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 — BIOLOGICAL
    Given 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

Locations (3)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093
Ezra E. Cohen
858-543-6161
Ezra E. Cohen (PRINCIPAL_INVESTIGATOR)
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Deborah J. Wong
310-794-4955
Deborah J. Wong (PRINCIPAL_INVESTIGATOR)
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Jorge J. Nieva
323-865-0421
Jorge J. Nieva (PRINCIPAL_INVESTIGATOR)

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