NCT04280848

Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Glioblastoma (GBM) is the most frequent primary brain tumor and the brain tumor with the poorest prognosis. The current treatment relies on surgical resection of gross tumor followed by radiochemotherapy and adjuvant therapy with temozolomide. After such therapy, most patients experiment recurrence and few therapeutic option are available. Despite such therapies, median survival only reaches around fifteen months. There is a strong rational to develop telomerase vaccine in GBM. Telomerase (TERT) is a major oncogene, particularly in primary brain tumors 24. Alterations in TERT are very frequent in central nervous system tumors, seen most commonly in gliomas25. Mutations in the TERT promoter are found in approximately 80% of primary glioblastoma (GBM). These findings strongly support the rational to develop vaccine targeting telomerase in GBM. The aim of this project is to evaluate UCPVax treatment in glioblastoma. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	UCPVax	The UCPVax vaccination protocol will start at least one month after glioblastoma patients have completed the concomitant radiochemotherapy (Radiotherapy + Temozolomide RT/TMZ). UCPVax vaccine will injected subcutaneously at days 1, 8, 15, 29, 36 and 43 (priming phase) following by boost vaccination one month after the last injection and then every 8 weeks for 12 months maximum.
DRUG	Temozolomide	6 additional monthly cures of Temozolomide (after concomitant radiotherapy and temozolomide) according to standard of care

Timeline

• Start date: 2020-05-26
• Primary completion: 2023-12-21
• Completion: 2024-12-31
• First posted: 2020-02-21
• Last updated: 2025-01-09

Locations

5 sites across 1 country: France