A Phase III Study of Pembrolizumab Immunotherapy Before Surgery and in Combination with Standard Therapy After Surgery for Stage III-IVA Head and Neck Cancer

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Full Title

A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC) (WIRB)

Purpose

Radiation therapy with or without cisplatin chemotherapy is a standard treatment for squamous cell carcinoma of the head and neck. In this study, researchers want to see if adding pembrolizumab immunotherapy to standard therapy both before and after surgery is more effective than standard therapy alone for patients with operable head and neck cancers. Pembrolizumab works by boosting the power of the immune system to find and kill cancer cells.

Patients in this study will be randomly assigned to one of two groups:

  • Pembrolizumab before surgery and pembrolizumab plus radiation therapy with or without cisplatin after surgery.
  • Radiation therapy with or without cisplatin after surgery.

Patients with high-risk cancers will receive a higher dose of radiation therapy and cisplatin, while those in the low-risk group will receive a lower dose of radiation therapy and no cisplatin. Pembrolizumab and cisplatin are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have operable squamous cell cancer of the mouth, oropharynx, hypopharynx, or larynx (stage III or IVA) that has not yet been treated and has not metastasized.
  • Prior treatment with an immunotherapy drug like pembrolizumab is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jung Julie Kang at 631-623-4272.

Protocol

19-202

Phase

III

Investigator