Head and Neck Cancer Clinical Trial
Official title:
A Randomized, Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Proxinium Plus Best Supportive Care Versus Best Supportive Care Alone in Patients With Advanced SCCHN Who Have Received at Least One Anti-cancer Treatment Regimen for Advanced Disease
The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.
Head and neck cancer is a general description of a disease that includes several types of
soft tissue carcinomas that develop in the head and neck regions.
Proxinium is a recombinant fusion protein that binds to the epithelial cell adhesion
molecule (Ep-CAM) that is highly expressed on squamous cell carcinomas of the head and neck
(SCCHN). Proxinium is administered via intratumoural injection.
The primary objective of the study is to compare the overall survival time for patients
treated with intratumourally injected Proxinium plus BSC versus BSC alone. Secondary
objectives of the study include comparison of locoregional tumour control, local
progression-free survival, symptomatic benefit and safety profile in patients who receive
Proxinium plus BSC versus patients who receive BSC
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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