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: 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 (Estimated): 831
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1093
    • Active, not recruiting
    • Local Institution - 0084
  • Caba, Argentina, 1199
    • Active, not recruiting
    • Local Institution - 0100
  • Caba, Argentina, 1426
    • Active, not recruiting
    • Local Institution - 0072
  • Buenos Aires
    • Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina, 1431
      • Active, not recruiting
      • Local Institution - 0073
  • RIO Negro
    • Viedma, RIO Negro, Argentina, 8500
      • Completed
      • Local Institution - 0074
• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
      • Contact: Adnan Nagrial, Site 0019; Phone Number: 02 8890 3343
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Princess Alexandra Hospital
      • Contact: Rahul Ladwa, Site 0053; Phone Number: 61731766577
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Recruiting
      • Calvary Central Districts Hospital
      • Contact: Rohit Joshi, Site 0018; Phone Number: 0430129616
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Medical Centre Clayton
      • Contact: David Lau, Site 0041; Phone Number: (03)95946666
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Local Institution - 0017
      • Contact: Site 0017
• Austria
  • Graz, Austria, 8036
    • Active, not recruiting
    • Local Institution - 0064
  • Linz, Austria, 4010
    • Active, not recruiting
    • Local Institution - 0068
  • Salzburg, Austria, 5020
    • Active, not recruiting
    • Local Institution - 0120
  • Wien, Austria, 1090
    • Active, not recruiting
    • Local Institution - 0065
  • Wiener Neustadt, Austria, 2700
    • Active, not recruiting
    • Local Institution - 0067
• Belgium
  • Brussel, Belgium, 1090
    • Withdrawn
    • Local Institution
  • Bruxelles, Belgium, 1000
    • Active, not recruiting
    • Local Institution - 0025
  • Leuven, Belgium, 3000
    • Active, not recruiting
    • Local Institution - 0024
  • Antwerpen
    • Bonheiden, Antwerpen, Belgium, 2820
      • Active, not recruiting
      • Local Institution - 0045
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Completed
    • Local Institution - 0199
  • São Paulo, Brazil, 01246-000
    • Active, not recruiting
    • Local Institution - 0193
  • Minas Gerais
    • Ipatinga, Minas Gerais, Brazil, 35160-158
      • Active, not recruiting
      • Local Institution - 0096
  • RIO Grande DO Norte
    • Natal, RIO Grande DO Norte, Brazil, 59075-740
      • Active, not recruiting
      • Local Institution - 0200
  • RIO Grande DO SUL
    • Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
      • Active, not recruiting
      • Local Institution - 0192
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Withdrawn
      • Local Institution - 0097
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14780-070
      • Active, not recruiting
      • Local Institution - 0102
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 01509-010
      • Active, not recruiting
      • Local Institution - 0095
    • São José do Rio Preto, São Paulo, Brazil, 15090000
      • Active, not recruiting
      • Local Institution - 0094
• Canada
  • Quebec, Canada, G1R 2J6
    • Withdrawn
    • Local Institution
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Completed
      • Local Institution - 0011
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Completed
      • Local Institution - 0039
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Withdrawn
      • Local Institution
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Completed
      • Local Institution - 0013
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Active, not recruiting
      • Local Institution - 0016
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Completed
      • Local Institution - 0015
• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 8320000
      • Active, not recruiting
      • Local Institution - 0069
    • Santiago, Metropolitana, Chile, 7500921
      • Active, not recruiting
      • Local Institution - 0071
  • Santiago
    • Independencia, Santiago, Chile
      • Completed
      • Local Institution - 0070
• China
  • Anhui
    • Hefei, Anhui, China, 230061
      • Completed
      • Local Institution - 0146
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Not yet recruiting
      • Local Institution
      • Contact: Site 0136
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Feng Ye, Site 0163; Phone Number: 8613860458889
    • Zhangzhou, Fujian, China, 363000
      • Recruiting
      • Local Institution - 0207
      • Contact: Site 0207
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Recruiting
      • Local Institution - 0211
      • Contact: Site 0211
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • Local Institution - 0158
      • Contact: Site 0158
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yat-sen University
      • Contact: Yanhong Deng, Site 0149; Phone Number: 8613925106525
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Local Institution - 0167
      • Contact: Site 0167
    • Guangzhou, Guangdong, China, 510095
      • Recruiting
      • Local Institution - 0153
      • Contact: Site 0153
    • Guangzhou, Guangdong, China, 510030
      • Withdrawn
      • Local Institution - 0194
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • Guangxi Medical University Affiliated Tumor Hospital
      • Contact: Yongqiang Li, Site 0196; Phone Number: 13457161928
    • Nanning, Guangxi, China, 530000
      • Recruiting
      • The people's hospital of Guangxi Zhuang Autonomous Region
      • Contact: Kehe Chen, Site 0160; Phone Number: 13877122406
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150040
      • Recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: Yanqiao Zhang, Site 0180; Phone Number: +8613845120210
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The First Affiliated hospital of Zhengzhou University
      • Contact: jinbo liu, Site 0181; Phone Number: +8613633862757
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer hospital
      • Contact: Xianli Yin, Site 0197; Phone Number: 8613319602869
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Recruiting
      • The First People's Hospital of Changzhou
      • Contact: Wenwei Hu, Site 0145; Phone Number: +8613912330886
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The 1st Affiliate Hospital Of Nanchang University
      • Contact: Jianping Xiong, Site 0151; Phone Number: +8613879109229
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • the 1st hospital of Jilin University
      • Contact: Wei Li, Site 0164; Phone Number: 8613756661267
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Recruiting
      • Liaoning Cancer Hospital and Institute
      • Contact: Jingdong Zhang, Site 0162; Phone Number: +862431936391
  • Shaanxi
    • Xi'an, Shaanxi, China, 710126
      • Recruiting
      • Local Institution - 0188
      • Contact: Site 0188
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
      • Contact: zuoxing niu, Site 0210; Phone Number: 13506413687
    • Linyi, Shandong, China, 276034
      • Recruiting
      • Local Institution - 0212
      • Contact: Site 0212
    • Qingdao, Shandong, China, 266061
      • Recruiting
      • Local Institution - 0154
      • Contact: Site 0154
    • Yantai, Shandong, China, 264000
      • Completed
      • Local Institution - 0165
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Recruiting
      • Shanghai East Hospital
      • Contact: Yong Gao, Site 0131; Phone Number: 8613310167477
    • Shanghai, Shanghai, China, 200080
      • Completed
      • Local Institution - 0143
  • Yunnan
    • Kunming, Yunnan, China, 650106
      • Recruiting
      • Yunnan Province Cancer Hospital
      • Contact: Yunfeng Li, Site 0195; Phone Number: 13330445776
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The 2nd Affiliated Hospital Of Z.U.S.M
      • Contact: Ying Yuan, Site 0137; Phone Number: 8613858193601
    • Ningbo, Zhejiang, China, 315041
      • Recruiting
      • Local Institution - 0206
      • Contact: Site 0206
• Czechia
  • Brno, Czechia, 656 53
    • Active, not recruiting
    • Local Institution - 0087
  • Hradec Kralove, Czechia, 500 05
    • Active, not recruiting
    • Local Institution - 0085
  • Novy Jicin, Czechia, 741 01
    • Completed
    • Local Institution - 0088
  • Olomouc, Czechia, 779 00
    • Active, not recruiting
    • Local Institution - 0086
• Denmark
  • Herlev, Denmark, 2730
    • Active, not recruiting
    • Local Institution - 0038
  • Odense, Denmark, 5000
    • Withdrawn
    • Local Institution
  • Vejle, Denmark, 7100
    • Active, not recruiting
    • Local Institution - 0036
• France
  • Bayonne, France, 64109
    • Completed
    • Local Institution - 0186
  • Besancon Cedex, France, 25030
    • Active, not recruiting
    • Local Institution - 0028
  • Lyon, France, 69008
    • Completed
    • Local Institution - 0183
  • Lyon Cedex 08, France, 69373
    • Active, not recruiting
    • Local Institution - 0029
  • Marseille, France, 13005
    • Active, not recruiting
    • Local Institution - 0066
  • Montpellier, France, 34298
    • Active, not recruiting
    • Local Institution - 0030
  • Nantes, France, 44093
    • Active, not recruiting
    • Local Institution - 0032
  • Paris, France, 75012
    • Active, not recruiting
    • Local Institution - 0027
  • Pessac Cedex, France, 33604
    • Active, not recruiting
    • Local Institution - 0061
  • Poitiers, France, 86000
    • Active, not recruiting
    • Local Institution - 0031
  • Rouen, France, 76000
    • Withdrawn
    • Local Institution
  • Strasbourg, France, 67200
    • Completed
    • Local Institution - 0184
  • Toulouse, France, 31059
    • Active, not recruiting
    • Local Institution - 0040
  • Haute-Vienne
    • Limoges, Haute-Vienne, France, 87042
      • Recruiting
      • Local Institution - 0176
      • Contact: Site 0176
  • Nord
    • Lille, Nord, France, 59000
      • Active, not recruiting
      • Local Institution - 0138
• Germany
  • Dresden, Germany, 01307
    • Active, not recruiting
    • Local Institution - 0042
  • Essen, Germany, 45122
    • Active, not recruiting
    • Local Institution - 0007
  • Hamburg, Germany, 20249
    • Active, not recruiting
    • Local Institution - 0043
  • Hamburg, Germany, 22763
    • Active, not recruiting
    • Local Institution - 0117
  • Hannover, Germany, 30625
    • Active, not recruiting
    • Local Institution - 0008
  • Heidelberg, Germany, 69120
    • Active, not recruiting
    • Local Institution - 0009
  • Marburg, Germany, 35043
    • Active, not recruiting
    • Local Institution - 0044
  • Munich, Germany, 81377
    • Active, not recruiting
    • Local Institution - 0010
• Greece
  • Athens, Greece, 11528
    • Active, not recruiting
    • Local Institution - 0123
  • Heraklion, Greece, 71110
    • Completed
    • Local Institution - 0125
  • Holargos, Greece, 15562
    • Active, not recruiting
    • Local Institution - 0124
  • Ioannina, Greece, 45500
    • Completed
    • Local Institution - 0126
• Ireland
  • Dublin, Ireland
    • Completed
    • Local Institution - 0022
  • Limerick, Ireland, V94 F858
    • Completed
    • Local Institution - 0026
  • Dublin
    • Dublin 8, Dublin, Ireland
      • Completed
      • Local Institution - 0091
• Italy
  • Catania, Italy, 95122
    • Active, not recruiting
    • Local Institution - 0055
  • Genova, Italy, 16132
    • Completed
    • Local Institution - 0003
  • Milan, Italy, 20162
    • Active, not recruiting
    • Local Institution - 0001
  • Napoli, Italy, 80131
    • Completed
    • Local Institution - 0004
  • Padova, Italy, 35128
    • Active, not recruiting
    • Local Institution - 0002
  • Roma, Italy, 00168
    • Active, not recruiting
    • Local Institution - 0054
• Japan
  • Osaka, Japan, 540-0006
    • Recruiting
    • Local Institution - 0114
    • Contact: Site 0114
  • Aichi
    • Nagoya-shi, Aichi, Japan, 4648681
      • Recruiting
      • Local Institution - 0109
      • Contact: Site 0109
  • Chiba
    • Chiba-shi, Chiba, Japan, 260-8717
      • Recruiting
      • Local Institution - 0112
      • Contact: Site 0112
    • Kashiwa-shi, Chiba, Japan, 2778577
      • Recruiting
      • Local Institution - 0107
      • Contact: Site 0107
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Recruiting
      • Local Institution - 0132
      • Contact: Site 0132
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 8111395
      • Recruiting
      • Local Institution - 0116
      • Contact: Site 0116
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 0608648
      • Recruiting
      • Local Institution - 0174
      • Contact: Site 0174
  • Ishikawa
    • Kanazawa-city, Ishikawa, Japan, 9208641
      • Recruiting
      • Local Institution - 0128
      • Contact: Site 0128
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 2168511
      • Recruiting
      • Local Institution - 0111
      • Contact: Site 0111
    • Yokohama, Kanagawa, Japan, 241-8515
      • Recruiting
      • Kanagawa Cancer Center
      • Contact: Nozomu Machida, Site 0175; Phone Number: 81559895222
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan, 8608556
      • Recruiting
      • Local Institution - 0133
      • Contact: Site 0133
  • Miyagi
    • Osaki, Miyagi, Japan, 9896183
      • Recruiting
      • Local Institution - 0189
      • Contact: Site 0189
  • Okayama
    • Kurashiki, Okayama, Japan, 7108602
      • Recruiting
      • Local Institution - 0177
      • Contact: Site 0177
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0871
      • Recruiting
      • Local Institution - 0115
      • Contact: Site 0115
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Recruiting
      • Local Institution - 0187
      • Contact: Site 0187
    • Kitaadachigun, Saitama, Japan, 362-0806
      • Recruiting
      • Local Institution - 0110
      • Contact: Site 0110
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 4118777
      • Recruiting
      • Local Institution - 0108
      • Contact: Site 0108
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 1040045
      • Recruiting
      • National Cancer Center Hospital
      • Contact: Atsuo Takashima, Site 0118; Phone Number: +81335475201
    • Koto-ku, Tokyo, Japan, 135-8550
      • Recruiting
      • Japanese Foundation for Cancer Research
      • Contact: Kensei Yamaguchi, Site 0113; Phone Number: 81335200111
    • Minato-ku, Tokyo, Japan, 1058470
      • Recruiting
      • Local Institution - 0129
      • Contact: Site 0129
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Active, not recruiting
    • Local Institution - 0052
  • Amsterdam, Netherlands, 1105 AZ
    • Active, not recruiting
    • Local Institution - 0051
  • Utrecht, Netherlands, 3584 CX
    • Active, not recruiting
    • Local Institution - 0050
• Norway
  • Bergen, Norway, 5021
    • Active, not recruiting
    • Local Institution - 0033
  • Lorenskog, Norway, 1478
    • Completed
    • Local Institution - 0034
  • Oslo, Norway, 0450
    • Active, not recruiting
    • Local Institution - 0035
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Completed
    • Local Institution - 0058
• Romania
  • Brasov, Romania, 002200
    • Completed
    • Local Institution - 0168
  • Bucharest, Romania, 022328
    • Active, not recruiting
    • Local Institution - 0080
  • Constanta, Romania, 900591
    • Withdrawn
    • Local Institution
  • Iași, Romania, 700483
    • Completed
    • Local Institution - 0205
  • Suceava, Romania, 720237
    • Active, not recruiting
    • Local Institution - 0089
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400015
      • Active, not recruiting
      • Local Institution - 0076
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • Active, not recruiting
      • Local Institution - 0081
• Spain
  • A Coruna, Spain, 15006
    • Active, not recruiting
    • Local Institution - 0173
  • Barcelona, Spain, 08035
    • Active, not recruiting
    • Local Institution - 0006
  • Madrid, Spain, 28034
    • Withdrawn
    • Local Institution
  • Madrid, Spain, 28041
    • Active, not recruiting
    • Local Institution - 0005
  • Malaga, Spain, 29010
    • Active, not recruiting
    • Local Institution - 0172
  • Sevilla, Spain, 41013
    • Active, not recruiting
    • Local Institution - 0063
  • Valencia, Spain, 46014
    • Active, not recruiting
    • Local Institution - 0171
  • Barcelona [Barcelona]
    • Badalona, Barcelona [Barcelona], Spain, 08916
      • Active, not recruiting
      • Local Institution - 0056
• Turkey
  • Adana, Turkey, 01060
    • Active, not recruiting
    • Local Institution - 0092
  • Istanbul, Turkey, 34300
    • Active, not recruiting
    • Local Institution - 0101
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Active, not recruiting
    • Local Institution - 0127
  • Oxford, United Kingdom, OX3 7LE
    • Active, not recruiting
    • Local Institution - 0049
  • Greater London
    • London, Greater London, United Kingdom, SE1 9RY
      • Withdrawn
      • Local Institution
  • Yorkshire
    • Leeds, Yorkshire, United Kingdom, LS9 7TF
      • Withdrawn
      • Local Institution
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Withdrawn
      • Banner MD Anderson Cancer Center
  • California
    • Los Angeles, California, United States, 90033
      • Completed
      • Local Institution - 0059
    • Sacramento, California, United States, 95817
      • Active, not recruiting
      • Local Institution - 0130
  • Colorado
    • Denver, Colorado, United States, 80218
      • Active, not recruiting
      • Local Institution - 0103
  • Florida
    • Miami, Florida, United States, 33136
      • Withdrawn
      • Local Institution
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Withdrawn
      • Local Institution
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Completed
      • Local Institution - 0119
  • New York
    • New York, New York, United States, 10065
      • Active, not recruiting
      • Local Institution - 0060
  • Oregon
    • Portland, Oregon, United States, 97227
      • Completed
      • Local Institution - 0105
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Withdrawn
      • Local Institution
    • Pittsburgh, Pennsylvania, United States, 15232
      • Completed
      • Local Institution - 0121
  • Texas
    • Dallas, Texas, United States, 75246
      • Completed
      • Local Institution - 0106
    • Fort Worth, Texas, United States, 76104
      • Withdrawn
      • Local Institution
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Active, not recruiting
      • 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	Time Frame
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed)	Up to 5 years
PFS by BICR (arm B vs C, 1L, centrally confirmed)	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed)	Up to 5 years
Overall Survival (OS) (arm B vs A, all lines, centrally confirmed)	Up to 5 years
PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed)	Up to 5 years
PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing)	Up to 5 years
PFS by BICR (arm B vs A, 1L, centrally confirmed)	Up to 5 years
ORR by BICR (arm B vs C, 1L, centrally confirmed)	Up to 5 years
ORR by BICR (arm B vs A, 1L, centrally confirmed)	Up to 5 years
OS (arm B vs A, 1L, centrally confirmed)	Up to 5 years
PFS by BICR (arm A vs C, 1L, centrally confirmed)	Up to 5 years
OS (arm B vs C, 1L, centrally confirmed)	Up to 5 years
ORR by BICR (arm A vs C, 1L, centrally confirmed)	Up to 5 years
OS (arm A vs C, 1L, centrally confirmed)	Up to 5 years
PFS by Investigator (arm A, B and C, 1L, centrally confirmed)	Up to 5 years
PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing)	Up to 5 years
PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing)	Up to 5 years
PFS by BICR (arm B vs C, 1L, by each central test)	Up to 5 years
PFS by BICR (arm B vs A, all lines, by each central test)	Up to 5 years
PFS by BICR (crossover cohort, centrally confirmed)	Up to 5 years
ORR by BICR (crossover cohort, centrally confirmed)	Up to 5 years

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

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 (Estimated): June 9, 2025
• 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 (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Genomic Instability; Colorectal Neoplasms; Microsatellite Instability; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Micronutrients; Vitamins; Immune Checkpoint Inhibitors; Topoisomerase I Inhibitors; Antidotes; Vitamin B Complex; Fluorouracil; Oxaliplatin; Nivolumab; Bevacizumab; Leucovorin; Irinotecan; Ipilimumab; Cetuximab
• 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