RecruitingPhase 3NCT04966481

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

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


Sponsor

Washington University School of Medicine

Enrollment

81 participants

Start Date

Apr 6, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for people with a specific type of head and neck cancer (HPV-unrelated squamous cell carcinoma) that has a particular gene change called CDKN2A loss and has progressed after immunotherapy. **You may be eligible if...** - You have head and neck squamous cell carcinoma that is not related to HPV (specifically cancers of the oral cavity, larynx, hypopharynx, or HPV-negative oropharynx) - Your tumour has a confirmed CDKN2A gene mutation or deletion on genetic testing - Your cancer progressed during or after treatment with a PD-1 or PD-L1 immunotherapy drug - You have measurable disease on imaging - You have received no more than three prior lines of treatment **You may NOT be eligible if...** - Your head and neck cancer is HPV-positive - Your tumour does not have a CDKN2A alteration - You have not previously received immunotherapy - You have received more than three prior treatment regimens Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPalbociclib

Administered on an outpatient basis

DRUGCetuximab

Given intravenously over approximately 60 minutes


Locations(5)

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

View Full Details on ClinicalTrials.gov

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NCT04966481