Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma (UCPVax-Glio)
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|ClinicalTrials.gov Identifier: NCT04280848|
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: UCPVax||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2023|
Experimental: UCPVax vaccine
UCPVax is a therapeutic vaccine derived from telomerase combined with Montanide ISA51 VG as adjuvant.
The UCPVax vaccination protocol will start at least one month after glioblastoma patients have completed the concomitant radiochemotherapy (Radiotherapy + Temozolomide RT/TMZ), without the 6 additional monthly cures of temozolomide, with a maximum of 45 days.
UCPVax vaccine will be emulsified in Montanide ISA 51 and 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.
- Immunogenicity [ Time Frame: at day 60 ]Anti-TERT specific T cell responses measured in peripheral blood using IFN-gamma ELISPOT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280848
|Contact: Olivier ADOTEVI, Premail@example.com|
|Contact: Clotilde VERLUT, Dr|
|Principal Investigator: Clotilde VERLUT, Dr|
|Centre Georges François Leclerc||Not yet recruiting|
|Contact: François GHIRINGHELLI, Pr|
|Principal Investigator: François GHIRINGHELLI, Pr|
|Hôpital Saint-Louis||Not yet recruiting|
|Contact: Antoine CARPENTIER, Pr|
|Principal Investigator: Antoine CARPENTIER, Pr|
|Principal Investigator:||Clotilde VERLUT, Dr||CHU Besançon|