Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

April 27, 2018

Primary Completion Date

February 15, 2022

Study Completion Date

April 6, 2027

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Palbociclib

Palbociclib is an oral drug available as capsules (or as liquid suspension). The capsules should be taken with food

DRUG

Cetuximab

-Cetuximab must not be administered as an IV push or bolus

DRUG

Cisplatin

-Patients will receive cisplatin via intravenous (IV) infusion over 60 minutes.

RADIATION

Intensity-Modulated Radiation Therapy

-Once daily fractions Monday through Friday, with one additional fraction of RT administered on (preferably) Fridays

PROCEDURE

Tumor biopsy

"* Tumor tissue will be collected at baseline and then after two cycles of neoadjuvant palbociclib monotherapy~* If the patient has been previously enrolled in Washington University's TAP protocol (head and neck bank, HRPO #201102323), tissue that has been banked may be accessed in lieu of fresh biopsy at baseline."

PROCEDURE

Peripheral blood draw

Baseline and post-treatment

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Washington University School of Medicine

OTHER

NCT03389477 - Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter