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

NCT03534492 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-04-06

No results posted yet for this study

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

Interventions

DRUG

Durvalumab

Infusion

DRUG

Olaparib

P.O.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Sistemas Genómicos

    collaborator UNKNOWN

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Spanish Oncology Genito-Urinary Group

    lead OTHER

Principal Investigators

  • Jesús García-Donas, MD PhD · Centro Integral Oncológico Clara Campal

  • Juan F Rodriguez-Moreno, MD · Centro Integral Oncológico Clara Campal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-16
Primary Completion
2020-03-16
Completion
2020-03-16

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534492 on ClinicalTrials.gov