This study focuses on patients with stage II-III rectal cancer that is locally advanced. The treatment combines three different approaches: two medications – nivolumab and regorafenib – along with short-course radiotherapy. Both medications are given to patients before and after the radiotherapy treatment.
Nivolumab is administered through an intravenous infusion (through a vein), while regorafenib is taken as tablets by mouth. The study aims to determine if this combination of treatments can achieve a complete response in patients whose tumors have specific characteristics (referred to as pMMR/MSS tumors). A complete response means that there are no signs of cancer remaining after the treatment.
During the study, patients receive nivolumab infusions at a maximum daily dose of 240 mg, with a total maximum dose of 1200 mg over 5 weeks. Regorafenib tablets are given at a maximum daily dose of 60 mg, with a total maximum dose of 2040 mg over 34 weeks. Patients undergo regular medical examinations and imaging tests throughout the treatment period to monitor their response to the therapy.



Belgium