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Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients

NCT03799835 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 517

Last updated 2024-12-11

No results posted yet for this study

Summary

This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease.

The primary objective is to evaluate the efficacy of atezolizumab as measured by Event-Free survival.

Conditions

Interventions

DRUG

BCG

Intravesical administration OncoTice wil be used only under two conditions : BCG Medac® unavailable and the patient has received at minimum one instillation of BCG Medac®

DRUG

Atezolizumab

IV perfusion

Sponsors & Collaborators

Principal Investigators

  • Morgan Roupret, MD-PHD · Hôpital Pitié-Salpétrière

  • Yohann Loriot, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2025-06-30
Completion
2028-10-31

Countries

  • Belgium
  • France
  • 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 NCT03799835 on ClinicalTrials.gov