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, United States, Canada
|
— | 22 | — |
Investigational sites
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
Institut Gustave Roussy
Département d'Innovation Thérapeutique et des Essais Précoces, 114 Rue Edouard Vaillant, 94800, Villejuif
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
8 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 |