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NCT03618654 · ClinicalTrials.gov registry record · Early Phase 1
Durvalumab With or Without Metformin in Treating Participants With Head and Neck Squamous Cell Carcinoma
A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 38
- Enrollment target
NCT03618654: Completed Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT03618654 is a Early Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 38 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03618654, a Early Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
This pilot phase I trial studies how well durvalumab given with or without metformin works in treating participants with head and neck squamous cell carcinoma. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Metformin, a drug typically used for the treatment of diabetes, may help to reduce the metabolic activity of cancer cells and of surrounding supportive tissues. It is not yet known whether giving durvalumab with or without metformin may work better in treating participants with head and neck squamous carcinoma.
Primary Outcome
The biomarker data will be compared for differences in means (or geometric means) between treatment arms using Student's t-tests on the raw data (or on log-transformed data depending on the degree and nature of skew in the data). Non-parametric alternatives, such as permutation tests, will be considered if the data are not approximately normal for any continuous outcome variables after log-transformation. A similar approach will be used for making pre vs. post treatment comparisons, when necessa
Interventions
- BIOLOGICAL Durvalumab
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2022-12-07 |
| Phase | Early Phase 1 |
What the finished NCT03618654 record still lists
NCT03618654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Durvalumab is the first listed.
NCT03618654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03618654 about?
NCT03618654 is a clinical study titled "Durvalumab With or Without Metformin in Treating Participants With Head and Neck Squamous Cell Carcinoma". This pilot phase I trial studies how well durvalumab given with or without metformin works in treating participants with head and neck squamous cell carcinoma. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Metformin, a drug typically use...
What is the current status of trial NCT03618654?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 38 participants. The study started on 2018-11-01. Estimated completion is 2022-12-07.
What interventions are being tested in trial NCT03618654?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Metformin (DRUG).
Who is sponsoring clinical trial NCT03618654?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03618654's enrollment target sits among peer trials
38 699th of 2000 higher than 1,298 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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