Pembrolizumab for Leukoplakia
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Jonsson Comprehensive Cancer Center
Must not be taking: Immunosuppressants, Steroids, Monoclonal antibodies, others
Disqualifiers: Active infection, Autoimmune disease, HIV, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345How 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.
12356Eligibility 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
I am fully active or restricted in physically strenuous activity but can do light work.
Absolute neutrophil count (ANC) >= 1,500 /mcL within 10 days of treatment initiation
I can provide a biopsy sample or am willing to have a new biopsy for the study.
+16 more
Exclusion Criteria
I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.
I haven't had cancer treatment in the last 2 weeks or I've recovered from its side effects.
I do not have mild dysplasia or hyperplasia with my leukoplakia or erythroleukoplakia.
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
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.
6 months
Every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
At 30 days and every 3 months
Participant Groups
The study is testing the effectiveness of pembrolizumab, a monoclonal antibody designed to block tumor growth by interfering with certain proteins on cells. This phase II pilot trial aims to see how well it works against leukoplakia by potentially preventing the abnormal cells from growing and spreading.
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment1 Intervention
Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 6 months in the absence of disease progression or unacceptable toxicity.
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
🇺🇸 Approved in United States as KEYTRUDA for:
- 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
🇪🇺 Approved in European Union as KEYTRUDA for:
- 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
🇬🇧 Approved in United Kingdom as KEYTRUDA for:
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, CA
USC / Norris Comprehensive Cancer CenterLos Angeles, CA
UC San Diego Moores Cancer CenterLa Jolla, CA
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Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
References
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]New insights into the interaction between the immune system and the tumor microenvironment have led to the development of checkpoint inhibitors that target the PD-1/PD-L1 pathway. Pembrolizumab (MK-3475, lambrolizumab, Keytruda(®)) is a PD-1 inhibitor that has shown clinical activity in a variety of solid tumors and is currently approved for the second-line treatment of PD-L1-positive non-small-cell lung cancer and for unresectable/metastatic melanoma. This article will discuss the results of early-phase trials of pembrolizumab in thoracic malignancies as well as ongoing studies aimed to confirm clinical benefit.
Pembrolizumab-Induced Immune-Mediated Glossitis. [2022]Pembrolizumab (Keytruda), an anti-PD-1 antibody used in the treatment of several different malignancies has been identified to cause adverse effects pertaining to multiple body systems which include respiratory, gastrointestinal, dermatologic, and endocrine manifestations known as immune-related adverse events (IRAEs). Skin manifestations have been most described in current literature highlighting the most common adverse effects of this agent. However, adverse outcomes involving the oral mucosa have been rarely identified in the PD-1 and PD-L1 inhibitor classes of immunotherapeutic agents. We present a case of a 71-year-old male who was treated with a chemotherapeutic regimen including pembrolizumab for newly diagnosed squamous cell carcinoma of the lung, who later developed ulcerations on his tongue that were consistent with glossitis. Upon determining that this adverse effect may be immune-related, the patient was treated with oral prednisone 40 mg with a 10 mg taper each subsequent week, which resulted in significant improvement in the patient's symptoms following one month of treatment.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]A phase II trial investigating the therapeutic effect of neoadjuvant programmed cell death 1 (PD-1) inhibitor pembrolizumab (MK-3475, KEYTRUDA®) administered prior to surgery for the treatment of non-small cell lung cancer (NSCLC) has been conducted (NCT03197467). We report the first clinical results of a planned interim safety analysis after 15 patients were enrolled.
Severe oral erosive lichenoid reaction to pembrolizumab therapy. [2022]New advances in cancer immunotherapy have been flooding the market at a rapid rate. Pembrolizumab (Keytruda), a programmed cell death protein 1 inhibitor, introduced in 2014, has been used to treat several cancers. Immune-related adverse events associated with pembrolizumab and other immune checkpoint inhibitors are now well-described complications. We describe the case of a 65-year old female with severe oral lichenoid lesions occurring after treatment with pembrolizumab for bladder cancer. To the best of our knowledge, this is the first report of a biopsy-proven oral erosive lichenoid reaction confirmed through direct immunofluorescence.
Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer. [2023]Pembrolizumab (Keytruda) has been approved to treat metastatic or locally advanced esophageal or gastroesophageal junction cancer. It is used in combination with platinum- and fluoropyrimidine-based chemotherapy.
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]Pembrolizumab (MK-3475) is a monoclonal antibody that binds to the PD-1 receptor on T cells and prevents binding to its ligands PD-L1 and PD-L2. Blocking this receptor frees T cells from the inhibitory effects of PD-L1 and allows them to mediate antitumor effects against cancer cells. In a large Phase I study of 411 patients with melanoma, high durable response rates over a range of doses and schedules have been shown with very little toxicity. A Phase III study of pembrolizumab comparing two schedules of administration with the current standard treatment with the anti-CTLA-4 monoclonal antibody is in progress. Combinations with other checkpoint inhibitors as well as other anticancer agents are also being evaluated. Approval of pembrolizumab for the treatment of melanoma is expected.