Overview

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

Status:
Recruiting

Trial end date:
2025-02-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Martin-Luther-Universität Halle-Wittenberg

Collaborators:

Apotheke der Universitätsmedizin der Johannes Gutenberg-Universität Mainz (Germany)
Axel Hinke. CCRC Cancer Clinical Research Consulting (Düsseldorf, Germany
Ultimovacs ASA

Treatments:

Pembrolizumab
Sargramostim