Clinical Trials | A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have recurrent or metastatic head and neck squamous cell carcinoma. The purpose of the study is to test a new study treatment for the type of cancer that you have. The new test drug is called ficerafusp alfa (study drug). This study is testing the study drug in combination with pembrolizumab. The study consists of 2 phases, Phase 2 and Phase 3. In Phase 2, participants will be randomized to one of the three study treatment groups called “arms”: • Arm A: Study drug 1500 mg once a week + pembrolizumab 200 mg once every 3 weeks • Arm B: Study drug 750 mg once a week + pembrolizumab 200 mg once every 3 weeks • Arm C: Placebo once a week + pembrolizumab 200 mg once every 3 weeks The goal of phase 2 is to select the optimal dose for phase 3. In Phase 3, participants will be randomized to one of two study treatment arms: • Arm A or Arm B continued: Study drug (dose selected from Phase 2) once a week + pembrolizumab 200 mg once every 3 weeks • Arm C: Placebo once a week + pembrolizumab 200 mg once every 3 weeks This is a double-blind study. That means that neither you nor the study doctor will know which arm you are in. Therefore, you will not know if you are receiving placebo or study drug, though you will be receiving pembrolizumab regardless of the arm that you are in. You will receive the drugs via an IV infusion in your arm. This research study is expected to last for about 5 years. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: https://clinicaltrials.gov/study/NCT06788990 [email protected]