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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
5/08/2024
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)
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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
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Secondary ID [1]
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0
2018-000040-26
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Secondary ID [2]
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CA209-8HW
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 8HW
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
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Condition category
Condition code
Cancer
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Human Genetics and Inherited Disorders
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0
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed)
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Assessment method [1]
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Timepoint [1]
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Up to 5 years
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Primary outcome [2]
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PFS by BICR (arm B vs C, 1L, centrally confirmed)
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Assessment method [2]
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0
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Timepoint [2]
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Up to 5 years
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Secondary outcome [1]
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Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed)
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Assessment method [1]
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0
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Timepoint [1]
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Up to 5 years
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Secondary outcome [2]
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Overall Survival (OS) (arm B vs A, all lines, centrally confirmed)
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Assessment method [2]
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed)
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Assessment method [3]
0
0
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
0
0
PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing)
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Assessment method [4]
0
0
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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PFS by BICR (arm B vs A, 1L, centrally confirmed)
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Assessment method [5]
0
0
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Timepoint [5]
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Up to 5 years
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Secondary outcome [6]
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ORR by BICR (arm B vs C, 1L, centrally confirmed)
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Assessment method [6]
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0
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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ORR by BICR (arm B vs A, 1L, centrally confirmed)
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Assessment method [7]
0
0
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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OS (arm B vs A, 1L, centrally confirmed)
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Assessment method [8]
0
0
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Timepoint [8]
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Up to 5 years
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Secondary outcome [9]
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PFS by BICR (arm A vs C, 1L, centrally confirmed)
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Assessment method [9]
0
0
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Timepoint [9]
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Up to 5 years
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Secondary outcome [10]
0
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OS (arm B vs C, 1L, centrally confirmed)
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Assessment method [10]
0
0
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Timepoint [10]
0
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Up to 5 years
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Secondary outcome [11]
0
0
ORR by BICR (arm A vs C, 1L, centrally confirmed)
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Assessment method [11]
0
0
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Timepoint [11]
0
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Up to 5 years
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Secondary outcome [12]
0
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OS (arm A vs C, 1L, centrally confirmed)
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Assessment method [12]
0
0
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Timepoint [12]
0
0
Up to 5 years
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Secondary outcome [13]
0
0
PFS by Investigator (arm A, B and C, 1L, centrally confirmed)
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Assessment method [13]
0
0
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Timepoint [13]
0
0
Up to 5 years
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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)
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Assessment method [14]
0
0
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Timepoint [14]
0
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Up to 5 years
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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)
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Assessment method [15]
0
0
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Timepoint [15]
0
0
Up to 5 years
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Secondary outcome [16]
0
0
PFS by BICR (arm B vs C, 1L, by each central test)
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Assessment method [16]
0
0
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Timepoint [16]
0
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Up to 5 years
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Secondary outcome [17]
0
0
PFS by BICR (arm B vs A, all lines, by each central test)
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Assessment method [17]
0
0
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Timepoint [17]
0
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Up to 5 years
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Secondary outcome [18]
0
0
PFS by BICR (crossover cohort, centrally confirmed)
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Assessment method [18]
0
0
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Timepoint [18]
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Up to 5 years
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Secondary outcome [19]
0
0
ORR by BICR (crossover cohort, centrally confirmed)
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Assessment method [19]
0
0
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Timepoint [19]
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Up to 5 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/08/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
10/06/2026
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Actual
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Sample size
Target
831
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Local Institution - 0019 - Westmead
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Recruitment hospital [2]
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Local Institution - 0053 - Woolloongabba
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Recruitment hospital [3]
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Local Institution - 0018 - Elizabeth Vale
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Recruitment hospital [4]
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Local Institution - 0041 - Clayton
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Recruitment hospital [5]
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Local Institution - 0017 - Heidelberg
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment outside Australia
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United States of America
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Arizona
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Colorado
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Florida
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United States of America
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Kumamoto
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0
0
Japan
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0
Miyagi
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Japan
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Okayama
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Japan
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State/province [106]
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Osaka
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Japan
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Saitama
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Japan
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State/province [108]
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Shizuoka
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Japan
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Tokyo
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Netherlands
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Amsterdam
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Netherlands
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Utrecht
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Norway
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Bergen
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Norway
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Lorenskog
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Norway
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Oslo
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Country [115]
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Puerto Rico
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State/province [115]
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Rio Piedras
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Romania
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State/province [116]
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Cluj
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Romania
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Dolj
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Constanta
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Romania
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Ia?i
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Romania
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Suceava
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Spain
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Barcelona [Barcelona]
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Spain
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A Coruna
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Spain
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Valencia
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Turkey
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Adana
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Turkey
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Istanbul
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United Kingdom
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Greater London
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United Kingdom
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Yorkshire
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United Kingdom
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London
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Other collaborator category [1]
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0
Commercial sector/industry
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Name [1]
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Ono Pharmaceutical Co. Ltd
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Address [1]
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0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04008030
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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0
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Phone
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Fax
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0
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Email
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Contact person for public queries
Name
0
0
BMS Study Connect Contact Center www.BMSStudyConnect.com
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Address
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0
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Country
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0
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Phone
0
0
855-907-3286
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Fax
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0
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Email
0
0
[email protected]
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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.
Results not provided in
https://clinicaltrials.gov/study/NCT04008030
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