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)

November 5, 2024 updated by: Bristol-Myers Squibb

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Local Institution
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Local Institution - 0037
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0010
    • Victoria
      • Melbourne, Victoria, Australia, 3065
        • Local Institution - 0001
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0139
  • Austria
      • Graz, Austria, 8036
        • Local Institution - 0026
      • St. Polten, Austria, 3100
        • Local Institution - 0013
      • Vienna, Austria, 1100
        • Local Institution
      • West Springfield, Austria, 1090
        • Local Institution - 0078
      • Wiener Neustadt, Austria, 2700
        • Local Institution - 0048
  • Belgium
      • Brussels, Belgium, 1200
        • Local Institution - 0020
      • Federal District, Belgium, 72115700
        • Local Institution
      • Gent, Belgium, 9000
        • Local Institution - 0053
      • Plainfield, Belgium, 1070
        • Local Institution - 0050
  • Canada
      • Quebec, Canada, G1R 2J6
        • Local Institution - 0039
  • China
    • Beijing
      • Beijing Shi, Beijing, China, 100034
        • Local Institution - 0184
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Local Institution
      • Guangzhou, Guangdong, China, 510095
        • Local Institution
    • Hebei
      • Tianjin, Hebei, China, 300060
        • Local Institution
    • Jiangsu
      • Nanjing Shi, Jiangsu, China, 210009
        • Local Institution - 0196
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Local Institution - 0176
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Local Institution
    • Shan3xi
      • Xi'an, Shan3xi, China, 710100
        • Local Institution - 0209
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Local Institution - 0151
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Local Institution
      • Hangzhou, Zhejiang, China, 310022
        • Local Institution
  • Czechia
      • Olomouc, Czechia, 779 00
        • Local Institution - 0055
      • Praha 5, Czechia, 15000
        • Local Institution
  • France
      • Caen, France, 14033
        • Local Institution - 0132
      • Clichy, France, 92110
        • Local Institution - 0021
      • Dijon, France, 21000
        • Local Institution - 0064
      • Englewood, France, 34295
        • Local Institution - 0082
      • La Tronche, France, 38700
        • Local Institution - 0052
      • Marseil, France, 13285
        • Local Institution - 0061
      • Nantes, France, 44093
        • Local Institution - 0087
      • Nice, France, 6202
        • Local Institution - 0012
      • Paris, France, 75013
        • Local Institution - 0093
      • Reims, France, 51092
        • Local Institution - 0046
      • Villejuif cedex, France, 94805
        • Local Institution - 0094
    • Mount
      • Lille, Mount, France, 59037
        • Local Institution - 0014
  • Germany
      • Goettingen, Germany, 37075
        • Local Institution - 0035
      • Hannover, Germany, 30625
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution
      • Leipzig, Germany, 4103
        • Local Institution - 0071
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution - 0045
      • HongKong, Hong Kong
        • Local Institution - 0004
  • Italy
      • Messina, Italy, 98124
        • Local Institution
      • Milano, Italy, 20122
        • Local Institution - 0025
      • Monserrato, Italy, 9042
        • Local Institution
      • Parma, Italy, 43126
        • Local Institution
      • Roma, Italy, 78584
        • Local Institution
      • Siena, Italy, 53100
        • Local Institution - 0076
      • Vicenza, Italy, 36100
        • Local Institution - 0070
    • TO
      • Orbassano, TO, Italy, 10043
        • Local Institution - 0015
  • Japan
      • Hiroshima, Japan, 734-8551
        • Local Institution - 0119
      • Osaka, Japan, 589-8511
        • Local Institution - 0117
      • Saitama, Japan, 350-0495
        • Local Institution - 0123
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8677
        • Local Institution - 0108
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 790-0024
        • Local Institution - 0122
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Local Institution - 0148
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 9208641
        • Local Institution - 0118
    • Kanagawa
      • Yokohama-Shi, Kanagawa, Japan, 241-0815
        • Local Institution - 0113
      • Yokohama-shi, Kanagawa, Japan, 2320024
        • Local Institution - 0120
    • Kyoto
      • Kyoto-Shi, Kyoto, Japan, 602-0841
        • Local Institution - 0115
    • Osaka
      • Abeno-ku, Osaka, Japan, 545-8586
        • Local Institution - 0127
    • Shizuoka
      • Izunokuni-Shi, Shizuoka, Japan, 4102295
        • Local Institution - 0125
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-8470
        • Local Institution - 0116
      • Minato-ku, Tokyo, Japan, 105-8470
        • Local Institution - 0128
      • Musashino-shi, Tokyo, Japan, 180-8610
        • Local Institution - 0121
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Local Institution - 0114
      • Daegu, Korea, Republic of, 41944
        • Local Institution - 0135
      • Gyeongsangnam-do, Korea, Republic of, 050612
        • Local Institution - 0047
      • Hwasun-Gun, Korea, Republic of, 58128
        • Local Institution - 0097
      • Seoul, Korea, Republic of, 03080
        • Local Institution - 0161
      • Seoul, Korea, Republic of, 05505
        • Local Institution - 0186
      • Seoul, Korea, Republic of, 06351
        • Local Institution - 0160
      • Seoul, Korea, Republic of, 120-752
        • Local Institution - 0164
  • Poland
      • Warszawa, Poland, 02-034
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00902
        • Local Institution - 0049
  • Russian Federation
      • Barnaul, Russian Federation, 656049
        • Local Institution - 0016
      • Saint Petersburg, Russian Federation, 197758
        • Local Institution - 0077
      • Saint-Petersburg, Russian Federation, 198255
        • Local Institution - 0009
  • Singapore
      • Singapore, Singapore, 308433
        • Local Institution - 0011
      • Singapore, Singapore, 217562
        • Local Institution - 0089
      • Singapore, Singapore, 119074
        • Local Institution - 0027
  • Spain
      • Alicante, Spain, 03010
        • Local Institution - 0023
      • Cordoba, Spain, 14004
        • Local Institution - 0092
      • Madrid, Spain, 28007
        • Local Institution - 0101
      • Madrid, Spain, 28041
        • Local Institution - 0018
      • Madrid, Spain, 28027
        • Local Institution - 0183
      • Madrid, Spain, 28034
        • Local Institution - 0084
      • Pamplona, Spain, 31008
        • Local Institution - 0099
      • Sabadell, Spain, 8208
        • Local Institution - 0131
      • Santiago de Compostela, Spain, 15706
        • Local Institution - 0102
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Local Institution - 0141
      • Puzi City, Taiwan, 613
        • Local Institution - 0136
      • Taichung, Taiwan, 40705
        • Local Institution - 0057
      • Taichung City, Taiwan, 40447
        • Local Institution - 0030
      • Tainan City, Taiwan, 704
        • Local Institution - 0029
      • Taipei, Taiwan, 10002
        • Local Institution - 0002
      • Tapei, Taiwan, 11217
        • Local Institution - 0044
  • United States
    • California
      • Coronado, California, United States, 92118
        • Local Institution - 0189
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Local Institution
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Local Institution - 0005
      • Louisville, Kentucky, United States, 40217
        • Local Institution - 0059
    • Texas
      • Dallas, Texas, United States, 75203
        • Local Institution - 0109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nivolumab + Ipilimumab + TACE
TACE (Trans-arterial ChemoEmbolization)
Drug: nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
Procedure: TACE
TACE (Trans-arterial ChemoEmbolization)
Experimental: Nivolumab + TACE
Drug: nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Procedure: TACE
TACE (Trans-arterial ChemoEmbolization)
Active Comparator: TACE
Procedure: TACE
TACE (Trans-arterial ChemoEmbolization)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose that results in death, Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) or requires inpatient hospitalization or causes prolongation of existing hospitalization, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event.
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants Who Died
Time Frame: From first dose and 100 days after last dose of study therapy (up to approximately 27 months)
Number of participants who died due to any cause are summarized.
From first dose and 100 days after last dose of study therapy (up to approximately 27 months)
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Time Frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Time Frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). Highest grade measured for hemoglobin and albumin was Grade 3.
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Time Frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Blood samples were collected for specific thyroid test.
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
Time Frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Blood samples were collected for specific liver tests.
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Actual)

December 12, 2023

Study Completion (Actual)

December 12, 2023

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-74W

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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