Nivolumab for Patients With High-Risk Oral Leukoplakia: A Nonrandomized Controlled Trial.

ABSTRACT:

Importance

Proliferative verrucous leukoplakia (PVL) is an aggressive oral precancerous disease characterized by a high risk of transformation to invasive oral squamous cell carcinoma (OSCC), and no therapies have been shown to affect its natural history. A recent study of the PVL immune landscape revealed a cytotoxic T-cell-rich microenvironment, providing strong rationale to investigate immune checkpoint therapy.

Objective

To determine the safety and clinical activity of anti-programmed cell death 1 protein (PD-1) therapy to treat high-risk PVL.

Design, setting, and participants

This nonrandomized, open-label, phase 2 clinical trial was conducted from January 2019 to December 2021 at a single academic medical center; median (range) follow-up was 21.1 (5.4-43.6) mont

SUBMITTER: Hanna GJ 

PROVIDER: S-EPMC10654930 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature