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

NCT05100641 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CL-GBM-P02-US
• Study Type: interventional
• Target: 672
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Overall survival from date of randomization

  Overall survival

  2.0 years

Secondary Outcomes (4)

• PFS from date of first AV-GBM-1 injection

  2.0 years

• OS from date of first AV-GBM-1 injection

  2.0 years

• PFS from date of randomization

  2.0 years

• Determine and compare TEAE for both study arms

  2.0 years

Study Arms (2)

AV-GBM-1

EXPERIMENTAL

Autologous dendritic cells loaded with autologous tumor antigens cryopreserved in CryoStor 5, and admixed 500 mcg GM-CSF diluted in saline

Biological: AV-GBM-1

Autologous monocyte control (MC)

PLACEBO COMPARATOR

Autologous monocytes cryopreserved in CryoStor 5, and admixed 500 mcg GM-CSF diluted in saline

Biological: Autologous monocytes

Interventions

AV-GBM-1 BIOLOGICAL

Therapeutic autologous dendritic cell vaccine

AV-GBM-1

Autologous monocytes BIOLOGICAL

Autologous monocyte control

Autologous monocyte control (MC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aivita Biomedical, Inc.: lead

Study Officials

• Robert O Dillman, MD

  Aivita Biomedical, Inc.

  STUDY CHAIR

Central Study Contacts

Jim Langford

CONTACT

949-872-2555; jim@aivitabiomedical.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, 2:1 randomization

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Study Start: January 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share