Clinical trial NCT04340193: A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
Official title: A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer, Hepatocellular
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-04-09
Enrollment: 26
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 purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.


Eligibility criteria: Inclusion Criteria:

* Participant has intermediate-stage hepatocellular carcinoma (HCC) whose tumor characteristics exceed the Beyond Milan and Up-to-7 (BMU7) criteria and is eligible for trans-arterial ChemoEmbolization (TACE)
* Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI)
* 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 or participants who are on the waiting list for liver transplantation
* Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
measure: Number of Participants Who Died
timeFrame: From first dose and 100 days after last dose of study therapy (up to approximately 27 months)
measure: Number of Participants With Adverse Events Leading to Study Drug Discontinuation
timeFrame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
measure: Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
timeFrame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
measure: Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
measure: Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Coronado
country: United States
facility: Local Institution - 0189
state: California
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Louisville
country: United States
facility: Local Institution - 0005
state: Kentucky
city: Louisville
country: United States
facility: Local Institution - 0059
state: Kentucky
city: Dallas
country: United States
facility: Local Institution - 0109
state: Texas
city: Wollongong
country: Australia
facility: Local Institution
state: New South Wales
city: Birtinya
country: Australia
facility: Local Institution - 0037
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution - 0010
state: South Australia
city: Melbourne
country: Australia
facility: Local Institution - 0001
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0139
state: Western Australia
city: Graz
country: Austria
facility: Local Institution - 0026
city: St. Polten
country: Austria
facility: Local Institution - 0013
city: Vienna
country: Austria
facility: Local Institution
city: West Springfield
country: Austria
facility: Local Institution - 0078
city: Wiener Neustadt
country: Austria
facility: Local Institution - 0048
city: Brussels
country: Belgium
facility: Local Institution - 0020
city: Federal District
country: Belgium
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution - 0053
city: Plainfield
country: Belgium
facility: Local Institution - 0050
city: Quebec
country: Canada
facility: Local Institution - 0039
city: Beijing Shi
country: China
facility: Local Institution - 0184
state: Beijing
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Tianjin
country: China
facility: Local Institution
state: Hebei
city: Nanjing Shi
country: China
facility: Local Institution - 0196
state: Jiangsu
city: Nanchang
country: China
facility: Local Institution - 0176
state: Jiangxi
city: Shenyang
country: China
facility: Local Institution
state: Liaoning
city: Xi'an
country: China
facility: Local Institution - 0209
state: Shan3xi
city: Shanghai
country: China
facility: Local Institution - 0151
state: Shanghai
city: Chengdu
country: China
facility: Local Institution
state: Sichuan
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Olomouc
country: Czechia
facility: Local Institution - 0055
city: Praha 5
country: Czechia
facility: Local Institution
city: Lille
country: France
facility: Local Institution - 0014
state: Mount
city: Caen
country: France
facility: Local Institution - 0132
city: Clichy
country: France
facility: Local Institution - 0021
city: Dijon
country: France
facility: Local Institution - 0064
city: Englewood
country: France
facility: Local Institution - 0082
city: La Tronche
country: France
facility: Local Institution - 0052
city: Marseil
country: France
facility: Local Institution - 0061
city: Nantes
country: France
facility: Local Institution - 0087
city: Nice
country: France
facility: Local Institution - 0012
city: Paris
country: France
facility: Local Institution - 0093
city: Reims
country: France
facility: Local Institution - 0046
city: Villejuif cedex
country: France
facility: Local Institution - 0094
city: Goettingen
country: Germany
facility: Local Institution - 0035
city: Hannover
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution - 0071
city: Hong Kong
country: Hong Kong
facility: Local Institution - 0045
city: HongKong
country: Hong Kong
facility: Local Institution - 0004
city: Orbassano
country: Italy
facility: Local Institution - 0015
state: TO
city: Messina
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution - 0025
city: Monserrato
country: Italy
facility: Local Institution
city: Parma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution - 0076
city: Vicenza
country: Italy
facility: Local Institution - 0070
city: Chiba-shi
country: Japan
facility: Local Institution - 0108
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Local Institution - 0122
state: Ehime
city: Sapporo-shi
country: Japan
facility: Local Institution - 0148
state: Hokkaido
city: Kanazawa
country: Japan
facility: Local Institution - 0118
state: Ishikawa
city: Yokohama-shi
country: Japan
facility: Local Institution - 0120
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: Local Institution - 0113
state: Kanagawa
city: Kyoto-Shi
country: Japan
facility: Local Institution - 0115
state: Kyoto
city: Abeno-ku
country: Japan
facility: Local Institution - 0127
state: Osaka
city: Izunokuni-Shi
country: Japan
facility: Local Institution - 0125
state: Shizuoka
city: Minato-ku
country: Japan
facility: Local Institution - 0116
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution - 0128
state: Tokyo
city: Musashino-shi
country: Japan
facility: Local Institution - 0121
state: Tokyo
city: Hiroshima
country: Japan
facility: Local Institution - 0119
city: Osaka
country: Japan
facility: Local Institution - 0117
city: Saitama
country: Japan
facility: Local Institution - 0123
city: Busan
country: Korea, Republic of
facility: Local Institution - 0114
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0135
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Local Institution - 0047
city: Hwasun-Gun
country: Korea, Republic of
facility: Local Institution - 0097
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0161
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0186
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0160
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0164
city: Warszawa
country: Poland
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution - 0049
city: Barnaul
country: Russian Federation
facility: Local Institution - 0016
city: Saint Petersburg
country: Russian Federation
facility: Local Institution - 0077
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution - 0009
city: Singapore
country: Singapore
facility: Local Institution - 0027
city: Singapore
country: Singapore
facility: Local Institution - 0089
city: Singapore
country: Singapore
facility: Local Institution - 0011
city: Alicante
country: Spain
facility: Local Institution - 0023
city: Cordoba
country: Spain
facility: Local Institution - 0092
city: Madrid
country: Spain
facility: Local Institution - 0101
city: Madrid
country: Spain
facility: Local Institution - 0183
city: Madrid
country: Spain
facility: Local Institution - 0084
city: Madrid
country: Spain
facility: Local Institution - 0018
city: Pamplona
country: Spain
facility: Local Institution - 0099
city: Sabadell
country: Spain
facility: Local Institution - 0131
city: Santiago de Compostela
country: Spain
facility: Local Institution - 0102
city: Kaohsiung
country: Taiwan
facility: Local Institution - 0141
city: Puzi City
country: Taiwan
facility: Local Institution - 0136
city: Taichung City
country: Taiwan
facility: Local Institution - 0030
city: Taichung
country: Taiwan
facility: Local Institution - 0057
city: Tainan City
country: Taiwan
facility: Local Institution - 0029
city: Taipei
country: Taiwan
facility: Local Institution - 0002
city: Tapei
country: Taiwan
facility: Local Institution - 0044
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: