Overview
Sponsor-declared trial summary
The target population of the trial consists of patients with locally advanced irresectable or metastatic solid malignancies, such as advanced thyroid cancer, squamous cell carcinoma originating from head and neck region, vulvar or cervix squamous cell carcinoma, and non-small cell lung cancer.
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Feb 2025 → ongoing
- Decision date (initial)
- 2024-09-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
The target population of the trial consists of patients with locally advanced irresectable or metastatic solid malignancies, such as advanced thyroid cancer, squamous cell carcinoma originating from head and neck region, vulvar or cervix squamous cell carcinoma, and non-small cell lung cancer.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041848 | Squamous cell carcinoma of the cervix | 100000004864 |
| 21.1 | PT | 10002240 | Anaplastic thyroid cancer | 100000004864 |
| 26.1 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
| 21.1 | PT | 10071030 | Thyroid cancer stage IV | 100000004864 |
| 26.1 | PT | 10041875 | Squamous cell carcinoma of the vulva | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Eugeniavagen 3
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Robert Bränström
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Robert Bränström
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
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 |
|---|---|---|---|---|---|
| Sweden | 2025-02-10 | 2025-02-27 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-25 | Sweden | Acceptable 2024-09-09
|
2024-09-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-18 | Sweden | Acceptable 2025-01-09
|
2025-01-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-15 | Sweden | Acceptable 2026-03-03
|
2026-03-06 |