Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
53
Countries
3
Sites
6
Intermediate-risk Non-muscle Invasive Bladder Cancer
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Dec 2024 → ongoing
- Decision date (initial)
- 2025-03-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514983-23-01
- WHO UTN
- U1111-1308-6998
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Intermediate-risk Non-muscle Invasive Bladder Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10022877 | Invasive bladder cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Hema Dave
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Hema Dave
Locations
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 19 | 3 |
| Netherlands | Ongoing, recruiting | 2 | 1 |
| Spain | Ongoing, recruiting | 10 | 2 |
| Rest of world
United Kingdom, Canada, United States
|
— | 22 | — |
Investigational sites
Institut Gustave Roussy
Département d'Innovation Thérapeutique et des Essais Précoces, 114 Rue Edouard Vaillant, 94800, Villejuif
CHU Henri Mondor
Service d'Oncologie Médicale - CLIPP, 1 Rue Gustave Eiffel, Maladies Infectieuses & U2TI, Creteil
Centre Hospitalier Universitaire De Lille
Urologie, 1 Place De Verdun, 59000, Lille
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
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 | 2025-05-07 | 2025-09-04 | |||
| Netherlands | 2025-04-04 | 2025-12-09 | |||
| Spain | 2024-12-16 | 2024-12-20 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-21 | Spain | Acceptable 2024-12-13
|
2024-12-13 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2024-12-19 | Acceptable 2024-12-13
|
2025-03-18 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-12-19 | Acceptable 2024-12-13
|
2025-03-31 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-14 | Spain | Acceptable 2025-07-14
|
2025-07-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-30 | Spain | Acceptable 2025-09-09
|
2025-09-09 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-15 | Spain | Acceptable 2025-09-09
|
2025-09-15 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-22 | Acceptable | 2025-10-28 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-19 | Spain | Acceptable 2026-01-16
|
2026-01-16 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-26 | Spain | Acceptable 2026-06-12
|
2026-06-12 |