Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
90
Countries
3
Sites
8
stage II melanoma
Key facts
- Sponsor
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 8 Mar 2024 → ongoing
- Decision date (initial)
- 2025-06-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505945-19-00
- ClinicalTrials.gov
- NCT06240143
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
stage II melanoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Sponsor organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Address
- Plesmanlaan 121
- City
- Amsterdam
- Postcode
- 1066 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Contact name
- Principal Investigator
Public contact point
- Organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Contact name
- Principal Investigator
Locations
3 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 5 | 1 |
| Netherlands | Ongoing, recruiting | 80 | 6 |
| Sweden | Authorised, recruitment pending | 5 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Tuebingen AöR
Department of Dermatology, Liebermeisterstrasse 25, Innenstadt, Tuebingen
Universitair Medisch Centrum Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Academisch Ziekenhuis Leiden
Medical Oncology, Albinusdreef 2, 2333 ZA, Leiden
Universitair Medisch Centrum Utrecht
Medical Oncology, Heidelberglaan 100, 3584 CX, Utrecht
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Amsterdam UMC
Medical Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-03-08 | 2024-03-08 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-18 | Netherlands | Acceptable 2023-11-06
|
2024-02-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-25 | Netherlands | Acceptable 2024-05-17
|
2024-05-17 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-04-10 | 2025-06-13 | ||
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-04-24 | Acceptable 2024-05-17
|
2025-06-25 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-19 | Netherlands | Acceptable 2026-04-20
|
2026-04-20 |