Cancer Type: Cutaneous
Study Type: Treatment
Phase: Phase III
Principal Investigator: Zager, Jonathan
An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage IIIB/C Melanoma Patients
The purpose of this clinical study is to test efficacy of Daromun neoadjuvant treatment followed by surgery to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma participants with respect to the standard of care (surgery alone).
Primary Objective: Efficacy of Daromun neoadjuvant treatment followed by surgery to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery alone). Secondary Objectives: The key secondary objective of the study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery improves in a statistically significant manner the overall survival (OS) of patients with resectable Stage IIIB or C melanoma patients with respect to the standard of care (surgery alone). Other secondary objectives include improvement of RFS as determined by the local investigator, local recurrence-free survival (LRFS) and distant metastasis-free survival (DMFS) as well as demonstration of safety and tolerability of the Daromun treatment.
Daromun (); Not Applicable ()
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