Brief description of trial (Data source: BASEC)
Der Zweck dieser Studie ist es die Wirksamkeit und Sicherheit von Nivolumab gegenüber Placebo bei Patienten zu untersuchen, bei denen kürzlich eine radikale Operation wegen invasivem Urothelkrebs durchgeführt wurde.
Health conditions investigated(Data source: BASEC)
Invasives Hochrisiko-Urothelkarzinom
Health conditions
(Data source: WHO)
Various Advanced Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Nivolumab, Opdivo
Interventions
(Data source: WHO)
Other: Placebo;Biological: Nivolumab
Criteria for participation in trial
(Data source: BASEC)
- Müssen invasiven Urothelkrebs - ausgehend von Harnblase, Harnleiter oder Nierenbecken - mit einem hohen Risiko eines Rezidivs gehabt haben.
- Müssen eine innerhalb der letzten 90 Tage vorgenommene radikale chirurgische Resektion (z.B. radikale Zystektomie) gehabt haben.
- Müssen innerhalb von 4 Wochen vor der ersten Dosierung einen durch Bildgebungsverfahren nachgewiesenen krankheitsfreien Zustand aufweisen.
- Für Biomarker-Analysen muss Tumorgewebe zur Verfügung stehen.
- Patienten, die keine vorherige neo-adjuvante Cisplatin-Chemotherapie erhalten haben, müssen fur eine adjuvante Cisplatin-Chemotherapie ungeeignet sein oder diese ablehnen.
Exclusion criteria
(Data source: BASEC)
- Unvollständige Blasen- oder Nierenentfernung (z.B. unvollständige Zystektomie)
- Sekundäre Behandlung (z.B. adjuvante systemische Chemotherapie gegen Blasenkrebs) nach radikaler chirurgischer Entfernung des Blasenkrebs
- Patienten mit aktiver, bekannter oder vermuteter Autoimmunerkrankung.
- Vorherige aktive Malignitäten innerhalb der vergangenen 3 Jahre, ausgenommen lokal heilbare Krebsarten, die offensichtlich geheilt wurden
- Zustand, der eine systemische Behandlung mit entweder Kortikosteroiden oder anderen Immunsuppressiva innerhalb von 14 Tagen vor der ersten Verabreichung des Prüfpraparats erfordert
- Positiver Test auf das Hepatitis-B-Virus-Oberflächenantigen (HBV s Ag) oder die Hepatitis-C-Virus-Ribonukleinsäure (HCV-Antikörper), was auf eine akute oder chronische Infektion hindeutet
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Must have had invasive urothelial cancer at high risk of recurrence originating in the
bladder, ureter, or renal pelvis
- Must have had radical surgical resection (e.g. radical cystectomy), performed within
the last 120 days
- Must have disease free status as determined by imaging within 4 weeks of dosing
- Tumor tissue must be provided for biomarker analysis
- Patients who have not received prior neoadjuvant cisplatin chemotherapy must be
ineligible for or refuse cisplatin-based adjuvant chemotherapy
Exclusion Criteria:
- Partial bladder or partial kidney removal (eg, partial cystectomy or partial
nephrectomy)
- Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following
surgical removal of bladder cancer
- Subjects with active, known or suspected autoimmune disease
- Prior malignancy active within the previous 3 years except for locally curable cancers
that have been apparently cured
- Condition requiring systemic treatment with either corticosteroids or other
immunosuppressive medications within 14 day of study drug administration
- Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus
ribonucleic acid (HCV antibody) indicating acute or chronic infection
-
Further information on trial
Date trial registered
Dec 14, 2015
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Disease Free Survival (DFS);Disease Free Survival (DFS) in PD-L1 Expression = 1% Population
Secundary end point
(Data source: WHO)
Non-Urothelial Tract Recurrence Free Survival;Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression = 1% Population;Overall Survival;Overall Survival in Participants With PD-L1 Expression = 1%;Disease Specific Survival;Disease Specific Survival in Participants With PD-L1 Expression = 1%
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
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, Zurich
Countries
(Data source: WHO)
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, Peru, Poland, Republic of, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
PD Dr. med. Frank Stenner
+41-61 265 5074
Frank.Stenner@usb.ch
Contact for general information
(Data source: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Contact for scientific information
(Data source: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
18.09.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-00572
Secondary ID (Data source: WHO)
2014-003626-40
CA209-274
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