OncoMatch/Clinical Trials/NCT07807163
A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC
Official title: A Multicenter, Open-label, Randomized Phase 2 Study Evaluating Continuous Weekly Dosing of Ficerafusp Alfa (BCA101) in Combination With Pembrolizumab Versus an Alternative Ficerafusp Alfa Dosing Regimen for First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Is NCT07807163 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Ficerafusp alfa and Pembrolizumab (KEYTRUDA®) for metastatic head and neck squamous cell carcinoma.
Treatment: Ficerafusp alfa · Pembrolizumab (KEYTRUDA®) — Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). The study aims to demonstrate that the antitumor activity of an alternative dosing regimen of ficerafusp alfa in combination with pembrolizumab is comparable to the weekly ficerafusp alfa regimen in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (cps ≥1)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy for recurrent or metastatic hnscc
Exception: completed systemic therapy >6 months prior if given as part of multimodal treatment for locoregionally advanced disease in the adjuvant or definitive setting
Cannot have received: anti-tgfβ therapy
Cannot have received: anti-egfr antibody
Exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease
Lab requirements
Blood counts
Adequate organ function, as defined in the protocol.
Kidney function
Adequate organ function, as defined in the protocol.
Liver function
Adequate organ function, as defined in the protocol.
Adequate organ function, as defined in the protocol.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Site US074 · Tyler, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07807163 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy for recurrent or metastatic hnscc, anti-tgfβ therapy, anti-egfr antibody disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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