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:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 91 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35249, United States More Info
Mohd Khushman, Site 0022
Contact
205-975-1269
Mayo Clinic Hospital
Phoenix Arizona, 85054, United States
USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Heinz-Josef Lenz, Site 0027
Contact
323-865-3967
Usc
Los Angeles California, 90089, United States More Info
Heinz-Josef Lenz, Site 0067
Contact
323-865-3967
Local Institution - 0001
San Francisco California, 94158, United States
Poudre Valley Health System
Fort Collins Colorado, 80598, United States
Local Institution
North Haven Connecticut, 06473, United States More Info
Site 0035
Contact
UF Health Medical Oncology - Davis Cancer Pavilion
Gainesville Florida, 32610, United States More Info
Thomas George, Site 0107
Contact
352-265-0725
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami Florida, 33136, United States More Info
Agustin Pimentel, Site 0111
Contact
305-972-2446
Local Institution
Marietta Georgia, 30060, United States
Local Institution
Indianapolis Indiana, 46202, United States
Sidney kimmel comprehensive cancer center at johns hopkins
Baltimore Maryland, 21287, United States More Info
Nilofer Azad, Site 0028
Contact
410-502-2995
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Aparna Parikh, Site 0033
Contact
847-971-3738
Beth Israel Desc. Med Ctr
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg Mississippi, 39401, United States More Info
John Hrom, Site 0116
Contact
601-261-1700
Washington University School Of Medicine
Saint Louis Missouri, 63110, United States More Info
Katrina Pedersen, Site 0103
Contact
314-508-7474
Laura & Isaac Perlmutter Cancer Ctr at NYU Langone
New York New York, 10016, United States
Laura and Isaac Perlmutter Cancer Center at Ambulatory Care Center
New York New York, 10016, United States More Info
Nina Beri, Site 0104
Contact
212-731-5770
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Jimmy Hwang, Site 0029
Contact
571-214-2266
Local Institution
Durham North Carolina, 27710, United States
Ann B. Barshinger Cancer Institute
Lancaster Pennsylvania, 17604, United States More Info
Nandi Reddy, Site 0100
Contact
717-544-0516
Local Institution - 0003
Philadelphia Pennsylvania, 19104, United States
Local Institution
Philadelphia Pennsylvania, 19107, United States More Info
Site 0110
Contact
MD Anderson Cancer Center
Houston Texas, 77030, United States
Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology
Temple Texas, 76508, United States More Info
Lucas Wong, Site 0101
Contact
254-760-0867
University Of Wisconsin
Madison Wisconsin, 53792, United States More Info
Dustin Deming, Site 0002
Contact
608-265-1700
Local Institution
Capital Federal Buenos Aires, 1264, Argentina
Local Institution
Ciudad Autonoma Beunos Aires Buenos Aires, 1431, Argentina
Local Institution - 0120
Ciudad Autónoma de Buenos Aires Buenos Aires, C1426, Argentina More Info
Site 0120
Contact
Local Institution - 0122
Buenos Aires Distrito Federal, C1096, Argentina More Info
Site 0122
Contact
Local Institution - 0123
Ciudad Autónoma de Buenos Aires Distrito Federal, 1181, Argentina More Info
Site 0123
Contact
Local Institution
Viedma RIO Negro, 8500, Argentina
Local Institution
Viedma RIO Negro, 8500, Argentina More Info
Site 0121
Contact
Local Institution - 0119
Buenos Aires , 1431, Argentina More Info
Site 0119
Contact
Local Institution
Caba , 1199, Argentina
Local Institution
Caba , 1426, Argentina
Local Institution - 0044
Blacktown New South Wales, 2148, Australia More Info
Site 0044
Contact
Local Institution
Herston Queensland, , Australia
Local Institution - 0043
Southport Queensland, 4215, Australia More Info
Site 0043
Contact
Local Institution - 0068
Elizabeth Vale South Australia, 05112, Australia More Info
Site 0068
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Local Institution - 0055
Clayton Victoria, 0, Australia More Info
Site 0055
Contact
Local Institution - 0069
Heidelberg Victoria, 3084, Australia More Info
Site 0069
Contact
Local Institution
Brussels , 1000, Belgium
Local Institution
Brussels , B-100, Belgium
Local Institution
Brussel , 1090, Belgium
Local Institution
Bruxelles , 1200, Belgium
Local Institution
Edegem , 2650, Belgium
Local Institution
Gent , 9000, Belgium
Local Institution
Leuven , 3000, Belgium
Local Institution
Liège , 4000, Belgium
Local Institution
Woluwe-Saint-Lambert , 1200, Belgium More Info
Site 0087
Contact
Local Institution - 0113
Edmonton Alberta, T6G 1, Canada More Info
Site 0113
Contact
Local Institution
Ottawa Ontario, , Canada
Local Institution - 0099
Toronto Ontario, M5G 1, Canada
Local Institution - 0070
Toronto Ontario, M5G 2, Canada More Info
Site 0070
Contact
Local Institution
Toronto Ontario, , Canada
Local Institution - 0077
Montréal Quebec, H2X 3, Canada More Info
Site 0077
Contact
Local Institution - 0076
Ottawa , K1H 8, Canada More Info
Site 0076
Contact
Local Institution
Quebec , , Canada
Local Institution - 0117
Santiago Metropolitana, 00000, Chile More Info
Site 0117
Contact
Local Institution - 0118
Santiago Metropolitana, 84203, Chile More Info
Site 0118
Contact
Local Institution
Brno , 625 0, Czechia
Local Institution
Brno , 656 5, Czechia
Local Institution - 0071
Brno , 65653, Czechia More Info
Site 0071
Contact
Local Institution
Hradec Kralove , 500 0, Czechia
Local Institution - 0073
Hradec Kralove , 50005, Czechia More Info
Site 0073
Contact
Local Institution - 0072
Olomouc , 779 0, Czechia More Info
Site 0072
Contact
Local Institution
Cologne , 50937, Germany
Local Institution
Hamburg , 20251, Germany
Local Institution
Hannover , 30625, Germany
Local Institution
Heilbronn , 74078, Germany
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Mannheim , 68163, Germany
Local Institution
Munich , 81377, Germany
Local Institution
Ulm , 89081, Germany
Local Institution
Wuerzburg , 97080, Germany
Local Institution
Catania , 95122, Italy More Info
Site 0095
Contact
Local Institution
Milano , 20133, Italy
Local Institution - 0093
Milan , 20133, Italy More Info
Site 0093
Contact
Local Institution
Modena , 41124, Italy
Local Institution - 0092
Padova , 35128, Italy More Info
Site 0092
Contact
Local Institution
Padova , Padov, Italy
Local Institution - 0094
Rozzano , 20089, Italy More Info
Site 0094
Contact
Local Institution
Moscow , 11547, Russian Federation
Local Institution
Rostov-on-don , 34403, Russian Federation
Local Institution - 0079
Badalona , 08916, Spain More Info
Site 0079
Contact
Local Institution - 0052
Barcelona , 08035, Spain More Info
Site 0052
Contact
Local Institution - 0114
Madrid , 28007, Spain More Info
Site 0114
Contact
Local Institution - 0051
Madrid , 28041, Spain More Info
Site 0051
Contact
Local Institution - 0115
Madrid , 28050, Spain More Info
Site 0115
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Local Institution
Madrid , 28050, Spain
Local Institution - 0080
Pamplona , 31008, Spain More Info
Site 0080
Contact
Local Institution - 0096
Sevilla , 41013, Spain More Info
Site 0096
Contact
Local Institution
Aberdeen Aberdeenshire, AB25 , United Kingdom
Local Institution
Bristol Avon, BS2 8, United Kingdom
Local Institution
London Greater London, SW17 , United Kingdom
Local Institution
London Greater London, SW3 6, United Kingdom
Local Institution
Coventry , CV2 2, United Kingdom
Local Institution
Manchester , M20 4, United Kingdom
Local Institution
Surrey , sm2 5, United Kingdom

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:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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