Clinical trial NCT03383458: A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Official title: A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Liver Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2017-12-26
Enrollment: 545
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: This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence


Eligibility criteria: Inclusion Criteria:

* Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
* Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
* 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
* Any evidence of tumor metastasis or co-existing malignant disease
* Participants previously receiving any prior therapy for HCC, including loco-regional therapies
* Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
* Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella \[MMR\]).

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Recurrence-free Survival (RFS)
timeFrame: Up to 49 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 7 years
measure: Time to recurrence (TTR)
timeFrame: Up to 49 months
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Local Institution - 0081
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona - Phoenix
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution - 0135
state: California
city: Palo Alto
country: United States
facility: Local Institution - 0088
state: California
city: San Francisco
country: United States
facility: Local Institution - 0085
state: California
city: Aurora
country: United States
facility: Local Institution - 0235
state: Colorado
city: Miami
country: United States
facility: Miami VA Healthcare System
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center/ UMHC
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0163
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0009
state: Georgia
city: Westwood
country: United States
facility: Local Institution - 0025
state: Kansas
city: New Orleans
country: United States
facility: Local Institution - 0086
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Saint Louis
country: United States
facility: Local Institution - 0209
state: Missouri
city: New York
country: United States
facility: Local Institution - 0075
state: New York
city: New York
country: United States
facility: Local Institution - 0208
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: White Plains
country: United States
facility: Local Institution - 0219
state: New York
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Portland
country: United States
facility: Local Institution - 0206
state: Oregon
city: Austin
country: United States
facility: Local Institution - 0272
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0156
state: Texas
city: Tyler
country: United States
facility: Local Institution - 0273
state: Texas
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Seattle
country: United States
facility: Local Institution - 0154
state: Washington
city: Gorriti
country: Argentina
facility: Local Institution - 0243
state: Buenos Aires
city: Pilar
country: Argentina
facility: Local Institution - 0254
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution - 0244
state: Santa FE
city: Blacktown
country: Australia
facility: Local Institution - 0239
state: New South Wales
city: Camperdown
country: Australia
facility: Local Institution - 0166
state: New South Wales
city: Concord
country: Australia
facility: Local Institution - 0141
state: New South Wales
city: Herston
country: Australia
facility: Local Institution - 0220
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution - 0164
state: South Australia
city: Heidelberg
country: Australia
facility: Local Institution - 0224
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution - 0124
state: Western Australia
city: Graz
country: Austria
facility: Local Institution - 0012
city: Vienna
country: Austria
facility: Local Institution - 0001
city: Wien
country: Austria
facility: Local Institution - 0003
city: Brussels
country: Belgium
facility: Local Institution - 0033
city: Bruxelles
country: Belgium
facility: Local Institution - 0064
city: Edegem
country: Belgium
facility: Local Institution - 0068
city: Gent
country: Belgium
facility: Local Institution - 0071
city: Leuven
country: Belgium
facility: Local Institution - 0108
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0090
state: Minas Gerais
city: Barretos
country: Brazil
facility: Local Institution - 0275
state: Sao Paulo
city: Cerqueira Cesar
country: Brazil
facility: Local Institution - 0237
state: SAO Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Local Institution
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution - 0023
city: Sao Paulo
country: Brazil
facility: Local Institution - 0236
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution - 0116
city: Santiago de Chile
country: Chile
facility: Local Institution - 0248
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0246
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0245
state: Región Metropolitana De Santiago
city: Vina del Mar
country: Chile
facility: Local Institution - 0247
state: Valparaiso
city: Bogota
country: Colombia
facility: Local Institution - 0256
city: Bobigny
country: France
facility: Local Institution - 0057
city: Brest
country: France
facility: Local Institution - 0052
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Clichy
country: France
facility: Local Institution - 0046
city: Creteil Cedex
country: France
facility: Local Institution - 0061
city: Grenoble Cedex 09
country: France
facility: Local Institution - 0013
city: Lille
country: France
facility: Local Institution - 0222
city: Lyon Cedex 04
country: France
facility: Local Institution - 0051
city: Montpellier Cedex
country: France
facility: Local Institution - 0043
city: Nice
country: France
facility: Local Institution - 0037
city: Poitiers
country: France
facility: Local Institution
city: Reims
country: France
facility: Local Institution - 0098
city: Rennes Cedex 9
country: France
facility: Local Institution - 0212
city: Saint-Priest-en-Jarez
country: France
facility: Local Institution - 0044
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Local Institution - 0011
city: Villejuif
country: France
facility: Local Institution - 0054
city: Aachen
country: Germany
facility: Local Institution - 0024
city: Berlin
country: Germany
facility: Local Institution - 0258
city: Bonn
country: Germany
facility: Local Institution - 0020
city: Essen
country: Germany
facility: Local Institution - 0026
city: Frankfurt am Main
country: Germany
facility: Local Institution - 0093
city: Hannover
country: Germany
facility: Local Institution - 0040
city: Homburg
country: Germany
facility: Local Institution - 0019
city: Koln
country: Germany
facility: Local Institution - 0050
city: Leipzig
country: Germany
facility: Local Institution
city: Magdeburg
country: Germany
facility: Local Institution - 0036
city: Mainz
country: Germany
facility: Local Institution - 0048
city: Mannheim
country: Germany
facility: Universitatsmedizin Mannheim
city: Muenchen
country: Germany
facility: Local Institution - 0096
city: Tuebingen
country: Germany
facility: Local Institution - 0008
city: Wuerzburg
country: Germany
facility: Local Institution
city: Hong Kong
country: Hong Kong
facility: Local Institution - 0120
city: Hong Kong
country: Hong Kong
facility: Local Institution - 0076
city: Messina
country: Italy
facility: Local Institution - 0136
state: ME
city: Bologna
country: Italy
facility: Local Institution - 0102
city: Firenze
country: Italy
facility: Local Institution - 0077
city: Meldola
country: Italy
facility: Local Institution - 0104
city: Milano
country: Italy
facility: Local Institution - 0091
city: Modena
country: Italy
facility: Local Institution
city: Monserrato
country: Italy
facility: Local Institution - 0134
city: Napoli
country: Italy
facility: Azienda Ospedaliera Specialistica dei Colli Monaldi-Cotugno-CTO
city: Napoli
country: Italy
facility: Local Institution - 0119
city: Padova
country: Italy
facility: Local Institution - 0103
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli - Universita Cattolica del Sacro Cuore
city: Chiba-shi
country: Japan
facility: Local Institution - 0187
state: Chiba
city: Kashiwa-shi
country: Japan
facility: Local Institution - 0183
state: Chiba
city: Kurume-shi
country: Japan
facility: Local Institution - 0201
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Local Institution - 0184
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution - 0200
state: Hokkaido
city: Nishinomiya-shi
country: Japan
facility: Local Institution - 0216
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Local Institution - 0180
state: Ishikawa
city: Morioka-shi
country: Japan
facility: Local Institution - 0257
state: Iwate
city: Kumamoto-shi
country: Japan
facility: Local Institution - 0202
state: Kumamoto
city: Osaka-sayama
country: Japan
facility: Local Institution
state: Osaka
city: Osaka-shi
country: Japan
facility: Local Institution - 0203
state: Osaka
city: Osaka-shi
country: Japan
facility: Local Institution - 0198
state: Osaka
city: Suita-shi
country: Japan
facility: Local Institution - 0214
state: Osaka
city: Tokushima-shi
country: Japan
facility: Local Institution - 0185
state: Tokushima
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0215
state: Tokyo
city: Chuo-ku
country: Japan
facility: Local Institution - 0196
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Local Institution - 0182
state: Tokyo
city: Musashino-shi
country: Japan
facility: Local Institution - 0210
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0186
state: Tokyo
city: Hiroshima
country: Japan
facility: Local Institution - 0179
city: Kanagawa
country: Japan
facility: Local Institution - 0197
city: Suwon-si
country: Korea, Republic of
facility: Local Institution - 0191
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0127
state: Seoul-teukbyeolsi [Seoul]
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0177
city: Goyang-si
country: Korea, Republic of
facility: Local Institution - 0190
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Local Institution - 0188
city: Jeollanam-do
country: Korea, Republic of
facility: Local Institution - 0178
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0169
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0128
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0168
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0167
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0195
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0189
city: Cuauhtemoc
country: Mexico
facility: Local Institution - 0148
state: Durango
city: Monterrey
country: Mexico
facility: Local Institution - 0264
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Local Institution - 0121
state: Nuevo León
city: San Luis Potosi
country: Mexico
facility: Local Institution - 0226
city: Maastricht
country: Netherlands
facility: Local Institution - 0263
city: Utrecht
country: Netherlands
facility: Local Institution - 0260
city: Auckland
country: New Zealand
facility: Local Institution - 0240
city: San Juan
country: Puerto Rico
facility: Local Institution - 0231
city: Brasov
country: Romania
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution - 0078
city: Cluj-Napoca
country: Romania
facility: Local Institution - 0232
city: Constanta
country: Romania
facility: Local Institution - 0242
city: Craiova
country: Romania
facility: Local Institution - 0074
city: Timisoara
country: Romania
facility: Local Institution - 0070
city: St. Petersburg
country: Russian Federation
facility: Local Institution - 0032
state: Sankt-Peterburg
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary
city: Leningrad Region
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution - 0230
city: Singapore
country: Singapore
facility: Local Institution - 0042
city: Singapore
country: Singapore
facility: Local Institution - 0067
city: Singapore
country: Singapore
facility: Local Institution - 0039
city: Barcelona
country: Spain
facility: Local Institution - 0069
city: Barcelona
country: Spain
facility: Local Institution - 0031
city: Córdoba
country: Spain
facility: Local Institution - 0016
city: Donostia-San Sebastian
country: Spain
facility: Local Institution - 0072
city: Madrid
country: Spain
facility: Local Institution - 0199
city: Madrid
country: Spain
facility: Local Institution - 0109
city: Pamplona
country: Spain
facility: Local Institution - 0100
city: Sabadell (Barcelona)
country: Spain
facility: Local Institution - 0010
city: Sevilla
country: Spain
facility: Local Institution - 0028
city: Valencia
country: Spain
facility: Local Institution - 0082
city: Zaragoza
country: Spain
facility: Local Institution - 0097
city: Tainan
country: Taiwan
facility: Local Institution - 0131
state: TNN
city: Kaohsiung
country: Taiwan
facility: Local Institution - 0204
city: Taichung
country: Taiwan
facility: Local Institution - 0130
city: Taichung
country: Taiwan
facility: Local Institution - 0140
city: Tainan
country: Taiwan
facility: Local Institution - 0174
city: Taipei
country: Taiwan
facility: Local Institution - 0207
city: Taipei
country: Taiwan
facility: Local Institution - 0173
city: Taipei
country: Taiwan
facility: Local Institution - 0129
city: Taoyuan
country: Taiwan
facility: Local Institution - 0175
city: Yunlin
country: Taiwan
facility: Local Institution - 0176
city: London
country: United Kingdom
facility: Local Institution - 0111
city: London
country: United Kingdom
facility: Local Institution - 0092
city: London
country: United Kingdom
facility: Local Institution - 0153
city: Manchester
country: United Kingdom
facility: Local Institution - 0114
city: Wirral
country: United Kingdom
facility: Local Institution - 0142
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: