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NCT03603223
Pembrolizumab in Treating Participants With Leukoplakia
Recruiting now
Phase 2
Last updated 30 July 2025
What this trial tests
Phase 2 trial testing Pembrolizumab in Erythroleukoplakia in 26 participants. Currently enrolling.
Timeline
3 May 2019
Primary endpoint
1 August 2026
1 August 2026
1 August 2027
Quick facts
| Lead sponsor | Jonsson Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 3 May 2019 |
| Primary completion | 1 August 2026 |
| Estimated completion | 1 August 2027 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Erythroleukoplakia — all drugs for Erythroleukoplakia →
- Leukoplakia — all drugs for Leukoplakia →
- Verrucous Oral Leukoplakia — all drugs for Verrucous Oral Leukoplakia →
Sponsor
Jonsson Comprehensive Cancer Center — full company profile →
Who can join
18 and older, any sex, with Erythroleukoplakia or Leukoplakia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Multidrug Resistance in Cancer: Understanding Molecular Mechanisms, Immunoprevention and Therapeutic Approaches.
Emran TB, Shahriar A, Mahmud AR, Rahman T, et al · · 2022 · cited 355× · PMID 35814435 · DOI 10.3389/fonc.2022.891652 -
Tumor initiation and early tumorigenesis: molecular mechanisms and interventional targets.
Zhang S, Xiao X, Yi Y, Wang X, et al · · 2024 · cited 192× · PMID 38890350 · DOI 10.1038/s41392-024-01848-7 -
Overview of Oral Potentially Malignant Disorders: From Risk Factors to Specific Therapies.
Lorini L, Bescós Atín C, Thavaraj S, Müller-Richter U, et al · · 2021 · cited 49× · PMID 34359597 · DOI 10.3390/cancers13153696 -
Comprehensive Immunoprofiling of High-Risk Oral Proliferative and Localized Leukoplakia.
Hanna GJ, Villa A, Mistry N, Jia Y, et al · · 2021 · cited 22× · PMID 36860910 · DOI 10.1158/2767-9764.crc-21-0060 -
Microenvironment in Oral Potentially Malignant Disorders: Multi-Dimensional Characteristics and Mechanisms of Carcinogenesis.
Deng S, Wang S, Shi X, Zhou H. · · 2022 · cited 15× · PMID 36012205 · DOI 10.3390/ijms23168940 -
Transcriptional analysis highlights three distinct immune profiles of high-risk oral epithelial dysplasia.
Gan CP, Lee BKB, Lau SH, Kallarakkal TG, et al · · 2022 · cited 13× · PMID 36119104 · DOI 10.3389/fimmu.2022.954567 -
Early-Phase Interventional Trials in Oral Cancer Prevention.
McCarthy C, Fedele S, Ottensmeier C, Shaw RJ. · · 2021 · cited 12× · PMID 34359746 · DOI 10.3390/cancers13153845 -
A Review of Immunotherapy for Head and Neck Cancer.
Goetz JW, Rabinowits G, Kalman N, Villa A. · · 2024 · cited 10× · PMID 39370694 · DOI 10.1177/00220345241271992
Verify or expand the search:
- PubMed search for NCT03603223
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jonsson Comprehensive Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03603223 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center
- Last refreshed: 30 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03603223.
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