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
Sponsor: Washington University School of Medicine • ClinicalTrials.gov ID: NCT04966481
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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).
Interventions
-
Palbociclib
(Drug)
Administered on an outpatient basis
-
Cetuximab
(Drug)
Given intravenously over approximately 60 minutes
Eligibility criteria
Conditions
Locations
- Sanford Worthington Medical Center — Worthington, Minnesota, United States
- Saint Luke's Hospital — Kansas City, Missouri, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
- Sanford Medical Center — Sioux Falls, South Dakota, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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