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.
Who Can Participate?
Eligibility
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 ivy.belskie@duke.edu.
- 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 ivy.belskie@duke.edu.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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.
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Georgia
Beasley
Protocol Number
PRO00110577
NCT ID
NCT03567889
Phase
III
Enrollment Status
OPEN TO ACCRUAL