A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers

Trial Information
Who is this study for? Adult patients with Stage IV Metastatic Colorectal Adenocarcinoma
Status: Recruiting
Location: See all (96) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Healthy Volunteers:
No

• 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)

Where is this trial taking place?
United States
Alabama
University of Alabama at Birmingham
Recruiting
Birmingham
Arizona
Mayo Clinic Hospital
Withdrawn
Phoenix
California
Usc
Recruiting
Los Angeles
USC Norris Comprehensive Cancer Center
Recruiting
Los Angeles
Ucsf Cancer Center
Active, not recruiting
San Francisco
Colorado
Poudre Valley Health System
Withdrawn
Fort Collins
Connecticut
Local Institution
Not yet recruiting
North Haven
Florida
UF Health Medical Oncology - Davis Cancer Pavilion
Recruiting
Gainesville
Local Institution
Not yet recruiting
Miami
Georgia
Local Institution
Withdrawn
Marietta
Indiana
Local Institution
Withdrawn
Indianapolis
Massachusetts
Beth Israel Desc. Med Ctr
Withdrawn
Boston
Dana Farber Cancer Institute
Withdrawn
Boston
Local Institution
Not yet recruiting
Boston
Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Recruiting
Baltimore
Minnesota
Mayo Clinic
Withdrawn
Rochester
Missouri
Local Institution
Not yet recruiting
Saint Louis
Mississippi
Hattiesburg Clinic Hematology/Oncology
Recruiting
Hattiesburg
North Carolina
Levine Cancer Institute
Recruiting
Charlotte
Local Institution
Withdrawn
Durham
New York
Laura & Isaac Perlmutter Cancer Ctr at NYU Langone
Withdrawn
New York
Laura and Isaac Perlmutter Cancer Center at Ambulatory Care Center
Recruiting
New York
Memorial Sloan Kettering Cancer Center
Withdrawn
New York
Pennsylvania
Ann B. Barshinger Cancer Institute
Recruiting
Lancaster
Local Institution
Not yet recruiting
Philadelphia
University Of Pennsylvania
Completed
Philadelphia
Texas
MD Anderson Cancer Center
Withdrawn
Houston
Local Institution
Not yet recruiting
Temple
Wisconsin
University Of Wisconsin
Recruiting
Madison
Other Locations
Argentina
10 locations
Local Institution - 0119
Recruiting
Buenos Aires
Local Institution - 0122
Recruiting
Buenos Aires
Local Institution
Withdrawn
Caba
Local Institution
Withdrawn
Caba
Local Institution
Withdrawn
Capital Federal
Local Institution - 0120
Recruiting
Capital Federal
Local Institution
Withdrawn
Ciudad Autonoma Beunos Aires
Local Institution
Not yet recruiting
Ciudad Autónoma De Buenos Aires
Local Institution
Not yet recruiting
Viedma
Local Institution
Withdrawn
Viedma
Australia
6 locations
Local Institution - 0044
Recruiting
Blacktown
Local Institution - 0055
Recruiting
Clayton
Local Institution - 0068
Recruiting
Elizabeth Vale
Local Institution - 0069
Recruiting
Heidelberg
Local Institution
Withdrawn
Herston
Local Institution - 0043
Recruiting
Southport
Belgium
9 locations
Local Institution
Withdrawn
Brussel
Local Institution
Withdrawn
Brussels
Local Institution
Withdrawn
Brussels
Local Institution
Withdrawn
Bruxelles
Local Institution
Withdrawn
Edegem
Local Institution
Withdrawn
Gent
Local Institution
Withdrawn
Leuven
Local Institution
Withdrawn
Liège
Local Institution
Not yet recruiting
Woluwe-saint-lambert
Canada
8 locations
Local Institution
Not yet recruiting
Edmonton
Local Institution - 0077
Recruiting
Montréal
Local Institution
Withdrawn
Ottawa
Local Institution - 0076
Recruiting
Ottawa
Local Institution
Withdrawn
Quebec
Local Institution
Not yet recruiting
Toronto
Local Institution
Withdrawn
Toronto
Local Institution - 0070
Recruiting
Toronto
Chile
Local Institution - 0117
Recruiting
Santiago
Local Institution - 0118
Recruiting
Santiago
Germany
8 locations
Local Institution
Withdrawn
Cologne
Local Institution
Withdrawn
Hamburg
Local Institution
Withdrawn
Hannover
Local Institution
Withdrawn
Heilbronn
Local Institution
Withdrawn
Mannheim
Local Institution
Withdrawn
Munich
Local Institution
Withdrawn
Ulm
Local Institution
Withdrawn
Wuerzburg
Italy
7 locations
Local Institution
Not yet recruiting
Catania
Local Institution - 0093
Recruiting
Milan
Local Institution
Withdrawn
Milano
Local Institution
Withdrawn
Modena
Local Institution
Withdrawn
Padova
Local Institution - 0092
Recruiting
Padova
Local Institution - 0094
Recruiting
Rozzano
Russian Federation
Local Institution
Withdrawn
Moscow
Local Institution
Withdrawn
Rostov-on-don
Spain
8 locations
Local Institution - 0079
Recruiting
Badalona
Local Institution - 0052
Recruiting
Barcelona
Local Institution
Withdrawn
Madrid
Local Institution - 0051
Recruiting
Madrid
Local Institution - 0114
Recruiting
Madrid
Local Institution - 0115
Recruiting
Madrid
Local Institution - 0080
Recruiting
Pamplona
Local Institution - 0096
Recruiting
Sevilla
United Kingdom
7 locations
Local Institution
Withdrawn
Aberdeen
Local Institution
Withdrawn
Bristol
Local Institution
Withdrawn
Coventry
Local Institution
Withdrawn
London
Local Institution
Withdrawn
London
Local Institution
Withdrawn
Manchester
Local Institution
Withdrawn
Surrey
Who do I contact about this trial?
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
When is this trial taking place?
Start Date: February 1, 2018
Estimated Completion Date: January 30, 2026
How many participants will be in this trial?
Target number of participants: 232
What treatment is being studied in this trial?
Experimental: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
Experimental: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib
Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib
Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib
Experimental: Part 2 Cohort 5 (3L): Regorafenib
Experimental: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib

This content was sourced from clinicaltrials.gov

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