Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

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

Treatment groups

45 Participants
are divided into 3 treatment groups