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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

StatusRecruiting
PhasePhase 3
Started2022-04-06
View on ClinicalTrials.gov ↗
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).

Amendment record

Amended 20 times since 2021-07-07; most recent filed 2026-05-15. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-05-15
Amendment Study Status, Contacts/Locations v20
2026-04-16
Amendment Study Status, Contacts/Locations v19
2025-08-20
Amendment Study Status, Contacts/Locations v18
2025-08-04
Amendment Study Status, Contacts/Locations v17
2025-07-24
Amendment Study Status, Contacts/Locations v16
2025-04-02
Amendment Study Status v15
2025-01-28
Amendment Study Status, Contacts/Locations v14
2024-12-26
Amendment Study Status, Eligibility v13
2024-10-01
Amendment Study Status, Contacts/Locations v12
2024-09-30
Amendment Study Status, Contacts/Locations v11
2024-06-13
Amendment Study Status, Outcome Measures v10
2024-05-13
Amendment Study Status v9
2023-05-08
Amendment Study Status, Eligibility, Contacts/Locations v8
2023-04-24
Amendment Study Status v7
2023-04-11
Amendment Study Status v6
2022-04-07
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
2022-03-15
Amendment Study Status v4
2022-01-07
Amendment Study Status, Sponsor/Collaborators v3
2022-01-06
Amendment Study Status v2
2021-11-01
Amendment Study Identification, Study Status, Outcome Measures v1
2021-07-07
Original filing
Trial Details
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