Phase 2 Study Comparing Fianlimab Plus Cemiplimab to Cemiplimab Alone for First Treatment of PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are studying an experimental drug called fianlimab combined with cemiplimab, comparing it to cemiplimab combined with a placebo, in participants with recurrent or metastatic head and neck squamous cell carcinoma HNSCC that has not been previously treated. The study also explores side effects, drug levels in the blood, and whether the body produces antibodies against the study drugs, which could affect their action or cause side effects. Participants are divided into two groups based on HPV status and randomized to receive either the fixed-dose combination of fianlimab and cemiplimab or cemiplimab plus placebo. Approximately 60 participants each with HPV-positive and HPV-negative HNSCC will be enrolled. The drugs are administered according to the study protocol, and participants receive treatment as part of this randomized, phase II trial. During the study, participants will be monitored for treatment response, side effects, and drug levels in their blood. Researchers will assess overall response rates and various adverse events up to 90 days after the last treatment and for approximately 58 months total. Safety, disease control, progression, and immune responses will be closely evaluated throughout the study period.

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