NCT02986178

Lerapolturev in Recurrent Malignant Glioma

A Multicenter Phase 2 Study of Oncolytic Polio/Rhinovirus Recombinant (Lerapolturev) in Recurrent WHO Grade IV Malignant Glioma Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Istari Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study of lerapolturev, an oncolytic polio/rhinovirus recombinant, in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma.

Detailed description

This is a Phase 2 study of lerapolturev, an oncolytic polio/rhinovirus recombinant, in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma. The objective of this study is to investigate the safety and efficacy (anti-tumor response and survival) of lerapolturev in recurrent WHO grade IV malignant glioma. Patients will be administered lerapolturev intratumorally via convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. Retreatment with lerapolturev is allowed, provided retreatment eligibility criteria are met.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
BIOLOGICAL	lerapolturev	A single dose of lerapolturev, an oncolytic polio/rhinovirus recombinant
DRUG	Lomustine	one cycle of oral lomustine

Timeline

• Start date: 2017-06-01
• Primary completion: 2022-09-30
• Completion: 2023-02-03
• First posted: 2016-12-08
• Last updated: 2025-07-11
• Results posted: 2025-07-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study