Pembrolizumab for Leukoplakia
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or immunosuppressive therapy, you may need to stop or adjust these medications before starting the trial.
What data supports the effectiveness of the drug pembrolizumab for leukoplakia?
Pembrolizumab has shown effectiveness in treating various cancers, such as non-small cell lung cancer and melanoma, by targeting the PD-1/PD-L1 pathway, which helps the immune system attack cancer cells. While there is no direct evidence for leukoplakia, its success in other conditions suggests potential benefits.12345
How is the drug pembrolizumab unique for treating leukoplakia?
Pembrolizumab is unique because it is an immunotherapy drug that works by blocking the PD-1 receptor on T cells, which helps the immune system attack abnormal cells. This mechanism is different from traditional treatments for leukoplakia, which often involve surgical removal or topical treatments.12356
What is the purpose of this trial?
This trial studies how well pembrolizumab works in treating leukoplakia. Pembrolizumab helps the immune system fight cancer by blocking a protein that prevents immune cells from attacking cancer cells. The trial targets patients with leukoplakia, aiming to see if this medication can effectively treat this condition. Pembrolizumab is an immune checkpoint inhibitor that has been used in the treatment of various cancers, including non-small cell lung cancer, melanoma, and head and neck cancers.
Research Team
Deborah Wong, MD, PhD
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with moderate to severe dysplasia or carcinoma in situ within oral leukoplakia lesions that can't be removed surgically or treated with radiation, or for those who refuse such treatments. Participants must have measurable lesions, provide consent for photographs and biopsies, and meet specific health criteria including blood counts and organ function tests. Women of childbearing potential must use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab intravenously over 30 minutes on day 1. Courses repeat every 3 weeks for 6 months in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University