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Study identifier: NCT04966481 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: HPV-unrelated Head and Neck Squamous Cell Carcinoma  ·  Sponsor: Washington University School of Medicine

PhasePhase 3
Planned participants81
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Douglas Adkins, M.D.  ·  314-747-8475  ·  dadkins@wustl.edu

Always discuss trial participation with your own doctor first.

Locations (5)

Sanford Worthington Medical CenterWorthington, Minnesota, United StatesNot Yet Recruiting
Saint Luke's HospitalKansas City, Missouri, United StatesWithdrawn
Washington University School of MedicineSt Louis, Missouri, United StatesRecruiting
Sanford Roger Maris Cancer CenterFargo, North Dakota, United StatesRecruiting
Sanford Medical CenterSioux Falls, South Dakota, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04966481