Neoadjuvant Daromun + Surgery (Melanoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an investigational called Daromun (the study drug) is a safe and effective treatment for melanoma. We want to know if treating people with the drug before surgery to remove tumors can lower the chance of cancer recurrence.

What is the Condition Being Studied?

Stage IIIB and IIIC Metastatic Melanoma

Who Can Participate in the Study?

Adults ages 18+ who:

- Are diagnosed with stage IIIB or IIIC metastatic melanoma

- Are eligible to have surgical removal of all metastases

- Have injectable cutaneous, subcutaneous, or nodal lesions

For more information about who can join this study, please contact the study team at

Age Group

What is Involved?

If you choose to join this study, you will go through a 2-week long screening process to see if you are eligible.

During screening, you will:

- Have a physical exam

- Answer questionnaires

- Have blood draws

- Give urine samples

- Have different images of your tumor(s) taken (ultrasound, CT, PET/CT, MRI)

If you are found to be eligible, you will proceed to the study drug period. During this period, you will:

- Be randomly assigned (50/50 chance) to 1 of 2 arms in the study

-- Arm 1: the study drug plus surgery and adjuvant therapy (the study doctor's choice from a pre-approved list)

-- Arm 2: surgery and adjuvant therapy (the study doctor's choice from a pre-approved list)

The study drug consists of two recombinantly produced, fully human fusion proteins named L19IL2 and L19TNF. It will be administered directly into your tumors each week for 4 weeks before your surgery if you are assigned to Arm 1 of the study.

Study Details

Full Title
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
Principal Investigator
Surgical Oncologist
Protocol Number
IRB: PRO00110577
NCT: NCT03567889
Phase III
Enrollment Status
Open for Enrollment