Metastatic Colorectal CancerPhase 3CheckMate 8HWNCT04008030

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)

A Phase 3 study testing Ipilimumab, Oxaliplatin and Leucovorin in people with Metastatic Colorectal Cancer, run by Bristol-Myers Squibb at 157 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Colorectal Cancer
What is being tested?: Ipilimumab, Oxaliplatin and Leucovorin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 839 participants
Where: 157 sitesin 24 countries
Study dates: 5 Aug 2019to 23 Mar 2027
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

157 sites in 24 countries.

Country

City, postcode or hospital

157 sites in 24 countries

China28 sites

Local Institution - 0164
Changchun, Jilin, 130021
Local Institution - 0197
Changsha, Hunan, 410013
Local Institution - 0145
Changzhou, Jiangsu, 213003
Local Institution - 0158
Foshan, Guangdong, 528000
Local Institution - 0167
Guangzhou, Guangdong, 510080
Local Institution - 0153
Guangzhou, Guangdong, 510095
Local Institution - 0149
Guangzhou, Guangdong, 510655
Local Institution - 0137
Hangzhou, Zhejiang, 310009
Local Institution - 0180
Harbin, Heilongjiang, 150040
Local Institution - 0146
Hefei, Anhui, 230061
Local Institution - 0210
Jinan, Shandong, 250117
Local Institution - 0195
Kunming, Yunnan, 650106
Local Institution - 0211
Lanzhou, Gansu, 730030
Local Institution - 0212
Linyi, Shandong, 276001
Local Institution - 0151
Nanchang, Jiangxi, 330006
Local Institution - 0160
Nanning, Guangxi, 530000
Local Institution - 0196
Nanning, Guangxi, 530021
Local Institution - 0206
Ningbo, Zhejiang, 315041
Local Institution - 0154
Qingdao, Shandong, 266061
Local Institution - 0143
Shanghai, Shanghai Municipality, 200080
Local Institution - 0131
Shanghai, Shanghai Municipality, 200120
Local Institution - 0221
Shanghai, Shanghai Municipality, 200131
Local Institution - 0162
Shenyang, Liaoning, 110042
Local Institution - 0188
Xi'an, Shaanxi, 710126
Local Institution - 0163
Xiamen, Fujian, 361003
Local Institution - 0165
Yantai, Shandong, 264000
Local Institution - 0207
Zhangzhou, Fujian, 363000
Local Institution - 0181
Zhengzhou, Henan, 450052

Other trials in China

Japan20 sites

Local Institution - 0112
Chiba, Chiba, 260-8717
Local Institution - 0118
Chuo-ku, Tokyo, 1040045
Local Institution - 0116
Fukuoka, Fukuoka, 8111395
Local Institution - 0187
Hidaka, Saitama, 350-1298
Local Institution - 0128
Kanazawa, Ishikawa-ken, 9208641
Local Institution - 0107
Kashiwa-shi, Chiba, 2778577
Local Institution - 0111
Kawasaki, Kanagawa, 216-8511
Local Institution - 0110
Kitaadachigun, Saitama, 362-0806
Local Institution - 0113
Koto-ku, Tokyo, 135-8550
Local Institution - 0133
Kumamoto, Kumamoto, 8608556
Local Institution - 0177
Kurashiki, Okayama-ken, 7108602
Local Institution - 0132
Matsuyama, Ehime, 791-0280
Local Institution - 0129
Minato-ku, Tokyo, 1058470
Local Institution - 0109
Nagoya, Aichi-ken, 4648681
Local Institution - 0114
Osaka, 540-0006
Local Institution - 0189
Ōsaki, Miyagi, 9896183
Local Institution - 0174
Sapporo, Hokkaido, 0608648
Local Institution - 0115
Suita-shi, Osaka, 565-0871
Local Institution - 0108
Sunto-gun, Shizuoka, 4118777
Local Institution - 0175
Yokohama, Kanagawa, 241-8515

Other trials in Japan

France14 sites

Local Institution - 0186
Bayonne, 64109
Local Institution - 0028
Besançon, 25030
Local Institution - 0138
Lille, Nord, 59000
Local Institution - 0176
Limoges, Haute-Vienne, 87042
Local Institution - 0183
Lyon, 69008
Local Institution - 0029
Lyon, 69373
Local Institution - 0066
Marseille, 13005
Local Institution - 0030
Montpellier, 34298
Local Institution - 0032
Nantes, 44093
Local Institution - 0027
Paris, 75012
Local Institution - 0061
Pessac, 33604
Local Institution - 0031
Poitiers, 86000
Local Institution - 0184
Strasbourg, 67200
Local Institution - 0040
Toulouse, 31059

Other trials in France

United States9 sites

Local Institution - 0119
Arlington Heights, Illinois, 60005
Local Institution - 0106
Dallas, Texas, 75246
Local Institution - 0103
Denver, Colorado, 80218
Local Institution - 0059
Los Angeles, California, 90033
Local Institution - 0060
New York, New York, 10065
Local Institution - 0121
Pittsburgh, Pennsylvania, 15232
Local Institution - 0105
Portland, Oregon, 97227
Local Institution - 0104
Roanoke, Virginia, 24014
Local Institution - 0130
Sacramento, California, 95817

Other trials in United States

Brazil8 sites

Local Institution - 0102
Barretos, São Paulo, 14780-070
Local Institution - 0096
Ipatinga, Minas Gerais, 35160-158
Local Institution - 0200
Natal, Rio Grande do Norte, 59075-740
Local Institution - 0192
Porto Alegre, Rio Grande do Sul, 91350-200
Local Institution - 0199
Rio de Janeiro, 20231-050
Local Institution - 0094
São José do Rio Preto, São Paulo, 15090000
Local Institution - 0095
São Paulo, São Paulo, 01509-010
Local Institution - 0193
São Paulo, 01246-000

Other trials in Brazil

Germany8 sites

Local Institution - 0042
Dresden, 01307
Local Institution - 0007
Essen, 45122
Local Institution - 0043
Hamburg, 20249
Local Institution - 0117
Hamburg, 22763
Local Institution - 0008
Hanover, 30625
Local Institution - 0009
Heidelberg, 69120
Local Institution - 0044
Marburg, 35043
Local Institution - 0010
Munich, 81377

Other trials in Germany

Spain7 sites

Local Institution - 0173
A Coruña, 15006
Local Institution - 0056
Badalona, Barcelona [Barcelona], 08916
Local Institution - 0006
Barcelona, 08035
Local Institution - 0005
Madrid, 28041
Local Institution - 0172
Málaga, 29010
Local Institution - 0063
Seville, 41013
Local Institution - 0171
Valencia, 46014

Other trials in Spain

Italy6 sites

Local Institution - 0055
Catania, 95122
Local Institution - 0003
Genova, 16132
Local Institution - 0001
Milan, 20162
Local Institution - 0004
Naples, 80131
Local Institution - 0002
Padova, 35128
Local Institution - 0054
Roma, 00168

Other trials in Italy

Romania6 sites

Local Institution - 0168
Brasov, 002200
Local Institution - 0080
Bucharest, 022328
Local Institution - 0076
Cluj-Napoca, Cluj, 400015
Local Institution - 0081
Craiova, Dolj, 200542
Local Institution - 0205
Iași, 700483
Local Institution - 0089
Suceava, 720237

Other trials in Romania

Argentina5 sites

Local Institution - 0084
Buenos Aires, 1093
Local Institution - 0100
CABA, 1199
Local Institution - 0072
CABA, 1426
Local Institution - 0073
Ciudad Autonoma Beunos Aires, Buenos Aires, 1431
Local Institution - 0074
Viedma, Río Negro Province, 8500

Other trials in Argentina

Australia5 sites

Local Institution - 0041
Clayton, Victoria, 3168
Local Institution - 0018
Elizabeth Vale, South Australia, 5112
Local Institution - 0017
Heidelberg, Victoria, 3084
Local Institution - 0019
Westmead, New South Wales, 2145
Local Institution - 0053
Woolloongabba, Queensland, 4102

Other trials in Australia

Austria5 sites

Local Institution - 0064
Graz, 8036
Local Institution - 0068
Linz, 4010
Local Institution - 0120
Salzburg, 5020
Local Institution - 0065
Vienna, 1090
Local Institution - 0067
Wiener Neustadt, 2700

Other trials in Austria

Canada5 sites

Local Institution - 0011
Edmonton, Alberta, T6G 1Z2
Local Institution - 0016
Montreal, Quebec, H2X 3E4
Local Institution - 0015
Sherbrooke, Quebec, J1H 5N4
Local Institution - 0013
Toronto, Ontario, M5G 1X5
Local Institution - 0039
Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Greece5 sites

Local Institution - 0222
Athens, 11525
Local Institution - 0123
Athens, 11528
Local Institution - 0124
Cholargós, 15562
Local Institution - 0125
Heraklion, 71110
Local Institution - 0126
Ioannina, 45500

Other trials in Greece

Czechia4 sites

Local Institution - 0087
Brno, 656 53
Local Institution - 0085
Hradec Králové, 500 05
Local Institution - 0088
Nový Jičín, 741 01
Local Institution - 0086
Olomouc, 779 00

Other trials in Czechia

Belgium3 sites

Local Institution - 0025
Anderlecht, Bruxelles-Capitale, Région de, 1070
Local Institution - 0045
Bonheiden, Antwerpen, 2820
Local Institution - 0024
Leuven, 3000

Other trials in Belgium

Chile3 sites

Local Institution - 0070
Independencia, Santiago Metropolitan
Local Institution - 0071
Santiago, Santiago Metropolitan, 7500921
Local Institution - 0069
Santiago, Santiago Metropolitan, 8320000

Other trials in Chile

Ireland3 sites

Local Institution - 0091
Dublin, Dublin
Local Institution - 0022
Dublin
Local Institution - 0026
Limerick, V94 F858

Other trials in Ireland

Netherlands3 sites

Local Institution - 0052
Amsterdam, North Holland, 1066 CX
Local Institution - 0051
Amsterdam, North Holland, 1081 HV
Local Institution - 0050
Utrecht, 3584 CX

Other trials in Netherlands

Norway3 sites

Local Institution - 0033
Bergen, 5021
Local Institution - 0034
Lorenskog, 1478
Local Institution - 0035
Oslo, 0450

Other trials in Norway

Denmark2 sites

Local Institution - 0038
Herlev, 2730
Local Institution - 0036
Vejle, 7100

Other trials in Denmark

Turkey (Türkiye)2 sites

Local Institution - 0092
Adana, 01060
Local Institution - 0101
Istanbul, 34300

Other trials in Turkey (Türkiye)

United Kingdom2 sites

Local Institution - 0127
London, EC1A 7BE
Local Institution - 0049
Oxford, OX3 7LE

Other trials in United Kingdom

Puerto Rico1 site

Local Institution - 0058
Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions: Metastatic Colorectal Cancer
Being tested: Ipilimumab, Oxaliplatin, Leucovorin, Fluorouracil, Irinotecan
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IpilimumabBiological
Specified dose on specified days
OxaliplatinDrug
Specified dose on specified days
LeucovorinDrug
Specified dose on specified days
FluorouracilDrug
Specified dose on specified days
IrinotecanDrug
Specified dose on specified days
BevacizumabDrug
Specified dose on specified days
CetuximabDrug
Specified dose on specified days
NivolumabBiological
Specified dose on specified days

Study groups in NCT04008030
Study group	Role	What they receive
Arm A: Nivolumab Monotherapy	Experimental	Not described Receives: Biological: Nivolumab
Arm B: Nivolumab + Ipilimumab Combination	Experimental	Not described Receives: Biological: Ipilimumab; Biological: Nivolumab
Arm C: Investigator's Choice Chemotherapy	Active comparator	Participants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress Receives: Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil; Drug: Irinotecan; Drug: Bevacizumab; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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 outcomes (15)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomization to the date of death due to any cause

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 201923 Mar 2027

First posted5 Jul 2019
Study start5 Aug 2019
Primary completion28 Aug 2024
Study completion23 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 839 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04008030
Sponsor's protocol ID: CA209-8HW
Other IDs: 2018-000040-26, 2018
Acronym: CheckMate 8HW
Status last verified: Aug 2026
First submitted: 2 Jul 2019
Last updated: 20 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

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.
PubMed 39874977
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.
PubMed 39602630

Want to know more?

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Questions to ask the study team

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What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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