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.
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
4
sites
281 W. Lane Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Matthew Old, MD
Phone: 614-685-2127
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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234 Goodman Dr
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: Trisha Wise-Draper, MD, PhD
Phone: 513-584-7698
University of Cincinnati Medical Center Opening in 1823 as the country
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500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Frank Worden, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Paul O'Brien, MD
Phone: 843-792-6349
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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