Neoadjuvant Daromun + Surgery (Melanoma)

Neoadjuvant Daromun + Surgery (Melanoma)

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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.

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?

Description

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 get a random assignment (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 Enrollment
ClinicalTrials.gov