Nivolumab with definitive chemoradiotherapy for oesophageal squamous cell carcinoma (NOBEL): a multicentre, single-arm, phase 2 feasibility trial.

ABSTRACT:

Background

This single-arm, phase 2 trial investigated the safety, efficacy, and biomarkers associated with combining nivolumab, an immune checkpoint inhibitor, with definitive chemoradiotherapy in patients with operable or inoperable oesophageal squamous cell carcinoma (OSCC) because these have not been well established.

Methods

In this multicentre, single-arm, phase 2 feasibility trial, eligible patients (aged 20-75 years) with histologically confirmed OSCC, Eastern Cooperative Oncology Group performance status of 0-1, and adequate organ and bone marrow functions were enrolled from five Japanese institutions. The treatment involved concurrent chemoradiotherapy (cisplatin and 5-fluorouracil) with nivolumab, followed by maintenance nivolumab for up to 1 year. The primary end

SUBMITTER: Nomura M 

PROVIDER: S-EPMC12796608 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature