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

Sponsor
Spanish Oncology Genito-Urinary Group
Study ID
NCT03534492
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Nov 16, 2018
Status verified
Apr 2020
Primary completion
Mar 16, 2020
Completion
Mar 16, 2020

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab plus Olaparib
    Durvalumab 1500 mg every 4 weeks for up to a maximum of 2 months (up to 2 doses/cycles) plus Olaparib 300 mg b.i.d. up to 56 days (2 cycles of 28 days each cycle).

Primary Outcome Measure

Impact of neoadjuvant treatment with durvalumab plus olaparib in the molecular profile of resectable urothelial bladder cancer (Pathological complete response rate (pCRR)) [ Time Frame: 24 weeks ]

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