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

Sponsor: Trisha Wise-Draper

Sponsor score: 0

ClinicalTrials ID:NCT02641093

This Phase II trial evaluates the safety and efficacy of adding pembrolizumab to standard post-surgical radiation in head and neck cancer. Eligible patients include those with specific T and N stage criteria and adequate performance status. Interventions involve pembrolizumab, surgery, radiation, and cisplatin for high-risk cases. Pembrolizumab is given pre-surgery and post-operatively for 7 doses.

Patient Parameters

Parameter	Options

Program Overview

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.

Eligibility Criteria

Inclusion Criteria

Patients eligible for resection with one or more of the following
1. Any T stage with ≥ N2 disease;
2. T4 disease, any N stage;
3. T3 Oral Cavity, any N stage; or
4. Clinical evidence of extra-capsular extension on scans.
Must be willing to undergo definitive resection with neck dissection.
Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
Adequate labs
Appropriate staging imaging.

Exclusion Criteria

Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment.
Nasopharyngeal or sinonasal carcinoma
Confirmed metastatic disease
Human Papillomavirus (HPV)+ disease of the oropharynx
Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C

Locations

FACILITY	ZIP	CITY	STATE
University of Louisville - James Graham Brown Cancer Center	40202	Louisville	Kentucky
University of Michigan	48109	Ann Arbor	Michigan
University of Cincinnati Medical Center	45219	Cincinnati	Ohio
Ohio State University	43210	Columbus	Ohio
Medical University of South Carolina	29425	Charleston	South Carolina
MD Anderson Cancer Center	77030	Houston	Texas

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