OncoMatch/Clinical Trials/NCT05732389
Immunotherapy in Patients With Early dMMR Rectal Cancer
Is NCT05732389 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT05732389 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage I or II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify