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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Biological: Ipilimumab Drug: Oxaliplatin Drug: Leucovorin Drug: Fluorouracil Drug: Irinotecan Drug: Bevacizumab Drug: Cetuximab Biological: Nivolumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 831 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : June 9, 2025
Estimated Study Completion Date : June 10, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Nivolumab Monotherapy Biological: Nivolumab
Specified dose on specified days
Experimental: Arm B: Nivolumab + Ipilimumab Combination Biological: Ipilimumab
Specified dose on specified days

Biological: Nivolumab
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: 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


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  2. PFS by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  2. Overall Survival (OS) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  3. PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
  4. PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing) [ Time Frame: Up to 5 years ]
  5. PFS by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  6. ORR by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  7. ORR by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  8. OS (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  9. PFS by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  10. OS (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  11. ORR by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  12. OS (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  13. PFS by Investigator (arm A, B and C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
  14. 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 ]
  15. 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 ]
  16. PFS by BICR (arm B vs C, 1L, by each central test) [ Time Frame: Up to 5 years ]
  17. PFS by BICR (arm B vs A, all lines, by each central test) [ Time Frame: Up to 5 years ]
  18. PFS by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]
  19. ORR by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008030


Contacts
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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 #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04008030    
Other Study ID Numbers: CA209-8HW
2018-000040-26 ( EudraCT Number )
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Microsatellite Instability
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Genomic Instability
Pathologic Processes
Leucovorin
 Bevacizumab
Nivolumab
Cetuximab
Ipilimumab
Oxaliplatin
Fluorouracil
Irinotecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immune Checkpoint Inhibitors