Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
54
Countries
1
Sites
1
Metastatic uveal melanoma
Key facts
- Sponsor
- Institut Curie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Jul 2022 → ongoing
- Decision date (initial)
- 2024-07-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514657-30-00
- EudraCT number
- 2021-002248-60
- ClinicalTrials.gov
- NCT05282901
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic uveal melanoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Curie
- Sponsor organisation
- Institut Curie
- Address
- 26 Rue D Ulm
- City
- Paris
- Postcode
- 75005
- Country
- France
Scientific contact point
- Organisation
- Institut Curie
- Contact name
- Manuel RODRIGUES
Public contact point
- Organisation
- Institut Curie
- Contact name
- Manuel RODRIGUES
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 54 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| France | 2022-07-07 | 2022-07-07 | 2024-10-22 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-21 | France | Acceptable 2024-07-10
|
2024-07-25 |