Select Your Region
America
Europa
Afrika
Weltweit
Eine Studie zu Atezolizumab bei lokal fortgeschrittenem oder metastasierendem urothelialem oder nicht-urothelialem Karzinom der Harnwege
A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
- Krebs
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Dresden
- Erlangen
- Göttingen
- Halle (Saale)
- Hannover
- Heidelberg
- Lübeck
- Mönchengladbach
- München
- Münster
- Tübingen
- Ulm
Studien-ID:
NCT02928406 2016-002625-11 MO29983
Studienzusammenfassung
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
Sponsor
Phase 3
Phase
NCT02928406,MO29983,2016-002625-11
Studien-ID
Atezolizumab
Treatments
Urinary Tract Cancer
Condition
Official Title
An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
Einschlusskriterien
All
Gender
≥ 18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Um die aktuellste Version dieser Seite aufzurufen gehen Sie bitte auf www.Klinische-studien-für-patienten.de
