Actively Recruiting
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
Led by Philogen S.p.A. · Updated on 2025-12-17
186
Participants Needed
37
Research Sites
688 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with clinical stage IIIB, IIIC, or IIID melanoma that can be fully removed by surgery
- Have measurable disease with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion 10 mm or larger, or multiple injectable lesions with a combined size of 10 mm or larger
- Prior treatments allowed if stopped at least 6 weeks before and side effects are mild (Grade 1 or less)
- Male or female aged 18 years or older
- ECOG or WHO performance status of 0 or 1
- Life expectancy greater than 24 months
- Absolute neutrophil count above 1.5 x 10^9/L
- Hemoglobin above 9.0 g/dL
- Platelet count above 100 x 10^9/L
- Total bilirubin 30 micromol/L or less
- ALT and AST levels up to 2.5 times the upper normal limit
- Serum creatinine less than 1.5 times the upper normal limit
- LDH serum level up to 1.5 times the upper normal limit
- Negative tests for HIV, HBV, and HCV with specific HBV serology requirements
- All acute side effects from prior therapy resolved to mild levels (Grade 1 or less)
- Women of childbearing potential must have negative pregnancy tests and use effective contraception from screening until 3 months after last study drug
- Male patients with partners of childbearing potential must use two forms of contraception from screening until 3 months after last study drug
- Signed informed consent
- Willingness and ability to comply with study visits and procedures
You will not qualify if you...
- Diagnosis of uveal or mucosal melanoma
- Evidence of distant metastases at screening
- Other cancers except certain treated types like cervical carcinoma in situ or basal cell carcinoma unless treated over 5 years ago
- Active infections or severe diseases posing risk or interfering with study
- Acute or recent heart issues within the past year
- Uncontrolled arrhythmias or heart failure above Grade II
- Left ventricular ejection fraction 50% or less or significant ECG/echocardiogram abnormalities
- Uncontrolled high blood pressure
- Severe diabetic eye disease
- Active autoimmune disease
- History of organ or stem cell transplant
- Recent major trauma or surgery within 4 weeks prior to enrollment
- Known allergy to study drugs or components
- Breastfeeding women
- Recent anti-tumor therapy or monoclonal antibodies within specified timeframes before enrollment
- Planned growth factor or immunomodulatory treatment within 7 days before enrollment
- Long-term corticosteroid or immunosuppressant use unless approved case by case
- Any condition that could prevent following the study protocol
- Previous enrollment and randomization in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Active, Not Recruiting
3
UC Irvine Health-Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868-3201
Active, Not Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Winship Cancer Institute, Emory university
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Rush University Medical Center
Chicago, Illinois, United States, 60612
Active, Not Recruiting
7
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Active, Not Recruiting
8
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Rutgers Cancer Institute, 195 Little Albany Street
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
10
Ambulatory Care Center at NYC Langarone Health
New York, New York, United States, 10016
Active, Not Recruiting
11
Memorial Sloan Kettering Cancer Center - Main Campus
Ney York, New York, United States, 10065
Actively Recruiting
12
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
13
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
14
St. Luke's Cancer Center, Clinical Trial, 3rd floor, 1600 St. Luke's Blvd.
Easton, Pennsylvania, United States, 18045
Active, Not Recruiting
15
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
16
Fox Chase Cancer Center 333 Cottman Avenue
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
17
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Actively Recruiting
18
Huntsman Cancer Institute, University of Utah 2000 Circle of Hope
Salt Lake City, UT, Utah, United States, 84112
Actively Recruiting
19
VCU - McGlothlin Medical Education Center
Richmond, Virginia, United States, 980037
Actively Recruiting
20
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
21
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08025
Actively Recruiting
22
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
23
Hospital Clinic Barcelona
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
24
El Hospital Universitario De Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Canarie, Spain, 35010
Actively Recruiting
25
Fundacion Onkologikoa Fundazioa
Donostia / San Sebastian, Gipuzkoa, Spain, 20014
Actively Recruiting
26
MD Anderson Cancer Center
Madrid, Madrid, Spain, 28033
Active, Not Recruiting
27
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
28
Hospital Universitario Regional de Málaga
Málaga, Malaga, Spain, 29010
Actively Recruiting
29
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, Spain, 30120
Actively Recruiting
30
Hospital Universitario Virgen De La Macarena
Seville, Sevilla, Spain, 41009
Active, Not Recruiting
31
Hospital General Universitario de Valencia
Valencia, Spain
Actively Recruiting
32
Universitätsspital Basel
Basel, Basel, Switzerland, 4031
Active, Not Recruiting
33
Istituto Oncologico della Svizzera Italiana
Bellinzona, Bellinzona, Switzerland, 6500
Actively Recruiting
34
Insel Gruppe AG
Bern, Canton of Bern, Switzerland, 3010
Active, Not Recruiting
35
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland, 1205
Active, Not Recruiting
36
Kantonsspital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
37
Universitätsspital Zürich (USZ)
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
Research Team
S
Sheila Dakhel, PhD
CONTACT
C
Concetta Aulicino
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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