A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not contain any real medicine), collectively called "study drugs" in this form. The study is focused on participants with head and neck cancers who have not been previously treated for head and neck cancer that has come back or spread to other parts of the body, referred to as recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The study is look

Trial Details

NCT ID
NCT06769698
Phase
PHASE2
Sponsor
Regeneron Pharmaceuticals
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • FDC fianlimab+cemiplimab
  • Cemiplimab
  • Placebo
Locations (sample)
  • Omaha, Nebraska, United States|41.25626,-95.94043
  • Lubbock, Texas, United States|33.57786,-101.85517

Key Eligibility Criteria

  • Have histologically confirmed (by local pathology) R/M HNSCC that is considered incurable by local therapies
  • Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in…
  • PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening,…
  • Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgic…

For full eligibility, visit ClinicalTrials.gov.

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