OncoMatch/Clinical Trials/NCT05732389
Immunotherapy in Patients With Early dMMR Rectal Cancer
Is NCT05732389 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Ipilimumab for cancer of rectum.
Treatment: Nivolumab · Ipilimumab — The purpose of this investigator-initiated, multicenter phase II trial is to evaluate the efficacy and tolerability of nivolumab and ipilimumab in patients with stage 1-3 MSI/dMMR rectal cancer. The primary objective is: Number of patients with complete clinical response after one or two cycles of immunotherapy. Patients will be treated with 1 or 2 cycles of combination immunotherapy: Cycle 1: Nivolumab 3 mg/kg days 1 and 15 \& ipilimumab 1 mg/kg day 1 Cycle 2: Nivolumab 3 mg/kg days 50 and 65 \& ipilimumab 1 mg/kg day 50
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage I, II, III
non-metastatic rectal cancer stage 1-3
Performance status
WHO 0–1
Prior therapy
Cannot have received: chemotherapy
Cannot have received: radiotherapy
Cannot have received: immunotherapy
Lab requirements
Blood counts
neutrophils 1.5 x 10^9/l and platelets 100 x 10^9/l
Kidney function
GFR (may be calculated) > 30 ml/min
Liver function
bilirubin 1.5 x UNL (upper normal limit)
Adequate haematological function defined as neutrophils 1.5 x 10^9/l and platelets 100 x 10^9/l. Adequate organ function (bilirubin 1.5 x UNL (upper normal limit), GFR (may be calculated) > 30 ml/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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