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A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer (CheckMate 74W)

Primary Purpose

Cancer, Hepatocellular

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

About this trial

This is an interventional treatment trial for Cancer, Hepatocellular

Eligibility Criteria

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

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

Sites / Locations

  • Local Institution - 0189
  • Local Institution
  • Local Institution - 0005
  • Norton Cancer Institute Audubon
  • Local Institution - 0109
  • Local Institution
  • Local Institution - 0037
  • Local Institution - 0010
  • Local Institution - 0001
  • Local Institution - 0139
  • Local Institution - 0048
  • Local Institution - 0026
  • Local Institution - 0013
  • Local Institution
  • Local Institution - 0078
  • Local Institution - 0020
  • Local Institution
  • Local Institution - 0053
  • Local Institution - 0050
  • Local Institution - 0039
  • Local Institution - 0184
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0196
  • Local Institution - 0176
  • Local Institution
  • Local Institution - 0209
  • Local Institution - 0151
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0055
  • Local Institution
  • Local Institution - 0014
  • Local Institution - 0132
  • Local Institution - 0021
  • Local Institution - 0064
  • Local Institution - 0082
  • Local Institution - 0052
  • Local Institution - 0061
  • Local Institution - 0087
  • Local Institution - 0012
  • Local Institution - 0093
  • Local Institution - 0046
  • Local Institution - 0094
  • Local Institution
  • Local Institution - 0035
  • Local Institution
  • Local Institution
  • Local Institution - 0071
  • Local Institution - 0045
  • Local Institution - 0004
  • Local Institution - 0015
  • Local Institution
  • Local Institution - 0025
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0076
  • Local Institution - 0070
  • Local Institution - 0122
  • Local Institution - 0148
  • Local Institution - 0118
  • Local Institution - 0116
  • Local Institution - 0120
  • Local Institution - 0113
  • Local Institution - 0115
  • Local Institution - 0127
  • Local Institution - 0125
  • Local Institution - 0128
  • Local Institution - 0121
  • Local Institution - 0108
  • Local Institution - 0119
  • Local Institution - 0117
  • Local Institution - 0123
  • Local Institution - 0114
  • Local Institution - 0135
  • Local Institution - 0047
  • Local Institution - 0097
  • Local Institution - 0161
  • Local Institution - 0186
  • Local Institution - 0160
  • Local Institution - 0164
  • Local Institution
  • Local Institution - 0049
  • Local Institution - 0016
  • Local Institution - 0077
  • Local Institution - 0009
  • Local Institution
  • Local Institution - 0089
  • Local Institution - 0011
  • Local Institution - 0023
  • Local Institution - 0092
  • Local Institution - 0101
  • Local Institution - 0183
  • Local Institution - 0084
  • Local Institution - 0018
  • Local Institution - 0099
  • Local Institution - 0131
  • Local Institution - 0102
  • Local Institution - 0141
  • Local Institution - 0136
  • Local Institution - 0030
  • Local Institution - 0057
  • Local Institution - 0029
  • Local Institution - 0002
  • Local Institution - 0044

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Nivolumab + Ipilimumab + TACE

Nivolumab + TACE

TACE

Arm Description

TACE (Trans-arterial ChemoEmbolization)

Outcomes

Primary Outcome Measures

Number of treated participants with adverse events (AEs)
Number of deaths in all treated patients
Number of treated participants with laboratory abnormalities

Secondary Outcome Measures

Full Information

First Posted
April 7, 2020
Last Updated
October 11, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04340193
Brief Title
A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
Acronym
CheckMate 74W
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (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 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Nivolumab + Ipilimumab + TACE
Arm Type
Experimental
Arm Description
TACE (Trans-arterial ChemoEmbolization)
Arm Title
Nivolumab + TACE
Arm Type
Experimental
Arm Title
TACE
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
ipilimumab
Other Intervention Name(s)
Yervoy
Intervention Description
Specified dose on specified days
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
TACE (Trans-arterial ChemoEmbolization)
Primary Outcome Measure Information:
Title
Number of treated participants with adverse events (AEs)
Time Frame
Up to 2 years and 4 months
Title
Number of deaths in all treated patients
Time Frame
Up to 2 years and 4 months
Title
Number of treated participants with laboratory abnormalities
Time Frame
Up to 2 years and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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 - 0189
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Local Institution
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Local Institution - 0005
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Cancer Institute Audubon
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Local Institution - 0109
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Local Institution
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Local Institution - 0037
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4560
Country
Australia
Facility Name
Local Institution - 0010
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution - 0001
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Local Institution - 0139
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution - 0048
City
Wiener Neustadt
State/Province
Niederosterreich
ZIP/Postal Code
2700
Country
Austria
Facility Name
Local Institution - 0026
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution - 0013
City
St. Polten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Local Institution
City
Vienna
ZIP/Postal Code
1100
Country
Austria
Facility Name
Local Institution - 0078
City
West Springfield
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0020
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Federal District
ZIP/Postal Code
72115700
Country
Belgium
Facility Name
Local Institution - 0053
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0050
City
Plainfield
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Local Institution - 0039
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Local Institution - 0184
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Facility Name
Local Institution
City
Tianjin
State/Province
Hebei
ZIP/Postal Code
300060
Country
China
Facility Name
Local Institution - 0196
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Local Institution - 0176
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Local Institution
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Local Institution - 0209
City
Xi'an
State/Province
Shan3xi
ZIP/Postal Code
710032
Country
China
Facility Name
Local Institution - 0151
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Local Institution
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Local Institution - 0055
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Local Institution
City
Praha 5
ZIP/Postal Code
15000
Country
Czechia
Facility Name
Local Institution - 0014
City
Lille
State/Province
Mount
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution - 0132
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Local Institution - 0021
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Local Institution - 0064
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Local Institution - 0082
City
Englewood
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution - 0052
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Local Institution - 0061
City
Marseil
ZIP/Postal Code
13285
Country
France
Facility Name
Local Institution - 0087
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution - 0012
City
Nice
ZIP/Postal Code
6202
Country
France
Facility Name
Local Institution - 0093
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Local Institution - 0046
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Local Institution - 0094
City
Villejuif cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Local Institution - 0035
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution - 0071
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Local Institution - 0045
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Local Institution - 0004
City
HongKong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Local Institution - 0015
City
Orbassano
State/Province
TO
ZIP/Postal Code
10043
Country
Italy
Facility Name
Local Institution
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
Local Institution - 0025
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Local Institution
City
Monserrato
ZIP/Postal Code
9042
Country
Italy
Facility Name
Local Institution
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
78584
Country
Italy
Facility Name
Local Institution - 0076
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution - 0070
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Local Institution - 0122
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
Local Institution - 0148
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Local Institution - 0118
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
9208641
Country
Japan
Facility Name
Local Institution - 0116
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
2138587
Country
Japan
Facility Name
Local Institution - 0120
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2320024
Country
Japan
Facility Name
Local Institution - 0113
City
Yokohama-Shi
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Local Institution - 0115
City
Kyoto-Shi
State/Province
Kyoto
ZIP/Postal Code
602-0841
Country
Japan
Facility Name
Local Institution - 0127
City
Abeno-ku
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Local Institution - 0125
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 - 0121
City
Musashino-shi
State/Province
Tokyo
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Local Institution - 0108
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Local Institution - 0119
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Local Institution - 0117
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Local Institution - 0123
City
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Local Institution - 0114
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Local Institution - 0135
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Local Institution - 0047
City
Gyeongsangnam-do
ZIP/Postal Code
050612
Country
Korea, Republic of
Facility Name
Local Institution - 0097
City
Hwasun-Gun
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Local Institution - 0161
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution - 0186
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution - 0160
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 0164
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Local Institution - 0049
City
San Juan
ZIP/Postal Code
00902
Country
Puerto Rico
Facility Name
Local Institution - 0016
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
Local Institution - 0077
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution - 0009
City
Saint-Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Local Institution - 0089
City
Singapore
ZIP/Postal Code
217562
Country
Singapore
Facility Name
Local Institution - 0011
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Local Institution - 0023
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Local Institution - 0092
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Local Institution - 0101
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 0183
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Local Institution - 0084
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution - 0018
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0099
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution - 0131
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
Facility Name
Local Institution - 0102
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution - 0141
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Local Institution - 0136
City
Puzi City
ZIP/Postal Code
613
Country
Taiwan
Facility Name
Local Institution - 0030
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Local Institution - 0057
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Local Institution - 0029
City
Tainan City
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution - 0002
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Local Institution - 0044
City
Tapei
ZIP/Postal Code
11217
Country
Taiwan

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/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

A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer

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