Pembrolizumab in Treating Participants With Leukoplakia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03603223|
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Erythroleukoplakia Leukoplakia Verrucous Oral Leukoplakia||Biological: Pembrolizumab||Phase 2|
I. Clinical response rate at 6 months? percent of patients with complete response and partial response at 6 months.
I. Histologic response rate at 6 months. II. Change in clinical impression based on photographs of the lesion. III. Clinical response rate at 9 months and 12 months. IV. Toxicity.
I. PD-L1 expression in leukoplakia lesions and biomarker analysis.
Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 3 weeks for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30 days and every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Open Label, Single Arm Study to Evaluate the Efficacy of Pembrolizumab for Leukoplakia|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2022|
Experimental: Treatment (pembrolizumab)
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.
- Clinical response rate [ Time Frame: At 6 months ]If there is a signal of efficacy based on this analysis, further exploratory analyses using Cox-proportional hazards regression, will be performed to identify variables which correlate to improved 6-month clinical response rate will be performed. Variables will include demographics, age, gender, pack-years smoking history, size of the lesions, prior history of leukoplakia or erythroleukoplakia, and human papillomavirus (HPV) status. While the study is not powered to detect a statistically difference between these groups, such an analysis may help identify a population more likely to benefit from treatment.
- Clinical response rate [ Time Frame: At 9 and 12 months ]Response rate data will be reported in tabular form.
- PD-L1 positivity [ Time Frame: Up to 2 years ]lesions will be stained to determine % PDL1 positivity
- Correlation of response with PD-L1 positivity [ Time Frame: Up to 2 years ]PDL1 positivity of the lesions will be correlated to response to pembrolizumab
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603223
|United States, California|
|UC San Diego Moores Cancer Center||Not yet recruiting|
|La Jolla, California, United States, 92093|
|Contact: Ezra E. Cohen 858-543-6161 firstname.lastname@example.org|
|Principal Investigator: Ezra E. Cohen|
|USC / Norris Comprehensive Cancer Center||Not yet recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Jorge J. Nieva 323-865-0421 email@example.com|
|Principal Investigator: Jorge J. Nieva|
|UCLA / Jonsson Comprehensive Cancer Center||Not yet recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Deborah J. Wong 310-794-4955 firstname.lastname@example.org|
|Principal Investigator: Deborah J. Wong|
|Principal Investigator:||Deborah Wong||UCLA / Jonsson Comprehensive Cancer Center|