Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] 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). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. C

Trial Details

NCT ID
NCT04671667
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Carboplatin
  • Cisplatin
  • Computed Tomography
  • Intensity-Modulated Radiation Therapy
  • Magnetic Resonance Imaging
  • Pembrolizumab
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Anaheim, California, United States|33.83529,-117.9145
  • Bellflower, California, United States|33.88168,-118.11701
  • Irvine, California, United States|33.66946,-117.82311

Key Eligibility Criteria

  • 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:

For full eligibility, visit ClinicalTrials.gov.

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