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A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW)

  • Clinicaltrials.gov identifier

    NCT04008030

  • Recruitment Status

    Recruiting

  • First Posted

    July 5, 2019

  • Last update posted

    September 6, 2022

Study Description

Brief summary:

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.

  • Condition or Disease:Metastatic Colorectal Cancer
  • Intervention/Treatment: Biological: Ipilimumab
    Drug: Oxaliplatin
    Drug: Leucovorin
    Drug: Fluorouracil
    Drug: Irinotecan
    Drug: Bevacizumab
    Drug: Cetuximab
    Biological: Nivolumab
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 831 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: August 2025
  • Estimated Study Completion Date: August 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Arm B: Nivolumab + Ipilimumab Combination
Biological: Ipilimumab
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Active Comparator: Arm C: Investigator's Choice Chemotherapy
Participants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress
Drug: Oxaliplatin
Specified dose on specified days

Drug: Leucovorin
Specified dose on specified days

Drug: Fluorouracil
Specified dose on specified days

Drug: Irinotecan
Specified dose on specified days

Drug: Bevacizumab
Specified dose on specified days

Drug: Cetuximab
Specified dose on specified days
Experimental: Arm A: Nivolumab Monotherapy
Biological: Nivolumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 2. PFS by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • Secondary Outcome Measures: 1. PFS by BICR (arm B vs A, all lines, by each central test) [ Time Frame: Up to 5 years ]
  • 2. PFS by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 3. ORR by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 4. Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 5. Overall Survival (OS) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 6. PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 7. PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing) [ Time Frame: Up to 5 years ]
  • 8. PFS by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 9. ORR by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 10. ORR by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 11. OS (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 12. PFS by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 13. OS (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 14. ORR by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 15. OS (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 16. PFS by Investigator (arm A, B and C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • 17. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing) [ Time Frame: Up to 5 years ]
  • 18. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing) [ Time Frame: Up to 5 years ]
  • 19. PFS by BICR (arm B vs C, 1L, by each central test) [ Time Frame: Up to 5 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: Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study) Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study) Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1 Exclusion Criteria: An active, known or suspected autoimmune disease History of interstitial lung disease or pneumonitis Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

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

Locations

United States, Arizona
Local Institution
Gilbert

United States, California
Usc/Norris Comprehensive Cancer Center
Los Angeles

United States, California
University of California Davis Health-University of California Davis Comprehensive Cancer Center
Sacramento

United States, Colorado
Rocky Mountain Cancer Centers
Denver

United States, Florida
Local Institution
Miami

United States, Georgia
Local Institution
Marietta

United States, Illinois
Illinois Cancer Specialists
Arlington Heights

United States, New York
Memorial Sloan Kettering Nassau
New York

United States, Oregon
Northwest Cancer Specialists, P.C.
Portland

United States, Pennsylvania
Local Institution
Philadelphia

United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh

United States, Texas
Texas Oncology Sammons Cancer Center
Dallas

United States, Texas
Local Institution
Fort Worth

United States, Virginia
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Roanoke

Argentina, Buenos Aires
Local Institution - 0073
Ciudad Autonoma Beunos Aires

Argentina, RIO Negro
Local Institution - 0074
Viedma

Argentina, Tucuman
Local Institution
San Miguel de Tucumán

Argentina
Local Institution - 0084
Buenos Aires

Argentina
Local Institution - 0100
Caba

Argentina
Local Institution - 0072
Caba

Australia, New South Wales
Local Institution - 0019
Westmead

Australia, Queensland
Local Institution - 0053
Woolloongabba

Australia, South Australia
Local Institution - 0018
Elizabeth Vale

Australia, Victoria
Local Institution - 0041
Clayton

Australia, Victoria
Local Institution - 0017
Heidelberg

Austria
Lkh-Univ.Klinikum Graz
Graz

Austria
Local Institution - 0068
Linz

Austria
Local Institution - 0120
Salzburg

Austria
Local Institution - 0067
Wiener Neustadt

Austria
Local Institution - 0065
Wien

Belgium
Local Institution - 0045
Bonheiden

Belgium
Local Institution
Brussel

Belgium
Local Institution - 0025
Bruxelles

Belgium
Local Institution - 0024
Leuven

Brazil, Minas Gerais
Local Institution - 0096
Ipatinga

Brazil, RIO Grande DO Norte
Local Institution
Natal

Brazil, RIO Grande DO SUL
Local Institution - 0192
Porto Alegre

Brazil, Sao Paulo
Local Institution - 0102
Barretos

Brazil, São Paulo
Local Institution - 0094
São José do Rio Preto

Brazil
Local Institution - 0199
Rio de Janeiro

Brazil
Local Institution - 0095
Sao Paulo

Brazil
Local Institution - 0193
São Paulo

Canada, Alberta
Local Institution - 0011
Edmonton

Canada, British Columbia
Local Institution - 0039
Vancouver

Canada, Nova Scotia
Local Institution
Halifax

Canada, Ontario
Local Institution - 0013
Toronto

Canada, Quebec
Local Institution - 0016
Montreal

Canada, Quebec
Local Institution - 0015
Sherbrooke

Canada
Local Institution
Quebec

Chile, Metropolitana
Local Institution - 0071
Santiago

Chile, Metropolitana
Local Institution - 0069
Santiago

Chile, Santiago
Local Institution - 0070
Independencia

China, Anhui
Local Institution - 0146
Hefei

China, Fujian
Local Institution
Fuzhou

China, Fujian
Local Institution - 0163
Xiamen

China, Fujian
Local Institution - 0207
Zhangzhou

China, Gansu
Local Institution - 0211
Lanzhou

China, Guangdong
Local Institution - 0158
Foshan

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution - 0149
Guangzhou

China, Guangxi
Local Institution
Nanning

China, Guangxi
Local Institution - 0196
Nanning

China, Heilongjiang
Local Institution - 0180
Harbin

China, Henan
Local Institution
Zhengzhou

China, Hunan
Local Institution
Changsha

China, Jiangsu
Local Institution - 0145
Changzhou

China, Jiangxi
Local Institution - 0151
Nanchang

China, Jilin
Local Institution - 0164
Changchun

China, Liaoning
Local Institution - 0162
Shenyang

China, Shaanxi
Local Institution - 0188
Xi'an

China, Shandong
Local Institution - 0210
Jinan

China, Shandong
Local Institution - 0212
Linyi

China, Shandong
Local Institution
Qingdao

China, Shandong
Local Institution - 0165
Yantai

China, Shanghai
Local Institution - 0143
Shanghai

China, Shanghai
Local Institution - 0131
Shanghai

China, Yunnan
Local Institution
Kunming

China, Zhejiang
Local Institution - 0137
Hangzhou

China, Zhejiang
Local Institution
Ningbo

Czechia
Local Institution - 0087
Brno

Czechia
Local Institution - 0085
Hradec Kralove

Czechia
Local Institution - 0088
Novy Jicin

Czechia
Local Institution - 0086
Olomouc

Denmark
Local Institution - 0038
Herlev

Denmark
Local Institution
Odense

Denmark
Local Institution - 0036
Vejle

France, Haute-Vienne
Local Institution - 0176
Limoges

France
Centre Hospitalier de la Côte Basque-Hepato-Gastro-Enterology
Bayonne

France
Local Institution - 0028
Besancon Cedex

France
Local Institution - 0138
Lille

France
Local Institution - 0029
Lyon Cedex 08

France
Hopital Prive Jean Mermoz
Lyon

France
Local Institution - 0066
Marseille

France
Local Institution - 0030
Montpellier

France
Local Institution - 0032
Nantes

France
Local Institution - 0027
Paris

France
Local Institution - 0061
Pessac Cedex

France
Local Institution - 0031
Poitiers

France
Local Institution
Rouen

France
ICANS-Institut de cancerologie Strasbourg Europe
Strasbourg

France
Local Institution - 0040
Toulouse

Germany
Local Institution - 0042
Dresden

Germany
Local Institution - 0007
Essen

Germany
Local Institution - 0043
Hamburg

Germany
Local Institution - 0117
Hamburg

Germany
Local Institution - 0008
Hannover

Germany
Local Institution - 0009
Heidelberg

Germany
Local Institution - 0044
Marburg

Germany
Local Institution - 0010
Munich

Greece
Local Institution - 0123
Athens

Greece
Local Institution - 0125
Heraklion

Greece
Local Institution - 0124
Holargos

Greece
Local Institution - 0126
Ioannina

Ireland, Dublin
Local Institution - 0091
Dublin 8

Ireland
Local Institution
Dublin

Ireland
Local Institution
Limerick

Italy
PO Garibaldi Nesima AORN Garibaldi
Catania

Italy
Local Institution
Genova

Italy
ASST Grande Ospedale Niguarda
Milan

Italy
AOU della Campania Luigi Vanvitelli
Napoli

Italy
I.O.V. Istituto Oncologico Veneto Ircss
Padova

Italy
Policlinico Gemelli
Roma

Japan, Aichi
Local Institution
Nagoya-shi

Japan, Chiba
Local Institution - 0112
Chiba-shi

Japan, Chiba
Local Institution - 0107
Kashiwa-shi

Japan, Ehime
Local Institution - 0132
Matsuyama

Japan, Fukuoka
Local Institution - 0116
Fukuoka-shi

Japan, Hokkaido
Local Institution - 0174
Sapporo-shi

Japan, Ishikawa
Local Institution - 0128
Kanazawa-city

Japan, Kanagawa
Local Institution - 0111
Kawasaki-shi

Japan, Kanagawa
Local Institution
Yokohama

Japan, Kumamoto
Local Institution - 0133
Kumamoto-shi

Japan, Miyagi
Local Institution
Osaki

Japan, Okayama
Local Institution
Kurashiki

Japan, Osaka
Local Institution - 0115
Suita-shi

Japan, Saitama
Local Institution
Hidaka

Japan, Saitama
Local Institution
Kitaadachigun

Japan, Shizuoka
Local Institution - 0108
Sunto-gun

Japan, Tokyo
Local Institution - 0118
Chuo-ku

Japan, Tokyo
Local Institution - 0113
Koto-ku

Japan, Tokyo
Local Institution - 0129
Minato-ku

Japan
Local Institution - 0114
Osaka

Netherlands
Local Institution - 0052
Amsterdam

Netherlands
Local Institution
Amsterdam

Netherlands
Local Institution - 0050
Utrecht

Norway
Local Institution - 0033
Bergen

Norway
Local Institution - 0034
Lorenskog

Norway
Local Institution - 0035
Oslo

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

Romania, Cluj
Local Institution - 0076
Cluj-Napoca

Romania
Local Institution - 0168
Brasov

Romania
Institutul Clinic Fundeni
Bucharest

Romania
Local Institution
Constanta

Romania
Local Institution - 0081
Craiova

Romania
Local Institution - 0205
Iași

Romania
County Emergency Hospital Suceava
Suceava

Spain
Local Institution - 0173
A Coruna

Spain
Local Institution - 0056
Badalona-barcelona

Spain
Local Institution - 0006
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution - 0005
Madrid

Spain
Local Institution - 0172
Malaga

Spain
Local Institution - 0063
Sevilla

Spain
Local Institution - 0171
Valencia

Turkey
Local Institution - 0092
Adana

Turkey
Local Institution - 0101
Istanbul

United Kingdom, Greater London
Local Institution - 0127
London

United Kingdom, Greater London
Local Institution
London

United Kingdom, Yorkshire
Local Institution
Leeds

United Kingdom
Local Institution - 0049
Oxford

Sponsors and Collaborators

Bristol-Myers Squibb

Ono Pharmaceutical Co. Ltd

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04008030 History of Changes
  • Other Study ID Numbers: CA209-8HW, 2018-000040-26
  • First Posted: July 5, 2019 Key Record Dates
  • Last Update Posted: September 6, 2022
  • Last Verified: September 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Colorectal Neoplasms
    Microsatellite Instability
    Intestinal Neoplasms
    Gastrointestinal Neoplasms
    Digestive System Neoplasms
    Neoplasms by Site
    Neoplasms
    Digestive System Diseases
    Gastrointestinal Diseases
    Colonic Diseases
    Intestinal Diseases
    Rectal Diseases
    Genomic Instability
    Pathologic Processes