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NCT06177964 · ClinicalTrials.gov registry record · Phase 2
Lerapolturev (PVSRIPO) in GBM
A Phase 2 study of Recurrent Supratentorial Glioblastoma, sponsored by Darell Bigner.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT06177964: Recruiting Phase 2 study of Recurrent Supratentorial Glioblastoma, sponsored by Darell Bigner.
NCT06177964 is a Phase 2 study of Recurrent Supratentorial Glioblastoma that is actively recruiting participants, run by Darell Bigner. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06177964, a Phase 2 study of Recurrent Supratentorial Glioblastoma, is actively recruiting participants, sponsored by Darell Bigner.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to determine the safety and efficacy of administering two doses of lerapolturev in residual disease (within tumor margins) after surgery, followed later by repeated injections of lerapolturev in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adult patients diagnosed with recurrent glioblastoma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.
Primary Outcome
Dose-limiting toxicities (DLTs) are defined as any of the following events that are possibly, probably, or definitely attributable to study treatment (i.e., lerapolturev) during dose escalation (Stage 1): * Any Grade 3 or any Grade 4 toxicity within 2 weeks, including cerebral edema or worsening neurologic symptoms * Any life-threatening event within 2 weeks * Treatment-related death at least possibly, probably, or definitely attributable to study treatment * Any grade 2 or higher serious cytok
Conditions Studied
Interventions
- DRUG Lerapolturev
- DRUG Lomustine Pill
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2024-07-15 |
| Est. Completion | 2029-02 |
| Phase | Phase 2 |
What NCT06177964 shows while recruiting
NCT06177964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Recurrent Supratentorial Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Lerapolturev is the first listed.
NCT06177964 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06177964 about?
NCT06177964 is a clinical study titled "Lerapolturev (PVSRIPO) in GBM". The purpose of this research study is to determine the safety and efficacy of administering two doses of lerapolturev in residual disease (within tumor margins) after surgery, followed later by repeated injections of lerapolturev in the subcutaneous area (under the skin) around the lymph nodes of th...
What is the current status of trial NCT06177964?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2024-07-15. Estimated completion is 2029-02.
What conditions does trial NCT06177964 study?
This clinical trial studies the following conditions: Recurrent Supratentorial Glioblastoma.
What interventions are being tested in trial NCT06177964?
The interventions under investigation include: Lerapolturev (DRUG), Lomustine Pill (DRUG).
Who is sponsoring clinical trial NCT06177964?
This trial is sponsored by Darell Bigner, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06177964 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06177964's enrollment target sits among peer trials
92 767th of 2000 higher than 1,230 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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