At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Histologically or cytologically confirmed recurrent or metastatic HNSCC
- ✓Primary tumor from oral cavity, hypopharynx, larynx, or oropharynx
- ✓HPV-negative if oropharyngeal presentation
- ✕Disease suitable for local therapy with curative intent
- ✕Primary tumor location of paranasal sinuses or nasopharynx
- ✕Prior anti-TGFβ therapy
- ✕Prior anti-EGFR antibody therapy (except radiosensitizing or multimodal locoregional treatment)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Ficerafusp alfa, Pembrolizumab (KEYTRUDA®), and 1 other intervention for Metastatic Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma. Currently recruiting, targeting 650 participants across 173 sites in 23 countries.
Signals
Detailed 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).
Study Details
Timeline
Interventions
Investigational
Immunotherapy agent used in combination with investigational agent
Placebo Control