Last updated on July 2019

Regorafenib and Nivolumab in Combination With Radiotherapy for pMMR/MSS Metastatic Colorectal Cancer


Brief description of study

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.

Clinical Study Identifier: NCT04030260

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