Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable Squamous Cell Carcinoma of the Head and Neck: a Phase 2 Trial
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)
• Participants must have histologically or cytologically confirmed, untreated and newly diagnosed, locoregionally advanced head and neck squamous cell carcinoma (HNSCC) arising from oral cavity, oropharynx (with documented HPV-negative disease if presenting with oropharyngeal SCC), larynx, or hypopharynx.
• Participants should have resectable disease at baseline per the discretion of the treating surgical oncologist.
• Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):
‣ T1-2, N1-3: III
⁃ T3, any N: III, IVA, IVB
⁃ T4, any N: IVA, IVB
• Tumor must be PD-L1 positive with a CPS score equal to 1 or greater (by any approved assay or scoring method).
• Participants must be willing to provide blood and tissue pre-treatment and at the time of surgery for pathologic and correlative analyses. Specifically, willingness to provide a newly obtained core or excisional biopsy of a tumor lesion from the primary tumor site.
• Age 18 years or older at the time of informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Participants must have adequate organ and marrow function as defined below:
‣ absolute neutrophil count ≥1500/mcL
⁃ platelets ≥100 x 109/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
• Female participants of childbearing potential should have a negative urine or serum pregnancy test within 7 days of study registration. Female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication.
• Female participants of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 120 days after the last dose of study drugs.
• Unsterilized male patient having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until day 60 after the last dose of study drugs.
• Ability to understand and the willingness to sign a written informed consent document.