Protocol No.

137904 (PH-L19IL2TNF-01/18)

Principal Investigator

Asare, Elliot

Phase

III

Age Group

Adult

ClinicalTrials.Gov

NCT03567889 (Click to jump to clinicaltrials.gov)

Eligibility Detail

Eligibility Criteria.pdf

Title

Open-Label, Randomized, Controlled Multicenter Study of the Efficacy of Daromun Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients

Objective

• Efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C/D melanoma patients with respect to the standard of care (surgery and adjuvant therapy).

• The key secondary objective of the study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery and adjuvant therapy 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 and adjuvant therapy).
• Other secondary objectives include improvement of RFS and EFS  as determined by the local investigator and,  pathological responses (categorized int0 p Complete Response, p near-Complete Response, p Partial Response, p Non Response, according to INMC criteria) assessed at time of surgical resection, as well as demonstration of safety and tolerability of the Daromun treatment.

• Investigate efficacy of the neoadjuvant Daromun treatment by:
  • Local recurrence-free survival (LRFS)
  • Distant metastasis-free survival (DMFS)
  • Study of blood biomarkers 
  • RFS analysis according to prior Immune Checkpoint Inhibitor (ICI) treatment resistance

Applicable Disease Sites

Melanoma

Participating Institutions

Huntsman Cancer Institute

Status

Open