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

Korábbi kezelés

• Current or recent treatment with another investigational drug
• Carmustine implant during surgery
• Prohibited medications:
  • Chronic treatment with immunosuppressive drugs
  • Ongoing requirement for supraphysiologic steroid defined as >10 mg prednisone daily (or equivalent)
  • 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
• 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.
• 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.

Más betegség

• Presence of known extracranial metastatic or leptomeningeal disease Glioblastoma with mutated IDH1 (assessed by Immunohistochemistry)
• History of autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease…)
• 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.

Laborértékek

• Known positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C virus (HCV); presence in the serum of the antigens HBs

Egyéb

• Non-hematologic toxicities Grade >1 severity (or, at the investigator's discretion, Grade >2 if not considered a safety risk for the patient).
• Patients with LEVF<40%
• Pregnancy or lactating patients.
• Patients under guardianship, curatorship or under the protection of justice.

• 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.