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A Phase 1 Trial of Peptide-Based Glioma Vaccine IMA950 in Patients With Glioblastoma (GBM)
BACKGROUND: Active immunotherapy of cancer is based on the premise that the vaccine raises a cytotoxic immune response to tumor-associated antigens, thereby destroying malignant cells without harming normal cells. IMA950 is a therapeutic multi-peptide vaccine containing 11 tumor-associated peptides (TUMAPs) found in a majority of glioblastomas, and is designed to activate TUMAP-specific T cells. The use of 11 TUMAPs increases the likelihood of a multi-clonal, highly specific T-cell response against tumor cells leading to decreased likelihood of immune evasion of the tumor by down-regulation of target antigens. PURPOSE: The primary objective of this study is to determine the safety and tolerability of IMA950 when given with cyclophosphamide, granulocyte macrophage-colony stimulating factor (GM-CSF) and imiquimod in patients with glioblastoma and to determine if IMA950 shows sufficient immunogenicity in these patients. ELIGIBILITY: Patients with histologically proven GBMs who have completed radiotherapy, and have stable disease following at least 4 cycles of adjuvant temozolomide.
Details
| Lead sponsor | Immatics Biotechnologies GmbH |
|---|---|
| Phase | Phase 1 |
| Status | TERMINATED |
| Enrolment | 6 |
| Start date | 2011-08 |
| Completion | 2014-04 |
Conditions
- Glioblastoma
Interventions
- Cyclophosphamide
- IMA950 plus GM-CSF
- IMA950
- Imiquimod
Primary outcomes
- Safety and tolerability of IMA950 administered with granulocyte macrophage colony stimulating factor (GM-CSF) and topical imiquimod together following a single low-dose application of cyclophosphamide. — Continuously for up to 1 year plus follow-up
Number of AEs and percentage of patients with AEs (listed per grade and MedDRA preferred terms) will be reported. - Immunogenicity of IMA950 — 6 time points (blood drawings) during the first 3 months (pre- and post-vaccination)
Vaccine-induced immune responses to peptides contained in IMA950 will be measured by multimer assay using peripheral blood. Percentage of immune responders (patients with at least one vaccine-induced immune response to IMA950 peptides) and percentage of multi-TUMAP responders (patients with vaccine-induced immune responses to ≥2 peptides in IMA950) will be reported.
Countries
United States