Study Comparing Palbociclib and Cetuximab with Cetuximab Alone for Patients with Specific Head and Neck Cancer

Inclusion Criteria

• Diagnosed with a specific type of head and neck cancer that is not related to HPV.
• Cancer must have a genetic change called CDKN2A alteration.
• Cancer must be measurable by scans or physical exams.
• Cancer must have worsened after treatment with PD-1/L1 inhibitors.
• Have received no more than three previous treatments for this cancer.
• Be at least 18 years old.
• Be in good overall health, able to carry out daily activities with minimal restrictions.
• Have normal blood and organ function based on specific medical tests.
• Agree to use effective birth control during the study and for a period after the study ends.
• Be able to understand and sign a consent form to participate in the study.

Exclusion Criteria

• Have previously been treated with cetuximab for recurrent or metastatic cancer.
• Have previously been treated with a CDK4/6 inhibitor for this cancer.
• Have a genetic change called Rb loss.
• Currently taking other experimental drugs.
• Have had another type of cancer within the past year, unless it was treated and is not active.
• Have treated brain metastases that have not worsened for at least four weeks.
• Have allergies to similar drugs used in the study, except cetuximab.
• Have had a severe allergic reaction to cetuximab.
• Have uncontrolled serious illnesses, such as severe infections or heart problems.
• Have a specific heart condition measured by an ECG.
• Have HIV with low CD4+ T-cell counts or recent serious infections, unless on effective treatment.