OncoMatch/Clinical Trials/NCT07465276
Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC
Is NCT07465276 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07465276 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 positive (CPS score ≥ 1 by any approved assay or scoring method) is a required biomarker for enrollment.
Are patients with HPV alterations eligible?
No. HPV associated (p16 positivity by IHC and/or confirmatory HPV RNA ISH or PCR testing, or plasma HPV DNA testing results) is an exclusion criterion.
What disease stage is eligible?
Stage III or IVA or IVB is required.
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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