Overview
Sponsor-declared trial summary
Advanced, relapsed Clear Cell Renal Cell Carcinoma
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Jan 2021 → 13 Feb 2026
- Decision date (initial)
- 2024-06-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513379-41-00
- EudraCT number
- 2020-004383-25
- ClinicalTrials.gov
- NCT04895748
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced, relapsed Clear Cell Renal Cell Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10038396 | Renal carcinoma recurrent | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
3 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 10 | 1 |
| France | Ended | 12 | 1 |
| Spain | Ended | 6 | 1 |
| Rest of world
Japan, Singapore, United States
|
— | 122 | — |
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 |
|---|---|---|---|---|---|
| Czechia | 2022-04-06 | 2022-04-06 | 2023-09-22 | ||
| France | 2021-01-26 | 2021-01-26 | 2023-09-22 | ||
| Spain | 2022-04-19 | 2022-04-19 | 2023-09-22 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 3 · Art. 38 CTR
Temporary halt TH-31191
- Halt date
- 2023-09-22
- Member states concerned
- Czechia
- Publication date
- 2024-06-25
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-31195
- Halt date
- 2023-09-22
- Member states concerned
- Spain
- Publication date
- 2024-06-25
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-31193
- Halt date
- 2023-09-22
- Member states concerned
- France
- Publication date
- 2024-06-25
- Reason
- Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-02 | Czechia | Acceptable 2024-06-11
|
2024-06-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-26 | Czechia | Acceptable 2024-11-29
|
2024-12-03 |