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EA3191

Trial Overview

Official Title

Testing What Happens When An Immunotherapy Drug (Pembrolizumab) Is Added To Radiation Or Given By Itself Compared To The Usual Treatment Of Chemotherapy With Radiation After You Have Had Surgery For Your Recurrent Squamous Cell Carcinoma Of The Head And Neck

Study Purpose

To compare usual approach (chemotherapy plus radiation) to pembrolizumab alone and pembrolizumab in combination with radiation after having head and neck cancer surgically removed.

Diagnosis

Patients who had head and neck squamous cell carcinoma (HNSCC) before and now the tumor has comeback or a new head and neck cancer in a different area of the head and neck, which has been removed by surgery.

Eligibility

Locally recurrent/second primary squamous cell carcinoma, close margins, or positive margins (CIS and dysplasia included)

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

  • Group A: Patients in this group will get the radiation plus the study drug called pembrolizumab.
  • Group B: Patients in this group will get cisplatin or carboplatin, plus usual radiation treatment
  • Group C: Patients in this group will receive the study drug called pembrolizumab by itself.

For more information, visit ClinicalTrials.gov

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Enrollment Status
Recruiting
Phase
Phase II
Methodist Health System Trial Code
EA3191
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