Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer

This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the

Trial Details

NCT ID
NCT07195734
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • Biospecimen Collection
  • Carboplatin
  • Cemiplimab
  • Cisplatin
  • Computed Tomography
  • Paclitaxel
Locations (sample)
  • Sacramento, California, United States|38.58157,-121.4944
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Council Bluffs, Iowa, United States|41.26194,-95.86083
  • Des Moines, Iowa, United States|41.60054,-93.60911

Key Eligibility Criteria

  • Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCH…
  • PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
  • Verify insurance (or other payment) coverage for neoadjuvant chemotherapy
  • Measurable disease as defined by RECIST 1.1

For full eligibility, visit ClinicalTrials.gov.

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