Randomized Phase 3 Trial of Standard Care Plus AV-GBM-1 vs Autologous Monocytes as Adjunctive Therapy Following Primary Surgery Plus Concurrent Radiation-temozolomide in Patients With Newly Diagnosed Glioblastoma

Trial ID: NCT05100641

Interventional - Phase 3 - Not yet recruiting

This is a multi-center, double-blind, 2:1 randomized phase III trial to determine whether the addition of AV-GBM-1, a therapeutic, patient-specific dendritic cell vaccine, to standard therapy increases OS of patients with a recent diagnosis of primary GBM. The intent is to enroll approximately 726 patients for tumor collection to enroll 690 who are eligible for treatment at the time of randomization and who have granted consent for participation. Because of the lack of toxicity, there are no restrictions related to performance status or blood tests at the time of treatment. The key endpoint is OS from date of first injection after RT/TMZ; secondary endpoints are PFS from date of first injection, and OS and PFS from date of randomization prior to RT/TMZ. Date of PFS will be determined by the principal investigator at each site.

Conditions

• Primary Glioblastoma

Interventions

• AV-GBM-1
• Autologous monocytes

Eligibility

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

Sponsor

Aivita Biomedical, Inc.

Source: Clinicaltrials.gov

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