Recent Updates
Recently added Catalysts

sargramostim

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01222221Vaccine Therapy, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma MultiformePHASE1 COMPLETED 45 — — Jul 1, 2010Feb 1, 2015Oct 14, 20157 United Kingdom
Unlock Drug Trial Details
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)
Unlock Study Endpoints
Study Design & Arms
MaskingNONE
PurposeTREATMENT
Interventions
NameTypeDescription
glioblastoma multiforme multipeptide vaccine IMA950BIOLOGICAL -
sargramostimBIOLOGICAL -
temozolomideDRUG -
laboratory biomarker analysisOTHER -
pharmacological studyOTHER -
adjuvant therapyPROCEDURE -
radiation therapyRADIATION -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria