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

Status:	Recruiting
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	10/3/2018
Start Date:	January 2016
End Date:	July 2021
Contact:	UC Cancer Institute Clinical Trials Office
Email:	cancer@uchealth.com
Phone:	513-584-7698

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

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.

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

We found this trial at

sites

University of Cincinnati Medical Center

234 Goodman Dr
Cincinnati, Ohio 45229

(513) 584-1000