Study to Nivolumab Following Preoperative Chemoradiotherapy

Summary

This is a phase Ib/II, open-label, single-arm, multicenter study to investigate the safety, efficacy, and proof of concept (POC) of monotherapy with nivolumab, an anti-PD-1 antibody drug, as a sequential therapy following chemoradiotherapy (CRT) with capecitabine and subsequent surgical therapy in patients with locally advanced resectable rectal cancer.

Timeline

Start

2016-10

Primary completion

2021-12

Completion

2022-08

Publications

• Tsukada Y, Bando H, Inamori K, Wakabayashi M, Togashi Y, Koyama S, Kotani D, Yuki S, Komatsu Y, Homma S, Taketomi A, Uemura M, Kato T, Fukui M, Nakamura N, Kojima M, Kawachi H, Kirsch R, Yoshida T, Sato A, Nishikawa H, Ito M, Yoshino T. Three-year outcomes of preoperative chemoradiotherapy plus nivolumab in microsatellite stable and microsatellite instability-high locally advanced rectal cancer. Br J Cancer. 2024 Jul;131(2):283-289. doi: 10.1038/s41416-024-02730-7. Epub 2024 Jun 4.

Drugs

Indications