Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04883645 · ClinicalTrials.gov registry record · Early Phase 1
Neoadjuvant Imiquimod Immunotherapy for Oral Cancer
A Early Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
NCT04883645 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 16 participants.
The verdict
NCT04883645, a Early Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this research study is to find out what effects, good and/or bad, topical application of the drug Aldara will have on patients and on their oral cancer. Aldara is a drug that activates toll-like receptor (TLR) in oral cancer cells causing self-destruction of tumor cells. It also activates immune cells to attack and eliminate cancer cells. Aldara is currently approved by the Food and Drug Administration (FDA) for treatment of skin cancer and melanoma. Its use in this study is 'off-label' (use of a drug approved by FDA for skin cancer to treat oral cancer in this study). The preliminary efficacy of topical imiquimod in a neoadjuvant setting in patients with early-stage oral squamous cell carcinoma will be determined by a reduction in tumor cellularity in post-treatment tissue compared to pre-treatment tissue. Safety and tolerability will be evaluated by CTCAE v5 criteria. The effect of imiquimod on the tumor immune microenvironment will be assessed by performing quantitative multiplex immunofluorescence.
Interventions
- DRUG Imiquimod 5% Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-04-28 |
| Est. Completion | 2024-07-31 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04883645
The ClinicalTrials.gov registry entry for NCT04883645 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Imiquimod 5% Cream is the first listed.
NCT04883645 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04883645 about?
NCT04883645 is a clinical study titled "Neoadjuvant Imiquimod Immunotherapy for Oral Cancer". The purpose of this research study is to find out what effects, good and/or bad, topical application of the drug Aldara will have on patients and on their oral cancer. Aldara is a drug that activates toll-like receptor (TLR) in oral cancer cells causing self-destruction of tumor cells. It also activ...
What is the current status of trial NCT04883645?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2022-04-28. Estimated completion is 2024-07-31.
What interventions are being tested in trial NCT04883645?
The interventions under investigation include: Imiquimod 5% Cream (DRUG).
Who is sponsoring clinical trial NCT04883645?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.