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NCT03635164 · ClinicalTrials.gov registry record · Phase 1
Radiotherapy With Durvalumab Prior to Surgical Resection for HPV Negative Squamous Cell Carcinoma
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT03635164 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 21 participants.
The verdict
NCT03635164, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a multi-center, prospective, single-arm phase I/Ib safety trial. Patients eligible for treatment must be diagnosed with non-metastatic, biopsy-proven stage II-IVB oral cavity, stage III-IVB larynx and hypopharynx, or stage III-IVB HPV/p16 negative intermediate-high risk oropharynx head and neck cancer, and must be eligible and amenable to surgical resection.
Interventions
- DRUG Durvalumab
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
- PROCEDURE Standard of Care Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-11-12 |
| Est. Completion | 2023-05-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03635164
The ClinicalTrials.gov registry entry for NCT03635164 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Durvalumab is the first listed.
NCT03635164 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03635164 about?
NCT03635164 is a clinical study titled "Radiotherapy With Durvalumab Prior to Surgical Resection for HPV Negative Squamous Cell Carcinoma". This is a multi-center, prospective, single-arm phase I/Ib safety trial. Patients eligible for treatment must be diagnosed with non-metastatic, biopsy-proven stage II-IVB oral cavity, stage III-IVB larynx and hypopharynx, or stage III-IVB HPV/p16 negative intermediate-high risk oropharynx head and n...
What is the current status of trial NCT03635164?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2018-11-12. Estimated completion is 2023-05-02.
What interventions are being tested in trial NCT03635164?
The interventions under investigation include: Durvalumab (DRUG), Stereotactic Body Radiation Therapy (SBRT) (RADIATION), Standard of Care Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT03635164?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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