An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread
NCT ID: NCT03377361
Last Updated: 2025-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
325 participants
INTERVENTIONAL
2018-01-31
2024-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
Nivolumab
Specified dose on specified days
Trametinib
Specified dose on specified days
Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib
Nivolumab
Specified dose on specified days
Trametinib
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib
Nivolumab
Specified dose on specified days
Trametinib
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib
Nivolumab
Specified dose on specified days
Trametinib
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Part 2 Cohort 5 (3L): Regorafenib
Regorafenib
Specified dose on specified days
Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib
Nivolumab
Specified dose on specified days
Trametinib
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Trametinib
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Regorafenib
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Microsatellite status should be performed per local standard of practice, immunohistochemistry (IHC) and/or PCR. If IHC results are equivocal, PCR is required for determining microsatellite stable (MSS) status
* Must have measurable disease per RECIST 1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and on cycle 1 day 1 (C1D1)
Exclusion Criteria
* Active brain metastases or leptomeningeal metastases
* Active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
* History of interstitial lung disease or pneumonitis
* Prior treatment with immune checkpoint inhibitors and mitogen-activated protein kinase enzymes (MEK) inhibitors
* History of allergy or hypersensitivity to study drug components
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0022
Birmingham, Alabama, United States
Local Institution - 0027
Los Angeles, California, United States
Local Institution - 0067
Los Angeles, California, United States
Local Institution - 0001
San Francisco, California, United States
Local Institution - 0107
Gainesville, Florida, United States
Local Institution - 0111
Miami, Florida, United States
Local Institution - 0028
Baltimore, Maryland, United States
Local Institution - 0116
Hattiesburg, Mississippi, United States
Local Institution - 0103
St Louis, Missouri, United States
Local Institution - 0104
New York, New York, United States
Local Institution - 0029
Charlotte, North Carolina, United States
Local Institution - 0100
Lancaster, Pennsylvania, United States
Local Institution - 0003
Philadelphia, Pennsylvania, United States
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, United States
Local Institution - 0101
Temple, Texas, United States
Local Institution - 0002
Madison, Wisconsin, United States
Local Institution - 0120
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0123
Buenos Aires, Distrito Federal, Argentina
Local Institution - 0122
Buenos Aires, Distrito Federal, Argentina
Local Institution - 0119
Buenos Aires, , Argentina
Local Institution - 0044
Blacktown, New South Wales, Australia
Local Institution - 0043
Southport, Queensland, Australia
Local Institution - 0068
Elizabeth Vale, South Australia, Australia
Local Institution - 0055
Clayton, Victoria, Australia
Local Institution - 0069
Heidelberg, Victoria, Australia
Local Institution
Woluwe-Saint-Lambert, , Belgium
Local Institution - 0113
Edmonton, Alberta, Canada
Local Institution - 0070
Toronto, Ontario, Canada
Local Institution - 0077
Montreal, Quebec, Canada
Local Institution - 0076
Ottawa, , Canada
Local Institution - 0117
Santiago, Santiago Metropolitan, Chile
Local Institution - 0118
Santiago, Santiago Metropolitan, Chile
Local Institution - 0072
Olomouc, Olomoucký kraj, Czechia
Local Institution - 0071
Brno, , Czechia
Local Institution - 0073
Hradec Králové, , Czechia
Local Institution - 0004
Hanover, , Germany
Local Institution - 0095
Catania, , Italy
Local Institution - 0093
Milan, , Italy
Local Institution - 0092
Padua, , Italy
Local Institution - 0094
Rozzano, , Italy
Local Institution - 0079
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0080
Pamplona, Navarre, Spain
Local Institution - 0052
Barcelona, , Spain
Local Institution - 0114
Madrid, , Spain
Local Institution - 0051
Madrid, , Spain
Local Institution - 0115
Madrid, , Spain
Local Institution - 0096
Seville, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2017-001830-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-9N9
Identifier Type: -
Identifier Source: org_study_id
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