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Title 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
Therapeutic Area Head and Neck Cancer
Principal Investigator Yu Cao, MD
Min Age 18 Years
Max Age 79 Years
Gender Any
Contact Sarah Sexton
More Information


This trial will help to determine if either the experimental arm (adjuvant reirradiation plus pembrolizumab, followed by pembrolizumab to complete 12 months total of pembrolizumab and/or pembrolizumab alone for 12 months) significantly improves Overall Survival (OS) compared to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk patients.

Study Details

Inclusion Criteria

  • 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.
  • Patient must have had prior radiation to the area of recurrent or second primary tumor.

Exclusion Criteria

  • Patient must not have any evidence of distant disease based on baseline imaging done within 28 days prior to randomization.
  • Patient must not have received anti-PD-1/PD-L1 therapy for recurrent disease.
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.

Study Requirements

Subjects with locoregionally recurrent or second primary HNSCC who meet eligibility criteria will be randomized to one of three arms:

  • Arm A (Reirradiation plus pembrolizumab)
  • Arm B (Reirradiation plus platinum chemotherapy)
  • Arm C (Pembolizumab monotherapy)

Subjects will either get radiation for about 6 weeks plus the study drug pembrolizumab for up to 12 months, or get the study drug pembrolizumab by itself for up to 12 months, or get the usual approach which is radiation for about 6 weeks with weekly chemotherapy for about 6 weeks.

Subjects will be monitored closely by the study doctors. Subjects will have blood tests and imaging (CAT scan or MRI) done to look for signs that show if the cancer has come back.

Subjects will be followed for 5 years after starting the study.