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NCT03603223 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
A Phase 2 study of Leukoplakia and Erythroleukoplakia, sponsored by Jonsson Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 3
- Study locations
NCT03603223: Recruiting Phase 2 study of Leukoplakia and Erythroleukoplakia, sponsored by Jonsson Comprehensive Cancer Center.
NCT03603223 is a Phase 2 study of Leukoplakia and Erythroleukoplakia that is actively recruiting participants, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03603223, a Phase 2 study of Leukoplakia and Erythroleukoplakia, is actively recruiting participants, sponsored by Jonsson Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II pilot trial studies how well pembrolizumab works in treating leukoplakia. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
If there is a signal of efficacy based on this analysis, further exploratory analyses using Cox-proportional hazards regression, will be performed to identify variables which correlate to improved 6-month clinical response rate will be performed. Variables will include demographics, age, gender, pack-years smoking history, size of the lesions, prior history of leukoplakia or erythroleukoplakia, and human papillomavirus (HPV) status. While the study is not powered to detect a statistically differ
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
Study Locations (3)
California
- UC San Diego Moores Cancer Center - La Jolla
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-05-03 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 2 |
What NCT03603223 shows while recruiting
NCT03603223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 3 conditions, with Leukoplakia appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT03603223 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03603223 about?
NCT03603223 is a clinical study titled "Pembrolizumab in Treating Participants With Leukoplakia". This phase II pilot trial studies how well pembrolizumab works in treating leukoplakia. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
What is the current status of trial NCT03603223?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2019-05-03. Estimated completion is 2027-08-01.
What conditions does trial NCT03603223 study?
This clinical trial studies the following conditions: Leukoplakia, Erythroleukoplakia, Verrucous Oral Leukoplakia.
What interventions are being tested in trial NCT03603223?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03603223?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03603223 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leukoplakia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03603223's enrollment target sits among peer trials
26 1708th of 2000 higher than 283 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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