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NCT03719768 · ClinicalTrials.gov registry record · Phase 1
Avelumab With Radiotherapy in Patients With Leptomeningeal Disease
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03719768: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03719768 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03719768, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study is to find a safe dose of the combination of Avelumab and Whole Brain Radiotherapy (WBRT) in patients with Leptomeningeal Disease.
Primary Outcome
Adverse events will only include those that are determined to be related to study drug. A DLT will be defined as any one of the following adverse events occurring within 28 days from first dose of Avelumab. Central Nervous System (CNS) toxicities: Any grade 3 or higher central nervous adverse events, including but not limited to cerebral hemorrhage and new-onset neurologic deficit. Non-CNS toxicities: Any grade 3 or higher nonhematologic AE with the exception of alopecia and fatigue - Grade \>
Interventions
- DRUG Avelumab
- RADIATION Whole Brain Radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-06-10 |
| Est. Completion | 2024-08-21 |
| Phase | Phase 1 |
What the finished NCT03719768 record still lists
NCT03719768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Avelumab is the first listed.
NCT03719768 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03719768 about?
NCT03719768 is a clinical study titled "Avelumab With Radiotherapy in Patients With Leptomeningeal Disease". This study is to find a safe dose of the combination of Avelumab and Whole Brain Radiotherapy (WBRT) in patients with Leptomeningeal Disease.
What is the current status of trial NCT03719768?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-06-10. Estimated completion is 2024-08-21.
What interventions are being tested in trial NCT03719768?
The interventions under investigation include: Avelumab (DRUG), Whole Brain Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT03719768?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03719768's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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