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
This study is testing a new combination of two medications to see if it works better than a single treatment for certain types of head and neck cancer. Researchers want to find a more effective way to help patients whose cancer continued to grow after receiving immunotherapy.
You may be eligible if you have recurrent or metastatic cancer of the mouth, throat, or voice box that is not linked to HPV and has a specific gene change called CDKN2A. Additionally, your cancer must have progressed after treatment with a PD-1 or PD-L1 inhibitor.
Participants will be randomly assigned to one of two groups: one receiving a combination of two cancer-fighting drugs, and the other receiving only one of those drugs. Doctors will closely monitor your health and how your tumor responds to the treatment throughout the study.
The study is currently recruiting patients at medical centers in Worthington, Minnesota; Kansas City, Missouri; and St. Louis, Missouri. You can reach out to these locations to learn more about joining.
- 1Tests a two-drug approach versus a single-drug approach for specific head and neck cancers.
- 2Requires genetic testing to confirm the presence of a CDKN2A gene change.
- 3Designed for patients who have already tried immunotherapy without success.
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