NCT02641093

Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Trisha Wise-Draper · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.
PROCEDURE	Surgery	gross total surgical resection
RADIATION	Radiation Therapy	60-66 Gy over 6 weeks
DRUG	Cisplatin	Weekly during radiation therapy for 6 doses only for patients with high risk pathological features

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-04-16
• Completion: 2025-11-02
• First posted: 2015-12-29
• Last updated: 2024-08-29
• Results posted: 2023-05-06

Locations

6 sites across 1 country: United States