The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma

Official Title

A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector & Toca FC Versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma (GBM) or Anaplastic Astrocytoma (AA) "Toca 5"

Summary:

This is a multicentre, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection for first or second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment with one option of standard of care (Arm SOC). Stratification will be done by IDH1 mutation status. A second stratification factor is based on the patient's Karnofsky Performance Score (KPS) (70-80 vs 90-100). Further, to account for potential differences in treatment choices for the control arm in regions, the trial will be stratified by geographical region during the randomization process. Funding Source - FDA OOPD

Trial Description

Primary Outcome:

  • To compare the overall survival (OS) of subjects treated with Toca 511 combined with Toca FC to subjects treated according to standard of care after tumour resection for recurrence of glioblastoma or anaplastic astrocytoma
Secondary Outcome:
  • Durable Response Rate (CR or PR ≥ 24 weeks)
  • Durable Clinical Benefit Rate (CR or PR ≥ 24 weeks or SD ≥ 18 months)
  • Duration of Durable Response
  • Overall Survival at 12 months

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society