Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab

Summary

The primary objective of this study is to determine the clinical performance of UV1 vaccination as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS \>=1) head and neck squamous cell carcinoma. Secondary objectives are to determine the efficacy in terms of overall survival ,objective response rate and duration of response. Moreover, this study will explore patient subgroups most likely deriving benefit from a targeted immunotherapy approach combining a checkpoint inhibitor with a cancer vaccine and help to establish liquid biopsy tumor monitoring in HNSCC.

Timeline

Start

2021-08-02

Primary completion

2024-08

Completion

2025-02

Publications

• Paschold L, Schultheiss C, Schmidt-Barbo P, Klinghammer K, Hahn D, Tometten M, Schafhausen P, Blaurock M, Brandt A, Westgaard I, Kowoll S, Stein A, Hinke A, Binder M. Inflammation and limited adaptive immunity predict worse outcomes on immunotherapy in head and neck cancer. NPJ Precis Oncol. 2025 Aug 5;9(1):272. doi: 10.1038/s41698-025-01020-6.
• Brandt A, Klinghammer K, Schultheiss C, Paschold L, Wickenhauser C, Bauer M, Bergqvist A, Hahn D, Schafhausen P, Tometten M, Blaurock M, Zech HB, Busch CJ, Dietz A, Muller-Richter U, Alt J, Boehm A, Kowoll S, Steighardt J, Lasch A, Westgaard IH, Westhrin M, Stein A, Hinke A, Binder M. UV1 vaccination in pembrolizumab-treated patients with recurrent or metastatic head and neck cancer: A randomized multicenter phase 2 trial. Med. 2025 Jul 11;6(7):100647. doi: 10.1016/j.medj.2025.100647. Epub 2025 Apr 11.
• Brandt A, Schultheiss C, Klinghammer K, Schafhausen P, Busch CJ, Blaurock M, Hinke A, Tometten M, Dietz A, Muller-Richter U, Hahn D, Alt J, Stein A, Binder M. Tolerability and efficacy of the cancer vaccine UV1 in patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma planned for first-line treatment with pembrolizumab - the randomized phase 2 FOCUS trial. Front Oncol. 2024 Feb 7;14:1283266. doi: 10.3389/fonc.2024.1283266. eCollection 2024.

Drugs

Indications