About this trial
This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.
Eligibility criteria
Qualifiers
Pathologically confirmed either persistent and/ or locoregionally recurrent HNSCC of oral cavity, pharynx, larynx, unknown primary head and neck (H&N) squamous cell carcinoma
Resectable disease as determined by the surgeon and team
Eastern Cooperative Oncology Group (ECOG) performance status (PS) < 2
At least 18 years of age
Disqualifiers
Requirement of immunosuppressive therapy within 14 days of randomization
Salivary gland carcinomas, lip carcinoma, adenocarcinoma of the skin
Prior use of immune checkpoint blockade agent
History of human immunodeficiency virus (HIV), hepatitis B, C: Participants who test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection, those who test positive for human immunodeficiency virus (HIV) or have known acquired immunodeficiency syndrome (AIDS)
Trial design
Treatments tested in this trial
- External Beam Radiation Therapy
- Intraoperative Radiation Therapy
- Pembrolizumab
- Quality-of-Life Assessment
- Salvage Surgery