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NCT04826393 · ClinicalTrials.gov registry record · Phase 1
ASP8374 + Cemiplimab in Recurrent Glioma
A Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 4
- Study locations
NCT04826393: Completed Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Dana-Farber Cancer Institute.
NCT04826393 is a Phase 1 study of Glioblastoma and Recurrent Glioblastoma that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 14 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04826393, a Phase 1 study of Glioblastoma and Recurrent Glioblastoma, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study is looking at the safety and efficacy of the drug combination of ASP8374 with cemiplimab in people with recurrent malignant glioma. The study will be conducted in two parts, the first portion of the study will be to establish the highest dose of ASP8374 that can be given safely with cemiplimab and will be used as the recommended dose of ASP8374 in combination with cemiplimab for the second portion of the study. The second portion of the study will be to compare the effect of having ASP8374 in combination with cemiplimab prior to surgery. The names of the study drugs involved in this study are: * ASP8374 * Cemiplimab
Primary Outcome
primary endpoint for Cohort 1 will be determination of the MTD/RP2D of ASP8374 when administered with cemiplimab among recurrent malignant glioma participants.
Conditions Studied
Interventions
- DRUG cemiplimab
- DRUG ASP8374
Study Locations (4)
Massachusetts
- Brigham and Women's Hospital - Boston
New York
- Columbia University Medical Center - New York
Ohio
- University of Cincinnati Medical Center - Cincinnati
Pennsylvania
- Hospital of the University of Pennsylvania, Abramson Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-03-09 |
| Est. Completion | 2024-01-01 |
| Phase | Phase 1 |
What the finished NCT04826393 record still lists
NCT04826393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which cemiplimab is the first listed.
NCT04826393 reports a single indexed study location in Massachusetts, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT04826393 about?
NCT04826393 is a clinical study titled "ASP8374 + Cemiplimab in Recurrent Glioma". This study is looking at the safety and efficacy of the drug combination of ASP8374 with cemiplimab in people with recurrent malignant glioma. The study will be conducted in two parts, the first portion of the study will be to establish the highest dose of ASP8374 that can be given safely with cemi...
What is the current status of trial NCT04826393?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2022-03-09. Estimated completion is 2024-01-01.
What conditions does trial NCT04826393 study?
This clinical trial studies the following conditions: Glioblastoma, Recurrent Glioblastoma.
What interventions are being tested in trial NCT04826393?
The interventions under investigation include: cemiplimab (DRUG), ASP8374 (DRUG).
Who is sponsoring clinical trial NCT04826393?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04826393 being conducted?
This trial has 4 study locations across Massachusetts, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04826393's enrollment target sits among peer trials
14 176th of 199 higher than 23 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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