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NCT05084430 · ClinicalTrials.gov registry record · Phase 1
Study of Pembrolizumab and M032 (NSC 733972)
A Phase 1 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05084430: Recruiting Phase 1 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by University of Alabama at Birmingham.
NCT05084430 is a Phase 1 study of Glioblastoma Multiforme and Gliosarcoma that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 28 participants, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05084430, a Phase 1 study of Glioblastoma Multiforme and Gliosarcoma, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase I (Cohort I and Cohort II) and Phase II trial is designed to confirm the safety and tolerability of Pembrolizumab when given in conjunction with M032, an Oncolytic Herpes Simplex Virus (oHSV) that expresses IL-12 and perform the Phase II portion using a Recommended Phase 2 Dose (RP2D) of M032 (provided by the Phase I) when given in conjunction with Pembrolizumab for recurrent malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or glio-sarcoma).
Primary Outcome
Overall Survival at 12 and 24 months allows for a quantifiable outcome that should be straightforward to compare to historical data in this patient population.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG M032
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-02-25 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 1 |
What NCT05084430 shows while recruiting
NCT05084430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05084430 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT05084430 about?
NCT05084430 is a clinical study titled "Study of Pembrolizumab and M032 (NSC 733972)". This Phase I (Cohort I and Cohort II) and Phase II trial is designed to confirm the safety and tolerability of Pembrolizumab when given in conjunction with M032, an Oncolytic Herpes Simplex Virus (oHSV) that expresses IL-12 and perform the Phase II portion using a Recommended Phase 2 Dose (RP2D) of ...
What is the current status of trial NCT05084430?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2022-02-25. Estimated completion is 2028-03-01.
What conditions does trial NCT05084430 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Gliosarcoma, Anaplastic Astrocytoma.
What interventions are being tested in trial NCT05084430?
The interventions under investigation include: Pembrolizumab (DRUG), M032 (DRUG).
Who is sponsoring clinical trial NCT05084430?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05084430 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma Multiforme
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05084430's enrollment target sits among peer trials
28 64th of 88 higher than 25 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme 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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