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Phase II Randomized Trial of Adjuvant Therapy with Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma with High Risk Features

Objective

To evaluate OS of adjuvant reirradiation plus concurrent pembrolizumab followed by pembrolizumab to complete 12 months total of pembrolizumab to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk HNSCC patients. To evaluate OS of adjuvant pembrolizumab for 12 months compared to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk HNSCC patients.

Protocol #

EA3191

Trial Phase:

Phase II

Principal Investigator:

Alesi, Erin

Cancer Type
  • Esophagus
  • Larynx
  • Lip
  • Oral Cavity and Pharynx
Study Site
  • Stony Point
  • Virginia Commonwealth University

Patient must be between 18 and 79 years of age.
- Patient must have locoregionally recurrent or second primary HNSCC (oral cavity, oropharynx, larynx, hypopharynx) in a previously radiated field.
- Patient must have undergone surgery with gross total resection and must be randomized within 8 weeks of surgery.
- Patients must have high risk disease defined as:
- Positive Margins and/or Extra Nodal Extension (ENE)
- Positive margins are defined as malignancy at or within 1 mm of the margin. High grade dysplasia (i.e. carcinoma in situ) at the margin is also considered
positive
- ENE may be either gross or microscopic

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Adult
  • Protocol Type Treatment
  • Research Study Team Carrie Donovan, RN
    Phone: +1 804-628-3836
    Email Study Contact

Click "I'm Interested" to get started. If you have questions, call our study contact.

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