Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor

This multicenter, open-label, randomized phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab monotherapy (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as monotherapy or in combination with other therapy).

NCT Number	NCT04966481
Lead Sponsor	Washington University School of Medicine Collaborators: Pfizer, The Joseph Sanchez Foundation
Conditions	HPV-unrelated Head and Neck Squamous Cell Carcinoma
Enrollment	81 participants
Start Date	2022-04-06
Primary Completion	2028-02-28 (estimated)
Study Completion	2028-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-05-19