Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:August 2006
End Date:October 2013

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A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

The purpose of this clinical research study is to examine the safety and effectiveness (how
well the drug works) of two different treatments for patients with melanoma. One treatment is
an investigational compound (a drug that is not currently approved by the United States Food
and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016)
together with an approved chemotherapy drug called Dacarbazine

For the extension phase:

Allocation: single arm study; Masking: open label; Intervention Model: Single Group

Inclusion Criteria:

- Informed Consent

- Measurable Disease

- Eastern Cooperative Oncology Group (ECOG) 0 or 1

- Lab / imaging requirements

- Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C

- Men and Women > 18 years (16 were allowable)

- Prior therapy restriction (adjuvant only)

Exclusion:

- Pregnant / nursing

- Inadequate contraception

- Brain metastasis

- Primary ocular or mucosal melanoma
We found this trial at
33
sites
Stamford, Connecticut 06902
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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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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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Anaheim, California 92801
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Anaheim, CA
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Baltimore, MD
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Baltimore, MD
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801 Ostrum St
Bethlehem, Pennsylvania 18015
(484) 526-4000
St Luke'S Hospital And Health Network St. Luke's University Health Network (SLUHN) is a nonprofit,...
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Bethlehem, 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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Buenos Aires,
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Buenos Aires,
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Charlotte, North Carolina 28204
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Charlotte, NC
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Columbia, Missouri 65203
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Fishers, Indiana 46037
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Fishers, IN
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114 Woodland St
Hartford, Connecticut 06105
(860) 714-4000
Saint Francis Hospital and Medical Center Saint Francis Hospital and Medical Center has come a...
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Hartford, CT
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Hazard, Kentucky 41701
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Hutchinson, Kansas 67502
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Indianapolis, Indiana 46202
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Jacksonville, Florida 32256
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1915 White Ave.
Knoxville, Tennessee 37916
(865) 541-1678
Thompson Cancer Survival Center The Thompson Cancer Survival Center Downtown facility has pioneered many advances...
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Knoxville, TN
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La Verne, California 91750
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Los Angeles, California 90025
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Lubbock, TX
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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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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New York, NY
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Normal, IL
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1400 South Orange Avenue
Orlando, Florida 32806
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Palm Springs, California 92262
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Park Ridge, Illinois 60068
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Richmond, Virginia 23235
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902 North Riverside Road
Saint Joseph, Missouri 64507
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San Diego, California 92123
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