FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

Official 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

Study identification

NCT ID

NCT06788990

Recruitment status

Recruiting

Study type

Interventional

Phase

Phase 2, Phase 3

Lead sponsor

Bicara Therapeutics

Industry

Enrollment

650 participants

Conditions and interventions

Eligibility (public fields only)

Age range

18 Years and older

Sex

All

Healthy volunteers

Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date

Jan 28, 2025 (Actual)

Primary completion

Apr 2028 (Estimated)

Completion

Jul 2029 (Estimated)

Last update posted

Oct 2, 2026

2025 – 2029

United States locations

U.S. sites

55

U.S. states

28

U.S. cities

44

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 176 non-U.S. sites.