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Neoadjuvant Durvalumab Alone Versus Durvalumab With Olaparib in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy

NCT04579133 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-06-16

No results posted yet for this study

Summary

This study is a phase II, randomized, open-label, clinical trial including patients with muscle-invasive transitional cell carcinoma of the bladder candidates for radical cystectomy. The study will include patients ineligible for cisplatin.

Patients will be centrally randomized in a 1:1 ratio to receive durvalumab plus olaparib (Arm A) or durvalumab alone (Arm B).

The clinical study´s hypothesis is that for patients with muscle-invasive transitional cell carcinoma of the bladder who are not fit for cisplatin-based neoadjuvant chemotherapy, Durvalumab monotherapy will have a similar efficacy to historical chemotherapy controls and Durvalumab in combination with olaparib will be associated with an even improved efficacy results in terms of pathologic complete response (pCR).

Conditions

Interventions

DRUG

Olaparib

300 mg BID OR 200 mg BID (if glomerular filtration rate \[GFR\] 31 to 50 mL/min)

DRUG

Durvalumab

Durvalumab 1500 mg IV

Sponsors & Collaborators

  • Latin American Cooperative Oncology Group

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-03-01
Completion
2021-03-01

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

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 NCT04579133 on ClinicalTrials.gov