NT219 Combined With Standard of Care Biologic Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Trial Parameters
Brief Summary
Fixed dose NT219 weekly plus pembrolizumab every 3 weeks or cetuximab weekly to be continued until progression, unacceptable toxicity, or investigator or participant decision.
Eligibility Criteria
Inclusion Criteria: * Age 18 and over. * ECOG PS 0-2. * Incurable head and neck squamous cell carcinoma of mucosal origin (oral cavity, tongue, oropharynx, pharynx, larynx, sinonasal and non-EBV-driven NPC). * Adequate organ and marrow function as defined by routine lab testing including calculated creatinine clearance \>60 mL/min, total bilirubin \< 1.5x the ULN, ALT and AST \<5x the ULN, ANC \>1500, and platelets \>100,000. * Measurable disease by RECIST on CT (including a diagnostic CT performed as part of a PET-CT) or MRI available for review. * Recovered from clinically significant adverse events of most recent anti-cancer therapy prior to enrollment. * Cohort 1: In addition to the general inclusion criterion, patients with tumor tissue CPS \>1 for whom single agent pembrolizumab is appropriate OR who derived significant clinical benefit from anti-PD-1 therapy (as single agent or combination) in the first line setting. No more than 7 patients with each profile (PD-1 inhibitor naïv