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Brief Title: Durvalumab Plus Olaparib Administered Prior to Surgery of Resectable Urothelial Bladder Cancer (NEODURVARIB)
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.
Study ID: NCT03534492
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
ICO Badalona, Badalona, Barcelona, Spain
Clinica IMQ Zorrotzaurre, Bilbao, , Spain
Hospital San Pedro de Alcántara, Cáceres, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital Ramón Y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hopsital Universitario Madrid Sanchinarro (CIOCC), Madrid, , Spain
Hospital de Navarra, Pamplona, , Spain
Hospital Virgen Macarena, Sevilla, , Spain
Name: Jesús García-Donas, MD PhD
Affiliation: Centro Integral Oncológico Clara Campal
Role: PRINCIPAL_INVESTIGATOR
Name: Juan F Rodriguez-Moreno, MD
Affiliation: Centro Integral Oncológico Clara Campal
Role: PRINCIPAL_INVESTIGATOR