Sponsor: Bicara Therapeutics
Sponsor Study ID: BCA101X301
Study Title: 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
CTO #: 103951
NCT Number: NCT06788990
Phase: II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Larynx, Lip, Oral Cavity and Pharynx
Study Objectives: To identify optimal biological dose by assessing safety and tolerability of ficerafusp alfa in subjects randomized to ficerafusap alpha 1500 mg once weekly with pembrolizumab (treatment arm A) and ficerafusp alfa 750 mg QW pembrolizumab. Assessing antitumor activity of ficerafusp alfa in subjects randomized to ficerafusp alfa 1500 mg QW with pembrolizumab (treatment Arm A) and ficerafusp alfa 750 mg QW and pembrolizumab (treatment Arm B).