A Study of Fianlimab and Cemiplimab for Head and Neck Cancer

This study is looking at whether combining two medications, fianlimab and cemiplimab, works better than cemiplimab alone for people with head and neck squamous cell carcinoma (HNSCC) that has returned or spread (recurrent or metastatic). You might be able to join if you are 18 or older and have HNSCC that started in your mouth, throat, or voice box, and has not been treated before for its recurrence or spread. Researchers will measure how many participants respond to the treatment to see if the combination is effective. The study aims to enroll 120 participants.

Study design
This interventional study plans to enroll 120 participants. It compares fianlimab plus cemiplimab against cemiplimab plus a placebo (an inactive substance that looks like medicine).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 90 days after their last study treatment, for approximately 58 months in total.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06769698

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Regeneron Pharmaceuticals
~120 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:FDC fianlimab+cemiplimabCemiplimabPlacebo

At a glance

Recruiting sites
35 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR)
Measured over Up to 90 days after last study treatment, approximately 58 months
Head and Neck Squamous Cell Carcinoma (HNSCC)
35 sites across 26 states
Queensland3
Spain3
California2
Kentucky2
Tennessee2
Texas2
Virginia2
Florida1
  • Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals

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  • Overall Response Rate (ORR)Up to 90 days after last study treatment, approximately 58 months