A randomized, multicenter, double-blind, placebo-controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide Targeting IGF-1R, in Newly Diagnosed Patients With Glioblastoma Multiforme-the Immunesense Study (Brain Tumors)
ImmuneSense Study: IGV-001 in Newly Diagnosed Patients With Glioblastoma
Sponsor: Imvax
Enrolling: Male and Female Patients
IRB Number: AAAT5656
U.S. Govt. ID: NCT04485949
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to see how safe the study medicine, IGV-001 plus standard of care (SOC), is and to compare IGV-001 with placebo see if it works in slowing glioblastoma multiforme (GBM) tumor regrowth. SOC refers to the usual medicine(s) or procedures used to treat your cancer. A placebo looks like the study medicine but does not contain any medication (active ingredient). Researchers use a placebo to see if a study medicine works better or is safer than not taking anything at all. The procedures in this study include answering questions about symptoms, taking vital signs, blood tests, urine sample collection, questionnaires, Electrocardiogram (ECG) to check your heart, craniotomy and tumor resection, surgery to remove part of your brain tumor, and the use of study drug IGV-001. The time frame for the study in the first part of this study will last approximately 10 months. If you continue into the follow-up and long-term follow-up periods, your participation could last approximately 36 months. How long you participate in the study will depend on how well the cancer responds to the study drug.
This study is closed
Brian Gill, MD
Do You Qualify?
Are you 18 to 70 years old? Yes No
Have you been diagnosed with a brain tumor called glioblastoma multiforme (GBM)? Yes No
You may be eligible for this study

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