Pembrolizumab in Treating Participants With Leukoplakia
Part of paid clinical trials in La Jolla, California.
- Sponsor
- Jonsson Comprehensive Cancer Center
- Study ID
- NCT03603223
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Erythroleukoplakia
- Leukoplakia
- Verrucous Oral Leukoplakia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pembrolizumab — BIOLOGICALGiven IV
Study Details
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.
Key Dates
- Start date
- May 3, 2019
- Status verified
- Jul 2025
- Primary completion
- Aug 1, 2026
- Completion
- Aug 1, 2027
Study Design
- Enrollment
- 26 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (pembrolizumab)Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 6 months in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Clinical response rate [ Time Frame: At 6 months ]
Central Contacts
- Thu P Ly310-794-2464
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | Ezra E. Cohen (PRINCIPAL_INVESTIGATOR) |
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | Deborah J. Wong (PRINCIPAL_INVESTIGATOR) |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Jorge J. Nieva (PRINCIPAL_INVESTIGATOR) |
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