P2, N=188, Active, not recruiting, Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2026 --> May 2026

P1, N=44, Active, not recruiting, Abramson Cancer Center at Penn Medicine | Trial completion date: Dec 2025 --> Mar 2027 | Trial primary completion date: Dec 2025 --> Dec 2026

P1/2, N=52, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026

present findings from the phase 2 FOCUS trial evaluating UV1 vaccine combined with pembrolizumab in PD-L1-positive recurrent/metastatic head and neck squamous cell carcinoma. While UV1 elicited human telomerase reverse transcriptase-specific T cell responses in 86% of patients, clinical outcomes showed no improvement over pembrolizumab monotherapy.1 This discordance between immune activation and therapeutic efficacy underscores the necessity for further disease understanding and vaccine design in the future.

P1/2, N=35, Completed, Inovio Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> May 2025 | Trial primary completion date: Dec 2025 --> May 2025

P1, N=44, Active, not recruiting, University of Pennsylvania | Recruiting --> Active, not recruiting

The addition of UV1 to pembrolizumab was safe but did not show an efficacy signal in this study population.

P2, N=184, Recruiting, Nordic Society of Gynaecological Oncology - Clinical Trials Unit | Trial completion date: Dec 2026 --> Dec 2030 | Trial primary completion date: Dec 2024 --> Dec 2026

While DNA vaccines demonstrate promising immunogenicity, peptide vaccines, such as UV1, UCPVax, and Vx-001, have shown clinical efficacy in certain cancer types. Accordingly, we discuss the mechanisms of action, preclinical and clinical data, and the potential of these vaccines to elicit robust and durable anti-tumor immune responses. This review highlights the potential of telomerase-based vaccines as a promising strategy for cancer treatment and identifies areas for future research.

Patients with pleural mesothelioma treated with nivolumab and ipilimumab with or without UV1 vaccine in the NIPU study were included. Elevated levels of certain cytokines, both before and after onset of treatment, correlate with specific irAEs in PM patients receiving ICIs. These cytokines may be used as biomarkers to predict and detect irAES.

P1/2, N=18, Completed, Ultimovacs ASA | Active, not recruiting --> Completed

P1/2, N=22, Completed, Ultimovacs ASA | Active, not recruiting --> Completed