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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04008030




Registration number
NCT04008030
Ethics application status
Date submitted
2/07/2019
Date registered
5/07/2019
Date last updated
19/09/2024

Titles & IDs
Public title
A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)
Scientific 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
Secondary ID [1] 0 0
2018-000040-26
Secondary ID [2] 0 0
CA209-8HW
Universal Trial Number (UTN)
Trial acronym
CheckMate 8HW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ipilimumab
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Leucovorin
Treatment: Drugs - Fluorouracil
Treatment: Drugs - Irinotecan
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Cetuximab
Treatment: Other - Nivolumab

Experimental: Arm A: Nivolumab Monotherapy -

Experimental: Arm B: Nivolumab + Ipilimumab Combination -

Active comparator: Arm C: Investigator's Choice Chemotherapy - Participants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress


Treatment: Other: Ipilimumab
Specified dose on specified days

Treatment: Drugs: Oxaliplatin
Specified dose on specified days

Treatment: Drugs: Leucovorin
Specified dose on specified days

Treatment: Drugs: Fluorouracil
Specified dose on specified days

Treatment: Drugs: Irinotecan
Specified dose on specified days

Treatment: Drugs: Bevacizumab
Specified dose on specified days

Treatment: Drugs: Cetuximab
Specified dose on specified days

Treatment: Other: Nivolumab
Specified dose on specified days

Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed)
Timepoint [1] 0 0
Up to 5 years
Primary outcome [2] 0 0
PFS by BICR (arm B vs C, 1L, centrally confirmed)
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Overall Survival (OS) (arm B vs A, all lines, centrally confirmed)
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed)
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing)
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
PFS by BICR (arm B vs A, 1L, centrally confirmed)
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
ORR by BICR (arm B vs C, 1L, centrally confirmed)
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
ORR by BICR (arm B vs A, 1L, centrally confirmed)
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
OS (arm B vs A, 1L, centrally confirmed)
Timepoint [8] 0 0
Up to 5 years
Secondary outcome [9] 0 0
PFS by BICR (arm A vs C, 1L, centrally confirmed)
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
OS (arm B vs C, 1L, centrally confirmed)
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
ORR by BICR (arm A vs C, 1L, centrally confirmed)
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
OS (arm A vs C, 1L, centrally confirmed)
Timepoint [12] 0 0
Up to 5 years
Secondary outcome [13] 0 0
PFS by Investigator (arm A, B and C, 1L, centrally confirmed)
Timepoint [13] 0 0
Up to 5 years
Secondary outcome [14] 0 0
PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing)
Timepoint [14] 0 0
Up to 5 years
Secondary outcome [15] 0 0
PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing)
Timepoint [15] 0 0
Up to 5 years
Secondary outcome [16] 0 0
PFS by BICR (arm B vs C, 1L, by each central test)
Timepoint [16] 0 0
Up to 5 years
Secondary outcome [17] 0 0
PFS by BICR (arm B vs A, all lines, by each central test)
Timepoint [17] 0 0
Up to 5 years
Secondary outcome [18] 0 0
PFS by BICR (crossover cohort, centrally confirmed)
Timepoint [18] 0 0
Up to 5 years
Secondary outcome [19] 0 0
ORR by BICR (crossover cohort, centrally confirmed)
Timepoint [19] 0 0
Up to 5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0019 - Westmead
Recruitment hospital [2] 0 0
Local Institution - 0053 - Woolloongabba
Recruitment hospital [3] 0 0
Local Institution - 0018 - Elizabeth Vale
Recruitment hospital [4] 0 0
Local Institution - 0041 - Clayton
Recruitment hospital [5] 0 0
Local Institution - 0017 - Heidelberg
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
RIO Negro
Country [14] 0 0
Argentina
State/province [14] 0 0
Caba
Country [15] 0 0
Austria
State/province [15] 0 0
Graz
Country [16] 0 0
Austria
State/province [16] 0 0
Linz
Country [17] 0 0
Austria
State/province [17] 0 0
Salzburg
Country [18] 0 0
Austria
State/province [18] 0 0
Wiener Neustadt
Country [19] 0 0
Austria
State/province [19] 0 0
Wien
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Belgium
State/province [20] 0 0
Antwerpen
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles-Capitale, Région De
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Belgium
State/province [22] 0 0
Brussel
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Belgium
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Leuven
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Brazil
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Minas Gerais
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Brazil
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RIO Grande DO Norte
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Brazil
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Rio Grande Do Sul
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Brazil
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RIO Grande DO SUL
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Brazil
State/province [30] 0 0
Rio de Janeiro
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Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
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Canada
State/province [33] 0 0
Nova Scotia
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Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
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Chile
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Metropolitana
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Chile
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Santiago
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China
State/province [38] 0 0
Anhui
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China
State/province [39] 0 0
Fujian
Country [40] 0 0
China
State/province [40] 0 0
Gansu
Country [41] 0 0
China
State/province [41] 0 0
Guangdong
Country [42] 0 0
China
State/province [42] 0 0
Guangxi
Country [43] 0 0
China
State/province [43] 0 0
Heilongjiang
Country [44] 0 0
China
State/province [44] 0 0
Henan
Country [45] 0 0
China
State/province [45] 0 0
Hunan
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China
State/province [46] 0 0
Jiangsu
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China
State/province [47] 0 0
Jiangxi
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China
State/province [48] 0 0
Jilin
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China
State/province [49] 0 0
Liaoning
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China
State/province [50] 0 0
Shaanxi
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China
State/province [51] 0 0
Shandong
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China
State/province [52] 0 0
Shanghai
Country [53] 0 0
China
State/province [53] 0 0
Yunnan
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China
State/province [54] 0 0
Zhejiang
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Czechia
State/province [55] 0 0
Brno
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Czechia
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Hradec Kralove
Country [57] 0 0
Czechia
State/province [57] 0 0
Novy Jicin
Country [58] 0 0
Czechia
State/province [58] 0 0
Olomouc
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Denmark
State/province [59] 0 0
Herlev
Country [60] 0 0
Denmark
State/province [60] 0 0
Odense
Country [61] 0 0
Denmark
State/province [61] 0 0
Vejle
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France
State/province [62] 0 0
Haute-Vienne
Country [63] 0 0
France
State/province [63] 0 0
Nord
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France
State/province [64] 0 0
Bayonne
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France
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Besancon Cedex
Country [66] 0 0
France
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Lyon Cedex 08
Country [67] 0 0
France
State/province [67] 0 0
Lyon
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France
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Marseille
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France
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Montpellier
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France
State/province [70] 0 0
Nantes
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France
State/province [71] 0 0
Paris
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France
State/province [72] 0 0
Pessac Cedex
Country [73] 0 0
France
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Poitiers
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France
State/province [74] 0 0
Rouen
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France
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Strasbourg
Country [76] 0 0
France
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Toulouse
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Germany
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Dresden
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Germany
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Essen
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Germany
State/province [79] 0 0
Hamburg
Country [80] 0 0
Germany
State/province [80] 0 0
Hannover
Country [81] 0 0
Germany
State/province [81] 0 0
Heidelberg
Country [82] 0 0
Germany
State/province [82] 0 0
Marburg
Country [83] 0 0
Germany
State/province [83] 0 0
Munich
Country [84] 0 0
Greece
State/province [84] 0 0
Athens
Country [85] 0 0
Greece
State/province [85] 0 0
Heraklion
Country [86] 0 0
Greece
State/province [86] 0 0
Holargos
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Greece
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Ioannina
Country [88] 0 0
Ireland
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Dublin
Country [89] 0 0
Ireland
State/province [89] 0 0
Limerick
Country [90] 0 0
Italy
State/province [90] 0 0
Catania
Country [91] 0 0
Italy
State/province [91] 0 0
Genova
Country [92] 0 0
Italy
State/province [92] 0 0
Milan
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Italy
State/province [93] 0 0
Napoli
Country [94] 0 0
Italy
State/province [94] 0 0
Padova
Country [95] 0 0
Italy
State/province [95] 0 0
Roma
Country [96] 0 0
Japan
State/province [96] 0 0
Aichi
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Japan
State/province [97] 0 0
Chiba
Country [98] 0 0
Japan
State/province [98] 0 0
Ehime
Country [99] 0 0
Japan
State/province [99] 0 0
Fukuoka
Country [100] 0 0
Japan
State/province [100] 0 0
Hokkaido
Country [101] 0 0
Japan
State/province [101] 0 0
Ishikawa
Country [102] 0 0
Japan
State/province [102] 0 0
Kanagawa
Country [103] 0 0
Japan
State/province [103] 0 0
Kumamoto
Country [104] 0 0
Japan
State/province [104] 0 0
Miyagi
Country [105] 0 0
Japan
State/province [105] 0 0
Okayama
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Japan
State/province [106] 0 0
Osaka
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Japan
State/province [107] 0 0
Saitama
Country [108] 0 0
Japan
State/province [108] 0 0
Shizuoka
Country [109] 0 0
Japan
State/province [109] 0 0
Tokyo
Country [110] 0 0
Netherlands
State/province [110] 0 0
Amsterdam
Country [111] 0 0
Netherlands
State/province [111] 0 0
Utrecht
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Norway
State/province [112] 0 0
Bergen
Country [113] 0 0
Norway
State/province [113] 0 0
Lorenskog
Country [114] 0 0
Norway
State/province [114] 0 0
Oslo
Country [115] 0 0
Puerto Rico
State/province [115] 0 0
Rio Piedras
Country [116] 0 0
Romania
State/province [116] 0 0
Cluj
Country [117] 0 0
Romania
State/province [117] 0 0
Dolj
Country [118] 0 0
Romania
State/province [118] 0 0
Brasov
Country [119] 0 0
Romania
State/province [119] 0 0
Bucharest
Country [120] 0 0
Romania
State/province [120] 0 0
Constanta
Country [121] 0 0
Romania
State/province [121] 0 0
Ia?i
Country [122] 0 0
Romania
State/province [122] 0 0
Suceava
Country [123] 0 0
Spain
State/province [123] 0 0
Barcelona [Barcelona]
Country [124] 0 0
Spain
State/province [124] 0 0
A Coruna
Country [125] 0 0
Spain
State/province [125] 0 0
Barcelona
Country [126] 0 0
Spain
State/province [126] 0 0
Madrid
Country [127] 0 0
Spain
State/province [127] 0 0
Malaga
Country [128] 0 0
Spain
State/province [128] 0 0
Sevilla
Country [129] 0 0
Spain
State/province [129] 0 0
Valencia
Country [130] 0 0
Turkey
State/province [130] 0 0
Adana
Country [131] 0 0
Turkey
State/province [131] 0 0
Istanbul
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Greater London
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Yorkshire
Country [134] 0 0
United Kingdom
State/province [134] 0 0
London
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.