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Monoclonal Antibodies

Pembrolizumab for Leukoplakia

Phase 2
Recruiting
Led By Deborah Wong
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Baseline biopsy specimen available for biomarker analysis or willingness to undergo fresh baseline biopsy
Must not have
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
Patients with leukoplakia, erythroleukoplakia or PVL who have only mild dysplasia or hyperplasia are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs (e.g., lungs), skin reactions, hormone gland problems (like thyroid dysfunction), infusion-related reactions, fatigue, appetite changes, nausea, itching or rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can provide a biopsy sample or am willing to have a new biopsy for the study.
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My biopsy shows moderate or severe abnormal cell growth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.
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I do not have mild dysplasia or hyperplasia with my leukoplakia or erythroleukoplakia.
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I am currently being treated for an infection.
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I have or had lung inflammation not caused by an infection.
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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
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I have not received a live vaccine within the last 30 days, except for the flu shot.
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I have been diagnosed with HIV.
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I have an active tuberculosis infection.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I am not on high-dose steroids or other drugs that weaken my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical response rate
Other outcome measures
Correlation of response with PD-L1 positivity
PD-L1 positivity

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Leukoplakia, particularly those involving monoclonal antibodies like Pembrolizumab, work by modulating the immune system. Pembrolizumab targets the PD-1 pathway, a checkpoint that regulates immune responses. By inhibiting this pathway, Pembrolizumab enhances the immune system's ability to attack abnormal cells, including pre-cancerous cells found in Leukoplakia. This mechanism is crucial for Leukoplakia patients as it helps prevent the progression of these lesions into cancer, offering a targeted and potentially more effective treatment option.
Review Article: Immune Landscape and Immunotherapy Options in Cervical Carcinoma.Novel immune-modulating drugs for advanced head and neck cancer.Immunotherapy of head and neck cancer: current and future considerations.

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
369 Previous Clinical Trials
29,403 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,175,080 Total Patients Enrolled
Deborah WongPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Media Library

Leukoplakia Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03603223 — Phase 2
~1 spots leftby Dec 2024
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