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

Running, not enrolling · Phase 2

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT02641093

Run by

Trisha Wise-Draper

People needed

96

Starts

2016-01-01

Expected to finish

2026-11-02

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients eligible for resection with one or more of the following
• Any T stage with ≥ N2 disease;
• T4 disease, any N stage;
• T3 Oral Cavity, any N stage; or
• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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