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A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread (CheckMate142)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02060188
Recruitment Status : Active, not recruiting
First Posted : February 11, 2014
Last Update Posted : December 15, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.

Condition or disease Intervention/treatment Phase
Microsatellite Unstable Colorectal Cancer Microsatellite Stable Colorectal Cancer Mismatch Repair Proficient Colorectal Cancer Mismatch Repair Deficient Colorectal Cancer Drug: Ipilimumab Drug: Nivolumab Drug: Cobimetinib Drug: Daratumumab Drug: BMS-986016 Phase 2

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and Non-MSI-H Colon Cancer
Actual Study Start Date : March 12, 2014
Estimated Primary Completion Date : February 16, 2024
Estimated Study Completion Date : February 16, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab Monotherapy Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Nivolumab + Ipilimumab Drug: Ipilimumab
Specified dose on specified days
Other Name: Yervoy

Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Nivolumab + Ipilimumab Cohort C3 Drug: Ipilimumab
Specified dose on specified days
Other Name: Yervoy

Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Nivolumab + Ipilimumab + Cobimetinib Cohort C4 Drug: Ipilimumab
Specified dose on specified days
Other Name: Yervoy

Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Drug: Cobimetinib
Specified dose on specified days
Other Name: Cotellic
Experimental: Nivolumab + BMS-986016 Cohort C5 Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Drug: BMS-986016
Specified dose on specified days
Experimental: Nivolumab + Daratumumab Cohort C6 Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

Drug: Daratumumab
Specified dose on specified days
Other Name: Darzalex


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator [ Time Frame: The final analysis of the primary endpoint will occur at least 6 months after the last enrolled subject's first dose of study therapy (Approximately up to 34 months) ]

Secondary Outcome Measures :
  1. ORR by RECIST v1.1 by Independent Radiology Review Committee (IRRC) [ Time Frame: The final analysis of the secondary endpoint will occur the time of the primary endpoint analysis (Approximately up to 34 months) ]

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:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Histologically confirmed recurrent or metastatic colorectal cancer
  • Measurable disease per RECIST v1.1
  • Microsatellite instability expression detected by an accredited laboratory
  • Participants enrolled into the C3 Cohort must have not had treatment for their metastatic disease

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases are not allowed
  • Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • Prior malignancy active within the previous 3 years except for locally curable cancers
  • Participants with active, known or suspected autoimmune disease
  • Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration

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): NCT02060188


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02060188    
Other Study ID Numbers: CA209-142
2013-003939-30 ( EudraCT Number )
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: December 15, 2023
Last Verified: December 2023

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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
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Nivolumab
Ipilimumab
Relatlimab
Daratumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action