NCT02641093Active, not recruitingPhase 2
Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 21 Dec 2015
- Start date
- Jan 2016
- Primary completion date
- 16 Apr 2021
- Lead sponsor
- Trisha Wise-Draper
- Diseases
- Head and neck cancer
- NCT number
- NCT02641093
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 96
- From Jan 2016 to the primary completion date, 16 Apr 2021
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment.
Other illness
- 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
Other
- Nasopharyngeal or sinonasal carcinoma
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Louisville - James Graham Brown Cancer Center Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
Related publications
- Genome-wide variation in cell-free DNA end-motif entropy predicts immunotherapy response in head and neck cancer.J Clin Invest · 2026 · PMID 42154530
This page is information, not medical advice. Discuss any trial with your doctor.