Clinical Trial Finder

Inclusion Criteria:

• - Male or female patients, age ≥ 18 and ≤ 75 years old.

• - Written informed consent.

• - Histologically confirmed glioblastoma.

• - Patient with known MGMT status: Cohort A (recruitment closed) : unmethylated MGMT status ; Cohort B (recruiting) : unmethylated or methylated MGMT status.

• - 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.

Arms

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

UCPVax

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

UCPVax - Temozolomide according to standard of care

Interventions

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