OncoMatch/Clinical Trials/NCT07465276
Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC
Is NCT07465276 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ficerafusp alfa and Pembrolizumab for head and neck squamous cell carcinoma (hnscc).
Treatment: Ficerafusp alfa · Pembrolizumab — This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC). The names of the study drugs used in this research study are: * ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein) * pembrolizumab (a type of monoclonal antibody)
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) positive (CPS score ≥ 1 by any approved assay or scoring method) (CPS ≥ 1)
Tumor must be PD-L1 positive with a CPS score equal to 1 or greater (by any approved assay or scoring method).
Excluded: HPV associated (p16 positivity by IHC and/or confirmatory HPV RNA ISH or PCR testing, or plasma HPV DNA testing results)
HPV-associated oropharyngeal cancer (as determined by p16 positivity by immunohistochemistry and/or confirmatory HPV RNA ISH or PCR testing, or by plasma HPV DNA testing results) [excluded]
Disease stage
Required: Stage III, IVA, IVB
Excluded: Stage I, II, IVC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-egfr antibody
Cannot have received: anti-pd-1 immunotherapy
Lab requirements
Blood counts
absolute neutrophil count ≥1500/mcL; platelets ≥100 x 10^9/L
Kidney function
Creatinine ≤institutional ULN or GFR of ≥30 mL/min/1.73 m2
Liver function
total serum bilirubin ≤1.5X ULN (except for subjects with documented Gilbert syndrome); AST (SGOT) and ALT (SGPT) ≤2.5X ULN; AST(SGOT) / ALT (SGPT) ≤3X ULN
Participants must have adequate organ and marrow function as defined below: * absolute neutrophil count ≥1500/mcL * platelets ≥100 x 10^9/L * total serum bilirubin ≤1.5X upper limit of normal (ULN) (except for subjects with documented Gilbert syndrome) and AST (SGOT) and ALT (SGPT) ≤2.5X ULN * AST(SGOT) / ALT (SGPT) ≤3X ULN * Creatinine ≤institutional ULN or GFR of ≥30 mL/min/1.73 m2 * Coagulation PT/INR or activated partial thromboplastin time (aPTT) ≤1.5X ULN unless subject is receiving anticoagulant therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
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