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)

A Phase 3 Randomized Clinical Trial of Nivolumab Alone, Nivolumab in Combination With Ipilimumab, or Investigator's Choice Chemotherapy in Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Biological: Nivolumab; Biological: Ipilimumab; Drug: Fluorouracil; Drug: Cetuximab; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Actual): 839
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1093
    • Local Institution - 0084
  • CABA, Argentina, 1199
    • Local Institution - 0100
  • CABA, Argentina, 1426
    • Local Institution - 0072
  • Buenos Aires
    • Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina, 1431
      • Local Institution - 0073
  • Río Negro Province
    • Viedma, Río Negro Province, Argentina, 8500
      • Local Institution - 0074
• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Local Institution - 0019
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Local Institution - 0053
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Local Institution - 0018
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Local Institution - 0041
    • Heidelberg, Victoria, Australia, 3084
      • Local Institution - 0017
• Austria
  • Graz, Austria, 8036
    • Local Institution - 0064
  • Linz, Austria, 4010
    • Local Institution - 0068
  • Salzburg, Austria, 5020
    • Local Institution - 0120
  • Vienna, Austria, 1090
    • Local Institution - 0065
  • Wiener Neustadt, Austria, 2700
    • Local Institution - 0067
• Belgium
  • Leuven, Belgium, 3000
    • Local Institution - 0024
  • Antwerpen
    • Bonheiden, Antwerpen, Belgium, 2820
      • Local Institution - 0045
  • Bruxelles-Capitale, Région de
    • Anderlecht, Bruxelles-Capitale, Région de, Belgium, 1070
      • Local Institution - 0025
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Local Institution - 0199
  • São Paulo, Brazil, 01246-000
    • Local Institution - 0193
  • Minas Gerais
    • Ipatinga, Minas Gerais, Brazil, 35160-158
      • Local Institution - 0096
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59075-740
      • Local Institution - 0200
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Local Institution - 0192
  • São Paulo
    • Barretos, São Paulo, Brazil, 14780-070
      • Local Institution - 0102
    • São José do Rio Preto, São Paulo, Brazil, 15090000
      • Local Institution - 0094
    • São Paulo, São Paulo, Brazil, 01509-010
      • Local Institution - 0095
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Local Institution - 0011
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Local Institution - 0039
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Local Institution - 0013
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Local Institution - 0016
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Local Institution - 0015
• Chile
  • Santiago Metropolitan
    • Independencia, Santiago Metropolitan, Chile
      • Local Institution - 0070
    • Santiago, Santiago Metropolitan, Chile, 7500921
      • Local Institution - 0071
    • Santiago, Santiago Metropolitan, Chile, 8320000
      • Local Institution - 0069
• China
  • Anhui
    • Hefei, Anhui, China, 230061
      • Local Institution - 0146
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Local Institution - 0163
    • Zhangzhou, Fujian, China, 363000
      • Local Institution - 0207
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Local Institution - 0211
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Local Institution - 0158
    • Guangzhou, Guangdong, China, 510080
      • Local Institution - 0167
    • Guangzhou, Guangdong, China, 510095
      • Local Institution - 0153
    • Guangzhou, Guangdong, China, 510655
      • Local Institution - 0149
  • Guangxi
    • Nanning, Guangxi, China, 530000
      • Local Institution - 0160
    • Nanning, Guangxi, China, 530021
      • Local Institution - 0196
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150040
      • Local Institution - 0180
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Local Institution - 0181
  • Hunan
    • Changsha, Hunan, China, 410013
      • Local Institution - 0197
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Local Institution - 0145
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Local Institution - 0151
  • Jilin
    • Changchun, Jilin, China, 130021
      • Local Institution - 0164
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Local Institution - 0162
  • Shaanxi
    • Xi'an, Shaanxi, China, 710126
      • Local Institution - 0188
  • Shandong
    • Jinan, Shandong, China, 250117
      • Local Institution - 0210
    • Linyi, Shandong, China, 276001
      • Local Institution - 0212
    • Qingdao, Shandong, China, 266061
      • Local Institution - 0154
    • Yantai, Shandong, China, 264000
      • Local Institution - 0165
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200080
      • Local Institution - 0143
    • Shanghai, Shanghai Municipality, China, 200120
      • Local Institution - 0131
    • Shanghai, Shanghai Municipality, China, 200131
      • Local Institution - 0221
  • Yunnan
    • Kunming, Yunnan, China, 650106
      • Local Institution - 0195
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Local Institution - 0137
    • Ningbo, Zhejiang, China, 315041
      • Local Institution - 0206
• Czechia
  • Brno, Czechia, 656 53
    • Local Institution - 0087
  • Hradec Králové, Czechia, 500 05
    • Local Institution - 0085
  • Nový Jičín, Czechia, 741 01
    • Local Institution - 0088
  • Olomouc, Czechia, 779 00
    • Local Institution - 0086
• Denmark
  • Herlev, Denmark, 2730
    • Local Institution - 0038
  • Vejle, Denmark, 7100
    • Local Institution - 0036
• France
  • Bayonne, France, 64109
    • Local Institution - 0186
  • Besançon, France, 25030
    • Local Institution - 0028
  • Lyon, France, 69008
    • Local Institution - 0183
  • Lyon, France, 69373
    • Local Institution - 0029
  • Marseille, France, 13005
    • Local Institution - 0066
  • Montpellier, France, 34298
    • Local Institution - 0030
  • Nantes, France, 44093
    • Local Institution - 0032
  • Paris, France, 75012
    • Local Institution - 0027
  • Pessac, France, 33604
    • Local Institution - 0061
  • Poitiers, France, 86000
    • Local Institution - 0031
  • Strasbourg, France, 67200
    • Local Institution - 0184
  • Toulouse, France, 31059
    • Local Institution - 0040
  • Haute-Vienne
    • Limoges, Haute-Vienne, France, 87042
      • Local Institution - 0176
  • Nord
    • Lille, Nord, France, 59000
      • Local Institution - 0138
• Germany
  • Dresden, Germany, 01307
    • Local Institution - 0042
  • Essen, Germany, 45122
    • Local Institution - 0007
  • Hamburg, Germany, 20249
    • Local Institution - 0043
  • Hamburg, Germany, 22763
    • Local Institution - 0117
  • Hanover, Germany, 30625
    • Local Institution - 0008
  • Heidelberg, Germany, 69120
    • Local Institution - 0009
  • Marburg, Germany, 35043
    • Local Institution - 0044
  • Munich, Germany, 81377
    • Local Institution - 0010
• Greece
  • Athens, Greece, 11525
    • Local Institution - 0222
  • Athens, Greece, 11528
    • Local Institution - 0123
  • Cholargós, Greece, 15562
    • Local Institution - 0124
  • Heraklion, Greece, 71110
    • Local Institution - 0125
  • Ioannina, Greece, 45500
    • Local Institution - 0126
• Ireland
  • Dublin, Ireland
    • Local Institution - 0022
  • Limerick, Ireland, V94 F858
    • Local Institution - 0026
  • Dublin
    • Dublin, Dublin, Ireland
      • Local Institution - 0091
• Italy
  • Catania, Italy, 95122
    • Local Institution - 0055
  • Genova, Italy, 16132
    • Local Institution - 0003
  • Milan, Italy, 20162
    • Local Institution - 0001
  • Napoli, Italy, 80131
    • Local Institution - 0004
  • Padua, Italy, 35128
    • Local Institution - 0002
  • Roma, Italy, 00168
    • Local Institution - 0054
• Japan
  • Osaka, Japan, 540-0006
    • Local Institution - 0114
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 4648681
      • Local Institution - 0109
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Local Institution - 0112
    • Kashiwa-shi, Chiba, Japan, 2778577
      • Local Institution - 0107
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Local Institution - 0132
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 8111395
      • Local Institution - 0116
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 0608648
      • Local Institution - 0174
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 9208641
      • Local Institution - 0128
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 216-8511
      • Local Institution - 0111
    • Yokohama, Kanagawa, Japan, 241-8515
      • Local Institution - 0175
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 8608556
      • Local Institution - 0133
  • Miyagi
    • Ōsaki, Miyagi, Japan, 9896183
      • Local Institution - 0189
  • Okayama-ken
    • Kurashiki, Okayama-ken, Japan, 7108602
      • Local Institution - 0177
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0871
      • Local Institution - 0115
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Local Institution - 0187
    • Kitaadachigun, Saitama, Japan, 362-0806
      • Local Institution - 0110
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 4118777
      • Local Institution - 0108
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 1040045
      • Local Institution - 0118
    • Koto-ku, Tokyo, Japan, 135-8550
      • Local Institution - 0113
    • Minato-ku, Tokyo, Japan, 1058470
      • Local Institution - 0129
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Local Institution - 0050
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066 CX
      • Local Institution - 0052
    • Amsterdam, North Holland, Netherlands, 1081 HV
      • Local Institution - 0051
• Norway
  • Bergen, Norway, 5021
    • Local Institution - 0033
  • Lorenskog, Norway, 1478
    • Local Institution - 0034
  • Oslo, Norway, 0450
    • Local Institution - 0035
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Local Institution - 0058
• Romania
  • Brasov, Romania, 002200
    • Local Institution - 0168
  • Bucharest, Romania, 022328
    • Local Institution - 0080
  • Iași, Romania, 700483
    • Local Institution - 0205
  • Suceava, Romania, 720237
    • Local Institution - 0089
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400015
      • Local Institution - 0076
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • Local Institution - 0081
• Spain
  • A Coruña, Spain, 15006
    • Local Institution - 0173
  • Barcelona, Spain, 08035
    • Local Institution - 0006
  • Madrid, Spain, 28041
    • Local Institution - 0005
  • Málaga, Spain, 29010
    • Local Institution - 0172
  • Seville, Spain, 41013
    • Local Institution - 0063
  • Valencia, Spain, 46014
    • Local Institution - 0171
  • Barcelona [Barcelona]
    • Badalona, Barcelona [Barcelona], Spain, 08916
      • Local Institution - 0056
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01060
    • Local Institution - 0092
  • Istanbul, Turkey (Türkiye), 34300
    • Local Institution - 0101
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Local Institution - 0127
  • Oxford, United Kingdom, OX3 7LE
    • Local Institution - 0049
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Local Institution - 0059
    • Sacramento, California, United States, 95817
      • Local Institution - 0130
  • Colorado
    • Denver, Colorado, United States, 80218
      • Local Institution - 0103
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Local Institution - 0119
  • New York
    • New York, New York, United States, 10065
      • Local Institution - 0060
  • Oregon
    • Portland, Oregon, United States, 97227
      • Local Institution - 0105
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Local Institution - 0121
  • Texas
    • Dallas, Texas, United States, 75246
      • Local Institution - 0106
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Local Institution - 0104

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Nivolumab Monotherapy	Biological: Nivolumab; Specified dose on specified days
Experimental: Arm B: Nivolumab + Ipilimumab Combination	Biological: Nivolumab; Specified dose on specified days; Biological: Ipilimumab; 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: Fluorouracil; Specified dose on specified days; Drug: Cetuximab; Specified dose on specified days; Drug: Oxaliplatin; Specified dose on specified days; Drug: Leucovorin; Specified dose on specified days; Drug: Irinotecan; Specified dose on specified days; Drug: Bevacizumab; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Lines Centrally Confirmed MSI-H/dMMR	BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm C 1L Participants Centrally Confirmed MSI-H/dMMR	BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 32 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - 1L Participants	BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Randomized Participants	BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - 1L Randomized Participants	BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Crossover and First Line Arm	BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) by Polymerase Chain Reaction (PCR) - Arm B vs. Arm A	BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) by Immunohistochemistry (IHC) - Arm B vs. Arm A	BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) by Polymerase Chain Reaction (PCR) - Arm B vs. Arm C	BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 32 months)
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) by Immunohistochemistry (IHC) - Arm B vs. Arm C	BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 32 months)
Progression-free Survival (PFS) by Investigator- Arm B vs. Arm A All Lines	Investigator-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)
Progression-free Survival (PFS) by Investigator - Arm A and Arm B All Lines With dMMR/MSI-H mCRC	Investigator-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)
Progression-free Survival (PFS) by Investigator - 1L Participants	Investigator-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.	From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months for arm A and arm B; up to 32 months for arm C)
Objective Response Rate (ORR) by Blinded Independent Review Center (BICR) - Arm A and Arm B All Lines With dMMR/MSI-H mCRC	Objective Response Rate (ORR) is defined as the percentage of all randomized participants whose best overall response is either confirmed complete response (CR) or confirmed partial response (PR). CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. the sum must also demonstrate an absolute increase of at least 5 mm.	From date of randomization to the date of the initial objectively documented tumor progression, or the date of initiation of subsequent therapy, whichever occurs first (Up to approximately 60 months)
Objective Response Rate (ORR) by Blinded Independent Review Center (BICR) - 1L Participants	Objective Response Rate (ORR) is defined as the percentage of all randomized participants whose best overall response is either confirmed complete response (CR) or confirmed partial response (PR). CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. the sum must also demonstrate an absolute increase of at least 5 mm.	From date of randomization to the date of the initial objectively documented tumor progression, or the date of initiation of subsequent therapy, whichever occurs first (Up to approximately 60 months)
Overall Survival (OS) - Arm B vs. Arm A All Lines With dMMR/MSI-H mCRC	Overall Survival (OS) is defined as the time from the randomization date to the date of death due to any cause. A participant who has not died will be censored at last known date alive.	From randomization to the date of death due to any cause (Up to approximately 60 months)
Overall Survival (OS) - 1L Participants	Overall Survival (OS) is defined as the time from the randomization date to the date of death due to any cause. A participant who has not died will be censored at last known date alive.	From randomization to the date of death due to any cause

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Actual): August 28, 2024
• Study Completion (Estimated): June 10, 2026

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Camptothecin; Alkaloids; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Oxaliplatin; Nivolumab; Bevacizumab; Irinotecan; Ipilimumab; Cetuximab; Fluorouracil; Leucovorin
• Other Study ID Numbers: CA209-8HW; 2018-000040-26 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No