RecruitingErythroleukoplakiaLeukoplakiaVerrucous Oral Leukoplakia
Pembrolizumab in Treating Participants With Leukoplakia
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Jonsson Comprehensive Cancer Center
You may qualify if…
- ✓ Be willing and able to provide written informed consent/assent for the trial.
- ✓ Subjects must have leukoplakia, erythroleukoplakia or proliferative verrucous leukoplakia (PVL) with lesions measurable in 2 dimensions, not amenable to surgical resection or radiation or who have refused surgery or radiation. Patients must have at least 1 lesion that can be followed on treatment. (Patients who have undergone complete excision of lesions and are clinically without evidence of disease will not be eligible for study.)
- ✓ Evidence of moderate or severe dysplasia or carcinoma in situ.
- ✓ Baseline biopsy specimen available for biomarker analysis or willingness to undergo fresh baseline biopsy.
- ✓ Willingness to consent to photographs of lesions.
- ✓ Willingness to undergo biopsy at 6 months.
- ✓ Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
- ✓ Absolute neutrophil count (ANC) \>= 1,500 /mcL within 10 days of treatment initiation.
You may not qualify if…
- ✕ Patients with leukoplakia, erythroleukoplakia or PVL who have only mild dysplasia or hyperplasia are excluded.
- ✕ Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- ✕ Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy \> prednisone 10 mg daily or equivalent, or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- ✕ Has a known history of active TB (Bacillus tuberculosis).
- ✕ Hypersensitivity to pembrolizumab or any of its excipients.
- ✕ Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- ✕ Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent.
- ✕ Note: Subjects with =\< grade 2 neuropathy are an exception to this criterion and may qualify for the study.
Where it's recruiting
California
La Jolla · Los Angeles
Source: ClinicalTrials.gov · NCT03603223 · last updated 2026-08-20