Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
136
Countries
4
Sites
13
Advanced Urothelial Carcinoma
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
- 22 May 2023 → 24 Feb 2026
- Decision date (initial)
- 2024-02-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506385-30-00
- EudraCT number
- 2022-001371-14
- WHO UTN
- U1111-1293-7564
- ClinicalTrials.gov
- NCT05845814
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Urothelial Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10064467 | Urothelial carcinoma | 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
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Abhi Bavle
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Abhi Bavle
Locations
4 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 15 | 5 |
| Italy | Ended | 7 | 3 |
| Netherlands | Ended | 17 | 3 |
| Spain | Ended | 10 | 2 |
| Rest of world
Taiwan, Korea, Republic of, Israel, United Kingdom, Chile, United States, Canada, Australia
|
— | 87 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
service de cancerologie, 20 Rue Leblanc, 75015, Paris
Centr Georges Francois Leclerc
Centre de Recherche Clinique, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier Universitaire De Toulouse
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Bordeaux
service d'oncologie Medicale, 1 Rue Jean Burguet, 33000, Bordeaux
Centre Hospitalier Lyon Sud
service d'oncologie Medicale, Chemin Du Grand Revoyet, 69310, Pierre Benite
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Clinical Trials, Via Mariano Semmola 52, 80131, Naples
Ospedale San Raffaele S.r.l.
Medical Oncology, Via Olgettina 60, 20132, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Medical Oncology 1, Via Giacomo Venezian 1, 20133, Milan
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
University Hospital Maastricht
Medical Oncology, P Debyelaan 25, 6229 HX, Maastricht
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 | 2023-07-27 | 2026-01-19 | 2023-08-02 | 2024-02-09 | |
| Italy | 2023-12-29 | ||||
| Netherlands | 2023-05-22 | 2026-02-24 | 2023-06-23 | 2024-02-09 | |
| Spain | 2023-10-13 | 2025-07-15 | 2023-11-15 | 2024-02-09 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-21 | Netherlands | Acceptable 2024-02-07
|
2024-02-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-22 | Netherlands | Acceptable with conditions 2024-06-24
|
2024-06-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-04 | Netherlands | Acceptable 2024-10-15
|
2024-10-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-28 | Netherlands | Acceptable 2025-04-17
|
2025-04-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-29 | Netherlands | Acceptable 2025-09-15
|
2025-09-16 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-04 | Netherlands | Acceptable 2025-09-15
|
2025-11-04 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-17 | Netherlands | Acceptable 2026-03-16
|
2026-03-16 |