Actively Recruiting
Pembrolizumab in Treating Participants With Leukoplakia
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-07-30
26
Participants Needed
3
Research Sites
430 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab in Treating Participants With Leukoplakia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the trial
- Diagnosed with leukoplakia, erythroleukoplakia, or proliferative verrucous leukoplakia (PVL) with measurable lesions not suitable for surgery or radiation, or who have refused these treatments
- Have at least one lesion that can be followed during treatment
- Evidence of moderate or severe dysplasia or carcinoma in situ
- Baseline biopsy specimen available or willingness to undergo fresh biopsy
- Willing to consent to lesion photographs and to undergo biopsy at 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count (ANC) ≥ 1,500/mcL within 10 days before treatment
- Platelet count ≥ 100,000/mcL within 10 days before treatment
- Hemoglobin ≥ 9 g/dL without transfusion or erythropoietin dependency within 7 days before assessment
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min within 10 days before treatment
- Serum total bilirubin ≤ 1.5 times ULN or direct bilirubin ≤ ULN within 10 days before treatment
- AST and ALT ≤ 2.5 times ULN or ≤ 5 times ULN if liver metastases present within 10 days before treatment
- Albumin ≥ 2.5 mg/dL within 10 days before treatment
- INR or prothrombin time ≤ 1.5 times ULN unless on anticoagulant therapy with therapeutic range within 10 days before treatment
- Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN unless on anticoagulant therapy with therapeutic range within 10 days before treatment
- Female of childbearing potential must have negative pregnancy test within 10 days before first dose
- Female of childbearing potential agrees to use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during study and 120 days after last dose
- Male agrees to use adequate contraception from first dose through 120 days after last dose
You will not qualify if you...
- Patients with only mild dysplasia or hyperplasia of leukoplakia, erythroleukoplakia, or PVL
- Currently participating or recently participated (within 4 weeks) in another investigational study
- Diagnosis of immunodeficiency or receiving systemic steroids > prednisone 10 mg daily or immunosuppressive therapy within 7 days before first dose
- History of active tuberculosis
- Hypersensitivity to pembrolizumab or its components
- Prior anti-cancer monoclonal antibody therapy within 4 weeks or unresolved adverse events from earlier therapy
- Prior chemotherapy, targeted therapy, or radiation within 2 weeks or unresolved side effects except for ≤ grade 2 neuropathy
- Known progressing malignancy requiring active treatment (except certain skin cancers or in situ cervical cancer)
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Conditions or laboratory abnormalities interfering with trial participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant, breastfeeding, or planning conception during study and 120 days after last dose
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
- Known HIV infection
- Active hepatitis B or C infection
- Receipt of live vaccine within 30 days before study therapy (inactivated flu vaccines allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Not Yet Recruiting
2
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Not Yet Recruiting
3
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
T
Thu P Ly
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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