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

  • Clinicaltrials.gov identifier

    NCT04340193

  • Recruitment Status

    Recruiting

  • First Posted

    April 9, 2020

  • Last update posted

    August 25, 2021

Study Description

Brief summary:

The purpose of this study is to compare effectiveness and safety of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer

  • Condition or Disease:Liver Cancer
  • Intervention/Treatment: Biological: nivolumab
    Biological: ipilimumab
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 765 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • 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)
  • Actual Study Start Date: September 2020
  • Estimated Primary Completion Date: February 2026
  • Estimated Study Completion Date: June 2028

Arms and interventions

Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab + TACE
TACE (Trans-arterial Chemoembolization)
Biological: nivolumab
specified dose on specified days

Biological: ipilimumab
specified dose on specified days
Experimental: Nivolumab + Ipilimumab Placebo + TACE
TACE (Trans-arterial Chemoembolization)
Biological: nivolumab
specified dose on specified days

Biological: ipilimumab
specified dose on specified days
Placebo Comparator: Nivolumab Placebo + Ipilimumab Placebo + TACE
TACE (Trans-arterial Chemoembolization)
Biological: nivolumab
specified dose on specified days

Biological: ipilimumab
specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm A versus Arm C [ Time Frame: up to 2 years ]
  • 2. Overall Survival (OS): Arm A versus Arm C [ Time Frame: up to 2.5 years ]
  • Secondary Outcome Measures: 1. Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm B versus Arm C [ Time Frame: up to 2 years ]
  • 2. Overall Survival (OS): Arm B versus Arm C [ Time Frame: up to 2.5 years ]
  • 3. Event-Free Survival (EFS) [ Time Frame: up to 2 years ]
  • 4. Progression-free survival (PFS) [ Time Frame: up to 2 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participant has intermediate-stage HCC (hepatocellular carcinoma) whose tumor characteristics exceed the BMU7 criteria and is eligible for TACE - Participant has histologic confirmation of HCC - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 - Men and Women must agree to follow methods of contraception - Participants are eligible to enroll if they have non-viral related HCC, or if they have HBV-HCC, or HCV-HCC 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 - Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications - Any previous TACE or TAE (trans-arterial embolization without instillation of chemotherapy agent) procedure for HCC - Known or suspected allergy to nivolumab, ipilimumab, or study drug components given in association with this trial Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
Southern California Research Center
Coronado

United States, California
Local Institution
Duarte

United States, California
Local Institution
La Jolla

United States, California
Local Institution
Pasadena

United States, District of Columbia
Local Institution
Washington

United States, Iowa
Local Institution
Iowa City

United States, Kansas
Local Institution
Westwood

United States, Kentucky
University of Louisville-James Graham Brown Cancer Center
Louisville

United States, Kentucky
Local Institution
Louisville

United States, New York
Local Institution
New York

United States, Pennsylvania
Local Institution
Philadelphia

United States, Tennessee
Local Institution
Knoxville

United States, Texas
The Liver Institute at Methodist Dallas Medical Center
Dallas

United States, Texas
Local Institution
Houston

United States, Texas
Local Institution
Houston

United States, Texas
Local Institution
San Antonio

United States, Virginia
Local Institution
Charlottesville

Argentina, Buenos Aires
Local Institution
Pilar

Argentina, Tucuman
Local Institution
San Miguel De Tucuman

Argentina
Local Institution
Cordoba

Australia, New South Wales
Local Institution
Sydney

Australia, New South Wales
Local Institution
Wollongong

Australia, Queensland
Sunshine Coast University Hospital
Birtinya

Australia, South Australia
Royal Adelaide Hospital
Adelaide

Australia, Victoria
Local Institution
Fitzroy

Australia, Victoria
St. Vincents Hospital
Melbourne

Australia, Western Australia
Fiona Stanley Hospital
Murdoch

Austria
Medizinische Universitat Graz
Graz

Austria
Local Institution
Linz

Austria
Universitatsklinikum St. Polten - Lilienfeld Standort St. Polten
St. Polten

Austria
Local Institution
Vienna

Austria
Allgemeines Krankenhaus Wien
West Springfield

Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt

Belgium
Local Institution
Brussels

Belgium
Cliniques Univ St Luc - Gastro-Enterology
Brussels

Belgium
Local Institution
Charleroi

Belgium
Local Institution
Federal District

Belgium
AZ Maria Middelares
Gent

Belgium
Universite Libre de Bruxelles (ULB) - Hopital Erasme
Plainfield

Brazil, Bahia
Local Institution
Salvador

Brazil, Bahia
Local Institution
Salvador

Brazil, RIO Grande DO SUL
Local Institution
Ijui

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution
Barretos

Brazil, SAO Paulo
Local Institution
Ribeirao Preto

Brazil
Local Institution
Porto Alegre

Brazil
Local Institution
Rio de Janeiro

Brazil
Local Institution
Sao Paulo

Brazil
Local Institution
Sao Paulo

Brazil
Local Institution
Sao Paulo

Canada, British Columbia
Local Institution
Vancouver

Canada
Centre Hospitalier Affilie Universitaire - Hotel-Dieu de Quebec
Quebec

China, Anhui
Local Institution
Hefei

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Chongqing
Local Institution
Chongqing

China, Chongqing
Local Institution
Chongqing

China, Fujian
Local Institution
Fuzhou Shi

China, Fujian
Local Institution
Fuzhou

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Guangzhou

China, Hebei
Local Institution
Tianjin

China, Henan
Local Institution
Zhengzhou

China, Hunan
Local Institution
Changsha

China, Jiangsu
Local Institution
Nanjing Shi

China, Jiangsu
Local Institution
Nanjing

China, Jiangsu
Local Institution
Nantong

China, Jiangsu
Local Institution
Suzhou

China, Jiangxi
Local Institution
Nanchang

China, Liaoning
Local Institution
Shenyang

China, Shan3xi
Local Institution
Xi'an

China, Shan3xi
Local Institution
Xian

China, Shan3xi
Local Institution
Xian

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Sichuan
Local Institution
Chengdu

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Hangzhou

Czechia
Fakultni nemocnice Olomouc
Olomouc

Czechia
Local Institution
Praha 5

France
Centre Hospitalier Universitaire Caen
Caen

France
Hopitaux Universitaires Paris Nord Val de Seine - Hopital Beaujon
Clichy

France
Centre Georges-Franois Leclerc
Dijon

France
Local Institution
Englewood

France
Hopital Michallon
La Tronche

France
CHU de Lille - Hopital Claude Huriez
Lille

France
Hopital Saint Joseph
Marseil

France
Centre Hospitalier Universitaire de Nantes CHU de Nantes
Nantes

France
CHU de Nice - Hospital Larchet
Nice

France
Local Institution
Paris

France
Local Institution
Poitiers

France
CHU Reims
Reims

France
Gustave Roussy
Villejuif cedex

Germany
Local Institution
Dresden

Germany
Local Institution
Essen

Germany
Local Institution
Essen

Germany
Local Institution
Frankfurt

Germany
Universitatsmedizin Gttingen - Universitat GeottingenKlinik fuer Gastroenterologie und Gastrointesti
Goettingen

Germany
Local Institution
Halle

Germany
Local Institution
Hamburg

Germany
Local Institution
Hamburg

Germany
Local Institution
Hannover

Germany
Local Institution
Heidelberg

Germany
Local Institution
Jena

Germany
Local Institution
Landshut

Germany
Universitatsklinikum Leipzig
Leipzig

Germany
Local Institution
Muenster

Hong Kong
Local Institution
Hong Kong

Hong Kong
Local Institution
Shatin, New Territories

Italy
Local Institution
Feltre

Italy
Local Institution
Messina

Italy
Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
Milano

Italy
Local Institution
Monserrato

Italy
A.O.U. San Luigi Gonzaga
Orbassano

Italy
Local Institution
Padua

Italy
Local Institution
Parma

Italy
Local Institution
Pisa

Italy
Local Institution
Roma

Italy
A.O.U. Senese Policlinico Le Scotte
Siena

Italy
Azienda ULSS 8 Berica
Vicenza

Japan, Chiba
Chiba University Hospital
Chiba-shi

Japan, Chiba
Local Institution
Kashiwa-shi

Japan, Ehime
Ehime Prefectural Central Hospital
Matsuyama

Japan, Hokkaido
Sapporo-Kosei General Hospital
Sapporo-shi

Japan, Ishikawa
Kanazawa University Hospital
Kanazawa

Japan, Kanagawa
Toranomon Hospital Kajigaya
Kawasaki

Japan, Kanagawa
Yokohama City University Medical Center
Yokohama-Shi

Japan, Kanagawa
Kanagawa Cancer Center
Yokohama-Shi

Japan, Kyoto
Kyoto Prefectural University of Medicine KPUM - University Hospital
Kyoto-Shi

Japan, Nara
Local Institution
Kashihara-Shi

Japan, Osaka
Osaka city University Hospital
Abeno-ku

Japan, Osaka
Local Institution
Tennoji-ku

Japan, Saga
Local Institution
Saga Shi

Japan, Shizuoka
Juntendo University Shizuoka Hospital
Izunokuni-Shi

Japan, Tokyo
Toranomon Hospital
Minato

Japan, Tokyo
Local Institution
Mitaka-Shi

Japan, Tokyo
Japanese Red Cross Musashino Hospital
Musashino-shi

Japan
Hiroshima University Hospital
Hiroshima

Japan
Kindai University Hospital
Osaka

Japan
Saitama Medical University Hospital
Saitama

Korea, Republic of, Daegu Gwang Yeogsi
Local Institution
Daegu

Korea, Republic of
Local Institution
Busan

Korea, Republic of
Local Institution
Gyeongsangnam-do

Korea, Republic of
Local Institution
Hwasun-Gun

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Poland
Local Institution
Gdansk

Poland
Local Institution
Warszawa

Poland
Local Institution
Wroclaw

Puerto Rico
Pan American Center for Oncology Trials, LLC
San Juan

Russian Federation
Altai Regional Oncology Dispensary
Barnaul

Russian Federation
Local Institution
Moscow

Russian Federation
A.M.Granovs Russian Scientific Center of Radiology and Surgical Technologies, St.Petersburg, Russia
Saint Petersburg

Russian Federation
City Clinical Oncology Dispensary
Saint-Petersburg

Russian Federation
Local Institution
Ufa

Singapore
Local Institution
Singapore

Singapore
Local Institution
Singapore

Singapore
Local Institution
Singapore

Spain
Hospital General Universitario de Alicante
Alicante

Spain
Local Institution
Barcelona

Spain
Hospital Universitario Reina Sofia
Cordoba

Spain
Hospital General Universitario Gregorio Maranon HGUGM
Madrid

Spain
Clinica Universidad de Navarra-Madrid
Madrid

Spain
Hospital Universitario Ramon y Cajal
Madrid

Spain
Hospital Universitario 12 de Octubre
Madrid

Spain
Local Institution
Oviedo

Spain
Clinica Universidad de Navarra
Pamplona

Spain
Parc Tauli Sabadell Hospital Universitari
Sabadell

Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela

Spain
Local Institution
Sevilla

Switzerland
Local Institution
Basel-Stadt

Switzerland
Local Institution
St.Gallen

Switzerland
Local Institution
Zurich

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
Puzi City

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Tainan City

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taoyuan City

Taiwan
Local Institution
Tapei

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04340193 History of Changes
  • Other Study ID Numbers: CA209-74W
  • First Posted: April 9, 2020 Key Record Dates
  • Last Update Posted: August 25, 2021
  • Last Verified: August 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Liver Neoplasms