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A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma (CheckMate 9DW)

Primary Purpose

Hepatocellular Carcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Sorafenib
lenvatinib
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:

  • Participants must have a diagnosis of HCC based on histological confirmation
  • Participants must have an advanced HCC
  • Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
  • Child-Pugh score 5 or 6
  • 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
  • Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
  • Active brain metastases or leptomeningeal metastases

Other protocol-defined inclusion/exclusion criteria apply.

Sites / Locations

  • Local Institution - 0292
  • Local Institution - 0288
  • Local Institution - 0157
  • Local Institution - 0077
  • Local Institution - 0027
  • Local Institution - 0190
  • Local Institution
  • Local Institution - 0018
  • Local Institution - 0295
  • Local Institution - 0043
  • Local Institution - 0284
  • Local Institution - 0304
  • Local Institution - 0202
  • Local Institution - 0046
  • Local Institution - 0172
  • Local Institution - 0136
  • Local Institution - 0037
  • Local Institution - 0194
  • Local Institution - 0282
  • Local Institution - 0058
  • Local Institution - 0003
  • Local Institution - 0038
  • Local Institution - 0002
  • Local Institution - 0004
  • Local Institution - 0013
  • Local Institution - 0009
  • Local Institution - 0019
  • Local Institution - 0026
  • Local Institution - 0001
  • Local Institution - 0020
  • Local Institution - 0057
  • Local Institution - 0188
  • Local Institution - 0065
  • Local Institution - 0114
  • Local Institution - 0186
  • Local Institution - 0008
  • Local Institution - 0124
  • Local Institution - 0298
  • Local Institution - 0099
  • Local Institution - 0034
  • Local Institution - 0064
  • Local Institution - 0104
  • Local Institution
  • Local Institution - 0061
  • Local Institution - 0181
  • Local Institution - 0278
  • Local Institution - 0016
  • Local Institution - 0279
  • Local Institution - 0060
  • Local Institution - 0054
  • Local Institution - 0280
  • Local Institution - 0015
  • Local Institution - 0023
  • Local Institution - 0022
  • Local Institution - 0050
  • Local Institution - 0192
  • Local Institution - 0296
  • Local Institution - 0094
  • Local Institution - 0095
  • Local Institution - 0024
  • Local Institution - 0156
  • Local Institution - 0283
  • Local Institution - 0216
  • Local Institution - 0012
  • Local Institution - 0120
  • Local Institution - 0146
  • Local Institution - 0175
  • Local Institution - 0152
  • Local Institution - 0121
  • Local Institution - 0151
  • Local Institution - 0125
  • Local Institution - 0150
  • Local Institution - 0135
  • Local Institution - 0109
  • Local Institution - 0059
  • Local Institution - 0130
  • Local Institution - 0145
  • Local Institution - 0149
  • Local Institution - 0162
  • Local Institution - 0166
  • Local Institution - 0131
  • Local Institution - 0123
  • Local Institution - 0132
  • Local Institution - 0147
  • Local Institution - 0133
  • Local Institution - 0153
  • Local Institution - 0134
  • Local Institution - 0179
  • Local Institution - 0108
  • Local Institution - 0107
  • Local Institution - 0307
  • Local Institution - 0274
  • Local Institution
  • Local Institution - 0068
  • Local Institution - 0116
  • Local Institution - 0069
  • Local Institution - 0138
  • Local Institution - 0081
  • Local Institution - 0070
  • Local Institution
  • Local Institution - 0082
  • Local Institution - 0067
  • Local Institution - 0025
  • Local Institution - 0137
  • Local Institution - 0042
  • Local Institution - 0071
  • Local Institution - 0051
  • Local Institution - 0005
  • Local Institution - 0231
  • Local Institution - 0052
  • Local Institution - 0185
  • Local Institution - 0006
  • Local Institution - 0102
  • Local Institution - 0028
  • Local Institution - 0118
  • Local Institution - 0031
  • Local Institution - 0056
  • Local Institution
  • Local Institution - 0053
  • Local Institution - 0032
  • Local Institution - 0036
  • Local Institution - 0110
  • Local Institution - 0101
  • Local Institution - 0084
  • Local Institution - 0039
  • Local Institution - 0100
  • Local Institution - 0219
  • Local Institution - 0033
  • Local Institution - 0112
  • Local Institution - 0079
  • Local Institution - 0111
  • Local Institution - 0044
  • Local Institution - 0204
  • Local Institution - 0193
  • Local Institution - 0203
  • Local Institution - 0155
  • Local Institution - 0176
  • Local Institution - 0200
  • Local Institution - 0262
  • Local Institution - 0189
  • Local Institution - 0261
  • Local Institution - 0263
  • Local Institution - 0127
  • Local Institution - 0281
  • Local Institution - 0259
  • Local Institution - 0128
  • Local Institution - 0201
  • Local Institution - 0199
  • Local Institution - 0178
  • Local Institution - 0177
  • Local Institution - 0122
  • Local Institution - 0258
  • Local Institution - 0097
  • Local Institution - 0062
  • Local Institution - 0142
  • Local Institution - 0098
  • Local Institution - 0143
  • Local Institution - 0141
  • Local Institution - 0140
  • Local Institution - 0139
  • Local Institution - 0167
  • Local Institution - 0047
  • Local Institution - 0148
  • Local Institution - 0049
  • Local Institution - 0092
  • Local Institution - 0289
  • Local Institution - 0035
  • Local Institution - 0103
  • Local Institution - 0164
  • Local Institution - 0165
  • Local Institution
  • Local Institution - 0163
  • Local Institution - 0029
  • Local Institution - 0066
  • Local Institution - 0074
  • Local Institution - 0007
  • Local Institution - 0072
  • Local Institution - 0075
  • Local Institution - 0091
  • Local Institution - 0073
  • Local Institution - 0048
  • Local Institution - 0017
  • Local Institution - 0174
  • Local Institution - 0297
  • Local Institution - 0055
  • Local Institution - 0089
  • Local Institution - 0090
  • Local Institution - 0087
  • Local Institution - 0041
  • Local Institution - 0093
  • Local Institution - 0290
  • Local Institution - 0045
  • Local Institution - 0085
  • Local Institution - 0088
  • Local Institution - 0040
  • Local Institution - 0063
  • Local Institution - 0272
  • Local Institution - 0096
  • Local Institution - 0105
  • Local Institution - 0271
  • Local Institution - 0168
  • Local Institution - 0270
  • Local Institution - 0144
  • Local Institution - 0173
  • Local Institution - 0078
  • Local Institution - 0171
  • Local Institution - 0154
  • Local Institution - 0286
  • Local Institution - 0160
  • Local Institution - 0129

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nivolumab + Ipilimumab

Sorafenib/lenvatinib

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival (OS)

Secondary Outcome Measures

Objective Response Rate (ORR)
Duration of Response (DOR)
Time to Symptom Deterioration (TTSD)

Full Information

First Posted
July 30, 2019
Last Updated
October 5, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04039607
Brief Title
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
Acronym
CheckMate 9DW
Official Title
A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

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 main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

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
732 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab + Ipilimumab
Arm Type
Experimental
Arm Title
Sorafenib/lenvatinib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Participants will receive nivolumab as intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Intervention Description
Participants will receive ipilimumab as IV infusion.
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Participants will receive sorafenib as oral tablets.
Intervention Type
Drug
Intervention Name(s)
lenvatinib
Intervention Description
Participants will receive lenvatinib as oral capsules.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
Up to 4 years
Title
Duration of Response (DOR)
Time Frame
Up to 4 years
Title
Time to Symptom Deterioration (TTSD)
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have a diagnosis of HCC based on histological confirmation Participants must have an advanced HCC Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion Child-Pugh score 5 or 6 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 Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization Active brain metastases or leptomeningeal metastases 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 - 0292
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Local Institution - 0288
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Local Institution - 0157
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3012
Country
United States
Facility Name
Local Institution - 0077
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Local Institution - 0027
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Local Institution - 0190
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Local Institution
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Local Institution - 0018
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Local Institution - 0295
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Local Institution - 0043
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Local Institution - 0284
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Local Institution - 0304
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Local Institution - 0202
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 0046
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Local Institution - 0172
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Local Institution - 0136
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0037
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1090AAS
Country
Argentina
Facility Name
Local Institution - 0194
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629AHJ
Country
Argentina
Facility Name
Local Institution - 0282
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Local Institution - 0058
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution - 0003
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Local Institution - 0038
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
1871
Country
Australia
Facility Name
Local Institution - 0002
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution - 0004
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4560
Country
Australia
Facility Name
Local Institution - 0013
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Local Institution - 0009
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution - 0019
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution - 0026
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Local Institution - 0001
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution - 0020
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Local Institution - 0057
City
Wiener Neustadt
State/Province
Niederosterreich
ZIP/Postal Code
2700
Country
Austria
Facility Name
Local Institution - 0188
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution - 0065
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Local Institution - 0114
City
St. Polten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Local Institution - 0186
City
Viena
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0008
City
Federal District
ZIP/Postal Code
72115700
Country
Belgium
Facility Name
Local Institution - 0124
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0298
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0099
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Local Institution - 0034
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0064
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0104
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41253190
Country
Brazil
Facility Name
Local Institution - 0061
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41950-640
Country
Brazil
Facility Name
Local Institution - 0181
City
Brasilia
State/Province
DF
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Local Institution - 0278
City
Vitoria
State/Province
Espirito Santo
ZIP/Postal Code
29055-450
Country
Brazil
Facility Name
Local Institution - 0016
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520060
Country
Brazil
Facility Name
Local Institution - 0279
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution - 0060
City
Pelotas
State/Province
RIO Grande DO SUL
ZIP/Postal Code
960400-10
Country
Brazil
Facility Name
Local Institution - 0054
City
Jau
State/Province
SAO Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
Local Institution - 0280
City
Sao Jose do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Local Institution - 0015
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Local Institution - 0023
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Local Institution - 0022
City
Sao Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Facility Name
Local Institution - 0050
City
Sao Paulo
ZIP/Postal Code
04038-034
Country
Brazil
Facility Name
Local Institution - 0192
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution - 0296
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Facility Name
Local Institution - 0094
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Facility Name
Local Institution - 0095
City
Santiago de Chile
State/Province
Metropolitana
ZIP/Postal Code
0
Country
Chile
Facility Name
Local Institution - 0024
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7620002
Country
Chile
Facility Name
Local Institution - 0156
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Local Institution - 0283
City
Santiago
State/Province
RM
ZIP/Postal Code
7630372
Country
Chile
Facility Name
Local Institution - 0216
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2540402
Country
Chile
Facility Name
Local Institution - 0012
City
Viña del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Local Institution - 0120
City
Hefei Shi
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Local Institution - 0146
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230065
Country
China
Facility Name
Local Institution - 0175
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100089
Country
China
Facility Name
Local Institution - 0152
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Local Institution - 0121
City
Fuzhou City
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Local Institution - 0151
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350002
Country
China
Facility Name
Local Institution - 0125
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Local Institution - 0150
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Local Institution - 0135
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Local Institution - 0109
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
Local Institution - 0059
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Local Institution - 0130
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Local Institution - 0145
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Local Institution - 0149
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330019
Country
China
Facility Name
Local Institution - 0162
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution - 0166
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130102
Country
China
Facility Name
Local Institution - 0131
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116023
Country
China
Facility Name
Local Institution - 0123
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Local Institution - 0132
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110117
Country
China
Facility Name
Local Institution - 0147
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Local Institution - 0133
City
Xian
State/Province
Shan3xi
ZIP/Postal Code
710038
Country
China
Facility Name
Local Institution - 0153
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Local Institution - 0134
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201315
Country
China
Facility Name
Local Institution - 0179
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
400030
Country
China
Facility Name
Local Institution - 0108
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Local Institution - 0107
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Local Institution - 0307
City
Xi'an
ZIP/Postal Code
710126
Country
China
Facility Name
Local Institution - 0274
City
Praha
State/Province
Prague
ZIP/Postal Code
14059
Country
Czechia
Facility Name
Local Institution
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Facility Name
Local Institution - 0068
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Local Institution - 0116
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Local Institution - 0069
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Local Institution - 0138
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Local Institution - 0081
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution - 0070
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Local Institution
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Local Institution - 0082
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution - 0067
City
Nice
ZIP/Postal Code
6202
Country
France
Facility Name
Local Institution - 0025
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution - 0137
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Local Institution - 0042
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 0071
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Local Institution - 0051
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Local Institution - 0005
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution - 0231
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Local Institution - 0052
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution - 0185
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Local Institution - 0006
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution - 0102
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution - 0028
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution - 0118
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Local Institution - 0031
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution - 0056
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Local Institution
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Local Institution - 0053
City
North Rhine-Westphalia
ZIP/Postal Code
45136
Country
Germany
Facility Name
Local Institution - 0032
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Local Institution - 0036
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Local Institution - 0110
City
Meldola
State/Province
Forli-Cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution - 0101
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Local Institution - 0084
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
Local Institution - 0039
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Local Institution - 0100
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Local Institution - 0219
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution - 0033
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Local Institution - 0112
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Local Institution - 0079
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution - 0111
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution - 0044
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Local Institution - 0204
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
2608677
Country
Japan
Facility Name
Local Institution - 0193
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Local Institution - 0203
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
Local Institution - 0155
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Local Institution - 0176
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Local Institution - 0200
City
Yokohama-Shi
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Local Institution - 0262
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Local Institution - 0189
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Local Institution - 0261
City
Kashihara City
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Local Institution - 0263
City
Abeno-ku
State/Province
Osaka
ZIP/Postal Code
5458586
Country
Japan
Facility Name
Local Institution - 0127
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution - 0281
City
Saga Shi
State/Province
Saga
ZIP/Postal Code
8408571
Country
Japan
Facility Name
Local Institution - 0259
City
Izunokuni-shi
State/Province
Shizuoka
ZIP/Postal Code
4102295
Country
Japan
Facility Name
Local Institution - 0128
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
1058470
Country
Japan
Facility Name
Local Institution - 0201
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Local Institution - 0199
City
Musashino-shi
State/Province
Tokyo
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Local Institution - 0178
City
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Local Institution - 0177
City
Hiroshima
ZIP/Postal Code
7348551
Country
Japan
Facility Name
Local Institution - 0122
City
Kanagawa
ZIP/Postal Code
213-8587
Country
Japan
Facility Name
Local Institution - 0258
City
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Local Institution - 0097
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Local Institution - 0062
City
Jongno-gu
State/Province
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution - 0142
City
Busan
ZIP/Postal Code
049241
Country
Korea, Republic of
Facility Name
Local Institution - 0098
City
Gyeongsangnam-do
ZIP/Postal Code
050612
Country
Korea, Republic of
Facility Name
Local Institution - 0143
City
Seongnam-si
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Local Institution - 0141
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution - 0140
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution - 0139
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 0167
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Local Institution - 0047
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
Local Institution - 0148
City
Gdansk
ZIP/Postal Code
80219
Country
Poland
Facility Name
Local Institution - 0049
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Local Institution - 0092
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Local Institution - 0289
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Local Institution - 0035
City
San Juan
ZIP/Postal Code
00927-4308
Country
Puerto Rico
Facility Name
Local Institution - 0103
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200542
Country
Romania
Facility Name
Local Institution - 0164
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Local Institution - 0165
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Facility Name
Local Institution - 0163
City
Timisoara
ZIP/Postal Code
300166
Country
Romania
Facility Name
Local Institution - 0029
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Local Institution - 0066
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Local Institution - 0074
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Local Institution - 0007
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution - 0072
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Local Institution - 0075
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution - 0091
City
Saint-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Local Institution - 0073
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Local Institution - 0048
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Facility Name
Local Institution - 0017
City
Singapore
ZIP/Postal Code
258499
Country
Singapore
Facility Name
Local Institution - 0174
City
Singapore
ZIP/Postal Code
308442
Country
Singapore
Facility Name
Local Institution - 0297
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0055
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution - 0089
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Local Institution - 0090
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Local Institution - 0087
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Local Institution - 0041
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 0093
City
Madrid
ZIP/Postal Code
28028
Country
Spain
Facility Name
Local Institution - 0290
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Local Institution - 0045
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution - 0085
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution - 0088
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution - 0040
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Local Institution - 0063
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Local Institution - 0272
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Local Institution - 0096
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Local Institution - 0105
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Local Institution - 0271
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Local Institution - 0168
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution - 0270
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Local Institution - 0144
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution - 0173
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Local Institution - 0078
City
Tapei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Local Institution - 0171
City
London
State/Province
Greater London
ZIP/Postal Code
W12 OHS
Country
United Kingdom
Facility Name
Local Institution - 0154
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Local Institution - 0286
City
Christchurch
ZIP/Postal Code
BH23 2JX
Country
United Kingdom
Facility Name
Local Institution - 0160
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Local Institution - 0129
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/us/en/home.html
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/medical-product-safety-information
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

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