OncoMatch/Clinical Trials/NCT03567889
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
Is NCT03567889 recruiting? Yes, currently enrolling (May 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
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 →
Could you qualify for this trial?
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