Personalized Vaccine + TTFields for Glioblastoma
Trial Summary
What is the purpose of this trial?
The purpose of this study is to use precision medicine in the form of a vaccine, a mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields).The study is designed to determine whether this treatment combination is well tolerated and safe.
Research Team
Adilia Hormigo, MD, PhD
Principal Investigator
Albert Einstein College of Medicine
Eligibility Criteria
Adults over 18 with confirmed Glioblastoma (GBM) who have stable disease after radiation and chemotherapy, a life expectancy of more than 16 weeks, and good performance status. They must have completed maximal surgery, radiotherapy with Temozolomide, and be on a low dose of Dexamethasone. Participants need sufficient tumor tissue for sequencing and acceptable organ function. They should not have certain autoimmune diseases or implanted electronic devices in the brain.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation and Chemotherapy
Participants undergo radiation and chemotherapy as part of the standard care treatment for glioblastoma
Treatment
Participants receive the MTA-based personalized vaccine in conjunction with Tumor Treating Fields during the maintenance phase of temozolomide
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are assessed for overall response rate using RANO criteria
Treatment Details
Interventions
- MTA-based vaccine
- Poly-ICLC
- Tumor Treating Fields
Find a Clinic Near You
Who Is Running the Clinical Trial?
Albert Einstein College of Medicine
Lead Sponsor
Adilia Hormigo
Lead Sponsor
NovoCure Ltd.
Industry Sponsor
Ashley Cordova
NovoCure Ltd.
Chief Executive Officer
Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel
Uri Weinberg
NovoCure Ltd.
Chief Medical Officer since 2020
MD from an unspecified institution