An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

CompletadoFase 3ClinicalTrials.gov

ID: NCT02928406Tipo: INTERVENTIONALInicio: 30 de nov de 2016Fin estimado: 12 de dic de 2022

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Atezolizumab

Atezolizumab 1200 milligrams (mg) will be administered by intravenous (IV) infusion Q3W.

Ubicaciones

Inst. Alexander Fleming; Oncologia

Buenos Aires, Argentina

Hospital Aleman

Caba, Argentina

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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