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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05084430
The ClinicalTrials.gov registry entry for NCT05084430 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (71% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.