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NCT02827838 · ClinicalTrials.gov registry record · Early Phase 1
Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer
A Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 17
- Enrollment target
NCT02827838: Clinical Trial Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT02827838 is a Early Phase 1 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 17 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02827838, a Early Phase 1 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This pilot clinical trial studies how well durvalumab before surgery works in treating patients with oral cavity or oropharynx cancer. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Concentration of certain immune effector will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre-
Interventions
- BIOLOGICAL Durvalumab
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Therapeutic Conventional Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-01 |
| Est. Completion | 2022-04-22 |
| Phase | Early Phase 1 |
Why NCT02827838 stopped before completion
NCT02827838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Durvalumab is the first listed.
NCT02827838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02827838 about?
NCT02827838 is a clinical study titled "Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer". This pilot clinical trial studies how well durvalumab before surgery works in treating patients with oral cavity or oropharynx cancer. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread.
What is the current status of trial NCT02827838?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 17 participants. The study started on 2017-01. Estimated completion is 2022-04-22.
What interventions are being tested in trial NCT02827838?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Therapeutic Conventional Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT02827838?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02827838's enrollment target sits among peer trials
17 1350th of 2000 higher than 632 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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