drugset / Trial / NCT01403285

Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma

NCT01403285 ↗

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2011-08
Primary completion
2014-04
Completion
2014-04

Outcome

Met primary endpoint

Stopped (Enrollment): “Due to poor accrual. This decision was taken without any safety reasons. Since beginning of the study (June 2011) only six patients were enrolled.”

release “A new cancer vaccine (IMA950) for glioblastoma has met the two primary endpoints of safety and immunogenicity in a trial conducted by Cancer Research UK” immatics.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject IMA950 Vaccine — —
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Background GM-CSF Protein / enzyme biologic — —
Background Imiquimod Other / unclassified — Topical

Indications