A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

  • Câncer
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Status do estudo:

Concluído

Este estudo é realizado em
Cidades
  • Ceará
  • Paraná
  • Rio Grande do Sul
  • São Paulo
Identificador de estudo:

NCT02928406 2016-002625-11 MO29983

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      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.

      Results Disclaimer

      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.

      Hoffmann-La Roche Patrocinador
      Phase 3 Fase
      NCT02928406,MO29983,2016-002625-11 Identificador de estudo
      Atezolizumab Tratamento
      Urinary Tract Cancer Condição
      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

      Critérios de elegibilidade

      Todos Gênero
      ≥ 18 Anos Idade
      Não Voluntários Saudáveis
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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