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sargramostim

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

sargramostim · 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 TumorsUnlock trial analytics

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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Frequently asked questions about sargramostim

What is sargramostim used for in brain and central nervous system tumors?

Sargramostim is being studied for use in brain and central nervous system tumors, specifically in the treatment of newly diagnosed glioblastoma multiforme. It is administered as part of a vaccine therapy combined with temozolomide and radiation therapy. The drug is currently in clinical development for this indication.

Who is developing sargramostim?

Sargramostim is being developed by Immatics N.V., a biopharmaceutical company traded on the stock exchange under the ticker IMTX. The company is conducting clinical research on this drug for oncology applications, specifically targeting brain and central nervous system tumors.

What phase is sargramostim in?

Sargramostim is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial for sargramostim has been completed, and the drug remains under investigation for its safety and efficacy in treating brain and central nervous system tumors.

What clinical trials is sargramostim in?

Sargramostim is associated with clinical trial NCT01222221, titled "Vaccine Therapy, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme." This Phase 1 trial was completed and enrolled 45 participants in the United Kingdom. The trial was uncontrolled and did not use randomization or blinding.

What does sargramostim target?

Sargramostim is a monoclonal antibody, a type of drug designed to bind to specific proteins in the body. In the context of its clinical trial, it is used as part of a vaccine therapy for glioblastoma multiforme, a type of brain tumor. The specific molecular target of sargramostim is not disclosed in the available information.

Is sargramostim the same as other drugs?

Sargramostim is also known by other names, though specific alternative names are not provided in the available information. It is a distinct drug being developed by Immatics N.V. for oncology indications. Patients and healthcare providers should refer to the drug by its generic name, sargramostim, when discussing treatment options.