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: A Multicenter, Open-Label, Randomized Phase 3 Trial
Washington University School of Medicine
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed RM-HNSCC that is HPV-unrelated disease; defined as SCC of the oral cavity, larynx, or hypopharynx and p16 negative SCC of the oropharynx or p16 negative non-cutaneous SCC unknown primary of the neck. * CDKN2A loss-of-function (LOF) alteration: mutation or homozygous deletion described on genomic sequencing report. * Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinica…
Interventions
- DrugPalbociclib
Administered on an outpatient basis
- DrugCetuximab
Given intravenously over approximately 60 minutes
Locations (5)
- Sanford Worthington Medical CenterWorthington, Minnesota
- Saint Luke's HospitalKansas City, Missouri
- Washington University School of MedicineSt Louis, Missouri
- Sanford Roger Maris Cancer CenterFargo, North Dakota
- Sanford Medical CenterSioux Falls, South Dakota