Status:
COMPLETED
Phase I/II Trial of IMA950 Multi-peptide Vaccine Plus Poly-ICLC in Glioblastoma
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
Immatics Biotechnologies GmbH
Oncovir, Inc.
Conditions:
CNS Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE : IMA 950 is multi tumour-associated peptides (TUMAPs) vaccine, these peptides have been identified on primary glioblastoma multiforme (GBM) cells. Poly-ICLC is a potent vaccine adjuvant wit...
Detailed Description
OBJECTIVES Primary * Tolerability and safety of IMA950 adjuvanted with Poly-ICLC when given together with temozolomide, using CTCAE V 4.0. * Immunogenicity of IMA950 plus Poly-ICLC when given togeth...
Eligibility Criteria
Inclusion
- Histological documentation of glioblastoma. For experimental purposes only, 5 additional grade III astrocytoma may be included (these cases will not be included in the endpoints analysis).
- Patients must have completed radiation therapy with concomitant temozolomide.
- HLA-A2 positive.
- Eastern Cooperative Oncology Group performance status of 0 or 1 (Appendix1).
- Age \> 18 years, life expectancy of least 4 months.
- Patient must be on stable or decreasing dose of steroids, with a maximal dose of Dexamethasone of 4mg/day.
- Adequate bone marrow, liver and kidney function.
- Hepatitis B serology negative (HBcAg-seronegative)
- Written (signed and dated) informed consent. Capable of co-operating with standard therapy and IMA950 with Poly-ICLC vaccinations and follow-up.
Exclusion
- Any other vaccination given within 2 weeks before first IMA950 vaccination.
- History of cardiac disease: congestive heart failure \> New York heart association class 2, active CAD, cardiac requiring anti-arrhythmic therapy or uncontrolled hypertension.
- History of HIV infection or chronic hepatitis B or C or clinical active infections.
- Patients with evidence of history bleeding diathesis.
- Pregnant or potentially pregnant patients. Women of childbearing age must be tested for pregnancy (serum or urine HCG) before treatment and must not contemplate pregnancy during the study
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01920191
Start Date
August 1 2013
End Date
March 1 2016
Last Update
April 20 2016
Active Locations (1)
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1
Geneva University Hospitals, Centre of Oncology
Geneva, Switzerland, CH-1211