Brief description of trial (Data source: BASEC)
In dieser Studie soll gezeigt werden, dass Nivolumab im Vergleich zu Sorafenib effektiver in der Behandlung von fortgeschrittenem hepatozellulärem Karzinom ist.
Health conditions investigated(Data source: BASEC)
Hepatozelluläres Karzinom
Health conditions
(Data source: WHO)
Hepatocellular Carcinoma
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Nivolumab experimentell
Sorafenib Komparator
Interventions
(Data source: WHO)
Drug: Nivolumab;Drug: Sorafenib
Criteria for participation in trial
(Data source: BASEC)
- Histologische bestätigtes hepatozelluläres Karzinom, nicht geeignet für operative und/oder locoregionale Therapien; oder fortschreitende Erkrankung nach einer operativen und/oder locoregionalen Therapie
- Eine locoregionale Therapie des HCC muss wenigstens 4 Wochen vor der Baseline Bildgebung beendet werden.
- Child-Pugh Klasse A
- Leistungsstatus nach der Eastern Cooperative Oncology Group (ECOG) von ≤ 1.
Exclusion criteria
(Data source: BASEC)
- Bekanntes fibrolamelläres HCC, sakromatoides HCC oder gemischtes Gallengangskarzinom und HCC
- Frühere Lebertransplantation
- Aktive, bekannte oder vermutete Autoimmunerkrankung
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical
and/or locoregional therapies; or progressive disease after surgical and /or
locoregional therapies
- Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4
weeks prior to the baseline scan
- Child-Pugh Class A
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria:
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Prior liver transplant
- Active, known, or suspected autoimmune disease
Other protocol-defined inclusion/exclusion criteria apply
-
Further information on trial
Date trial registered
Oct 13, 2015
Recruitment status
Completed
Academic title
(Data source: WHO)
A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Overall Survival (OS)
Secundary end point
(Data source: WHO)
Objective Response Rate (ORR) Per BICR RECIST 1.1;Progression-Free Survival (PFS);Efficacy Based on PD-L1 Expression - OS and PFS;Efficacy Based on PD-L1 Expression - ORR
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, Bern
Countries
(Data source: WHO)
Australia, Austria, Belgium, Canada, China, Czech Republic, Czechia, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Poland, Republic of, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Frau Prof. Viviane Hess
+41 61 265 50 59
vivane.hess@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
06.04.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2015-00119
Secondary ID (Data source: WHO)
CA209-459
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