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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing how well pembrolizumab works to treat leukoplakia (a precancerous condition). Monoclonal antibodies, which pembrolizumab is, may stop tumor cells from growing and spreading.

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.Check my eligibility
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.See study design
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.

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.
Secondary 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%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
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
~2010

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
360 Previous Clinical Trials
27,686 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,059,909 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects could arise from using pembrolizumab?

"Our team at Power assigned Pembrolizumab a score of 2 on the safety scale due to its Phase 2 trial nature, which indicates that there is supportive data confirming it's security but none affirming effectiveness."

Answered by AI

Have any other experiments utilized Pembrolizumab to measure efficacy?

"Currently, 961 studies are actively investigating the medicinal effects of Pembrolizumab, with 122 in the third phase. Most trials for this drug occur within Houston's borders; however, there is a global effort to study it across 35,727 sites around the world."

Answered by AI

Are new enrollees being accepted for this experiment?

"Data from clinicaltrials.gov confirms that this medical trial is actively accepting patients, with the original postdate being May 3rd 2019 and most recent update occurring on June 23rd 2022."

Answered by AI

What are the common applications for Pembrolizumab?

"Pembrolizumab is frequently employed to combat malignant neoplasms, as well as unresectable melanoma, microsatellite instability high conditions, and the exacerbation of disease after chemotherapy."

Answered by AI

How many people have registered for this experiment?

"Affirmative. Reports published on clinicaltrials.gov verify that this trial is recruiting participants as of now. It was launched on May 3rd 2019 and updated lastly on June 23rd 2022, with 26 patients needing to be enrolled at three medical sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab in Treating Participants With Leukoplakia
2019. "Pembrolizumab in Treating Participants With Leukoplakia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03603223.
~0 spots leftby Jun 2024
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