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An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients

The purpose of this study is to test the 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 melanoma patients with respect to the standard of care (surgery and adjuvant therapy)

• Blood collection for laboratory tests • CT/MRI/PET/CT scans • ECG • Take study drug • Tumor assessment

Joseph Drabick
Laurie ONeal - at or 717-531-0003, ext=343429

18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Diagnosis of clinical stage IIIB and IIIC (AJCC v7) metastatic melanoma, eligible for complete surgical resection of all metastases (surgically resectable).
Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion
Males or females, age ≥ 18 years
ECOG Performance Status/WHO Performance Status ≤ 1.
Life expectancy of > 24 months

Exclusion Criteria:
Uveal melanoma or mucosal melanoma
Evidence of distant metastases at screening
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ
Presence of active infections
History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris
Experimental drug compared to an approved drug
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Location Contacts
Hershey, PA ,