Immunotherapy and Nodal-Sparing Irradiation for T-Cell Induction and Unmasking of Tumor Antigenicity in the Microenvironment for Head and Neck Cancer
Medical College of Wisconsin
Summary
This is a non-comparative randomized Phase 2 study using the INITIUM regimen with or without elective nodal irradiation (ENI) delivered before surgery for resectable head and neck squamous cell carcinoma (HNSCC).
Description
Patients with surgically resectable HPV-negative HNSCC with no prior history of head and neck radiation and a life expectancy of at least 12 months will be enrolled. Patients will undergo pre-radiation pembrolizumab for two cycles followed by pre-operative radiotherapy and two additional cycles of pembrolizumab. Radiation will be given to a total dose of 35 Gy in 5 fractions to gross disease, followed by response-directed surgery approximately eight weeks after completion of radiation. Patients randomized to ENI will concurrently receive 27 Gy in 5 fractions to elective nodal regions during r…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients 18 years or older. * Patients with surgically resectable squamous cell carcinoma of the oral cavity or HPV-negative squamous cell carcinoma of the oropharynx. Resectability will be determined by the treating surgeon. Patients must have locoregionally advanced disease defined by clinical T3-4 staging and/or clinical node positive staging. * A CPS score of at least 1 on initial biopsy. * Zubrod, or Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Pregnancy. It is not known what effects this treatment has on human pregnancy or development of the…
Interventions
- DrugPembrolizumab
All patients will undergo induction with pembrolizumab (200 mg) given intravenously every three weeks for two cycles prior to radiation and two cycles after radiation.
- RadiationRadiotherapy
All patients will receive 7 Gy daily for 5 fractions to gross disease.
- RadiationENI
Patients receiving ENI will be treated to 5.4 Gy daily to the elective nodal basins for 5 fractions concurrent with treatment to gross disease.
- ProcedureSurgery
Patients will be scheduled for surgery at ten weeks (-7 days) after radiation to allow for maximal tumor regression and healing of any radiation-related mucositis. Surgical resection will be tailored to the treatment response.
Location
- Froedtert & the Medical College of WisconsinMilwaukee, Wisconsin