received: anti-PD-L1 therapy
Prior therapy with an ... anti-PD-L1 ... agent.
Cannot have received: anti-CTLA-4 therapy
Prior therapy with an ... anti-CTLA-4 agent.
Lab requirements
Blood counts
absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 75,000/mm3; hemoglobin ≥ 9.0 g/dl
Kidney function
creatinine clearance (crcl) ≥60 ml/min
Liver function
ast and alt ≤ 2.5 × uln; bilirubin ≤ 1.5 × uln or direct bilirubin ≤ uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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