Colon Cancer Clinical Trial
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
Summary
The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on Cancer (version 4.0) at study entry
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:
BRAF V600 mutant colorectal cancer
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
Other protocol defined inclusion/exclusion criteria apply
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There are 47 Locations for this study
Birmingham Alabama, 35249, United States
Los Angeles California, 90033, United States
Los Angeles California, 90089, United States
San Francisco California, 94158, United States
Gainesville Florida, 32610, United States
Miami Florida, 33136, United States
Baltimore Maryland, 21287, United States
Hattiesburg Mississippi, 39401, United States
Saint Louis Missouri, 63110, United States
New York New York, 10016, United States
Charlotte North Carolina, 28204, United States
Lancaster Pennsylvania, 17604, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Temple Texas, 76508, United States
Madison Wisconsin, 53792, United States
Ciudad Autónoma de Buenos Aires Buenos Aires, C1426, Argentina
Buenos Aires Distrito Federal, C1096, Argentina
Ciudad Autónoma de Buenos Aires Distrito Federal, 1181, Argentina
Buenos Aires , 1431, Argentina
Blacktown New South Wales, 2148, Australia
Southport Queensland, 4215, Australia
Elizabeth Vale South Australia, 05112, Australia
Clayton Victoria, 0, Australia
Heidelberg Victoria, 3084, Australia
Woluwe-Saint-Lambert , 1200, Belgium
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 2, Canada
Montréal Quebec, H2X 3, Canada
Ottawa , K1H 8, Canada
Santiago Metropolitana, 00000, Chile
Santiago Región Metropolitana De Santiago, 84203, Chile
Olomouc Olomoucký Kraj, 779 0, Czechia
Brno , 65653, Czechia
Hradec Kralove , 500 0, Czechia
Hannover , 30625, Germany
Catania , 95124, Italy
Milan , 20133, Italy
Padova , 35128, Italy
Rozzano , 20089, Italy
Badalona Barcelona [Barcelona], 08916, Spain
Barcelona , 08035, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Pamplona , 31008, Spain
Sevilla , 41013, Spain
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