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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female patients, age ≥ 18 and ≤ 75 years old.
  • - Written informed consent.
  • - Histologically confirmed glioblastoma.
  • - Patient with unmethylated MGMT status (cohort A) or Patient with methylated MGMT status (cohort B) - Patients previously pre-treated with standard radiochemotherapy (without the additional cures of temozolomide.
  • - Karnofsky Performance status ≥ 70% - Life-expectancy > 3 months.
  • - Adequate hematological, hepatic, and renal function.
  • - Females must be using highly effective contraceptive measures , and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential.
Females of childbearing potential should use reliable methods of contraception from the time of the screening until 5 weeks after discontinuing study treatment. Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 5 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 5 months after discontinuing study treatment.
  • - Affiliation to French social security or receiving such a regime.

Exclusion Criteria:

  • - Presence of known extracranial metastatic or leptomeningeal disease Glioblastoma with mutated IDH1 (assessed by Immunohistochemistry) - Current or recent treatment with another investigational drug.
  • - Carmustine implant during surgery.
  • - History of autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease…) - Prohibited medications: 1.
Chronic treatment with immunosuppressive drugs. 2. Ongoing requirement for supraphysiologic steroid defined as >10 mg prednisone daily (or equivalent) 3. Treatment with therapeutic oral or IV antibiotics within 4 weeks prior to enrollment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or pulmonary disease) are eligible for the study.
  • - Known positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C virus (HCV); presence in the serum of the antigens HBs.
  • - Non-hematologic toxicities Grade >1 severity (or, at the investigator's discretion, Grade >2 if not considered a safety risk for the patient).
  • - Patient with intra-alveolar hemorrhage, pulmonary fibrosis, or uncontrolled asthma, or chronic obstructive disease (COPD), defined as at least 1 hospitalization within 4 months prior to enrollment or as at least 3 exacerbations during the last year prior to enrollment Hospitalization for cardiovascular or pulmonary disease within 4 weeks prior to enrollment.
  • - Patients with LEVF<40% - Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment or patient in the exclusion period of a previous clinical trial.
  • - Pregnancy or lactating patients.
  • - Patients with any severe/uncontrolled inter current illness, significant co morbid or psychiatric conditions that in the opinion of the investigator would impair study participation or cooperation.
  • - Patients under guardianship, curatorship or under the protection of justice.

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Universitaire de Besancon
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clotilde VERLUT, Dr
Principal Investigator Affiliation CHU Besançon
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries France

The disease, disorder, syndrome, illness, or injury that is being studied.

Arms & Interventions


Experimental: Cohort A: UCPVax vaccine (patient with unmethylated MGMT status)


Experimental: Cohort B: UCPVax vaccine + Temozolomide (patient with methylated MGMT status)

UCPVax + Temozolomide according to standard of care


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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Besançon, Besançon, France




CHU Besançon

Besançon, ,

Site Contact

Clotilde VERLUT, Dr


CHU Bordeaux, Bordeaux, France




CHU Bordeaux

Bordeaux, ,

Site Contact

Charlotte BRONNIMANN, Dr


Centre Georges François Leclerc, Dijon, France




Centre Georges François Leclerc

Dijon, ,

Site Contact



Hôpital Saint-Louis, Paris, France




Hôpital Saint-Louis

Paris, ,

Site Contact



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