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Trial record 74 of 196 for:    colon cancer | ( Map: Colorado, United States )

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Patients 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 4, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b Randomized Clinical Trial of Nivolumab Alone, Nivolumab in Combination With Ipilimumab, or an Investigator's Choice Chemotherapy in Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : October 30, 2024
Estimated Study Completion Date : July 6, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: Nivolumab Monotherapy
Specified dose on specified days
Biological: Nivolumab
Specified dose on specified days

Experimental: Arm B: Nivolumab + Ipilimumab Combination
Specified dose on specified days
Biological: Ipilimumab
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Active Comparator: Arm C: Investigator's Choice Chemotherapy
Specified dose on specified days. 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




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Progression-Free Survival by Investigator Assessment [ Time Frame: Up to 5 years ]
  2. Overall Response Rate (ORR) by Blinded Independent Central Review [ Time Frame: Up to 5 years ]
  3. Overall Survival (OS) [ Time Frame: Up to 5 years ]
  4. Disease Control Rate (DCR) by Blinded Independent Central Review [ Time Frame: Up to 5 years ]
  5. Time to Response (TTR) [ Time Frame: Up to 5 years ]
  6. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
  7. Overall Response Rate (ORR) by investigator assessment [ Time Frame: Up to 5 years ]
  8. Disease Control Rate by Investigator Assessment [ Time Frame: Up to 5 years ]


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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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
  • Known tumor MSI-H or dMMR status per local standard of practice
  • Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

Exclusion Criteria:

  • Participants with 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


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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 110 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04008030     History of Changes
Other Study ID Numbers: CA209-8HW
2018-000040-26 ( EudraCT Number )
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

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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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Microsatellite Instability
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Genomic Instability
Pathologic Processes
Bevacizumab
Nivolumab
Cetuximab
Ipilimumab
Oxaliplatin
Irinotecan
Fluorouracil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors