Pembrolizumab in Treating Participants With Leukoplakia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab
Biological/VaccineGiven IV
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: Treatment (pembrolizumab)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical response rate
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 difference between these groups, such an analysis may help identify a population more likely to benefit from treatment.
Time frame
At 6 monthsSecondary outcomes
1
Clinical response rate
Response rate data will be reported in tabular form.
Time frame
At 9 and 12 monthsOther outcomes
1
PD-L1 positivity
lesions will be stained to determine % PDL1 positivity
Time frame
Up to 2 years2
Correlation of response with PD-L1 positivity
PDL1 positivity of the lesions will be correlated to response to pembrolizumab
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jonsson Comprehensive Cancer Center
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov