NCT03377361
Recruiting
December 19, 2017
May 10, 2022
Brief 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.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib |
Biological: Nivolumab Specified dose on specified days Drug: Trametinib Specified dose on specified days |
Experimental: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib |
Biological: Nivolumab Specified dose on specified days Drug: Trametinib Specified dose on specified days Biological: Ipilimumab Specified dose on specified days |
Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib |
Biological: Nivolumab Specified dose on specified days Drug: Trametinib Specified dose on specified days Biological: Ipilimumab Specified dose on specified days |
Experimental: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib |
Biological: Nivolumab Specified dose on specified days Drug: Trametinib Specified dose on specified days Biological: Ipilimumab Specified dose on specified days |
Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib |
Biological: Nivolumab Specified dose on specified days Drug: Trametinib Specified dose on specified days Biological: Ipilimumab Specified dose on specified days |
Experimental: Part 2 Cohort 5 (3L): Regorafenib |
Drug: Regorafenib Specified dose on specified days |
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
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Alabama
University Of Alabama At Birmingham
Birmingham
United States, Arizona
Mayo Clinic Hospital
Phoenix
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles
United States, California
Usc
Los Angeles
United States, California
Ucsf Cancer Center
San Francisco
United States, Colorado
Poudre Valley Health System
Fort Collins
United States, Connecticut
Local Institution
North Haven
United States, Florida
UF Health Medical Oncology - Davis Cancer Pavilion
Gainesville
United States, Florida
Local Institution
Miami
United States, Georgia
Local Institution
Marietta
United States, Indiana
Local Institution
Indianapolis
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore
United States, Massachusetts
Local Institution
Boston
United States, Massachusetts
Beth Israel Desc. Med Ctr
Boston
United States, Massachusetts
Dana Farber Cancer Institute
Boston
United States, Minnesota
Mayo Clinic
Rochester
United States, Mississippi
Hattiesburg Clinic Hematology/Oncology
Hattiesburg
United States, Missouri
Local Institution
Saint Louis
United States, New York
Laura & Isaac Perlmutter Cancer Ctr at NYU Langone
New York
United States, New York
Laura and Isaac Perlmutter Cancer Center at Ambulatory Care Center
New York
United States, New York
Memorial Sloan Kettering Cancer Center
New York
United States, North Carolina
Local Institution
Charlotte
United States, North Carolina
Local Institution
Durham
United States, Pennsylvania
Ann B. Barshinger Cancer Institute
Lancaster
United States, Pennsylvania
University Of Pennsylvania
Philadelphia
United States, Pennsylvania
Local Institution
Philadelphia
United States, Texas
MD Anderson Cancer Center
Houston
United States, Texas
Local Institution
Temple
United States, Wisconsin
University Of Wisconsin
Madison
Argentina, Buenos Aires
Local Institution
Capital Federal
Argentina, Buenos Aires
Local Institution
Ciudad Autonoma Beunos Aires
Argentina, Distrito Federal
Local Institution - 0122
Buenos Aires
Argentina, Distrito Federal
Local Institution
Capital Federal
Argentina, Distrito Federal
Local Institution
Ciudad Autónoma de Buenos Aires
Argentina, RIO Negro
Local Institution
Viedma
Argentina, RIO Negro
Local Institution
Viedma
Argentina
Local Institution - 0119
Buenos Aires
Argentina
Local Institution
Caba
Argentina
Local Institution
Caba
Australia, New South Wales
Local Institution
Blacktown
Australia, Queensland
Local Institution
Herston
Australia, Queensland
Local Institution
Southport
Australia, South Australia
Local Institution
Elizabeth Vale
Australia, Victoria
Local Institution
Clayton
Australia, Victoria
Local Institution
Heidelberg
Belgium
Local Institution
Brussels
Belgium
Local Institution
Brussels
Belgium
Local Institution
Brussel
Belgium
Local Institution
Bruxelles
Belgium
Local Institution
Edegem
Belgium
Local Institution
Gent
Belgium
Local Institution
Leuven
Belgium
Local Institution
Liège
Belgium
Local Institution
Woluwe-Saint-Lambert
Canada, Alberta
Local Institution
Edmonton
Canada, Ontario
Local Institution
Ottawa
Canada, Ontario
Local Institution - 0070
Toronto
Canada, Ontario
Local Institution
Toronto
Canada, Ontario
Local Institution
Toronto
Canada, Quebec
Local Institution - 0077
Montréal
Canada
Local Institution
Ottawa
Canada
Local Institution
Quebec
Chile, Metropolitana
Local Institution - 0117
Santiago
Chile, Metropolitana
Local Institution - 0118
Santiago
Czechia
Local Institution
Brno
Czechia
Local Institution
Brno
Czechia
Local Institution - 0071
Brno
Czechia
Local Institution
Hradec Kralove
Czechia
Local Institution - 0073
Hradec Kralove
Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika
Olomouc
Germany
Local Institution
Cologne
Germany
Local Institution
Hamburg
Germany
Local Institution
Hannover
Germany
Local Institution
Heilbronn
Germany
Local Institution
Mannheim
Germany
Local Institution
Munich
Germany
Local Institution
Ulm
Germany
Local Institution
Wuerzburg
Italy
Local Institution
Catania
Italy
Local Institution
Milano
Italy
Local Institution - 0093
Milan
Italy
Local Institution
Modena
Italy
Local Institution - 0092
Padova
Italy
Local Institution
Padova
Italy
Local Institution - 0094
Rozzano
Russian Federation
Local Institution
Moscow
Russian Federation
Local Institution
Rostov-on-don
Spain
Local Institution - 0079
Badalona
Spain
Local Institution
Barcelona
Spain
Hospital Gral. Univ. Gregorio Maranon
Madrid
Spain
Hosp Univer 12 De Octubre
Madrid
Spain
Hospital Madrid Norte Sanchinarro
Madrid
Spain
Local Institution
Madrid
Spain
COMPLEJO HOSPITALARIO DE NAVARRA-oncologia médica
Pamplona
Spain
Local Institution
Seville
United Kingdom, Aberdeenshire
Local Institution
Aberdeen
United Kingdom, Avon
Local Institution
Bristol
United Kingdom, Greater London
Local Institution
London
United Kingdom, Greater London
Local Institution
London
United Kingdom
Local Institution
Coventry
United Kingdom
Local Institution
Manchester
United Kingdom
Local Institution
Surrey
Bristol-Myers Squibb
Novartis
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb