At a glance
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Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab, Surgery, and 2 other interventions for Head and Neck Cancer. Active but no longer recruiting, targeting 96 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.
gross total surgical resection
60-66 Gy over 6 weeks
Weekly during radiation therapy for 6 doses only for patients with high risk pathological features