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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: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT03635164 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Maximum Tolerated Dose (MTD) and Dose Limiting Toxicities (DLT) will be discovered by using the 3+3 study design.
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 |
What the finished NCT03635164 record still lists
NCT03635164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Durvalumab is the first listed.
NCT03635164 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03635164's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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