Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma

Phase 1

Terminated

• Conditions: Glioblastoma

• Registration Number: NCT01403285
• Lead Sponsor: Immatics Biotechnologies GmbH

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Study Start: 2011-08
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	Monthly for 1 year	FACT-Br(4.0) questionnaire will be used to assess HRQL. HRQL scores (total, Trial Outcome Index, subscales) will be reported at baseline. Changes from baseline will also be evaluated.
Immune status parameters	6 time points (blood drawings) during the first 3 months on study (pre-vaccination and during vaccination period)	Relative frequencies and absolute numbers per µl blood of regulatory T-cells and (if sufficient cells are available) other immune cell populations will be measured from peripheral blood. Focus is on analysis of pre-vaccination frequencies.
Biomarker assessment and correlation to clinical and immunological response	Analysis time points are before the first vaccination and 15 weeks thereafter	Serum levels of proteins and other factors that are indicative of the immune status of the patients will be measured (e.g TGF-beta) and will be correlated with immune response rates and clinical outcome.
Clinical anti-tumor activity (response rate, 6-month progression-free survival)	Will be followed for 1 year (until end of study visit), overall survival will also be followed thereafter	Clinical response rates, survival and progression-free survival (PFS) will be followed. PFS at 6 month will be reported.
Influence of corticosteroids on immunogenicity of IMA950	6 time points (blood drawings) during the first 3 months (pre- and post-vaccination)	Corticosteroid levels are not limited in this trial. It will descriptively reported whether the known immunosuppressive effects of corticosteroids are reflected in different immune response rates for patients treated or not treated with corticosteroids.

Trial Locations

Locations (1)

Neuro-Oncology Branch of the National Cancer Institute, National Institutes of Health; 🇺🇸 Bethesda, Maryland, United States