NCT03534492

Durvalumab Plus Olaparib Administered Prior to Surgery of Resectable Urothelial Bladder Cancer (NEODURVARIB)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Spanish Oncology Genito-Urinary Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Infusion
DRUG	Olaparib	P.O.

Timeline

• Start date: 2018-11-16
• Primary completion: 2020-03-16
• Completion: 2020-03-16
• First posted: 2018-05-23
• Last updated: 2020-04-06

Locations

10 sites across 1 country: Spain