OncoMatch/Clinical Trials/NCT03567889
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
Is NCT03567889 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Daromun and Adjuvant therapy for melanoma stage iiib.
Treatment: Daromun · Adjuvant therapy — 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/D melanoma patients with respect to the standard of care (surgery and adjuvant therapy).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Melanoma
Disease stage
Required: Stage IIIB, IIIC, IIID
Performance status
ECOG/WHO 0–1
ECOG Performance Status/WHO Performance Status ≤ 1
Prior therapy
Cannot have received: anti-tumor therapy
Exception: small surgery
Anti-tumor therapy (except small surgery) within 4 weeks before enrollment
Cannot have received: monoclonal antibody for biological therapy
Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before enrollment
Cannot have received: growth factors or immunomodulatory agents
Planned administration of growth factors or immunomodulatory agents within 7 days before enrollment
Lab requirements
Blood counts
Absolute neutrophil count > 1.5 x 10^9/L; Hemoglobin > 9.0 g/dL; Platelets > 100 x 10^9/L
Kidney function
Serum creatinine < 1.5 x ULN
Liver function
Total bilirubin ≤ 30 μmol/L (or ≤ 2.0 mg/dl); ALT and AST ≤ 2.5 x ULN
Cardiac function
LVEF > 50%; no abnormalities on baseline ECG/Echocardiogram considered clinically significant; no inadequately controlled arrhythmias; no heart insufficiency (> Grade II, NYHA criteria); no history within last year of acute or subacute coronary syndromes
Absolute neutrophil count > 1.5 x 10^9/L. Hemoglobin > 9.0 g/dL. Platelets > 100 x 10^9/L. Total bilirubin ≤ 30 μmol/L (or ≤ 2.0 mg/dl). ALT and AST ≤ 2.5 x ULN. Serum creatinine < 1.5 x ULN. LVEF ≤ 50% and/or abnormalities observed during baseline ECG and Echocardiogram investigations that are considered as clinically significant by the investigator.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Hospital · Phoenix, Arizona
- UC San Diego Moores Cancer Center · La Jolla, California
- UC Irvine Health-Chao Family Comprehensive Cancer Center · Orange, California
- Moffitt Cancer Center · Tampa, Florida
- Winship Cancer Institute, Emory university · Atlanta, Georgia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03567889 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-tumor therapy, monoclonal antibody for biological therapy, growth factors or immunomodulatory agents disqualifies patients from enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IIID is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages