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.

View Eligibility Criteria

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

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

232

Study ID:

NCT03377361

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 47 Locations for this study

See Locations Near You

Local Institution - 0022
Birmingham Alabama, 35249, United States
Local Institution - 0027
Los Angeles California, 90033, United States
Local Institution - 0067
Los Angeles California, 90089, United States
Local Institution - 0001
San Francisco California, 94158, United States
Local Institution - 0107
Gainesville Florida, 32610, United States
Local Institution - 0111
Miami Florida, 33136, United States
Local Institution - 0028
Baltimore Maryland, 21287, United States
Local Institution - 0116
Hattiesburg Mississippi, 39401, United States
Local Institution - 0103
Saint Louis Missouri, 63110, United States
Local Institution - 0104
New York New York, 10016, United States
Local Institution - 0029
Charlotte North Carolina, 28204, United States
Local Institution - 0100
Lancaster Pennsylvania, 17604, United States
Local Institution - 0003
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University - Clinical Research Institute
Philadelphia Pennsylvania, 19107, United States
Local Institution - 0101
Temple Texas, 76508, United States
Local Institution - 0002
Madison Wisconsin, 53792, United States
Local Institution - 0120
Ciudad Autónoma de Buenos Aires Buenos Aires, C1426, Argentina
Local Institution - 0122
Buenos Aires Distrito Federal, C1096, Argentina
Local Institution - 0123
Ciudad Autónoma de Buenos Aires Distrito Federal, 1181, Argentina
Local Institution - 0119
Buenos Aires , 1431, Argentina
Local Institution - 0044
Blacktown New South Wales, 2148, Australia
Local Institution - 0043
Southport Queensland, 4215, Australia
Local Institution - 0068
Elizabeth Vale South Australia, 05112, Australia
Local Institution - 0055
Clayton Victoria, 0, Australia
Local Institution - 0069
Heidelberg Victoria, 3084, Australia
Local Institution
Woluwe-Saint-Lambert , 1200, Belgium
Local Institution - 0113
Edmonton Alberta, T6G 1, Canada
Local Institution - 0070
Toronto Ontario, M5G 2, Canada
Local Institution - 0077
Montréal Quebec, H2X 0, Canada
Local Institution - 0076
Ottawa , K1H 8, Canada
Local Institution - 0117
Santiago Metropolitana, 00000, Chile
Local Institution - 0118
Santiago Región Metropolitana De Santiago, 84203, Chile
Local Institution - 0072
Olomouc Olomoucký Kraj, 779 0, Czechia
Local Institution - 0071
Brno , 65653, Czechia
Local Institution - 0073
Hradec Kralove , 500 0, Czechia
Local Institution - 0004
Hannover , 30625, Germany
Local Institution - 0095
Catania , 95124, Italy
Local Institution - 0093
Milan , 20133, Italy
Local Institution - 0092
Padova , 35128, Italy
Local Institution - 0094
Rozzano , 20089, Italy
Local Institution - 0079
Badalona Barcelona [Barcelona], 08916, Spain
Local Institution - 0052
Barcelona , 08035, Spain
Local Institution - 0114
Madrid , 28007, Spain
Local Institution - 0051
Madrid , 28041, Spain
Local Institution - 0115
Madrid , 28050, Spain
Local Institution - 0080
Pamplona , 31008, Spain
Local Institution - 0096
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

232

Study ID:

NCT03377361

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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