LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma
NCT04479241 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-06-05
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.
Conditions
- Glioblastoma
- Recurrent Glioblastoma
- Supratentorial Glioblastoma
- Brain Tumor
Interventions
- BIOLOGICAL
-
lerapolturev
Lerapolturev (5x10\^7 TCID50) delivered intratumorally via convection enhanced delivery (CED).
- BIOLOGICAL
-
Pembrolizumab (200 mg IV) given every 3 weeks.
Sponsors & Collaborators
-
Istari Oncology, Inc.
lead INDUSTRY
Principal Investigators
-
Lisa Franklin · Istari Oncology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-21
- Primary Completion
- 2024-06-05
- Completion
- 2024-06-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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