Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Oropharyngeal Cancer
- HNSCC
- Head and Neck Basaloid Carcinoma
- Stage IVB Oropharyngeal Squamous Cell Carcinoma
- Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
- Head and Neck Cancer
- Recurrent Head and Neck Squamous Cell Carcinoma
- Stage IVA Oropharyngeal Squamous Cell Carcinoma
- Stage IVC Nasopharyngeal Keratinizing Squamous Cell Carcinoma
- Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
- Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Stage IVA Nasopharyngeal Keratinizing Squamous Cell Carcinoma
- Recurrent Oropharyngeal Squamous Cell Carcinoma
- Squamous Cell Carcinoma of Unknown Primary Origin
- Stage IV Lip and Oral Cavity Squamous Cell Carcinoma
- Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma
- Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma
- Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
- Stage IVC Oropharyngeal Squamous Cell Carcinoma
- Stage IVB Nasopharyngeal Keratinizing Squamous Cell Carcinoma
- Stage IV Oropharyngeal Squamous Cell Carcinoma
- Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma
- Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03422536
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Julie E. Bauman, MD, MPH The University of Arizona