Neoadjuvant Daromun + Surgery for Melanoma
(NeoDREAM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to evaluate 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).
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 Neoadjuvant Daromun + Surgery for Melanoma safe for humans?
The safety of neoadjuvant therapies, including those involving immune checkpoint inhibitors like nivolumab, has been studied in melanoma, showing some treatment-related side effects. Surgical complications and management of adverse events are important considerations, but ongoing research aims to ensure these treatments are safe and effective.12345
What makes the treatment Daromun + Surgery unique for melanoma?
Daromun + Surgery is unique because it combines a neoadjuvant (pre-surgery) approach with surgery, aiming to shrink the tumor before removal, which is different from traditional treatments that often involve surgery first. This approach is part of a new wave of treatments that use systemic therapies to improve surgical outcomes and potentially reduce the risk of cancer returning.23678
What evidence supports the effectiveness of the neoadjuvant treatment for melanoma?
Research shows that neoadjuvant therapy, which is treatment given before surgery, can improve outcomes for patients with melanoma by making tumors more operable and potentially improving survival rates. Studies have found that using drugs like nivolumab and pembrolizumab before surgery can lead to high response rates, including complete responses, in some patients.237910
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