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NCT04479241 · ClinicalTrials.gov registry record · Phase 2
LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma
A Phase 2 study of Glioblastoma and Brain Tumor, sponsored by Istari Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 10
- Study locations
NCT04479241: Completed Phase 2 study of Glioblastoma and Brain Tumor, sponsored by Istari Oncology.
NCT04479241 is a Phase 2 study of Glioblastoma and Brain Tumor that has completed, run by Istari Oncology. The registered enrollment target is 25 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (77% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04479241, a Phase 2 study of Glioblastoma and Brain Tumor, has completed, sponsored by Istari Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
Objective response rate (comprised of patients meeting an objective radiographic response or ORR): Patients achieving a complete response (CR) or partial response (PR).
Conditions Studied
Interventions
- BIOLOGICAL pembrolizumab
- BIOLOGICAL lerapolturev
Study Locations (10)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana Farber Cancer Institute - Boston
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- The Ohio State University - Columbus
California
- University of California San Francisco - San Francisco
Connecticut
- UConn Health - Farmington
Florida
- Baptist MD Anderson Cancer Center - Jacksonville
North Carolina
- Duke University Medical Center - Durham
Oregon
- Oregon Health and Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-10-21 |
| Est. Completion | 2024-06-21 |
| Phase | Phase 2 |
What the finished NCT04479241 record still lists
NCT04479241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (77% lower).
The record links to 4 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab is the first listed.
NCT04479241 lists 10 locations in 7 states (Massachusetts, Ohio, California).
Frequently Asked Questions
What is clinical trial NCT04479241 about?
NCT04479241 is a clinical study titled "LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma". 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.
What is the current status of trial NCT04479241?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2020-10-21. Estimated completion is 2024-06-21.
What conditions does trial NCT04479241 study?
This clinical trial studies the following conditions: Glioblastoma, Brain Tumor, Recurrent Glioblastoma, Supratentorial Glioblastoma.
What interventions are being tested in trial NCT04479241?
The interventions under investigation include: pembrolizumab (BIOLOGICAL), lerapolturev (BIOLOGICAL).
Who is sponsoring clinical trial NCT04479241?
This trial is sponsored by Istari Oncology, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04479241 being conducted?
This trial has 10 study locations across California, Connecticut, Florida, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04479241's enrollment target sits among peer trials
25 138th of 199 higher than 60 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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