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glioblastoma multiforme multipeptide vaccine IMA950

Phase 1

Brain and Central Nervous System Tumors | Monoclonal antibody | Oncology |Immatics N.V.|Last Updated: Oct 14, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

glioblastoma multiforme multipeptide vaccine IMA950 · 1 trial · 1 indication

Phase 1 1
NCT01222221Vaccine Therapy, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma MultiformeBrain and Central Nervous System Tumors
COMPLETED45 Analytics
PHASE1COMPLETED
Vaccine Therapy, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Brain and Central Nervous System Tumors
NCT0122222145
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Study Endpoints

Primary Endpoints

Causality of each adverse event (AE) to glioblastoma multiform multi-antigen vaccine IMA950 and GM-CSF and AE severity according to NCI CTCAE Version 4.0
Total number of patients showing patient-individual T-cell responses against a single or multiple tumor-associated peptides (TUMAP) contained in the study vaccine IMA950 at one or more post-vaccination time points by HLA multimer analysis

Secondary Endpoints

Progression-free survival (PSF) at 6 and 9 months post-surgery as assessed by the Macdonald criteria from conventional gadolinium-enhanced MRI and clinical assessment
Correlation between steroid levels and observed T-cell responses
Correlation between O6-methyl-DNA-methyltransferase (MGMT) promoter methylation status in tumor tissue using methylation-specific polymerase chain reaction and clinical benefit (PFS at 6 months and 9 months)
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Study Design & Arms

MaskingNONE
PurposeTREATMENT

Interventions

NameTypeDescription
glioblastoma multiforme multipeptide vaccine IMA950BIOLOGICAL -
sargramostimBIOLOGICAL -
temozolomideDRUG -
laboratory biomarker analysisOTHER -
pharmacological studyOTHER -
adjuvant therapyPROCEDURE -
radiation therapyRADIATION -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed glioblastoma multiforme (astrocytoma WHO grade IV disease) * Newly diagnosed disease * Resectable tumor (not including patients undergoing biopsy only or tumors involving the brain stem or cerebellum) * Meets 1 of the followi...

Countries:United Kingdom
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