Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
80
Countries
1
Sites
8
High-Risk, Surgically Resectable Melanoma
Key facts
- Sponsor
- Fondazione Melanoma Onlus
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-09-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
High-Risk, Surgically Resectable Melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088049 | Cutaneous melanoma | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fondazione Melanoma Onlus
- Sponsor organisation
- Fondazione Melanoma Onlus
- Address
- Via Mariano Semmola
- City
- Naples
- Postcode
- 80131
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione Melanoma Onlus
- Contact name
- Medical Monitor
Public contact point
- Organisation
- Fondazione Melanoma Onlus
- Contact name
- Medical Monitor
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 80 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Istituto Oncologico Veneto
UOC Oncologia 2, Via Gattamelata 64, 35128, Padova
Fondazione IRCCS Istituto Nazionale Dei Tumori
SS Oncologia Medica Melanomi, Via Giacomo Venezian 1, 20133, Milan
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
SSD di Immunoterapia, Via Piero Maroncelli 40, 47014, Meldola
I.F.O. Istituti Fisioterapici Ospitalieri
UOSD Sarcomi e Tumori Rari, Via Elio Chianesi N 53, 00144, Rome
Istituto Europeo Di Oncologia S.r.l.
Divisione Sviluppo Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Santa Maria Della Misericordia
SC Oncologia Medica, Piazzale Giorgio Menghini 1, 06129, Perugia
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Melanoma. Cancer Immunotherapy and Development Therapeutics Unit, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOC Oncoematologia, Via Sergio Pansini 5, 80131, Naples
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-21 | Italy | Acceptable 2025-09-15
|
2025-09-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-09 | Italy | Acceptable 2026-03-23
|
2026-04-20 |