Overview
Sponsor-declared trial summary
Advanced Pancreatic cancer, Unresectable Glioblastoma and Variants, PD-1-exposed Advanced/Met HNSCC, Advanced/Met HNSCC, Advanced/Met NSCLC, Advance/Met RCC, Advanced/Met Gastric or GEJ adenocarcinoma, Ovarian Cancer. TNBC, Advanced Mesothelioma, Advanced Solid tumors(coformulation)
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
- 2 Mar 2020 → 26 Sep 2025
- Decision date (initial)
- 2024-03-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-509542-35-00
- EudraCT number
- 2019-003164-53
- WHO UTN
- U1111-1300-1952
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Pancreatic cancer, Unresectable Glioblastoma and Variants, PD-1-exposed Advanced/Met HNSCC, Advanced/Met HNSCC, Advanced/Met NSCLC, Advance/Met RCC, Advanced/Met Gastric or GEJ adenocarcinoma, Ovarian Cancer. TNBC, Advanced Mesothelioma, Advanced Solid tumors(coformulation)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10025648 | Malignant mast cell tumors unspecified site extranodal and solid organ sites | 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
- Julia Wanda Cohen
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Julia Wanda Cohen
Locations
4 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 3 |
| Greece | Ended | 21 | 2 |
| Poland | Ended | 55 | 2 |
| Spain | Ended | 59 | 2 |
| Rest of world
Israel, Australia, South Africa, Japan, Korea, Republic of, Canada, China, United States
|
— | 329 | — |
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 | 2023-03-17 | 2025-09-17 | 2023-04-04 | 2023-09-19 | |
| Greece | 2020-08-04 | 2025-06-06 | 2020-09-17 | 2023-09-19 | |
| Poland | 2020-03-02 | 2025-09-22 | 2020-06-02 | 2023-09-19 | |
| Spain | 2020-03-05 | 2025-09-23 | 2020-03-09 | 2023-09-19 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-19 | Poland | Acceptable 2024-03-15
|
2024-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-09 | Poland | Acceptable | 2024-06-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-19 | Poland | Acceptable 2024-10-07
|
2024-10-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-03 | Poland | Acceptable 2025-02-24
|
2025-02-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-24 | Acceptable | 2025-03-27 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-27 | Poland | Acceptable | 2025-03-27 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-20 | Poland | Acceptable | 2025-08-20 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-25 | Poland | Acceptable | 2025-08-25 |