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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: Completed Early Phase 1 study, sponsored by Medical University of South Carolina.
NCT04883645 is a Early Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 16 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A minimum of 50% reduction in tumor cell count assessed by quantitative multiplex immunofluorescence (qmIF) within the tumor bed of the surgical tissue (post-treatment) compared to the biopsy tissue (pre-treatment). In addition, the major pathologic response to be assessed using Immune-Related Pathologic Response Criteria (irPCR) in the tumor bed of the post-treatment surgical tissue.
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 |
What the finished NCT04883645 record still lists
NCT04883645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Imiquimod 5% Cream is the first listed.
NCT04883645 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04883645's enrollment target sits among peer trials
16 1369th of 2000 higher than 598 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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