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Clinical Trial Details

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Brief Title A Phase III Study of Atezolizumab Treatment Versus Observation as Adjuvant Therapy in Patients With PD-L1 Positive, High Risk Muscle Invasive Bladder Cancer After Cystectomy [IMvigor010]
Official Title A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With PD-L1-Selected, High-Risk Muscle-Invasive Bladder Cancer After Cystectomy
Principal Investigator O'Donnell, Peter
Brief Summary This study is to evaluate the efficacy and safety of adjuvant treatment with Atezolizumab compared with observation in participants with PD-L1-selected muscle-invasive bladder cancer (MIBC) who are at high risk for recurrence following cystectomy.
Gender Both
Ages 18 Years
Enrollment 440
Accepts Healthy Volunteers No
Lead Sponsor Hoffmann-La RocheIndustry
Collaborator
Study Design Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 3
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Bladder Cancer, Cancer
Detail for Health Professional (on clinicaltrials.gov)
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