Immunotherapy in Patients With Early dMMR Rectal Cancer
Trial Parameters
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years. * Histologically verified non-metastatic rectal cancer stage 1-3. * No indication for local therapy like TEM. * Histologically verified dMMR or MSI. * Performance status (WHO) of 0-1. * No previous chemotherapy, radiotherapy or immunotherapy for colorectal cancer * Adequate haematological function defined as neutrophils ≥ 1.5 x 109/l and platelets ≥ 100 x 109/l. * Adequate organ function (bilirubin ≤ 1.5 x UNL (upper normal limit), GFR (may be calculated) \> 30 ml/min. * Women of childbearing potential must have been tested negative in a serum pregnancy test within five days prior to registration. Fertile patients must agree to use a highly effective method of birth control. (i.e., pregnancy rate of less than 1 % per year) (Appendix 1) during the study and for six months after the discontinuation of study medication. * Has provided written informed consent prior to performance of any study procedure. * Written informed consent must be obtained acco