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SNCTP000002076 | NCT02928406 | BASEC2016-01933

Untersuchung der Sicherheit von Atezolizumab beim Blasenkarzinom

Data source: BASEC (Imported from 19.04.2024), WHO (Imported from 18.04.2024)
Changed: Dec 23, 2023, 4:31 PM
Disease category: Bladder Cancer

Brief description of trial (Data source: BASEC)

Ziel dieser multizentrischen Studie ist die Beurteilung der Sicherheit von Atezolizumab als Zweitlinientherapie für Patienten mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom oder Nicht-Urothelkarzinom der Harnwege. Ausserdem sollen die Wirksamkeit von Atezolizumab sowie potenzielle Tumor-Biomarker im Zusammenhang mit Atezolizumab untersucht werden.

Health conditions investigated(Data source: BASEC)

Ein Urothelkarzinom ist eine Krebsart, die in den Harnwegen auftritt. Dazu gehören Blasenkrebs, Harnleiterkrebs und Nierenbeckenkrebs.

Health conditions (Data source: WHO)

Urinary Tract Cancer

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Atezolizumab wird einmal alle drei Wochen als intravenöse Infusion verabreicht (es wird eine kleine Nadel in eine Vene gelegt). Jede Infusion enthält 1200 mg des therapeutischen Antikörpers.
Die Teilnehmer müssen für die Verabreichung der Atezolizumab-Infusionen alle 3 Wochen ins Studienzentrum kommen, sodass das Studienpersonal die Verabreichung überwachen und bei medizinischen Notfällen reagieren kann.
Die Teilnehmer werden gebeten, 30 Tage nach ihrer letzten Atezolizumab-Infusion zu einem weiteren Termin ins Studienzentrum zu kommen. Die Teilnehmer werden über einen Zeitraum von 4 Jahren nach ihrer letzten Atezolizumab-Infusion auch alle 3 Monate angerufen.

Interventions (Data source: WHO)

Drug: Atezolizumab

Criteria for participation in trial (Data source: BASEC)

• Teilnehmer mit histologisch dokumentiertem lokal fortgeschrittenem oder metastasiertem Urothelkarzinom oder Nicht-Urothelkarzinom der Harnwege
• Teilnehmer mit messbarem und nicht messbarem Tumorbefall gemäss RECIST-Kriterien Version 1.1
• Die Patienten müssen eine vorherige Kombinationschemotherapie gegen das inoperable, lokal fortgeschrittene oder metastasierte Urothelkarzinom oder Nicht-Urothelkarzinom der Harnwege erhalten haben
• Repräsentative formalinfixierte und in Paraffin eingebettete Tumorprobe
• ECOG-Leistungsstatus (Eastern Cooperative Oncology Group) 0, 1 oder 2

Exclusion criteria (Data source: BASEC)

• Behandlung mit mehr als einer vorherigen systemischen Therapielinie bei inoperablem, lokal fortgeschrittenem oder metastasiertem Urothelkarzinom oder Nicht-Urothelkarzinom der Harnwege
• Behandlung mit anderen Prüfpräparaten oder Teilnahme an einer anderen therapeutischen klinischen Studie innerhalb von 4 Wochen vor Beginn der Studienbehandlung
• Anzeichen einer signifikanten unkontrollierten Begleiterkrankung, die die Einhaltung des Protokolls beeinträchtigen könnte
• Signifikante Nierenerkrankung, die eine Dialysebehandlung notwendig macht, oder Indikation für eine Nierentransplantation

Inclusion/Exclusion Criteria (Data source: WHO)


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

1. 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

2. 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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02928406

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02928406
Further information on trial

Date trial registered

Oct 7, 2016

Incorporation of the first participant

Nov 30, 2016

Recruitment status

Completed

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

Percentage of Participants With Adverse Events

Secundary end point (Data source: WHO)

Overall Survival (OS);Progression Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1);PFS as per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST);Percentage of Participants With Best Overall Response as Assessed by RECIST v1.1;Percentage of Participants With Best Overall Response as Assessed by Modified RECIST;Percentage of Participants With Disease Control as Assessed by RECIST v1.1;Percentage of Participants With Disease Control as Assessed by Modified RECIST;Duration of Response as Assessed by RECIST v1.1;Duration of Response as Assessed by Modified RECIST;Change From Baseline in Health-Related Quality of Life (HRQoL), as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score;Change from Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Basel, Bern, Chur, Geneva, Lugano, Winterthur

Countries (Data source: WHO)

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Czechia, Denmark, Egypt, Estonia, Germany, Greece, Hungary, India, Ireland, Italy, Lebanon, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Swaziland, Switzerland, Taiwan, Turkey, United Kingdom

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Clinical Trials
+41 61 715 43 91
switzerland.clinical-research@roche.com

Contact for general information (Data source: WHO)

Clinical Trials
Hoffmann-La Roche

Contact for scientific information (Data source: WHO)

Clinical Trials
Hoffmann-La Roche

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Bern

Date of authorisation by the ethics committee

01.02.2017

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2016-01933

Secondary ID (Data source: WHO)

2016-002625-11
MO29983
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