NISCAHN: a phase II trial of nivolumab in patients with salivary gland carcinoma (Unicancer ORL-08).

ABSTRACT:

Objective

Salivary gland cancers (SGC) are rare cancers with currently no standard treatment for recurrent/metastatic disease. Based on checkpoint inhibitors benefit in a broad range of tumours, NIvolumab in Salivary gland CArcinoma of the Head and Neck (NISCAHN) evaluated nivolumab efficacy in SGC.

Methods and analysis

In this phase II single-stage Fleming design, patients with SGC with a progressive disease progression within 6 months prior to entering the study, were divided into ACC (adenoid cytic carcinoma) and non-ACC. All received nivolumab for a maximum of 12 months. The primary endpoint was the non-progression rate at 6 months (NPR_6m) according to Response Evaluation Criteria in Solid Tumors V.1.1. Secondary endpoints included progression-free survival (P

SUBMITTER: Fayette J 

PROVIDER: S-EPMC11235021 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature