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A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma (CheckMate 9DW)

  • Clinicaltrials.gov identifier

    NCT04039607

  • Recruitment Status

    Active, not recruiting

  • First Posted

    July 31, 2019

  • Last update posted

    October 18, 2021

Study Description

Brief summary:

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

  • Condition or Disease:Hepatocellular Carcinoma
  • Intervention/Treatment: Drug: Nivolumab
    Drug: Ipilimumab
    Drug: Sorafenib
    Drug: lenvatinib
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 634 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: March 2023
  • Estimated Study Completion Date: January 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab
Drug: Nivolumab
Participants will receive nivolumab as intravenous (IV) infusion.

Drug: Ipilimumab
Participants will receive ipilimumab as IV infusion.
Active Comparator: Sorafenib/lenvatinib
Drug: Sorafenib
Participants will receive sorafenib as oral tablets.

Drug: lenvatinib
Participants will receive lenvatinib as oral capsules.

Outcome Measures

  • Primary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: Up to 4 years ]
  • Secondary Outcome Measures: 1. Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]
  • 2. Duration of Response (DOR) [ Time Frame: Up to 4 years ]
  • 3. Time to Symptom Deterioration (TTSD) [ Time Frame: Up to 4 years ]

Eligibility Criteria

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

Criteria

Inclusion Criteria: - Participants must have a diagnosis of HCC based on histological confirmation - Participants must have an advanced HCC - Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion - 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 - Prior liver transplant - Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization - Active brain metastases or leptomeningeal metastases Other protocol inclusion/exclusion criteria may apply.

Contacts and Locations

Contacts

Locations

Italy
Istituto Oncologico Veneto
Padova

Italy, Milano
Istituto Clinico Humanitas
Rozzano

Italy
Fondazione del Piemonte per lOncologia (IRCCS)
Candiolo

Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Meldola

Italy
Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
Milano

Italy
Azienda Ospedaliero-Universitaria Maggiore della Carita
Novara

Italy
Azienda Ospedaliero Universitaria di Parma
Parma

Italy
Policlinico Universitario Campus Bio-Medico
Roma

Italy
Policlinico Universitario A. Gemelli IRCCS
Rome

Italy
A.O.U.Senese - Policl.S.Maria alle Scotte
Siena

Italy
AULSS 8 Berica Ospedale san Bortolo UOC Oncologia
Vicenza

United States, Arizona
The University of Arizona Cancer Center - North
Tucson

United States, California
Southern California Research Center
Coronado

United States, California
City of Hope National Medical Center
Duarte

United States, District of Columbia
Georgetown University Medical Center Lombardi Cancer Center
Washington

United States, Kentucky
Norton Cancer Institute
Louisville

United States, Maryland
John Hopkins Medicine
Baltimore

United States, Michigan
Local Institution
Ann Arbor

United States, Michigan
Henry Ford Hospital
Detroit

United States, New Jersey
Rutgers, New Jersey Medical School
Newark

United States, Ohio
Toledo Clinic Cancer Center
Toledo

United States, Pennsylvania
Allegheny General Hospital AGH - Allegheny Cancer Center
Pittsburgh

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

United States, Texas
Houston Methodist Cancer Center
Houston

United States, Texas
Joe Arrington Can Reserch Cnt
Lubbock

United States, Utah
Utah Cancer Specialists
Salt Lake City

Argentina, Buenos Aires
Instituto Medico Especialazado Alexander Fleming
Caba

Argentina, Buenos Aires
Fundacion Favaloro Para La Docencia E Investigacion
Caba

Argentina, Buenos Aires
Hospital Universitario Austral
Pilar

Argentina, Santa FE
Hospital Provincial del Centenario
Rosario

Argentina
Centro Para La Atencion Integral Del Paciente Oncologico
Tucuman

Australia, New South Wales
Saint George Hospital
Kogarah

Australia, New South Wales
Liverpool Hospital
Liverpool

Australia, New South Wales
Westmead Hospital
Northmead

Australia, Queensland
Sunshine Coast University Hospital
Birtinya

Australia, Queensland
Royal Brisbane and Womens Hospital
Herston

Australia, South Australia
Royal Adelaide Hospital
Adelaide

Australia, Victoria
Monash Health
Clayton

Australia, Victoria
St Vincents Hospital Melbourne
Fitzroy

Australia, Victoria
Alfred Hospital
Melbourne

Australia, Victoria
Western Health
St Albans

Austria
Universitaetsklinikum Graz
Graz

Austria
Klinikum Klagenfurt am Woerthersee
Klagenfurt

Austria
UK St. Poelten
St. Polten

Austria
Medizinische Universitat Wien AKH - Allgemeines Krankenhaus Wien
Viena

Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt

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

Belgium
AZ Maria Middelares
Gent

Belgium
Hopital de Jolimont
Haine-Saint-Paul

Belgium
UZ Leuven
Leuven

Belgium
Chc - Montlegia
Liege

Brazil, Bahia
Local Institution
Salvador

Brazil, Bahia
Ensino e Terapia de Inovacao -Clinica AMO
Salvador

Brazil, Distrito Federal
DFSTAR- Brasilia
Brasilia

Brazil, Espirito Santo
CEDOES Pesquisa e Diagnostico
Vitoria

Brazil, Parana
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba

Brazil, RIO Grande DO SUL
Centro De Pesquisa Clinica do Hospital Escola
Pelotas

Brazil, SAO Paulo
Centro de Pesquisa Fundacao Dr. Amaral Carvalho
Jau

Brazil, SAO Paulo
Hospital de Base de Sao Jose do Rio Preto
Sao Jose do Rio Preto

Brazil
COI Clinicas Oncologicas Integradas SA
Rio de Janeiro

Brazil
Instituto do Cancer do Estado de Sao Paulo ICESP
Sao Paulo

Brazil
Instituto De Assistencia Medica Ao Servidor Publico Estadual
Sao Paulo

Brazil
Beneficiencia Portuguesa de Sao Paulo
Sao Paulo

Canada, Alberta
Alberta Health Services
Edmonton

Chile, Araucania
Sociedad de Investigaciones Medicas - SIM
Temuco

Chile, Coquimbo
IC La Serena Research
La Serena

Chile, Metropolitana
Clinica San Carlos de Apoquindo
Santiago

Chile, Metropolitana
Hospital Clinico de la Universidad De Chile
Santiago

Chile, Metropolitana
Bradford Hill Centro de Investigacion Clinica
Santiago

Chile, Valparaiso
Centro de Investigaciones Clinicas Vina del Mar
Vina del Mar

Chile, Valparaiso
Oncocentro Apys
Viña del Mar

Chile
Clinica Oncologica IRAM
Santiago

China, Anhui
Local Institution
Hefei Shi

China, Anhui
Local Institution
Hefei

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Fujian
Local Institution
Fuzhou

China, Fujian
Local Institution
Fuzhou

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Guangzhou

China, Heilongjiang
Local Institution
Harbin

China, Hunan
Local Institution
Changsha

China, Hunan
Local Institution
Changsha

China, Jiangsu
Local Institution
Nanjing

China, Jiangxi
Local Institution
Nanchang

China, Jilin
Local Institution
Changchun

China, Jilin
Local Institution
Changchun

China, Liaoning
Local Institution
Dalian

China, Liaoning
Local Institution
Shenyang

China, Liaoning
Local Institution
Shenyang

China, Shaanxi
Local Institution
Xian

China, Shan3xi
Local Institution
Xian

China, Shandong
Local Institution
Qingdao

China, Shanghai
Local Institution
Shanghai

China, Sichuan
Local Institution
Chongqing

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Hangzhou

Czechia
Local Institution
Brno

Czechia
Thomayerova nemocnice
Praha

France, Rhone Alpes
GHN- Hopital De la croix Rousse
Lyon Cedex 04

France
Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud
Amiens

France
Centre Hospitalier Universitaire Caen Normandie
Caen

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

France
Centre Georges-Franois Leclerc
Dijon

France
Hopital Michallon
Grenoble Cedex 9

France
Local Institution
Marseille

France
CHU Montpellier - Hopital St Eloi
Montpellier

France
CHU Nice-Hopital Archet I
Nice

France
CHU Bordeaux, Hopital Haut-Leveque
Pessac

France
CHU Poitiers
Poitiers

France
Hopital Rangueil
Toulouse Cedex 9

France
CHU de Nancy Hopitaux de Brabois
Vandoeuvre les Nancy

France
Hopital Paul Brousse
Villejuif

Germany
Universitaetsklinikum Bonn
Bonn

Germany
Universtitaetsklinikum Essen Medizinisches Zentrum I
Essen

Germany
University Hospital Frankfurt
Frankfurt

Germany
Klinik fur Innere Medizin II
Freiburg

Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg

Germany
Medizinische Hochschule Hannover
Hannover

Germany
University Hospital Cologne
Koeln

Germany
Universitaetsklinikum Leipzig
Leipzig

Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz

Germany
Universitatsmedizin Mannheim
Mannheim

Germany
Local Institution
Munchen

Germany
KEM - Evang. Kliniken Essen-Mitte/Huyssens-Stift gGmbH
North Rhine-Westphalia

Hong Kong
Local Institution
Hong Kong

Hong Kong
Local Institution
Hong Kong

Japan, Chiba
Chiba University Hospital
Chiba-shi

Japan, Chiba
National Cancer Center Hospital East
Kashiwa-shi

Japan, Ehime
Ehime Prefectural Central Hospital
Matsuyama

Japan, Hokkaido
Sapporo-Kosei General Hospital
Sapporo

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
University Hospital Kyoto Prefectural University Of Medicine
Kyoto-shi

Japan, Nara
Nara Medical University Hospital
Kashihara City

Japan, Osaka
Osaka city University Hospital
Abeno-ku

Japan, Saga
Saga-Ken Medical Centre Koseikan
Saga Shi

Japan, Shizuoka
Juntendo University Shizuoka Hospital
Izunokuni-shi

Japan, Tokyo
Toranomon Hospital
Minato

Japan, Tokyo
Kyorin University Hospital
Mitaka

Japan, Tokyo
Japanese Red Cross Musashino Hospital
Musashino-shi

Japan
Kurume University Hospital
Fukuoka

Japan
Hiroshima University Hospital
Hiroshima

Japan
Kindai University Hospital
Osaka

Japan
Saitama Medical University Hospital
Saitama

Korea, Republic of
Local Institution
Busan

Korea, Republic of
Local Institution
Guro-gu

Korea, Republic of
Local Institution
Gyeonggi-do

Korea, Republic of
Local Institution
Gyeongsangnam-do

Korea, Republic of
Local Institution
Jongno-gu

Korea, Republic of
Local Institution
Seongnam

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

New Zealand
Local Institution
Auckland

New Zealand
Local Institution
Christchurch

Poland
Wojewodzkie Centrum Onkologii
Gdansk

Poland
Europejskie Centrum Zdrowia Otwock
Otwock

Poland
M Sklodowska Curie Memorial Cancer Center
Warszawa

Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras

Puerto Rico
Local Institution
San Juan

Romania
Institutul Clinic Fundeni
Bucharest

Romania
Prof Dr I Chiricuta Institute of Oncology
Cluj Napoca

Romania
Centrul de Oncologie Sf. Nectarie
Craiova

Romania
Local Institution
Craiova

Romania
S.C. Oncocenter Oncologie Clinica S.R.L.
Timisoara

Russian Federation
State Budget Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk

Russian Federation
Altai Regional Oncology Dispensary
Barnaul

Russian Federation
Evimed Llc
Chelyabinsk

Russian Federation
N.N. Blokhin National Medical Research Center of Oncology
Moscow

Russian Federation
SBHI of Stavropol Region Pyatigorsk Oncology Dispensary
Pyatigorsk

Russian Federation
Research Institute Of Oncology
Saint-Petersburg

Russian Federation
City Clinical Oncology Dispensary
Saint-Petersburg

Singapore
Local Institution
Singapore

Singapore
Local Institution
Singapore

Singapore
Local Institution
Singapore

Spain
Hospital Clinic I Provincialde Barcelona
Barcelona

Spain
Institut Catala dOncologia ICO - Hospital Duran i Reynals Location
Barcelona

Spain
Hospital Universitario Reina Sofia
Cordoba

Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar

Spain
Hospital Gral. Univ. Gregorio Maranon
Madrid

Spain
Hospital Universitario Ramon y Cajal
Madrid

Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda

Spain
Hospital Universitario Marques de Valdecilla (Edificio Sur)
Santander

Spain
Hospital Miguel Servet
Zaragoza

Switzerland
Inselspital Bern
Bern

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Tainan

Taiwan
Local Institution
Tainan

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taoyuan

Taiwan
Local Institution
Tapei

United Kingdom, Surrey
Royal Surrey County Hospital
Guildford

United Kingdom
Western General Hospital
Edinburgh

United Kingdom
Kings College Hospital NHS Foundation Trust
London

United Kingdom
Imperial College Hospital - Hammersmith Hospital
London

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: NCT04039607 History of Changes
  • Other Study ID Numbers: CA209-9DW
  • First Posted: July 31, 2019 Key Record Dates
  • Last Update Posted: October 18, 2021
  • Last Verified: October 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Carcinoma, Hepatocellular Carcinoma