Neoadjuvant Daromun + Surgery for Melanoma
(NeoDREAM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Daromun (also known as Nidlegy) before surgery for individuals with Stage IIIB/C melanoma, a type of skin cancer. The goal is to determine if this approach can prevent cancer recurrence more effectively than the standard treatment, which involves surgery followed by additional therapy. The trial includes two groups: one will receive Daromun before surgery, and the other will proceed directly to surgery. It suits those with melanoma that can be surgically removed and have a visible tumor of at least 10 mm that can be injected. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients access to potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial requires that you do not take corticosteroids or other immunosuppressant drugs on a long-term basis. If you are on these medications, you may need to stop them before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Daromun, when used before melanoma surgery, is mostly safe for patients. Studies have found that most side effects are mild and occur at the application site. About 12.7% of patients experienced more serious side effects, though these were uncommon. No severe immune-related side effects were reported, indicating that Daromun is generally well-tolerated.12345
Why are researchers excited about this study treatment for melanoma?
Most treatments for melanoma focus on surgery followed by adjuvant therapies like chemotherapy or radiation to eliminate any remaining cancer cells. But Daromun is unique because it combines two cytokines, IL-2 and TNF, in a single formulation designed to stimulate the immune system directly against the tumor. Researchers are excited about Daromun because it targets melanoma cells more precisely and may enhance the body's natural immune response, potentially improving the effectiveness of surgery and reducing the chance of cancer recurrence.
What evidence suggests that Daromun plus surgery and adjuvant therapy could be effective for melanoma?
This trial will compare the use of Daromun plus surgery and adjuvant therapy with surgery and adjuvant therapy alone. Research has shown that using Daromun before surgery can help people with locally advanced melanoma live longer without cancer recurrence. In one study, patients who received Daromun had a 41% lower chance of cancer returning or dying compared to those who only had surgery. Another study found that Daromun also reduced the risk of cancer spreading to other parts of the body. These findings suggest that Daromun can effectively improve outcomes in melanoma patients.13678
Who Is on the Research Team?
Jonathan Zager, MD
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Stage IIIB/C melanoma that can be surgically removed. They must have a life expectancy over 24 months, good performance status, and normal organ function tests. Women of childbearing age must test negative for pregnancy and use effective contraception. Exclusions include other cancer types, uncontrolled diseases, recent major trauma or surgery, breastfeeding women, certain drug treatments within specific timeframes before enrollment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in Arm 1 receive Daromun neoadjuvant treatment for 4 weeks, followed by surgery within a maximum of another 4 weeks and adjuvant therapy. Arm 2 receives direct surgery within 4 weeks from randomization, followed by adjuvant therapy.
Follow-up
Participants are monitored for recurrence-free survival and overall survival, with follow-up assessments up to five years after randomization.
Extended Follow-up
Survival information is collected for an additional year after the initial follow-up period.
What Are the Treatments Tested in This Trial?
Interventions
- Adjuvant therapy
- Daromun
- Surgery
Daromun is already approved in European Union for the following indications:
- Locally advanced, fully resectable melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Philogen S.p.A.
Lead Sponsor