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NCT03522584 · ClinicalTrials.gov registry record · Phase 1
Durvalumab, Tremelimumab and Hypofractionated Radiation Therapy in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 1 study, sponsored by University of Washington.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03522584: Clinical Trial Phase 1 study, sponsored by University of Washington.
NCT03522584 is a Phase 1 study that was terminated before completion, run by University of Washington. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03522584, a Phase 1 study, was terminated before completion, sponsored by University of Washington.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects of durvalumab, tremelimumab and hypofractionated radiation therapy in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving durvalumab, tremelimumab, and hypofractionated radiation therapy may work better in treating patients with recurrent or metastatic head and neck squamous cell carcinoma.
Primary Outcome
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0
Interventions
- BIOLOGICAL Durvalumab
- RADIATION Stereotactic Body Radiation Therapy
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Tremelimumab
- PROCEDURE Hypofractionated Image-Guided Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-05-17 |
| Est. Completion | 2022-01-19 |
| Phase | Phase 1 |
Why NCT03522584 stopped before completion
NCT03522584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Durvalumab is the first listed.
NCT03522584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03522584 about?
NCT03522584 is a clinical study titled "Durvalumab, Tremelimumab and Hypofractionated Radiation Therapy in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma". This phase I/II trial studies the side effects of durvalumab, tremelimumab and hypofractionated radiation therapy in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or that has spread to other places in the body (metastatic). Immunotherapy with monoclonal ...
What is the current status of trial NCT03522584?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-05-17. Estimated completion is 2022-01-19.
What interventions are being tested in trial NCT03522584?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Stereotactic Body Radiation Therapy (RADIATION), Laboratory Biomarker Analysis (OTHER), Tremelimumab (BIOLOGICAL), Hypofractionated Image-Guided Radiation Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT03522584?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03522584's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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