NCT03567889 · Philogen S.p.A.
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C Melanoma Patients
(NeoDREAM)
What this study is about
The trial aims to evaluate the effectiveness 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 the usual treatment (surgery and adjuvant therapy).
View original scientific description
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).
Interventions
DRUG
Daromun
Patients will receive intratumoral administrations into injectable cutaneous, subcutaneous, and nodal tumors of Daromun once weekly for up to 4 weeks.
PROCEDURE
Surgery
Patients will receive surgery.
DRUG
Adjuvant therapy
Patients will receive adjuvant therapy at the investigator's discretion following the surgery.
Primary outcome measures
Recurrence Free Survival (RFS)
Time frame: From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months.
Recurrence Free Survival (RFS) in a time-to-event analysis in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus the surgery and adjuvant therapy control group (Arm 2). Analysis will be performed for the "Intention To Treat" population.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of clinical stage IIIB and IIIC (AJCC v7) metastatic melanoma, eligible for complete surgical resection of all metastases (surgically resectable). 2. Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm. 3. Males or females, age ≥ 18 years. 4. ECOG Performance Status/WHO Performance Status ≤ 1. 5. Life expectancy of \> 24 months. 6. Absolute neutrophil count \> 1.5 x 109/L. 7. Hemoglobin \> 9.0 g/dL. 8. Platelets \> 100 x 109/L. 9. Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/dl). 10. ALT and AST ≤ 2.5 x the upper limit of normal (ULN). 11. Serum creatinine \< 1.5 x ULN . 12. LDH serum level ≤ 1.5 x ULN. 13. Documented negative test for HIV, HBV and HCV. For HBV serology, the determination of HBsAg, and anti-HBcAg Ab is
Where
- Phoenix, Arizona
- La Jolla, California
- Orange, California
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Iowa City, Iowa
- Rochester, Minnesota
- New Brunswick, New Jersey
- New York, New York
- Ney York, New York
- Durham, North Carolina
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 17, 2025 · Source of record for eligibility and locations