Randomized Phase 2b Study of Safety And Efficacy Of TVI-Brain-1 Combined With Conformal Radiotherapy And Temozolomide Vs Standard Therapy In Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)

NCT05685004 Phase 2/Phase 3 ACTIVE_NOT_RECRUITING

This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The patients' own cancer cells collected after surgery are combined into a vaccine to produce an immune response that significantly increases the number of cancer neoantigen-specific effector T cell precursors in the patient's body. These cancer neoantigen-specific T cells are harvested from the blood, subsequently stimulated and expanded, and infused back into the patient.

Details

Lead sponsor	TVAX Biomedical
Phase	Phase 2/Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	120
Start date	2023-09-15
Completion	2027-03

Conditions

• Glioblastoma Multiforme of Brain

Interventions

• TVI-Brain-1
• Standard of Care
• Radiotherapy
• Temozolomide

Primary outcomes

• Survival — From date of randomization until the date of death from any cause assessed up to 24 months after randomization.
  All Subjects will be evaluated and contacted to evaluate their status

Countries

United States