The purpose of the study is to find out if the study drugs Avelumab, Cetuximab, and Palbociclib will slow or stop your cancer from getting worse, and whether it causes side effects. The second purpose is to measure whether your cancer responds to the study drugs Avelumab, Cetuximab, and Palbociclib. The study drugs Avelumab, Cetuximab, and Palbociclib are types of drugs called a monoclonal antibody. Monoclonal antibodies are made to recognize, target, and bind to specific proteins on cells the building blocks making up your tissues.
This is an open-label phase I trial with a 3+3 dose escalation design. All patients will receive avelumab, cetuximab, and palbociclib. This study will enroll patients with head and neck squamous cell carcinoma not amenable to curative intent therapy. Treatment will be administered in 28 day cycles with a pre-defined dose escalation schedule.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Avelumab (IV on days 1 and 15 of 28 day cycle)
Palbociclib (PO daily, days 1-21 of 28 day cycle) Palbociclib will be administered in capsules of 125 mg, 100 mg, and 75 mg, depending on dosage. Patients will be instructed to take their assigned dose once daily with food for 21 days followed by 7 days off therapy. Patients will be encouraged to take their dose at approximately the same time each day.
Cetuximab (IV 400 mg/m2 x 1, then weekly) Cetuximab is administered intravenously once weekly via infusion pump or syringe pump with infusion rate not to exceed 10 mg/min.
UC San Diego Moores Cancer Center
La Jolla, California, United States
maximum tolerated dose
maximum tolerated dose/recommended phase II dose.
Time frame: 12 months
Overall response rate
Determined by RECIST 1.1
Time frame: through study completion, an average of 3 years
progression free survival
progression free survival
Time frame: through study completion, an average of 3 years
overall survival
overall survival
Time frame: through study completion, an average of 3 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 3 years
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