Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
67
Countries
1
Sites
2
Endometrial 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
- 11 Jul 2025 → ongoing
- Decision date (initial)
- 2025-04-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516870-31-00
- WHO UTN
- U1111-1311-2807
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Endometrial Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10008226 | Cervical adenosquamous carcinoma | 10029104 |
| 21.0 | LLT | 10056044 | Oesophageal squamous cell carcinoma cervical stage unspecified | 10029104 |
| 20.0 | PT | 10005003 | Bladder cancer | 100000004864 |
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 25.1 | LLT | 10007342 | Carcinoma endometrial | 10029104 |
| 26.1 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
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
- Katie Maurer
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Katie Maurer
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 21 | 2 |
| Rest of world
United States, Israel
|
— | 46 | — |
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-07-11 | 2025-07-23 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-13 | Netherlands | Acceptable 2025-04-07
|
2025-04-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-30 | Netherlands | Acceptable 2025-05-20
|
2025-06-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-07 | Netherlands | Acceptable | 2025-07-23 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-05 | Netherlands | Acceptable | 2025-09-05 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-05 | Netherlands | Acceptable | 2025-09-05 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-05 | Netherlands | Acceptable | 2025-09-05 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-23 | Netherlands | Acceptable 2026-05-28
|
2026-05-28 |