Regorafenib and Nivolumab in Combination With Radiotherapy for pMMR/MSS Metastatic Colorectal Cancer
Status:
Unknown status
Trial end date:
2020-07-19
Target enrollment:
Participant gender:
Summary
REGONIVO is a Phase Ib study to explore the efficacy and safety of regorafenib in combination
with nivolumab in the treatment of gastric cancer and colorectal cancer with MSS. The study
enrolled 50 patients with advanced disease, including 25 cases of gastric cancer, 25 cases of
colorectal cancer, except for one case of colorectal cancer with MSI-H, and others were MSS
type. The results of the study showed that patients with colorectal cancer had an objective
response rate (ORR) of 36% and a progression-free survival (PFS) of 6.3 months.
Based on the preliminary results of the REGONIVO study, the aim of this phase 2 study is to
explore the safety and efficacy of regorafenib and nivolumab in combination with radiotherapy
with or without irinotecan in previously treated metastatic colorectal cancer patients with
pMMR/MSS.