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

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).

Trial Details

NCT ID
NCT06788990
Phase
PHASE2 / PHASE3
Sponsor
Bicara Therapeutics
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Ficerafusp alfa
  • Pembrolizumab (KEYTRUDA®)
  • Placebo
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • Sacramento, California, United States|38.58157,-121.4944

Key Eligibility Criteria

  • Age ≥18 years on the day the Informed Consent Form is signed.
  • Histologically or cytologically confirmed R or M HNSCC. Eligible primary tumor locations are oral cavity, hypopharynx, larynx or oropharynx (with d…
  • No prior systemic therapy administered in the R or M setting; and completed systemic therapy \>6 months prior if given as part of multimodal treatm…
  • Archival tumor tissue or willing to undergo pretreatment biopsy at Screening if archival tissue is insufficient or unavailable.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Head and Neck Cancer Trials on Trialify →