OncoMatch/Clinical Trials/NCT06788990
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Is NCT06788990 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 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). 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) CPS ≥1 (CPS ≥1)
PD-L1 CPS ≥1
Required: HPV negative
documented HPV-negative disease if presenting with OPSCC
Disease stage
Metastatic disease required
Measurable disease based on RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-TGFβ therapy
Prior treatment with anti-TGFβ therapy
Cannot have received: anti-EGFR antibody
Exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease
Prior therapy with an anti-EGFR antibody (exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease)
Cannot have received: immune checkpoint inhibitor
Exception: completed >6 months prior to study treatment initiation
Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation
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 # 0137 · Birmingham, Alabama
- Site #0147 · Phoenix, Arizona
- Site #0107 · La Jolla, California
- Site #0106 · Los Angeles, California
- Site#0144 · Sacramento, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06788990 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 CPS ≥1 is a required biomarker for enrollment.
Does this trial require HPV?
Yes, HPV negative 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.
Check if I qualify