NCT02414165: Toca5

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

Terminated Phase 2, PHASE3 Last updated 7 February 2020

What this trial tests

Phase 2, PHASE3 trial testing Toca 511 in Glioblastoma Multiforme in 403 participants. Terminated before completion.

Timeline

30 November 2015

Primary endpoint
31 May 2019

20 December 2019

Quick facts

Lead sponsor	Tocagen Inc.
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	403
Start date	30 November 2015
Primary completion	31 May 2019
Estimated completion	20 December 2019
Sites	67 locations across Canada, United States, Israel, South Korea

Drugs / interventions tested

• Toca 511
• Toca FC
• Lomustine (LOMUSTINE) — full drug profile →
• Temozolomide (temozolomide) — full drug profile →
• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →

Conditions studied

• Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
• Anaplastic Astrocytoma — all drugs for Anaplastic Astrocytoma →

Sponsor

Tocagen Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Glioblastoma Multiforme or Anaplastic Astrocytoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, 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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glioblastoma in adults: a Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) consensus review on current management and future directions.
   Wen PY, Weller M, Lee EQ, Alexander BM, et al · · 2020 · cited 908× · PMID 32328653 · DOI 10.1093/neuonc/noaa106
2. Emerging therapies for glioblastoma: current state and future directions.
   Rong L, Li N, Zhang Z. · · 2022 · cited 351× · PMID 35428347 · DOI 10.1186/s13046-022-02349-7
3. Glioblastoma targeted therapy: updated approaches from recent biological insights.
   Touat M, Idbaih A, Sanson M, Ligon KL. · · 2017 · cited 308× · PMID 28863449 · DOI 10.1093/annonc/mdx106
4. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
5. Advances in local therapy for glioblastoma - taking the fight to the tumour.
   van Solinge TS, Nieland L, Chiocca EA, Broekman MLD. · · 2022 · cited 219× · PMID 35277681 · DOI 10.1038/s41582-022-00621-0
6. Immunotherapy for glioblastoma: current state, challenges, and future perspectives.
   Liu Y, Zhou F, Ali H, Lathia JD, et al · · 2024 · cited 189× · PMID 39406966 · DOI 10.1038/s41423-024-01226-x
7. A Critical Overview of Targeted Therapies for Glioblastoma.
   Jain KK. · · 2018 · cited 161× · PMID 30374421 · DOI 10.3389/fonc.2018.00419
8. Glioblastoma Therapy: Past, Present and Future.
   Obrador E, Moreno-Murciano P, Oriol-Caballo M, López-Blanch R, et al · · 2024 · cited 147× · PMID 38473776 · DOI 10.3390/ijms25052529