MedTrace Logo

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

NCT03389477 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-04-21

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the results of treating patients with HPV-unrelated head and neck squamous cell carcinoma with neoadjuvant single-agent palbociclib, followed by chemoradiation (either cisplatin + IMRT or cetuximab + IMRT depending on patient characteristics), followed by adjuvant single-agent palbociclib.

Conditions

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Douglas R Adkins, M.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2022-02-15
Completion
2027-04-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03389477 on ClinicalTrials.gov