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Trial record 1 of 1 for:    NCT04008030
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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)

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ClinicalTrials.gov Identifier: NCT04008030
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : May 3, 2024
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date May 3, 2024
Actual Study Start Date  ICMJE August 5, 2019
Estimated Primary Completion Date June 9, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2020)
  • Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  • PFS by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)		 Progression-Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2020)
  • Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  • Overall Survival (OS) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  • PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  • PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing) [ Time Frame: Up to 5 years ]
  • PFS by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • ORR by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • ORR by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • OS (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • PFS by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • OS (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • ORR by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • OS (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  • PFS by Investigator (arm A, B and C, 1L, centrally confirmed) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to 5 years ]
  • PFS by BICR (arm B vs C, 1L, by each central test) [ Time Frame: Up to 5 years ]
  • PFS by BICR (arm B vs A, all lines, by each central test) [ Time Frame: Up to 5 years ]
  • PFS by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]
  • ORR by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Progression-Free Survival by Investigator Assessment [ Time Frame: Up to 5 years ]
  • Overall Response Rate (ORR) by Blinded Independent Central Review [ Time Frame: Up to 5 years ]
  • Overall Survival (OS) [ Time Frame: Up to 5 years ]
  • Disease Control Rate (DCR) by Blinded Independent Central Review [ Time Frame: Up to 5 years ]
  • Time to Response (TTR) [ Time Frame: Up to 5 years ]
  • Duration of Response (DOR) [ Time Frame: Up to 5 years ]
  • Overall Response Rate (ORR) by investigator assessment [ Time Frame: Up to 5 years ]
  • Disease Control Rate by Investigator Assessment [ Time Frame: Up to 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Biological: Ipilimumab
    Specified dose on specified days
  • Drug: Oxaliplatin
    Specified dose on specified days
  • Drug: Leucovorin
    Specified dose on specified days
  • Drug: Fluorouracil
    Specified dose on specified days
  • Drug: Irinotecan
    Specified dose on specified days
  • Drug: Bevacizumab
    Specified dose on specified days
  • Drug: Cetuximab
    Specified dose on specified days
  • Biological: Nivolumab
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Arm A: Nivolumab Monotherapy
    Intervention: Biological: Nivolumab
  • Experimental: Arm B: Nivolumab + Ipilimumab Combination
    Interventions:
    • Biological: Ipilimumab
    • Biological: Nivolumab
  • Active Comparator: Arm C: Investigator's Choice Chemotherapy
    Participants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress
    Interventions:
    • Drug: Oxaliplatin
    • Drug: Leucovorin
    • Drug: Fluorouracil
    • Drug: Irinotecan
    • Drug: Bevacizumab
    • Drug: Cetuximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2022)		 831
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2019)		 494
Estimated Study Completion Date  ICMJE June 10, 2026
Estimated Primary Completion Date June 9, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Czechia,   Denmark,   France,   Germany,   Greece,   Ireland,   Italy,   Japan,   Netherlands,   Norway,   Puerto Rico,   Romania,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries Poland
 
Administrative Information
NCT Number  ICMJE NCT04008030
Other Study ID Numbers  ICMJE CA209-8HW
2018-000040-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP