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An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Sorafenib
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 0066
  • Local Institution - 0020
  • Local Institution - 0015
  • Local Institution - 0084
  • Local Institution - 0061
  • Ochsner Medical Center - Jefferson Highway
  • Local Institution - 0083
  • Local Institution - 0093
  • Local Institution - 0016
  • Local Institution - 0095
  • Local Institution - 0019
  • UT Southwestern Medical Center
  • Local Institution - 0017
  • Scott & White Memorial Hospital And Clinic
  • Local Institution - 0026
  • University of Washington - Seattle Cancer Care Alliance
  • Local Institution - 0050
  • Local Institution - 0005
  • Local Institution - 0007
  • Local Institution - 0001
  • Local Institution - 0002
  • Local Institution - 0003
  • Local Institution - 0008
  • Local Institution - 0039
  • Local Institution - 0038
  • Local Institution - 0075
  • Local Institution - 0091
  • Local Institution - 0077
  • Local Institution - 0043
  • Local Institution - 0044
  • Local Institution - 0042
  • Local Institution - 0164
  • Local Institution - 0139
  • Local Institution - 0137
  • Local Institution - 0140
  • Local Institution - 0141
  • Local Institution - 0152
  • Local Institution - 0161
  • Local Institution - 0157
  • Local Institution - 0144
  • Local Institution - 0158
  • Local Institution - 0142
  • Local Institution - 0148
  • Local Institution - 0162
  • Local Institution - 0169
  • Local Institution - 0135
  • Local Institution - 0136
  • Local Institution - 0163
  • Local Institution - 0166
  • Local Institution - 0138
  • Local Institution - 0145
  • Local Institution - 0151
  • Local Institution - 0159
  • Local Institution - 0173
  • Local Institution - 0146
  • Local Institution - 0029
  • Local Institution - 0027
  • Local Institution - 0028
  • Local Institution - 0071
  • Local Institution - 0072
  • Local Institution - 0069
  • Local Institution - 0073
  • Local Institution - 0067
  • Local Institution - 0068
  • Local Institution - 0070
  • Local Institution - 0074
  • Local Institution - 0036
  • Local Institution - 0037
  • Local Institution - 0167
  • Local Institution - 0034
  • Local Institution - 0031
  • Local Institution - 0035
  • Local Institution - 0033
  • Local Institution - 0032
  • Local Institution - 0030
  • Local Institution - 0011
  • Local Institution - 0012
  • Local Institution - 0082
  • Local Institution - 0060
  • Local Institution - 0058
  • Local Institution - 0059
  • Local Institution - 0054
  • Local Institution - 0062
  • Local Institution - 0055
  • Local Institution - 0063
  • Local Institution - 0064
  • Local Institution - 0100
  • Local Institution - 0103
  • Local Institution - 0107
  • Local Institution - 0127
  • Local Institution - 0102
  • Local Institution - 0130
  • Local Institution - 0105
  • Local Institution - 0110
  • Local Institution - 0112
  • Local Institution - 0104
  • Local Institution - 0111
  • Local Institution - 0106
  • Local Institution - 0113
  • Local Institution - 0115
  • Local Institution - 0131
  • Local Institution - 0114
  • Local Institution - 0108
  • Local Institution - 0126
  • Local Institution - 0101
  • Local Institution - 0117
  • Local Institution - 0125
  • Local Institution - 0116
  • Local Institution - 0118
  • Local Institution - 0119
  • Local Institution - 0123
  • Local Institution - 0122
  • Local Institution - 0124
  • Local Institution - 0023
  • Local Institution - 0056
  • Local Institution - 0045
  • Local Institution - 0096
  • Local Institution - 0013
  • Local Institution - 0014
  • Local Institution - 0065
  • Local Institution - 0085
  • Local Institution - 0009
  • Local Institution - 0010
  • Local Institution - 0088
  • Local Institution - 0087
  • Local Institution - 0040
  • Local Institution - 0041
  • Local Institution - 0129
  • Local Institution - 0133
  • Local Institution - 0121
  • Local Institution - 0132
  • Local Institution - 0099
  • Local Institution - 0120
  • Local Institution - 0128
  • Local Institution - 0080
  • Local Institution - 0078
  • Local Institution - 0079
  • Local Institution - 0081

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nivolumab

Sorafenib

Arm Description

Nivolumab specified dose on specified days

Sorafenib specified dose on specified days

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause in all randomized participants. Participants who are alive will be censored at the last known alive dates. Based on Kaplan-Meier Estimates.

Secondary Outcome Measures

Objective Response Rate (ORR) Per BICR RECIST 1.1
ORR is defined as the proportion of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR is defined as the best response designation, as determined based on BICR-assessed tumor response according to RECIST 1.1, recorded between the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For a BOR of CR or PR, the initial response assessment must be confirmed by a consecutive assessment no less than 4 weeks (28 days) later. Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors
Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by BICR according to RECIST 1.1 or death due to any cause in all randomized participants. Participants who die without a reported prior progression and without initiation of subsequent anti-cancer therapy will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have baseline tumor assessment will be censored on the date they were randomized. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to subsequent anti-cancer therapy.
Efficacy Based on PD-L1 Expression - OS and PFS
PD-L1 expression is defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay unless otherwise specified. This is referred as quantifiable PD-L1 expression. If the PD-L1 staining could not be quantified, it is further classifies as: Indeterminate: Tumor cell membrane staining hampered for reasons attributed to the biology of the tumor biopsy specimen and not because of improper sample preparation or handling. Not evaluable: Tumor biopsy specimen was not optimally collected or prepared (e.g. PD-L1 expression is neither quantifiable nor indeterminate). PD-L1 status is a dichotomized variable using an X% cut-off for quantifiable PD-L1 expression: PD-L1 > X %: ≥ X % PD-L1 expression PD-L1 < X %: < X % PD-L1 expression where X% denotes the PD-L1 expression cut-off of 1%. Additional cut off values may also be explored. Confidence interval based on the Clopper and Pearson method.
Efficacy Based on PD-L1 Expression - ORR
PD-L1 expression is defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay unless otherwise specified. This is referred as quantifiable PD-L1 expression. If the PD-L1 staining could not be quantified, it is further classifies as: Indeterminate: Tumor cell membrane staining hampered for reasons attributed to the biology of the tumor biopsy specimen and not because of improper sample preparation or handling. Not evaluable: Tumor biopsy specimen was not optimally collected or prepared (e.g. PD-L1 expression is neither quantifiable nor indeterminate). PD-L1 status is a dichotomized variable using an X% cut-off for quantifiable PD-L1 expression: PD-L1 > X %: ≥ X % PD-L1 expression PD-L1 < X %: < X % PD-L1 expression where X% denotes the PD-L1 expression cut-off of 1%. Additional cut off values may also be explored. Confidence interval based on the Clopper and Pearson method.

Full Information

First Posted
October 13, 2015
Last Updated
September 15, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02576509
Brief Title
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 7, 2015 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
743 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab
Arm Type
Experimental
Arm Description
Nivolumab specified dose on specified days
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
Sorafenib specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Specified Dose on Specified Days
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Specified Dose on Specified Days
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death due to any cause in all randomized participants. Participants who are alive will be censored at the last known alive dates. Based on Kaplan-Meier Estimates.
Time Frame
time from the date of randomization to the date of death due to any cause, assessed up to June 2019 (approximately 41 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) Per BICR RECIST 1.1
Description
ORR is defined as the proportion of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR is defined as the best response designation, as determined based on BICR-assessed tumor response according to RECIST 1.1, recorded between the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For a BOR of CR or PR, the initial response assessment must be confirmed by a consecutive assessment no less than 4 weeks (28 days) later. Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors
Time Frame
the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by BICR according to RECIST 1.1 or death due to any cause in all randomized participants. Participants who die without a reported prior progression and without initiation of subsequent anti-cancer therapy will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have baseline tumor assessment will be censored on the date they were randomized. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to subsequent anti-cancer therapy.
Time Frame
time from the date of randomization to the date of the first objectively documented tumor progression or death, assessed up to May 2019 (approximately 40 months)
Title
Efficacy Based on PD-L1 Expression - OS and PFS
Description
PD-L1 expression is defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay unless otherwise specified. This is referred as quantifiable PD-L1 expression. If the PD-L1 staining could not be quantified, it is further classifies as: Indeterminate: Tumor cell membrane staining hampered for reasons attributed to the biology of the tumor biopsy specimen and not because of improper sample preparation or handling. Not evaluable: Tumor biopsy specimen was not optimally collected or prepared (e.g. PD-L1 expression is neither quantifiable nor indeterminate). PD-L1 status is a dichotomized variable using an X% cut-off for quantifiable PD-L1 expression: PD-L1 > X %: ≥ X % PD-L1 expression PD-L1 < X %: < X % PD-L1 expression where X% denotes the PD-L1 expression cut-off of 1%. Additional cut off values may also be explored. Confidence interval based on the Clopper and Pearson method.
Time Frame
the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)
Title
Efficacy Based on PD-L1 Expression - ORR
Description
PD-L1 expression is defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay unless otherwise specified. This is referred as quantifiable PD-L1 expression. If the PD-L1 staining could not be quantified, it is further classifies as: Indeterminate: Tumor cell membrane staining hampered for reasons attributed to the biology of the tumor biopsy specimen and not because of improper sample preparation or handling. Not evaluable: Tumor biopsy specimen was not optimally collected or prepared (e.g. PD-L1 expression is neither quantifiable nor indeterminate). PD-L1 status is a dichotomized variable using an X% cut-off for quantifiable PD-L1 expression: PD-L1 > X %: ≥ X % PD-L1 expression PD-L1 < X %: < X % PD-L1 expression where X% denotes the PD-L1 expression cut-off of 1%. Additional cut off values may also be explored. Confidence interval based on the Clopper and Pearson method.
Time Frame
the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0066
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Local Institution - 0020
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Local Institution - 0015
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Local Institution - 0084
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Local Institution - 0061
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ochsner Medical Center - Jefferson Highway
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Local Institution - 0083
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Local Institution - 0093
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 0016
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Local Institution - 0095
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution - 0019
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Local Institution - 0017
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Scott & White Memorial Hospital And Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Local Institution - 0026
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington - Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution - 0050
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Local Institution - 0005
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution - 0007
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution - 0001
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution - 0002
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 0003
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Local Institution - 0008
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution - 0039
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution - 0038
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0075
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Local Institution - 0091
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0077
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution - 0043
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Local Institution - 0044
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Local Institution - 0042
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Local Institution - 0164
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230061
Country
China
Facility Name
Local Institution - 0139
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Local Institution - 0137
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Local Institution - 0140
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Local Institution - 0141
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Local Institution - 0152
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Local Institution - 0161
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Local Institution - 0157
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Local Institution - 0144
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Local Institution - 0158
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Local Institution - 0142
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
155040
Country
China
Facility Name
Local Institution - 0148
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Local Institution - 0162
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Local Institution - 0169
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Local Institution - 0135
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Local Institution - 0136
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Local Institution - 0163
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution - 0166
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Facility Name
Local Institution - 0138
City
Xi'an
State/Province
Shan3xi
ZIP/Postal Code
710038
Country
China
Facility Name
Local Institution - 0145
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Local Institution - 0151
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Local Institution - 0159
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Local Institution - 0173
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Local Institution - 0146
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Local Institution - 0029
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Local Institution - 0027
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Local Institution - 0028
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Local Institution - 0071
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Local Institution - 0072
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution - 0069
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Local Institution - 0073
City
Montpellier Cedex
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution - 0067
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution - 0068
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution - 0070
City
Rennes Cedex
ZIP/Postal Code
35042
Country
France
Facility Name
Local Institution - 0074
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 0036
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Local Institution - 0037
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Local Institution - 0167
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution - 0034
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution - 0031
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Local Institution - 0035
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution - 0033
City
Munich
ZIP/Postal Code
81366
Country
Germany
Facility Name
Local Institution - 0032
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Local Institution - 0030
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution - 0011
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Local Institution - 0012
City
Hong Kong
Country
Hong Kong
Facility Name
Local Institution - 0082
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Local Institution - 0060
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution - 0058
City
Petah-tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Local Institution - 0059
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution - 0054
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
Local Institution - 0062
City
Bergamo
ZIP/Postal Code
0
Country
Italy
Facility Name
Local Institution - 0055
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution - 0063
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Local Institution - 0064
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution - 0100
City
Chiba City
State/Province
Chiba
ZIP/Postal Code
2608670
Country
Japan
Facility Name
Local Institution - 0103
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
7900024
Country
Japan
Facility Name
Local Institution - 0107
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
8300011
Country
Japan
Facility Name
Local Institution - 0127
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
5038502
Country
Japan
Facility Name
Local Institution - 0102
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0600033
Country
Japan
Facility Name
Local Institution - 0130
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution - 0105
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
9208641
Country
Japan
Facility Name
Local Institution - 0110
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
2138587
Country
Japan
Facility Name
Local Institution - 0112
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2320024
Country
Japan
Facility Name
Local Institution - 0104
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2418515
Country
Japan
Facility Name
Local Institution - 0111
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
6028566
Country
Japan
Facility Name
Local Institution - 0106
City
Osaka-Sayama-Shi
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution - 0113
City
Suita
State/Province
Osaka
ZIP/Postal Code
5650871
Country
Japan
Facility Name
Local Institution - 0115
City
Saga-shi
State/Province
Saga
ZIP/Postal Code
8408571
Country
Japan
Facility Name
Local Institution - 0131
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-0062
Country
Japan
Facility Name
Local Institution - 0114
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Local Institution - 0108
City
Musashino-shi
State/Province
Tokyo
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Local Institution - 0126
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
1628655
Country
Japan
Facility Name
Local Institution - 0101
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Local Institution - 0117
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Local Institution - 0125
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Local Institution - 0116
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Local Institution - 0118
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Local Institution - 0119
City
Seoul-si
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution - 0123
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution - 0122
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution - 0124
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 0023
City
Gdansk
ZIP/Postal Code
80952
Country
Poland
Facility Name
Local Institution - 0056
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0045
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Local Institution - 0096
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution - 0013
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Facility Name
Local Institution - 0014
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Local Institution - 0065
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Local Institution - 0085
City
Majadahonda - Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution - 0009
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution - 0010
City
Santiago Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution - 0088
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Local Institution - 0087
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Local Institution - 0040
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution - 0041
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Local Institution - 0129
City
Kaohsiung County
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Local Institution - 0133
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Local Institution - 0121
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution - 0132
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Local Institution - 0099
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Local Institution - 0120
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Local Institution - 0128
City
Taoyuan County
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Local Institution - 0080
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Local Institution - 0078
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Local Institution - 0079
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Local Institution - 0081
City
Liverpool
ZIP/Postal Code
L7 8YA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36111952
Citation
Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.
Results Reference
derived
PubMed Identifier
35101942
Citation
Shi J, Liu J, Tu X, Li B, Tong Z, Wang T, Zheng Y, Shi H, Zeng X, Chen W, Yin W, Fang W. Single-cell immune signature for detecting early-stage HCC and early assessing anti-PD-1 immunotherapy efficacy. J Immunother Cancer. 2022 Jan;10(1):e003133. doi: 10.1136/jitc-2021-003133.
Results Reference
derived
PubMed Identifier
34914889
Citation
Yau T, Park JW, Finn RS, Cheng AL, Mathurin P, Edeline J, Kudo M, Harding JJ, Merle P, Rosmorduc O, Wyrwicz L, Schott E, Choo SP, Kelley RK, Sieghart W, Assenat E, Zaucha R, Furuse J, Abou-Alfa GK, El-Khoueiry AB, Melero I, Begic D, Chen G, Neely J, Wisniewski T, Tschaika M, Sangro B. Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2022 Jan;23(1):77-90. doi: 10.1016/S1470-2045(21)00604-5. Epub 2021 Dec 13.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

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