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

Summary

This randomized phase II trial studies how well ficlatuzumab with or without cetuximab works 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.

Conditions

• 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 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 IV Oropharyngeal Squamous Cell Carcinoma
• Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma
• Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
• Stage IVA Nasopharyngeal Keratinizing Squamous Cell Carcinoma
• Stage IVA Oropharyngeal Squamous Cell Carcinoma
• Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma
• Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
• Stage IVB Nasopharyngeal Keratinizing Squamous Cell Carcinoma
• Stage IVB Oropharyngeal Squamous Cell Carcinoma
• Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma
• Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
• Stage IVC Nasopharyngeal Keratinizing Squamous Cell Carcinoma
• Stage IVC Oropharyngeal Squamous Cell Carcinoma
• Head and Neck Cancer
• Oropharyngeal Cancer
• HNSCC
• Stage IV Lip and Oral Cavity Squamous Cell Carcinoma

Interventions

BIOLOGICAL

Cetuximab

Given IV

DRUG

Ficlatuzumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Arizona

  lead OTHER

Principal Investigators

• Julie E. Bauman, MD, MPH · The University of Arizona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-05

Primary Completion

2022-03-29

Completion

2022-04-05

FDA Drug

Yes

Countries

• United States

Study Locations