An Investigational Immuno-therapy Study of Nivolumab, and Nivolumab in Combination With Other Anti-cancer Drugs, in Colon Cancer That Has Come Back or Has Spread



Status:Active, not recruiting
Conditions:Colorectal Cancer, Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:March 7, 2014
End Date:December 30, 2020

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A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite High (MSI-H) and Non-MSI-H Colon Cancer

The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination
with other anti-cancer drugs, will result in meaningful tumor size reduction, in patients
with colon cancer that has come back or has spread, and who have a specific biomarker in
their tumors.

Allocation: The Microsatellite Instability High (MSI-High) and C4 and C6 Cohort Parts of the
trial are Non-randomized, The Non-MSI high Dose Escalation Phase part of the trial contained
a randomized portion

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Men and women ≥ 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

- Histologically confirmed recurrent or metastatic colorectal cancer

- Measurable disease by CT or MRI

- Testing for MSI Status (by an accredited lab)

1. Subjects with microsatellite instability high (MSI-H) tumors will enroll in the
MSI-H Cohort (mStage and cStage groups), the C3 Cohort, and the C5 Cohort.

2. Subjects with phenotypes that are non-microsatellite instability high (non-MSI-H)
will enroll in the non- MSI-H Safety Cohort and the C6, C4 Cohorts.

- Adequate organ function as defined by study-specific laboratory tests

- Must use acceptable form of birth control throughout the study. After the final dose
of study drug, an acceptable form of birth control must be used for 23 weeks for women
of childbearing potential (WOCBP) and 31 weeks for men who are sexually active with
WOCBP

- Signed informed consent

- Willing and able to comply with study procedures

- Subjects enrolled into the C3 Cohort must have not had treatment for their metastatic
disease

Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases are not allowed.

- Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2,
anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or
drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

- Prior malignancy active within the previous 3 years except for locally curable cancers

- Subjects with active, known or suspected autoimmune disease

- Subjects with a condition requiring systemic treatment with either corticosteroids or
other immunosuppressive medications within 14 days of study drug administration

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
16
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-778-1900
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-9347
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Boston, MA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-936-5847
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Phone: 610-402-9543
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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Allentown, PA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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200 Trent Drive
Durham, North Carolina 27710
Phone: 919-668-1861
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Durham, NC
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Gilbert, Arizona 85234
Phone: 480-256-3429
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Gilbert, AZ
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Houston, Texas 77030
Phone: 713-563-7757
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Houston, TX
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Phone: 323-865-0820
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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2925 Chicago Avenue
Minneapolis, Minnesota 55407
Phone: 612-863-5658
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Minneapolis, MN
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
(412) 647-2811
Phone: 412-623-2677
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
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Portland, OR
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San Francisco, California 94115
Phone: 415-600-1775
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Westmead, New South Wales 2145
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Winston-Salem, North Carolina 27103
Phone: 336-718-8461
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