Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma

  • STATUS
    Not Recruiting
  • participants needed
    74
  • sponsor
    University of Arizona
Updated on 2 August 2021
platelet count
calcium
monoclonal antibodies
electrolytes
measurable disease
carcinoma
squamous cell carcinoma
potassium
induction chemotherapy
metastasis
progressive disease
neutrophil count
carboplatin
tumor cells
cetuximab
programmed cell death 1 ligand 1
squamous cell carcinoma of the head and neck
squamous cell carcinoma of head and neck
line of therapy
oropharyngeal
atezolizumab
salvage surgery
nasopharyngeal carcinoma
undifferentiated carcinoma
ficlatuzumab
squamous cell carcinoma of unknown primary

Summary

This randomized phase II trial studies how well ficlatuzumab with or without cetuximab work in treating patients with head and neck squamous cell carcinoma that has come back or spread to other places in the body and resistant to cetuximab treatment. Monoclonal antibodies, such as ficlatuzumab and cetuximab, may block growth signals that lets a tumor cell survive and reproduce, and helps the immune system recognize and fight head and neck squamous cell carcinoma.

Description

PRIMARY OBJECTIVES:

I. To assess the efficacy of ficlatuzumab, with or without concurrent cetuximab, in patients with cetuximab-resistant, recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) as measured by progression-free survival (PFS).

SECONDARY OBJECTIVES:

I. To describe toxicity and patient-reported quality of life. II. To evaluate response rate and overall survival in both treatment arms. III. To evaluate the relationship between clinical outcomes (PFS, response rate [RR]) and candidate tumoral, genomic, peripheral, and immune biomarkers, including: HGF/cMet, EGFR/EGFR, and EGFR/HER2 dimers; mutations in PIK3CA, PTEN, and HRAS; peripheral serum biomarkers including VeriStrat, HGF, soluble HGF, and IL6; peripheral lymphocyte populations; archived and baseline immune infiltrate.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients receive ficlatuzumab intravenously (IV) over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive cetuximab IV over 60 -120 minutes and ficlatuzumab IV over 30-60 minutes every 2 weeks in the absence of disease progression or unaccepted toxicity. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Details
Condition Oropharyngeal Cancer, head and neck cancer, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IV Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Lip and Oral Cavity Squamous Cell Carcinoma, Stage IV Oropharyngeal Squamous Cell Carcinoma, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma, HNSCC, Head and Neck Basaloid Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Unknown Primary Origin, Stage IV Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVB Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVC Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVA Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVB Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVC Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Treatment Cetuximab, laboratory biomarker analysis, questionnaire administration, quality-of-life assessment, Ficlatuzumab
Clinical Study IdentifierNCT03422536
SponsorUniversity of Arizona
Last Modified on2 August 2021

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