Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 21, 2013
End Date:February 6, 2019

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Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

The primary purpose of this study is to compare the objective response rate, as determined by
investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in
patients with untreated, unresectable, or metastatic melanoma


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

Key Inclusion Criteria:

- Eastern Cooperative Oncology Group performance status of 0 or 1

- Histologically confirmed unresectable Stage III or Stage IV melanoma

- No prior systemic anticancer therapy for unresectable or metastatic melanoma. Note
that prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed
at least 6 weeks prior to date of first dose, and all related adverse events have
either returned to baseline or stabilized

- Tumor tissue obtained in the metastatic setting or from an unresectable site must be
provided for biomarker analyses and sent to the central laboratory. Biopsy should be
excisional, incisional punch, or core needle. Fine needle aspirates or other cytology
samples are insufficient

- Known BRAF V600 mutation status as determined by an FDA-approved test. Patients with
either V600 wild-type or V600 mutation-positive melanoma are eligible.

Key Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases. Patients with treated brain
metastases are eligible if there is no evidence of progression on magnetic resonance
imaging scan for at least 8 weeks after completion of treatment and within 28 days
prior to first dose of study drug administration. There must also be no requirement
for high doses of systemic corticosteroids that could result in immunosuppression (>10
mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration

- Ocular melanoma

- Patients with active, known, or suspected autoimmune disease. Those with vitiligo,
type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only
requiring hormone replacement, psoriasis not requiring systemic treatment, or
conditions not expected to recur in the absence of an external trigger are permitted
to enroll.
We found this trial at
22
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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24 Sturtevant St
Orlando, Florida 32806
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Orlando, FL
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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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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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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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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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Cincinnati, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Easton, Pennsylvania 18045
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Greenville, South Carolina 29615
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Louisville, Kentucky 40202
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600 Highland Avenue
Madison, Wisconsin 53792
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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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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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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San Francisco, California 94115
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Toulouse, 31059
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