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

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trisha Wise-Draper
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cisplatin; Pembrolizumab

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