Palbociclib and Cetuximab for Head and Neck Cancer
This study is testing if a combination of two drugs, palbociclib and cetuximab, works better than cetuximab alone for certain head and neck cancers. You might be able to join if you have head and neck squamous cell carcinoma (HNSCC) that is not related to HPV and has a specific change in the CDKN2A gene. This is for people whose cancer has returned or spread, and who have already received treatment with a PD-1/L1 inhibitor. The main goal is to see if the combination treatment helps people live longer. The current status of this study is unclear, and it plans to enroll about 81 participants.
- Study design
- This is a randomized phase 3 study where about 81 participants will be assigned to receive either palbociclib and cetuximab or cetuximab alone. It is an open-label study, meaning both you and your doctors will know which treatment you are receiving.
- What's involved
- Palbociclib is given as an outpatient treatment, and cetuximab is given intravenously (through a vein) over about 60 minutes. The specific number of visits or tests is not detailed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your overall survival will be measured through the completion of follow-up, which is estimated to be 15 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04966481
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
Recruiting
PHASE3Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~81 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:PalbociclibCetuximab
At a glance
Recruiting sites
3 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over Through completion of follow-up (estimated to be 15 months)
Conditions
Where it's being run
5 sites across 4 statesMissouri2
Minnesota1
North Dakota1
South Dakota1
Study leadership
- Douglas Adkins, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 clinical exam, per RECIST 1.1.
Disease progression on a PD-1/L1 inhibitor-containing regimen (given as monotherapy or in combination with other therapy).
Received no more than three lines of prior therapy for RM-HNSCC.
At least 18 years of age.
ECOG performance status ≤ 1.
Normal bone marrow and organ function as defined below:
Hemoglobin ≥ 8 g/L
Absolute neutrophil count ≥ 1,000/mcl
Platelets ≥ 100,000/mcl
Total bilirubin ≤ 3 x institutional upper limit of normal (IULN)
AST(SGOT)/ALT(SGPT) ≤ 5 x IULN (for cases involving liver metastases, AST/ALT ≤ 10 x IULN)
Serum creatinine \< 3 x IULN or creatinine clearance \> 30 mL/min by Cockcroft-Gault
The effects of palbociclib and cetuximab on the developing human fetus are unknown. For this reason and because CDK 4/6 inhibitors are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 3 months days after completion of the study
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion
Prior treatment with cetuximab for recurrent or metastatic disease (however, prior cetuximab given as a component of multimodality therapy for newly diagnosed, locally advanced, non-metastatic HNSCC is allowable).
Prior treatment with a CDK4/6 inhibitor for RM-HNSCC.
Rb (retinoblastoma) loss: mutation or homozygous deletion described on genomic sequencing report.
Currently receiving any other investigational agents.
A history of other malignancy with the exception of malignancies for which all treatment was completed at least 1 year before registration and the patient has no evidence of recurrent/persistent disease.
Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in the study (excluding cetuximab).
Prior grade 3 or 4 (per CTCAE 5.0) hypersensitivity reaction to cetuximab.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
QTc \>500 msec (using Bazette formula).
Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated).
What this trial measures
- Overall survival (OS)Through completion of follow-up (estimated to be 15 months)
-Defined as the time from the date of treatment to the date of death, censored at the last follow-up otherwise.