Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-25 @ 1:47 PM
Study NCT ID:
NCT03534492
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2018-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Durvalumab Plus Olaparib Administered Prior to Surgery of Resectable Urothelial Bladder Cancer (NEODURVARIB)
Sponsor:
Spanish Oncology Genito-Urinary Group
Organization:
Study Overview
Official Title:
Impact of the Combination of Durvalumab (MEDI4736) Plus Olaparib (AZD2281) Administered Prior to Surgery in the Molecular Profile of Resectable Urothelial Bladder Cancer.
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEODURVARIB
Brief Summary:
The standard of care for muscle-invasive bladder cancer (MIBC) is radical cystectomy, which is rarely curative. Platinum-based neoadjuvant chemotherapy is associated with an improvement in Overall Survival (OS), but only a few patients can benefit from this approach. Therefore, new neoadjuvant treatments are required for muscle- invasive bladder cancer. In this study it will be explored the activity of durvalumab plus olaparib in advanced Transitional Cell Carcinoma of the Bladder and therefore may have beneficial outcomes in the neoadjuvant setting. Adverse events associated with durvalumab and olaparib is one of the potential risks in this study. Participation in this trial, in which 6-8 weeks of preoperative treatment will be administered, is not expected to result in delays of surgery for participants. It is not foreseen that treatment with durvalumab and olaparib has a relevant impact on operability or increases the risks associated with surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-002765-22 | EUDRACT_NUMBER | None | View |