An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:12 - Any
Updated:10/11/2018
Start Date:April 7, 2017
End Date:February 17, 2023

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A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma

The purpose of this study is to determine whether an investigational immunotherapy Nivolumab,
when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the
return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or
stage IV Melanoma


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

Inclusion Criteria:

- Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of
participation in study.

- Must have full activity or, if limited, must be able to walk and carry out activities
such as light house work or office work

- No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s)
and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for
central nervous system (CNS) lesions)

Exclusion Criteria:

- History of uveal melanoma

- Patients with active, known or suspected autoimmune disease

- Prior treatment with interferon (if complete < 6 months prior to participation in
study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any
other antibody or drug specifically targeting T-cell co-stimulation or checkpoint
pathways

Other protocol defined inclusion/exclusion criteria could apply
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-834-8611
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Phone: 734-936-2738
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Atlanta, Georgia 30322
Phone: 404-777-7099
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Aurora, Colorado 80045
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Bethlehem, Pennsylvania
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Boston, Massachusetts 02115
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-582-7116
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
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303 East Superior Street
Chicago, Illinois 60611
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Dallas, Texas 75246
Phone: 214-370-1000
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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8505 Arlington Boulevard
Fairfax, Virginia 22031
Phone: 703-970-6548
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Houston, Texas 77030
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Los Angeles, California 90025
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Miami Beach, Florida 33140
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Minneapolis, Minnesota 55408
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Nashville, Tennessee 37203
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New York, New York 10016
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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116 Pacific Highway
North Sydney, New South Wales 2060
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Park Ridge, Illinois 60068
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Portland, Oregon 97213
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-284-1246
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-747-3573
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84112
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
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825 Eastlake Avenue East
Seattle, Washington 98109
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Tucson, Arizona 85724
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Phone: 202-687-6871
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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