Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma

Exclusion Criteria

• •Primary tumor of nasopharyngeal, paranasal sinuses, nasal cavity or salivary gland, thyroid or parathyroid gland pathologies, skin, squamous cell carcinoma of unknown primary or non-squamous histologies (e.g., mucosal melanoma).
• •Patients having received prior systemic treatment for metastatic or recurrent disease.
• •Patients having received prior treatment with anti-EGFR antibody.
• •Patients having received prior treatment with anti-TGF-β therapy.
• •Patients having received prior therapy with anti-PD1, anti-PD-L1 (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
• •Known to be diagnosed and/or treated for any other additional malignancy within 2 years prior to registration/randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer defined as follows: Stage T1 up to T2a with a Gleason score ≤6 and prostatic specific antigen \<10 ng/mL either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to registration/randomization. Other exceptions may be considered with the Sponsor's consultation. The time requirement for no malignancy for 2 years does not apply to the cancer for which a patient is enrolled in the study.
• •Any of the following \<6 months before starting study treatment: ST-elevation myocardial infarction, severe/unstable angina, uncontrolled cardiac ventricular arrythmia, coronary/peripheral artery bypass graft or stent, cerebrovascular accident/stroke less than 6 months prior to enrollment or NYHA Class III/IV congestive heart failure. Subjects with deep vein thrombosis who are hemodynamically stable can enroll if they are on a stable dose of anticoagulants for at least 3 months.
• •Serious systemic infection (bacterial, viral, or fungal) within 4 weeks before first dose of study treatment, or active systemic infection requiring either hospitalization or parenteral anti-infective therapy within 2 weeks before first dose of study treatment.
• •History of (non-infectious) pneumonitis/ interstitial lung disease or has current pneumonitis/ Interstitial lung disease.