ASPEN 04: This phase II trial is trying to understand the effectiveness of immunotherapy (Pembrolizumab) and chemotherapy (Cisplatin/Carboplatin, 5FU) with or without targeted therapy (Evorpacept) in people with head and neck squamous cell carcinomaA Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

Summary

This is a randomised trial with two arms for people with metastatic or unresectable, recurrent head and neck squamous cell carcinoma who have not yet been treated for their advanced disease. In the Experimental Arm, participants will receive Evorpacept (ALX148) + Pembrolizumab + Chemotherapy (Cisplatin/Carboplatin; 5FU). Evorpacept will be administered intravenously (via IV) at a dose of 45mg/kg every three weeks. Pembrolizumab will be administered via IV at a dose of 200mg every three weeks. Chemotherapy will be given every three weeks via IV. In the Active Comparator Arm, participants will receive Pembrolizumab + Chemotherapy. Pembrolizumab will be administered via IV every three weeks at a dose of 200mg. Chemotherapy will be given every three weeks via IV.