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

NCT03498378 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 171386
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Avelumab; Palbociclib; Cetuximab; Head and Neck Squamous Cell Carcinoma; cancer; Recurrent Head and Neck Squamous Cell Carcinoma; Metastatic Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose

  maximum tolerated dose/recommended phase II dose.

  12 months

Secondary Outcomes (4)

• Overall response rate

  through study completion, an average of 3 years

• progression free survival

  through study completion, an average of 3 years

• overall survival

  through study completion, an average of 3 years

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  through study completion, an average of 3 years

Study Arms (1)

Avelumab, Palbociclib, and Cetuximab

EXPERIMENTAL

Identify the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) for the combination of palbociclib, avelumab, and cetuximab

Drug: Avelumab; Drug: Palbociclib; Drug: Cetuximab

Interventions

Avelumab DRUG

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

Also known as: Bavencio

Avelumab, Palbociclib, and Cetuximab

Palbociclib DRUG

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.

Also known as: IBRANCE

Avelumab, Palbociclib, and Cetuximab

Cetuximab DRUG

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.

Also known as: ERBITUX

Avelumab, Palbociclib, and Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven squamous cell carcinoma of the head and neck not amenable to curative intent therapy.
• Presence of measurable tumor lesions per RECIST criteria v1.1
• Life expectancy greater than 12 weeks.
• Adequate hematologic, hepatic, and renal function
• Negative serum or urine pregnancy test for women of child bearing potential

You may not qualify if:

• Prior therapy with an EGFR inhibitor or PD-1 or PD-L1 inhibitor in the recurrent or metastatic setting
• Uncontrolled central nervous system metastases (stable metastases permitted)
• Chemotherapy 28 days prior to first administration of study treatment and/or monoclonal antibody ≤8 weeks prior to first administration of study treatment.
• History of other malignancies,
• Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration of \>10 mg/day of prednisone or equivalent)
• Prior organ transplantation
• Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).

Sponsors & Collaborators

• Kathryn Gold: lead
• Pfizer: collaborator

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (1)

• Dennis MJ, Sacco AG, Qi Y, Bykowski J, Pittman E, Chen R, Messer K, Cohen EEW, Gold KA. A phase I study of avelumab, palbociclib, and cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma. Oral Oncol. 2022 Dec;135:106219. doi: 10.1016/j.oraloncology.2022.106219. Epub 2022 Oct 21.

  PMID: 36279618 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Neoplasms

Interventions

avelumab; palbociclib; Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kathryn A Gold, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor of Medicine

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 13, 2018
• Study Start: June 6, 2018
• Primary Completion: February 4, 2020
• Study Completion: December 30, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)