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NCT03381183 · ClinicalTrials.gov registry record · Phase 1
IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03381183: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03381183 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03381183, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to see if the IRX-2 regimen and Durvalumab, will have a tolerable safety profile and will increase the intratumoral immune profile compared with the pretreatment tumors.
Primary Outcome
MTD of combination of the IRX-2 regimen and durvalumab as outlined in treatment arm.
Interventions
- DRUG Durvalumab
- DRUG IRX-2 Regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-08-21 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 1 |
What the finished NCT03381183 record still lists
NCT03381183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Durvalumab is the first listed.
NCT03381183 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03381183 about?
NCT03381183 is a clinical study titled "IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma". The purpose of this study is to see if the IRX-2 regimen and Durvalumab, will have a tolerable safety profile and will increase the intratumoral immune profile compared with the pretreatment tumors.
What is the current status of trial NCT03381183?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-08-21. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT03381183?
The interventions under investigation include: Durvalumab (DRUG), IRX-2 Regimen (DRUG).
Who is sponsoring clinical trial NCT03381183?
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 NCT03381183's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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