Phase 3 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People diagnosed with a specific type of head and neck cancer (squamous cell carcinoma of the oral cavity, larynx, or hypopharynx, or certain types affecting the throat or neck) that is not linked to HPV, confirmed through a tissue or cell sample.
• People whose cancer has a specific genetic change called a CDKN2A loss-of-function alteration (a mutation or deletion), identified through genomic testing.
• People whose cancer has at least one tumour that is large enough to be measured on a scan or physical exam, according to standard measurement guidelines.
• People whose cancer got worse while receiving a treatment that included a PD-1 or PD-L1 inhibitor (a type of immunotherapy).
• People who have received no more than three prior treatment courses for their recurrent or metastatic head and neck cancer.
• People who are at least 18 years old.
• People who are generally well enough to carry out light activity and care for themselves (confirmed with trial site using a standard fitness scale).
• People whose blood counts and organ function (including bone marrow, liver, and kidneys) meet specific health thresholds as determined by blood tests.
• People who are willing and able to use reliable contraception (hormonal, barrier method, or abstinence) throughout the trial and for 3 months after it ends — this applies to both women who could become pregnant and men. Anyone who becomes pregnant or suspects pregnancy during the trial must inform their treating doctor immediately.
• People who are able to understand the trial and are willing to sign a consent form.

Who may not be able to join:

• People who have previously received cetuximab (a specific cancer treatment) for recurrent or metastatic disease. (Note: having received cetuximab as part of initial treatment for localised, non-metastatic disease is generally acceptable.)
• People who have previously been treated with a CDK4/6 inhibitor drug for their recurrent or metastatic head and neck cancer.
• People whose genomic test shows a loss of a gene called Rb (retinoblastoma), through mutation or deletion.
• People currently taking part in another clinical trial involving an experimental treatment.
• People with a history of another cancer, unless all treatment for that cancer was completed at least one year before joining and there is no sign the other cancer has returned.
• People with brain metastases (cancer that has spread to the brain) that have not been stable for at least 4 weeks after brain-directed treatment, confirmed by brain imaging and clinical review.
• People with a known history of serious allergic reactions to drugs chemically similar to palbociclib or other study drugs (not including cetuximab — that is covered separately).
• People who have had a severe (grade 3 or 4) allergic reaction to cetuximab in the past.
• People with serious uncontrolled health conditions such as an active serious infection, severe heart failure, unstable chest pain, or uncontrolled heart rhythm problems.
• People with a specific heart measurement on an ECG (QTc interval) above 500 milliseconds.
• People living with HIV whose immune cell count is below a certain level, or who have had a serious HIV-related illness in the past 12 months. Certain HIV medications that interact with the trial drugs may also affect eligibility (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.