Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
156
Countries
4
Sites
30
Resected stage IIB, IIC, or III melanoma requiring adjuvant treatment
Key facts
- Sponsor
- H e x a l AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Feb 2026 → ongoing
- Decision date (initial)
- 2026-05-07
- 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
Resected stage IIB, IIC, or III melanoma requiring adjuvant treatment
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10025650 | Malignant melanoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
H e x a l AG
- Sponsor organisation
- H e x a l AG
- Address
- Industriestrasse 25
- City
- Holzkirchen
- Postcode
- 83607
- Country
- Germany
Scientific contact point
- Organisation
- H e x a l AG
- Contact name
- Biosimilar Clinical Trials Information Point
Public contact point
- Organisation
- H e x a l AG
- Contact name
- Biosimilar Clinical Trials Information Point
Locations
4 EU/EEA countries · 30 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Authorised, recruitment pending | 6 | 3 |
| Italy | Authorised, recruiting | 8 | 4 |
| Romania | Authorised, recruiting | 15 | 1 |
| Spain | Ongoing, recruiting | 54 | 22 |
| Rest of world
Moldova, Republic of, Georgia, India
|
— | 73 | — |
Investigational sites
St. Luke's Hospital S.A.
Oncology Department, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Theageneio Cancer Hospital
Oncology Department, Simeonidi Alex 2, 546 39, Thessaloniki
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O. Oncologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Unita Sanitaria Locale Della Romagna
U.O. Oncologia, Dipartimento Onco-Ematologico, Viale Vincenzo Randi 5, 48121, Ravenna
Azienda Ospedaliero Universitaria Delle Marche
Dipartimento Di Medicina Interna – Sod Clinica Oncologica, Via Conca 71, 60126, Ancona
Azienda Ospedaliero-Universitaria Senese
Uoc Immunoterapia Oncologica, Viale Mario Bracci 2, 53100, Siena
Hospital San Pedro De Alcantara
Oncologia Medica, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario 12 De Octubre
Oncologia Medica, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario De Badajoz
Oncologia Medica, Avenida Elvas S/n, 06006, Badajoz
Hospital De La Santa Creu I Sant Pau
Oncologia Medica, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario De Torrejon
Oncologia Medica, Calle De Mateo Inurria 1, 28850, Torrejon De Ardoz
Hospital Clinic De Barcelona
Oncologia Medica, Calle Villarroel 170, 08036, Barcelona
Complejo Hospitalario Universitario Insular Materno Infantil
Oncologia Medica, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitario Regional De Malaga
Oncologia Medica, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Marques De Valdecilla
Oncologia Medica, Avenida Valdecilla Sn, 39008, Santander
Micancer Center S.L.P.
Oncologia Medica, Avinguda De Prat De La Riba 79, 25004, Lleida
Hospital Universitario De Canarias
Oncologia Medica, Carretera Ofra S/N, 38320, San Cristobal De La Laguna
Hospital Jerez Puerta Del Sur Grupo Hla S.A.
Oncologia Medica, Avenida De La Puerta Del Sur Sn, 11408, Jerez De La Frontera
Fundacion Instituto Valenciano De Oncologia
Oncologia Medica, Calle Professor Beltran Baguena 8, 46009, Valencia
MD Anderson Cancer Center
Oncologia Medica, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Beata Maria Ana
Oncologia Medica, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitari Dexeus Grupo Quironsalud
Oncologia Medica, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Central De Asturias
Oncologia Medica, Avenida De Roma S/n, 33011, Oviedo
Parc Tauli Hospital Universitari
Oncologia Medica, Parc Del Tauli 1, 08208, Sabadell
Hospital Universitario Quironsalud Madrid
Oncologia Medica, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
University Hospital Virgen Del Rocio S.L.
Oncologia Medica, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Clinico San Cecilio
Oncologia Medica, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Universitario Puerta De Hierro De Majadahonda
Oncologia Medica, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2026-05-05 | ||||
| Romania | 2026-03-13 | ||||
| Spain | 2026-02-10 | 2026-02-18 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-19 | Spain | Acceptable 2026-01-26
|
2026-01-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-17 | Spain | Acceptable 2026-01-26
|
2026-03-17 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2026-03-26 | Acceptable 2026-01-26
|
2026-05-07 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-17 | Spain | Acceptable | 2026-05-25 |