Pembrolizumab in Treating Patients With High Risk Oral Intraepithelial Neoplasia
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|ClinicalTrials.gov Identifier: NCT02882282|
Recruitment Status : Active, not recruiting
First Posted : August 29, 2016
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Oral Cavity Carcinoma Oral Intraepithelial Neoplasia||Other: Laboratory Biomarker Analysis Other: Patient Observation Biological: Pembrolizumab||Phase 2|
I. To determine oral cancer-free survival of patients with high risk oral intra-epithelial neoplasias (IEN) treated with pembrolizumab versus observation.
I. To determine the safety and tolerability of pembrolizumab for patients with oral IEN.
II. To determine the histologic and clinical response rates (in the subgroup of patients with clinically evident measurable oral IEN lesions) to pembrolizumab.
III. To characterize the immune infiltrate in oral IEN lesions before and after treatment with pembrolizumab.
I. To assess predictive, tissue-and blood-based, biomarkers of benefit from pembrolizumab in oral IEN.
II. To determine the presence of neo-antigens in IEN lesions before and after treatment, and their correlation with oral cancer-free survival and immune infiltrate characteristics.
III. To evaluate the oral micro-biome before and after treatment with pembrolizumab and its association with neo-antigens and benefit from treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo observation.
ARM B: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6, 9, 12, 18, 24, 30, and 36 months and then periodically thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Personalized, Randomized, Phase 2 Study of Pembrolizumab (MK-3475) for High Risk Oral Intra-Epithelial Neoplasias|
|Actual Study Start Date :||June 14, 2017|
|Estimated Primary Completion Date :||March 1, 2024|
|Estimated Study Completion Date :||March 1, 2024|
Active Comparator: Arm A (observation)
Patients undergo observation.
Other: Patient Observation
Experimental: Arm B (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Oral cancer-free survival [ Time Frame: From randomization to the development of histologically confirmed oral cancer or death of any cause, whichever occurs first, assessed up to 7 years ]Will be estimated by Kaplan-Meier method.
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): NCT02882282
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Renata Ferrarotto||M.D. Anderson Cancer Center|