Spots Global Cancer Trial Database for A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma
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Trial Identification
Brief Title: A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma
Official Title: A Multicenter, Randomized, Double Blind, Placebo - Controlled, Phase 3 Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV -Negative Head and Neck Squamous Cell Carcinoma. (FIERCE-HN)
Study ID: NCT06064877
Study Description
Brief Summary: 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.
Detailed Description: This multicenter, randomized, double-blind, placebo-controlled Phase 3 study is designed to compare the efficacy and safety of two dose levels of ficlatuzumab combined with cetuximab (Arm 1 or Arm 2) to a control arm of placebo plus cetuximab (Arm 3) in participants with R/M human papilloma virus (HPV)-negative HNSCC. Eligible participants must have failed prior therapy with an anti-PD-1 \[programmed cell death protein 1\] or PD-L1 \[programmed death ligand 1\] immune checkpoint inhibitor (ICI) and with platinum-based chemotherapy, administered in combination or sequentially. Failure of prior treatment may be due to progression of disease or intolerance to treatment. It is anticipated that the study will enroll approximately 410 participants across 3 arms.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Arizona Cancer Center, Tucson, Arizona, United States
The George Washington University, Washington, District of Columbia, United States
AdventHealth Medical Group Oncology & Hematology at Orlando, Orlando, Florida, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Siteman Cancer Center - Washington University, Saint Louis, Missouri, United States
University of Cincinnati - UC Health Barrett Cancer Center, Cincinnati, Ohio, United States
Ohio State University, James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Oncology Consultants, Houston, Texas, United States
Medical College of Wisconsin - Froedtert Hospital Cancer Center, Milwaukee, Wisconsin, United States
St George Hospital, Kogarah, New South Wales, Australia
St. Vincent's Hospital, Sydney, New South Wales, Australia
Princess Alexandra Hospital, Brisbane, Queensland, Australia
St. John of God Murdoch Hospital, Murdoch, Western Australia, Australia
Princess Margaret Cancer Center - University Health Network, Toronto, Ontario, Canada
NHS Grampian - Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
Contact Details
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