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

  • End date
    Jan 26, 2022
  • participants needed
  • sponsor
    Kathryn Gold
Updated on 26 January 2021
monoclonal antibodies
squamous cell carcinoma
kidney function tests
metastatic head and neck squamous cell carcinoma


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.

Condition Squamous Cell Carcinoma of the Head and Neck, Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck
Treatment Cetuximab, Avelumab, Palbociclib
Clinical Study IdentifierNCT03498378
SponsorKathryn Gold
Last Modified on26 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Head and Neck Squamous Cell Carcinoma?
Do you have any of these conditions: Head and Neck Squamous Cell Carcinoma or Squamous Cell Carcinoma of Head and Neck or Squamous Cell Carcinoma of the Head and Neck?
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

Exclusion Criteria

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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