Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
Sponsor: Trisha Wise-Draper
Summary
The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.
Official title: Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2016-01
Completion Date
2025-11-02
Last Updated
2024-08-29
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.
Surgery
gross total surgical resection
Radiation Therapy
60-66 Gy over 6 weeks
Cisplatin
Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Locations (6)
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States