Clinical trial NCT04039607: A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-07-31
Enrollment: 732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 4 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 4 years
measure: Duration of Response (DOR)
timeFrame: Up to 4 years
measure: Time to Symptom Deterioration (TTSD)
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 0292
state: Arizona
city: Coronado
country: United States
facility: Local Institution - 0288
state: California
city: Duarte
country: United States
facility: Local Institution - 0157
state: California
city: Washington
country: United States
facility: Local Institution - 0077
state: District of Columbia
city: Louisville
country: United States
facility: Local Institution - 0027
state: Kentucky
city: Baltimore
country: United States
facility: Local Institution - 0190
state: Maryland
city: Ann Arbor
country: United States
facility: Local Institution
state: Michigan
city: Detroit
country: United States
facility: Local Institution - 0018
state: Michigan
city: Newark
country: United States
facility: Local Institution - 0295
state: New Jersey
city: Toledo
country: United States
facility: Local Institution - 0043
state: Ohio
city: Pittsburgh
country: United States
facility: Local Institution - 0284
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution - 0304
state: Texas
city: Houston
country: United States
facility: Local Institution - 0202
state: Texas
city: Lubbock
country: United States
facility: Local Institution - 0046
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution - 0172
state: Utah
city: Caba
country: Argentina
facility: Local Institution - 0037
state: Buenos Aires
city: Pilar Provincia De Buenos Aires
country: Argentina
facility: Local Institution - 0194
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution - 0282
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution - 0136
city: Tucuman
country: Argentina
facility: Local Institution - 0058
city: Kogarah
country: Australia
facility: Local Institution - 0003
state: New South Wales
city: Liverpool
country: Australia
facility: Local Institution - 0038
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution - 0002
state: New South Wales
city: Birtinya
country: Australia
facility: Local Institution - 0004
state: Queensland
city: Herston
country: Australia
facility: Local Institution - 0013
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution - 0009
state: South Australia
city: Clayton
country: Australia
facility: Local Institution - 0019
state: Victoria
city: Fitzroy
country: Australia
facility: Local Institution - 0026
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0001
state: Victoria
city: St Albans
country: Australia
facility: Local Institution - 0020
state: Victoria
city: St. Polten
country: Austria
facility: Local Institution - 0114
state: Niederosterreich
city: Wiener Neustadt
country: Austria
facility: Local Institution - 0057
state: Niederosterreich
city: Graz
country: Austria
facility: Local Institution - 0188
city: Klagenfurt
country: Austria
facility: Local Institution - 0065
city: Viena
country: Austria
facility: Local Institution - 0186
city: Brussels
country: Belgium
facility: Local Institution - 0034
city: Federal District
country: Belgium
facility: Local Institution - 0008
city: Gent
country: Belgium
facility: Local Institution - 0124
city: Gent
country: Belgium
facility: Local Institution - 0298
city: Haine-Saint-Paul
country: Belgium
facility: Local Institution - 0099
city: Leuven
country: Belgium
facility: Local Institution - 0064
city: Liege
country: Belgium
facility: Local Institution - 0104
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Salvador
country: Brazil
facility: Local Institution - 0061
state: Bahia
city: Brasilia
country: Brazil
facility: Local Institution - 0181
state: DF
city: Vitoria
country: Brazil
facility: Local Institution - 0278
state: Espirito Santo
city: Ijui
country: Brazil
facility: Local Institution - 0279
state: Rio Grande Do Sul
city: Pelotas
country: Brazil
facility: Local Institution - 0060
state: RIO Grande DO SUL
city: Jau
country: Brazil
facility: Local Institution - 0054
state: SAO Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Local Institution - 0280
state: Sao Paulo
city: Parana
country: Brazil
facility: Local Institution - 0016
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0015
city: Sao Paulo
country: Brazil
facility: Local Institution - 0023
city: Sao Paulo
country: Brazil
facility: Local Institution - 0022
city: Sao Paulo
country: Brazil
facility: Local Institution - 0050
city: Edmonton
country: Canada
facility: Local Institution - 0192
state: Alberta
city: Temuco
country: Chile
facility: Local Institution - 0296
state: Araucania
city: La Serena
country: Chile
facility: Local Institution - 0094
state: Coquimbo
city: Santiago de Chile
country: Chile
facility: Local Institution - 0095
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0024
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0156
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0283
state: RM
city: Vina del Mar
country: Chile
facility: Local Institution - 0012
state: Valparaiso
city: Vina del Mar
country: Chile
facility: Local Institution - 0216
state: Valparaiso
city: Hefei Shi
country: China
facility: Local Institution - 0120
state: Anhui
city: Hefei
country: China
facility: Local Institution - 0146
state: Anhui
city: Beijing
country: China
facility: Local Institution - 0175
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0152
state: Beijing
city: Fuzhou City
country: China
facility: Local Institution - 0121
state: Fujian
city: Fuzhou
country: China
facility: Local Institution - 0151
state: Fujian
city: Guangzhou
country: China
facility: Local Institution - 0125
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0150
state: Guangdong
city: Harbin
country: China
facility: Local Institution - 0135
state: Heilongjiang
city: Changsha
country: China
facility: Local Institution - 0109
state: Hunan
city: Changsha
country: China
facility: Local Institution - 0059
state: Hunan
city: Nanjing
country: China
facility: Local Institution - 0130
state: Jiangsu
city: Nanchang
country: China
facility: Local Institution - 0145
state: Jiangxi
city: Nanchang
country: China
facility: Local Institution - 0149
state: Jiangxi
city: Changchun
country: China
facility: Local Institution - 0162
state: Jilin
city: Changchun
country: China
facility: Local Institution - 0166
state: Jilin
city: Dalian
country: China
facility: Local Institution - 0131
state: Liaoning
city: Shenyang
country: China
facility: Local Institution - 0123
state: Liaoning
city: Shenyang
country: China
facility: Local Institution - 0132
state: Liaoning
city: Xi'an
country: China
facility: Local Institution - 0307
state: Shan3xi
city: Xian
country: China
facility: Local Institution - 0133
state: Shan3xi
city: Xian
country: China
facility: Local Institution - 0147
state: Shan3xi
city: Qingdao
country: China
facility: Local Institution - 0153
state: Shandong
city: Shanghai
country: China
facility: Local Institution - 0134
state: Shanghai
city: Chongqing
country: China
facility: Local Institution - 0179
state: Sichuan
city: Hangzhou
country: China
facility: Local Institution - 0108
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0107
state: Zhejiang
city: Praha
country: Czechia
facility: Local Institution - 0274
state: Prague
city: Brno
country: Czechia
facility: Local Institution
city: Amiens
country: France
facility: Local Institution - 0068
city: Caen
country: France
facility: Local Institution - 0116
city: Clichy
country: France
facility: Local Institution - 0069
city: Dijon
country: France
facility: Local Institution - 0138
city: Grenoble Cedex 9
country: France
facility: Local Institution - 0081
city: Lyon
country: France
facility: Local Institution - 0070
city: Marseille
country: France
facility: Local Institution
city: Montpellier
country: France
facility: Local Institution - 0082
city: Nice
country: France
facility: Local Institution - 0067
city: Pessac
country: France
facility: Local Institution - 0025
city: Poitiers
country: France
facility: Local Institution - 0137
city: Toulouse Cedex 9
country: France
facility: Local Institution - 0042
city: Vandoeuvre les Nancy
country: France
facility: Local Institution - 0071
city: Villejuif
country: France
facility: Local Institution - 0051
city: Frankfurt
country: Germany
facility: Local Institution - 0005
state: Hessen
city: Bonn
country: Germany
facility: Local Institution - 0231
city: Essen
country: Germany
facility: Local Institution - 0052
city: Freiburg
country: Germany
facility: Local Institution - 0185
city: Hamburg
country: Germany
facility: Local Institution - 0006
city: Hannover
country: Germany
facility: Local Institution - 0102
city: Koeln
country: Germany
facility: Local Institution - 0028
city: Leipzig
country: Germany
facility: Local Institution - 0118
city: Mainz
country: Germany
facility: Local Institution - 0031
city: Mannheim
country: Germany
facility: Local Institution - 0056
city: Munchen
country: Germany
facility: Local Institution
city: North Rhine-Westphalia
country: Germany
facility: Local Institution - 0053
city: Hong Kong
country: Hong Kong
facility: Local Institution - 0036
city: Hong Kong
country: Hong Kong
facility: Local Institution - 0032
city: Meldola
country: Italy
facility: Local Institution - 0110
state: Forli-Cesena
city: Rozzano
country: Italy
facility: Local Institution - 0101
state: Milano
city: Candiolo
country: Italy
facility: Local Institution - 0084
city: Milano
country: Italy
facility: Local Institution - 0039
city: Novara
country: Italy
facility: Local Institution - 0100
city: Padova
country: Italy
facility: Local Institution - 0219
city: Parma
country: Italy
facility: Local Institution - 0033
city: Roma
country: Italy
facility: Local Institution - 0112
city: Rome
country: Italy
facility: Local Institution - 0079
city: Siena
country: Italy
facility: Local Institution - 0111
city: Vicenza
country: Italy
facility: Local Institution - 0044
city: Kashiwa-shi
country: Japan
facility: Local Institution - 0193
state: Chiba
city: Matsuyama
country: Japan
facility: Local Institution - 0203
state: Ehime
city: Kanazawa
country: Japan
facility: Local Institution - 0176
state: Ishikawa
city: Yokohama-Shi
country: Japan
facility: Local Institution - 0200
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Local Institution - 0262
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Local Institution - 0189
state: Kyoto
city: Kashihara City
country: Japan
facility: Local Institution - 0261
state: Nara
city: Abeno-ku
country: Japan
facility: Local Institution - 0263
state: Osaka
city: Osakasayama
country: Japan
facility: Local Institution - 0127
state: Osaka
city: Saga Shi
country: Japan
facility: Local Institution - 0281
state: Saga
city: Iruma-gun
country: Japan
facility: Local Institution - 0258
state: Saitama
city: Izunokuni-shi
country: Japan
facility: Local Institution - 0259
state: Shizuoka
city: Minato-ku
country: Japan
facility: Local Institution - 0122
state: Tokyo
city: Minato
country: Japan
facility: Local Institution - 0128
state: Tokyo
city: Mitaka
country: Japan
facility: Local Institution - 0201
state: Tokyo
city: Musashino-shi
country: Japan
facility: Local Institution - 0199
state: Tokyo
city: Chiba
country: Japan
facility: Local Institution - 0204
city: Fukuoka
country: Japan
facility: Local Institution - 0178
city: Hiroshima
country: Japan
facility: Local Institution - 0177
city: Sapporo
country: Japan
facility: Local Institution - 0155
city: Seongnam
country: Korea, Republic of
facility: Local Institution - 0143
state: Gyeonggi-do
city: Guro-gu
country: Korea, Republic of
facility: Local Institution - 0167
state: Seoul
city: Jongno-gu
country: Korea, Republic of
facility: Local Institution - 0062
state: Seoul
city: Busan
country: Korea, Republic of
facility: Local Institution - 0142
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution - 0097
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Local Institution - 0098
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0141
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0140
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0139
city: Christchurch
country: New Zealand
facility: Local Institution - 0286
state: Canterbury
city: Auckland
country: New Zealand
facility: Local Institution - 0047
city: Gdansk
country: Poland
facility: Local Institution - 0148
city: Otwock
country: Poland
facility: Local Institution - 0049
city: Warszawa
country: Poland
facility: Local Institution - 0092
city: Rio Piedras
country: Puerto Rico
facility: Local Institution - 0289
city: San Juan
country: Puerto Rico
facility: Local Institution - 0035
city: Craiova
country: Romania
facility: Local Institution - 0103
state: Dolj
city: Bucharest
country: Romania
facility: Local Institution - 0164
city: Cluj Napoca
country: Romania
facility: Local Institution - 0165
city: Craiova
country: Romania
facility: Local Institution
city: Timisoara
country: Romania
facility: Local Institution - 0163
city: Arkhangelsk
country: Russian Federation
facility: Local Institution - 0029
city: Barnaul
country: Russian Federation
facility: Local Institution - 0066
city: Chelyabinsk
country: Russian Federation
facility: Local Institution - 0074
city: Moscow
country: Russian Federation
facility: Local Institution - 0007
city: Pyatigorsk
country: Russian Federation
facility: Local Institution - 0072
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution - 0075
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution - 0091
city: Sochi
country: Russian Federation
facility: Local Institution - 0073
city: Singapore
country: Singapore
facility: Local Institution - 0048
city: Singapore
country: Singapore
facility: Local Institution - 0017
city: Singapore
country: Singapore
facility: Local Institution - 0174
city: Barcelona
country: Spain
facility: Local Institution - 0297
city: Barcelona
country: Spain
facility: Local Institution - 0055
city: Barcelona
country: Spain
facility: Local Institution - 0089
city: Cordoba
country: Spain
facility: Local Institution - 0090
city: El Palmar
country: Spain
facility: Local Institution - 0087
city: Madrid
country: Spain
facility: Local Institution - 0041
city: Madrid
country: Spain
facility: Local Institution - 0093
city: Madrid
country: Spain
facility: Local Institution - 0290
city: Majadahonda
country: Spain
facility: Local Institution - 0045
city: Pamplona
country: Spain
facility: Local Institution - 0085
city: Santander
country: Spain
facility: Local Institution - 0088
city: Zaragoza
country: Spain
facility: Local Institution - 0040
city: Bern
country: Switzerland
facility: Local Institution - 0063
city: Kaohsiung
country: Taiwan
facility: Local Institution - 0272
city: Kaohsiung
country: Taiwan
facility: Local Institution - 0096
city: Taichung
country: Taiwan
facility: Local Institution - 0105
city: Taichung
country: Taiwan
facility: Local Institution - 0271
city: Tainan
country: Taiwan
facility: Local Institution - 0168
city: Tainan
country: Taiwan
facility: Local Institution - 0270
city: Taipei
country: Taiwan
facility: Local Institution - 0144
city: Taipei
country: Taiwan
facility: Local Institution - 0078
city: Taoyuan
country: Taiwan
facility: Local Institution - 0173
city: London
country: United Kingdom
facility: Local Institution - 0171
state: Greater London
city: Guildford
country: United Kingdom
facility: Local Institution - 0154
state: Surrey
city: Edinburgh
country: United Kingdom
facility: Local Institution - 0160
city: London
country: United Kingdom
facility: Local Institution - 0129
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: