An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Patients With Previously Treated Cancer of the Colon or Rectum That Has Spread



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:January 22, 2018
End Date:November 24, 2022
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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

The purpose of this study is to investigate treatment with Nivolumab in combination with
Trametinib with or without Ipilimumab in patients with previously treated cancer of the colon
or rectum that has spread.


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Must have previously treated metastatic colorectal cancer

- Must have RAS mutation and microsatellite stability status results as part of medical
history

- Must agree to provide archival or newly obtained tumor tissue sample prior to the
start of treatment in this study

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

- Ability to swallow pills or capsules

- Adequate organ functions

- Ability to comply with study visits, treatment, procedures, PK and PD sample
collection, and required study follow-up

Exclusion Criteria:

- BRAF V600 mutant colorectal cancer

- Active brain metastases or leptomeningeal metastases

- Active, known or suspected autoimmune disease

- Histology other than adenocarcinoma

- 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 MEK inhibitors

- History of allergy to study treatments or any of its components of the study arm that
participant is enrolling

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
18
sites
Charlotte, North Carolina 28203
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Baltimore, Maryland 21237
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Boston, Massachusetts 02111
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Capital Federal, Buenos Aires
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Capital Federal,
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Durham, North Carolina 27710
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Fort Collins, Colorado 80528
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Fort Collins, CO
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46260
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Indianapolis, IN
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USC
Los Angeles, California 90033
Phone: 323-865-0467
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Phone: 323-865-3538
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Madison, Wisconsin 53792
(608) 263-2400
Phone: 800-622-8922
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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New Haven, Connecticut 06520
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New York, New York 10016
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New York, NY
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 267-319-2602
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Phoenix, Arizona 85016
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Rochester, Minnesota 55905
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Rochester, MN
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500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
Phone: 415-502-3310
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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San Francisco, CA
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