A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma

The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and/or overall survival.

Trial Details

NCT ID
NCT06064877
Phase
PHASE3
Sponsor
AVEO Pharmaceuticals, Inc.
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • Ficlatuzumab
  • Cetuximab
  • Placebo
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Westwood, Los Angeles, California, United States|34.05612,-118.43063
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637

Key Eligibility Criteria

  • Male or female and ≥ 18 years of age
  • Histologically and/or cytologically confirmed primary diagnosis of R/M HNSCC
  • Participants with oropharyngeal cancer will be required to have proof of p16 negative status submitted on the basis of a pathology report
  • At least 1 measurable lesion by contrast CT or MRI scan according to RECIST v.1.1. Such lesions must not have been previously irradiated; if the me…

For full eligibility, visit ClinicalTrials.gov.

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