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Estudo com Atezolizumabe em Carcinoma Urotelial ou Não Urotelial Localmente Avançado ou Metastático do Trato Urinário
A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
Câncer
Detalhes básicos
Patrocinador
Hoffmann-La Roche
Fase
Fase 3
Identificador de estudo
NCT02928406, MO29983, 2016-002625-11
Condição
Urinary Tract Cancer
Título
An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
Resumo do Estudo
This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab.
Critérios de elegibilidade
Todos
≥18 Anos
Não
Critérios de Inclusão
- Participants with histologically documented locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial carcinoma of the urinary tract
- Participants with measurable and/or non-measurable disease according to RECIST v1.1
- Participants must have progressed during or following treatment with at least one prior (and not more than 3) treatments for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
- If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block should be submitted
- Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2
Critérios de Exclusão
- Treatment with more than three prior lines of systemic therapy for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation
- Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were not on active drug in that prior trial are eligible
- Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were in the follow-up phase of that prior trial and had stopped receiving active drug 4 or more weeks before study treatment initiation are eligible
- Malignancies other than the one studied in this protocol within 5 years prior to Cycle 1, Day 1
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
- Significant renal disorder indicating a need for renal transplant
A seguinte informação vem do site ClinicalTrials.gov publicamente disponível e foi editada para leigos.
As informações abaixo se origina a partir do site ClinicalTrials.gov publicamente disponível e não foi modificado.
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For the latest version of this information please go to www.forpatients.roche.com
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