Trials / Completed
CompletedNCT04479241
LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Istari Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | lerapolturev | Lerapolturev (5x10\^7 TCID50) delivered intratumorally via convection enhanced delivery (CED). |
| BIOLOGICAL | pembrolizumab | Pembrolizumab (200 mg IV) given every 3 weeks. |
Timeline
- Start date
- 2020-10-21
- Primary completion
- 2024-06-05
- Completion
- 2024-06-21
- First posted
- 2020-07-21
- Last updated
- 2025-06-05
- Results posted
- 2025-03-25
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04479241. Inclusion in this directory is not an endorsement.