At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
lerapolturev +1 morebiological
Likely dose
pembrolizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Open-label, Single-arm Study Evaluating the Efficacy, Safety and Tolerability of Lerapolturev (PVSRIPO) and the Immune Checkpoint Inhibitor Pembrolizumab in the Treatment of Patients With Recurrent Glioblastoma
In Brief
A Phase 2 clinical trial evaluating lerapolturev and pembrolizumab for Glioblastoma and 3 related conditions. Completed, enrolled 25 participants across 10 sites.
Detailed Summary
This Phase 2 single arm trial in patients with rGBM will characterize the efficacy, safety, tolerability and initial efficacy of lerapolturev intratumoral infusion followed by intravenous pembrolizumab 14 to 28 days later, and every 3 weeks, thereafter.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartOct 2020
Primary CompletionJun 2024
Study CompletionJun 2024
TodayJul 2026
First PostedJul 21, 2020
Enrollment StartOct 21, 2020
Primary CompletionJun 5, 2024
Study CompletionJun 21, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 5.9 years ago
Interventions
lerapolturevbiological
Lerapolturev (5x10\^7 TCID50) delivered intratumorally via convection enhanced delivery (CED).
pembrolizumabbiological
Pembrolizumab (200 mg IV) given every 3 weeks.