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NCT03238365 · ClinicalTrials.gov registry record · Early Phase 1
Window of Opportunity Trial of Nivolumab and Tadalafil in Patients With Squamous Cell Carcinoma of the Head and Neck
A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
NCT03238365 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 50 participants.
The verdict
NCT03238365, 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
- 50 participants
- Enrollment target
Study Summary
This randomized pilot early phase I trial studies how well nivolumab with or without tadalafil work in treating patients with head and neck squamous cell carcinoma that has come back and can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Tadalafil may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab and tadalafil may work better in treating patients head and neck squamous cell carcinoma.
Interventions
- BIOLOGICAL Nivolumab
- PROCEDURE Therapeutic Conventional Surgery
- DRUG Tadalafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-08-10 |
| Est. Completion | 2022-09-08 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03238365
The ClinicalTrials.gov registry entry for NCT03238365 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT03238365 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03238365 about?
NCT03238365 is a clinical study titled "Window of Opportunity Trial of Nivolumab and Tadalafil in Patients With Squamous Cell Carcinoma of the Head and Neck". This randomized pilot early phase I trial studies how well nivolumab with or without tadalafil work in treating patients with head and neck squamous cell carcinoma that has come back and can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cell...
What is the current status of trial NCT03238365?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2017-08-10. Estimated completion is 2022-09-08.
What interventions are being tested in trial NCT03238365?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Therapeutic Conventional Surgery (PROCEDURE), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT03238365?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
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