Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 6, 2018

Primary Completion Date

February 4, 2020

Study Completion Date

December 30, 2025

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Avelumab

Avelumab (IV on days 1 and 15 of 28 day cycle)

DRUG

Palbociclib

"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."

DRUG

Cetuximab

"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."

Trial Locations (1)

92093

UC San Diego Moores Cancer Center, La Jolla

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Kathryn Gold

OTHER