NCT03973879

Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma

A Phase 1b/2 Trial of PVSRIPO in Combination With Atezolizumab in Recurrent WHO Grade IV Malignant Glioma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Darell Bigner · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety of PVSRIPO treatment in combination with Atezolizumab in patients with WHO grade IV malignant glioma. All patients will receive a single PVSRIPO infusion followed by atezolizumab infusions every three weeks for up to two years.

Detailed description

The purpose of this phase1b/2 study of atezolizumab in combination with oncolytic polio/rhinovirus recombinant (PVSRIPO) in patients with recurrent World Health Organization (WHO) grade IV malignant glioma is to assess the safety of the combination of PVSRIPO + atezolizumab, as well as describe the survival of patients receiving this novel therapy combination. Patients will receive an intratumoral infusion of PVSRIPO followed by atezolizumab treatment with possible surgical resection after the first atezolizumab treatment at the discretion of the treating neurosurgeon.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
BIOLOGICAL	PVSRIPO	Oncolytic polio/rhinovirus recombinant
DRUG	Atezolizumab	Antibody

Timeline

• Start date: 2020-02-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2019-06-04
• Last updated: 2020-02-11

Regulatory

• FDA-regulated drug study