EA3191: A 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

About this Study

Study the effect of pembrolizumab in combination with radiation therapy or pembrolizumab alone compared to the usual approach (chemotherapy plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary).

Sponsor Protocol ID:EA3191
IRB Number:2021-0520
Actively Enrolling
Interventional
Phase 2
July 12, 2022
Eligibility Criteria
18 years old
79 years old
Both Male and Female
Yes
No
No

Inclusion Criteria
  • Age 18 through 79
  • Locoregionally recurrent or second primary HNSCC (oral cavity, oropharynx, larynx, hypopharynx) in a previously radiated field
  • Have undergone surgery with gross total resection and randomized within 8 weeks of surgery
  • Must have high risk disease
  • Must have had prior radiation to the area of recurrent or second primary tumor
  • Completed prior radiation a a minimum of 6 months prior to randomization

Exclusion Criteria
  • Evidence of distant disease based on imaging
  • Prior anti-PD-1/PD-L1 therapy for recurrent disease
  • Pregnant or breast feeding
  • Current active infection that requires systemic treatment
  • History of non-infectious pneumonitis requiring steroids within 3 year prior to randomization
  • History of solid organ transplant or stem cell transplant
  • On immunosuppressive medication within 7 days prior to randomizat
  • Received live vaccine within 30 days prior to first dose of study treatment
  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • Known psychiatric or substance abuse disorder that would interfere with participation in study
  • Known history of hepatitis B or active hepatitis C virus

Categories Click category to view its trials.
Cancer
Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Eulisa Goins-Freeman
Phone Number: 601-815-3936
Email: efreeman2@umc.edu
Principal Investigator:Robert Hamilton
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