OncoMatch/Clinical Trials/NCT03603223
Pembrolizumab in Treating Participants With Leukoplakia
Is NCT03603223 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for erythroleukoplakia.
Treatment: Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Cannot have received: anti-cancer monoclonal antibody
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1
Cannot have received: chemotherapy
Exception: Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
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.
Cannot have received: targeted small molecule therapy
Exception: Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
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.
Cannot have received: radiation therapy
Exception: Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
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.
Lab requirements
Blood counts
ANC ≥ 1,500 /mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment).
Kidney function
Serum creatinine ≤ 1.5 X ULN OR measured or calculated creatinine clearance (CrCl) ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN within 10 days of treatment initiation.
Liver function
Serum total bilirubin ≤ 1.5 X ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN within 10 days of treatment initiation. AST/ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases within 10 days of treatment initiation. Albumin ≥ 2.5 mg/dL within 10 days of treatment initiation.
ANC ≥ 1,500 /mcL within 10 days of treatment initiation. Platelets ≥ 100,000/mcL within 10 days of treatment initiation. Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment). Serum creatinine ≤ 1.5 X ULN OR measured or calculated creatinine clearance (CrCl) ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN within 10 days of treatment initiation. Serum total bilirubin ≤ 1.5 X ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN within 10 days of treatment initiation. AST/ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases within 10 days of treatment initiation. Albumin ≥ 2.5 mg/dL within 10 days of treatment initiation. INR or PT ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. aPTT ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UC San Diego Moores Cancer Center · La Jolla, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, California
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