AV-GBM-1 vs Control as Adjunctive Therapy Following Surgery and RT/TMZ in Newly Diagnosed GBM

Launched by AIVITA BIOMEDICAL, INC. · Oct 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with primary glioblastoma (GBM), a type of brain cancer. Researchers want to find out if adding a personalized vaccine called AV-GBM-1 to the standard treatment, which includes surgery and radiation with chemotherapy, can help patients live longer. The trial will involve several medical centers and aims to enroll around 726 patients, ultimately treating about 690 who meet the eligibility criteria.

To be eligible for this trial, participants must be 18 years or older and have a confirmed diagnosis of primary GBM with plans for surgery. They should be willing to provide tumor and blood samples for research and must consent to participate. The trial is open to all genders, and there are no strict health restrictions, making it accessible for many patients. Participants will receive the vaccine after their initial treatment and will be monitored for how long they live and how well their cancer responds to the treatment. This study is not yet recruiting patients, but it represents an important step in exploring new options for those facing this challenging diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • For tumor collection: Age \>18, Presumptive diagnosis of primary GBM with plans for surgical resection, Written informed consent to provide tumor and blood and intent to proceed with leukapheresis
• • For randomization: Confirmation of GBM histology, AIVITA Biomedical confirmation of established cancer cell line and sufficient monocytes derived from PBMC during leukapheresis collection, age 70 years or greater or less than 70, KPS 90 or 100 vs 70 or 80, MGMT promotor methylation classified as positive or negative, IDH mutation classified as mutated or wild-type, and planning to initiate RT/TMZ. Written informed consent for randomization and treatment per protocol
• Exclusion Criteria:
• • For tumor collection: Prior history of astrocytoma or other glial tumor, Known autoimmune disease or immunodeficiency. Diagnosis of any other invasive cancer or disease process considered to be life-threatening within the next 5 years. Known allergy to GM-CSF
• • For randomization: Active infection or other active medical condition that could be life-threatening, Diagnosis of underlying cardiac disease that requires active medical treatment, Pregnant, Enrolled in another investigational trial to receive an investigational treatment, KPS \< 70, Did not meet inclusion/exclusion criteria for tumor collection