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Treatment Study for Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma

Clinical Trial Title: 
A phase I and expansion cohort study of adjuvant cisplatin, intensity-modulated radiotherapy, and MK-3475 (pembrolizumab) in high-risk head and neck squamous cell carcinoma (HNSCC).
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Neilayan Sen, MD
Clinical Trial Protocol Description: 

This phase I trial studies the side effects and best dose of pembrolizumab when given together with cisplatin and intensity-modulated radiation therapy, in treating patients with stage III-IV squamous cell carcinoma of the head and neck. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy uses high-energy X-rays to kill tumor cells and shrink tumors. Giving pembrolizumab with cisplatin and intensity-modulated radiation therapy may work better in treating patients with squamous cell carcinoma of the head and neck.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity (excluding lips), oropharynx (p16 negative), hypopharynx or larynx.
  • Have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx squamous cell carcinoma (SCC) within 63 days prior to registration.
  • Have pathologic stage III or IV HNSCC.

This is a partial list of elgibility requirements.

Clinical Trial Area: 
Ear, Nose and Throat
Head and Neck Cancer
Contact Phone: 
(312) 942-5183
Contact Name: 
Steffi Leung