Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Deborah J. Wong, MD, PhD (ucla)
Headshot of Deborah J. Wong
Deborah J. Wong

Description

Summary

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).

This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (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

Details

Keywords

Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Phase 2/3, Ficerafusp alfa, BCA101, Recurrent Head and Neck Squamous Cell Carcinoma (R HNSCC), Metastatic Head and Neck Squamous Cell Carcinoma (M HNSCC), Pembrolizumab, EGFR, TGF-beta, Carcinoma, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Recurrence, Pembrolizumab (KEYTRUDA®)

Eligibility

Locations

  • Site #0106 accepting new patients
    Los Angeles California 90095 United States
  • Site #0107 accepting new patients
    La Jolla California 92093 United States

Lead Scientist at University of California Health

  • Deborah J. Wong, MD, PhD (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 33 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bicara Therapeutics
ID
NCT06788990
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 650 study participants
Last Updated