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)
NCT ID: NCT04008030
Last Updated: 2025-10-03
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
839 participants
INTERVENTIONAL
2019-08-05
2026-06-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Nivolumab Monotherapy
Nivolumab
Specified dose on specified days
Arm B: Nivolumab + Ipilimumab Combination
Ipilimumab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Arm C: Investigator's Choice Chemotherapy
Participants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress
Oxaliplatin
Specified dose on specified days
Leucovorin
Specified dose on specified days
Fluorouracil
Specified dose on specified days
Irinotecan
Specified dose on specified days
Bevacizumab
Specified dose on specified days
Cetuximab
Specified dose on specified days
Interventions
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Ipilimumab
Specified dose on specified days
Oxaliplatin
Specified dose on specified days
Leucovorin
Specified dose on specified days
Fluorouracil
Specified dose on specified days
Irinotecan
Specified dose on specified days
Bevacizumab
Specified dose on specified days
Cetuximab
Specified dose on specified days
Nivolumab
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* History of interstitial lung disease or pneumonitis
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0210
Jinan, Shandong, China
Local Institution - 0212
Linyi, Shandong, China
Local Institution - 0154
Qingdao, Shandong, China
Local Institution - 0165
Yantai, Shandong, China
Local Institution - 0153
Guangzhou, Guangdong, China
Local Institution - 0149
Guangzhou, Guangdong, China
Local Institution - 0160
Nanning, Guangxi, China
Local Institution - 0196
Nanning, Guangxi, China
Local Institution - 0180
Harbin, Heilongjiang, China
Local Institution - 0181
Zhengzhou, Henan, China
Local Institution - 0197
Changsha, Hunan, China
Local Institution - 0145
Changzhou, Jiangsu, China
Local Institution - 0151
Nanchang, Jiangxi, China
Local Institution - 0164
Changchun, Jilin, China
Local Institution - 0162
Shenyang, Liaoning, China
Local Institution - 0188
Xi'an, Shaanxi, China
Local Institution - 0059
Los Angeles, California, United States
Local Institution - 0130
Sacramento, California, United States
Local Institution - 0103
Denver, Colorado, United States
Local Institution - 0119
Arlington Heights, Illinois, United States
Local Institution - 0060
New York, New York, United States
Local Institution - 0105
Portland, Oregon, United States
Local Institution - 0121
Pittsburgh, Pennsylvania, United States
Local Institution - 0106
Dallas, Texas, United States
Local Institution - 0104
Roanoke, Virginia, United States
Local Institution - 0073
Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
Local Institution - 0074
Viedma, Río Negro Province, Argentina
Local Institution - 0084
Buenos Aires, , Argentina
Local Institution - 0100
CABA, , Argentina
Local Institution - 0072
CABA, , Argentina
Local Institution - 0019
Westmead, New South Wales, Australia
Local Institution - 0053
Woolloongabba, Queensland, Australia
Local Institution - 0018
Elizabeth Vale, South Australia, Australia
Local Institution - 0041
Clayton, Victoria, Australia
Local Institution - 0017
Heidelberg, Victoria, Australia
Local Institution - 0064
Graz, , Austria
Local Institution - 0068
Linz, , Austria
Local Institution - 0120
Salzburg, , Austria
Local Institution - 0065
Vienna, , Austria
Local Institution - 0067
Wiener Neustadt, , Austria
Local Institution - 0045
Bonheiden, Antwerpen, Belgium
Local Institution - 0025
Anderlecht, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0024
Leuven, , Belgium
Local Institution - 0096
Ipatinga, Minas Gerais, Brazil
Local Institution - 0200
Natal, Rio Grande do Norte, Brazil
Local Institution - 0192
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0102
Barretos, São Paulo, Brazil
Local Institution - 0094
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0095
São Paulo, São Paulo, Brazil
Local Institution - 0199
Rio de Janeiro, , Brazil
Local Institution - 0193
São Paulo, , Brazil
Local Institution - 0011
Edmonton, Alberta, Canada
Local Institution - 0039
Vancouver, British Columbia, Canada
Local Institution - 0013
Toronto, Ontario, Canada
Local Institution - 0016
Montreal, Quebec, Canada
Local Institution - 0015
Sherbrooke, Quebec, Canada
Local Institution - 0070
Independencia, Santiago Metropolitan, Chile
Local Institution - 0071
Santiago, Santiago Metropolitan, Chile
Local Institution - 0069
Santiago, Santiago Metropolitan, Chile
Local Institution - 0146
Hefei, Anhui, China
Local Institution - 0163
Xiamen, Fujian, China
Local Institution - 0207
Zhangzhou, Fujian, China
Local Institution - 0211
Lanzhou, Gansu, China
Local Institution - 0158
Foshan, Guangdong, China
Local Institution - 0167
Guangzhou, Guangdong, China
Local Institution - 0143
Shanghai, Shanghai Municipality, China
Local Institution - 0131
Shanghai, Shanghai Municipality, China
Local Institution - 0221
Shanghai, Shanghai Municipality, China
Local Institution - 0195
Kunming, Yunnan, China
Local Institution - 0137
Hangzhou, Zhejiang, China
Local Institution - 0206
Ningbo, Zhejiang, China
Local Institution - 0087
Brno, , Czechia
Local Institution - 0085
Hradec Králové, , Czechia
Local Institution - 0088
Nový Jičín, , Czechia
Local Institution - 0086
Olomouc, , Czechia
Local Institution - 0038
Herlev, , Denmark
Local Institution - 0036
Vejle, , Denmark
Local Institution - 0176
Limoges, Haute-Vienne, France
Local Institution - 0138
Lille, Nord, France
Local Institution - 0186
Bayonne, , France
Local Institution - 0028
Besançon, , France
Local Institution - 0183
Lyon, , France
Local Institution - 0029
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, , France
Local Institution - 0031
Poitiers, , France
Local Institution - 0184
Strasbourg, , France
Local Institution - 0040
Toulouse, , France
Local Institution - 0042
Dresden, , Germany
Local Institution - 0007
Essen, , Germany
Local Institution - 0043
Hamburg, , Germany
Local Institution - 0117
Hamburg, , Germany
Local Institution - 0008
Hanover, , Germany
Local Institution - 0009
Heidelberg, , Germany
Local Institution - 0044
Marburg, , Germany
Local Institution - 0010
Munich, , Germany
Local Institution - 0222
Athens, , Greece
Local Institution - 0123
Athens, , Greece
Local Institution - 0124
Cholargós, , Greece
Local Institution - 0125
Heraklion, , Greece
Local Institution - 0126
Ioannina, , Greece
Local Institution - 0091
Dublin, Dublin, Ireland
Local Institution - 0022
Dublin, , Ireland
Local Institution - 0026
Limerick, , Ireland
Local Institution - 0055
Catania, , Italy
Local Institution - 0003
Genova, , Italy
Local Institution - 0001
Milan, , Italy
Local Institution - 0004
Napoli, , Italy
Local Institution - 0002
Padua, , Italy
Local Institution - 0054
Roma, , Italy
Local Institution - 0109
Nagoya, Aichi-ken, Japan
Local Institution - 0112
Chiba, Chiba, Japan
Local Institution - 0107
Kashiwa-shi, Chiba, Japan
Local Institution - 0132
Matsuyama, Ehime, Japan
Local Institution - 0116
Fukuoka, Fukuoka, Japan
Local Institution - 0174
Sapporo, Hokkaido, Japan
Local Institution - 0128
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0111
Kawasaki, Kanagawa, Japan
Local Institution - 0175
Yokohama, Kanagawa, Japan
Local Institution - 0133
Kumamoto, Kumamoto, Japan
Local Institution - 0189
Ōsaki, Miyagi, Japan
Local Institution - 0177
Kurashiki, Okayama-ken, Japan
Local Institution - 0115
Suita-shi, Osaka, Japan
Local Institution - 0187
Hidaka, Saitama, Japan
Local Institution - 0110
Kitaadachigun, Saitama, Japan
Local Institution - 0108
Sunto-gun, Shizuoka, Japan
Local Institution - 0118
Chuo-ku, Tokyo, Japan
Local Institution - 0113
Koto-ku, Tokyo, Japan
Local Institution - 0129
Minato-ku, Tokyo, Japan
Local Institution - 0114
Osaka, , Japan
Local Institution - 0052
Amsterdam, North Holland, Netherlands
Local Institution - 0051
Amsterdam, North Holland, Netherlands
Local Institution - 0050
Utrecht, , Netherlands
Local Institution - 0033
Bergen, , Norway
Local Institution - 0034
Lorenskog, , Norway
Local Institution - 0035
Oslo, , Norway
Local Institution - 0058
Rio Piedras, , Puerto Rico
Local Institution - 0076
Cluj-Napoca, Cluj, Romania
Local Institution - 0081
Craiova, Dolj, Romania
Local Institution - 0168
Brasov, , Romania
Local Institution - 0080
Bucharest, , Romania
Local Institution - 0205
Iași, , Romania
Local Institution - 0089
Suceava, , Romania
Local Institution - 0056
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0173
A Coruña, , Spain
Local Institution - 0006
Barcelona, , Spain
Local Institution - 0005
Madrid, , Spain
Local Institution - 0172
Málaga, , Spain
Local Institution - 0063
Seville, , Spain
Local Institution - 0171
Valencia, , Spain
Local Institution - 0092
Adana, , Turkey (Türkiye)
Local Institution - 0101
Istanbul, , Turkey (Türkiye)
Local Institution - 0127
London, , United Kingdom
Local Institution - 0049
Oxford, , United Kingdom
Countries
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References
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Andre T, Elez E, Lenz HJ, Jensen LH, Touchefeu Y, Van Cutsem E, Garcia-Carbonero R, Tougeron D, Mendez GA, Schenker M, de la Fouchardiere C, Limon ML, Yoshino T, Li J, Manzano Mozo JL, Dahan L, Tortora G, Chalabi M, Goekkurt E, Braghiroli MI, Joshi R, Cil T, Aubin F, Cela E, Chen T, Lei M, Jin L, Blum SI, Lonardi S. Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): a randomised, open-label, phase 3 trial. Lancet. 2025 Feb 1;405(10476):383-395. doi: 10.1016/S0140-6736(24)02848-4. Epub 2025 Jan 25.
Andre T, Elez E, Van Cutsem E, Jensen LH, Bennouna J, Mendez G, Schenker M, de la Fouchardiere C, Limon ML, Yoshino T, Li J, Lenz HJ, Manzano Mozo JL, Tortora G, Garcia-Carbonero R, Dahan L, Chalabi M, Joshi R, Goekkurt E, Braghiroli MI, Cil T, Cela E, Chen T, Lei M, Dixon M, Abdullaev S, Lonardi S; CheckMate 8HW Investigators. Nivolumab plus Ipilimumab in Microsatellite-Instability-High Metastatic Colorectal Cancer. N Engl J Med. 2024 Nov 28;391(21):2014-2026. doi: 10.1056/NEJMoa2402141.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2018-000040-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-8HW
Identifier Type: -
Identifier Source: org_study_id
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