Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:May 23, 2013
End Date:March 31, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with
Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab
alone.


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

Inclusion Criteria:

- Histologically confirmed stage III (unresectable) or stage IV melanoma

- Treatment naïve patients

- Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per
RECIST 1.1 criteria

- Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses

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

Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases

- Ocular melanoma

- Subjects with active, known or suspected autoimmune disease

- Subjects with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
days of treatment

- Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed
Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated
antigen-4 (anti-CTLA-4) antibody
We found this trial at
47
sites
Sarah Cannon Research Institute
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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University of New Mexico Cancer Center
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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Albuquerque, NM
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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University of Mississippi Medical Center
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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University of California at Los Angeles
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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Vanderbilt-Ingram Cancer Center
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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Orlando Health
24 Sturtevant St
Orlando, Florida 32806
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Orlando, FL
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UCSF Helen Diller Family Comprehensive Cancer Center
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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San Francisco, CA
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Univ of Washington
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Lehigh Valley Health Network
Allentown, Pennsylvania 18105
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Allentown, PA
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University of Michigan Health System
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Winship Cancer Institute
Atlanta, Georgia 30322
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Atlanta, GA
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University of Colorado Cancer Center
Aurora, Colorado 80045
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Aurora, CO
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Dana-Farber Cancer Institute
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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Dana-Farber Cancer Institute
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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Beth Israel Deaconness Medical Center
Boston, Massachusetts 02215
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Boston, MA
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Local Institution
Camperdown, New South Wales 2050
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Camperdown,
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Levine Cancer Institute
Charlotte, North Carolina 28211
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Charlotte, NC
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University Hospitals
Cleveland, Ohio 44106
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Cleveland, OH
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New York Oncology Hematology
Clifton Park, New York 12065
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Clifton Park, NY
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Texas Oncology, PA
Dallas, Texas 75246
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Dallas, TX
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Duke Cancer Institute
20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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Durham, NC
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St. Luke'S Cancer Center - Anderson Campus
Easton, Pennsylvania 18045
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Easton, PA
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Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
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Gilbert, AZ
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Greenville Health System
Greenville, South Carolina 29615
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University of Texas M.D. Anderson Cancer Center
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
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Jacksonville, FL
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UC San Diego Moores Cancer Center
3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, CA
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Comprehensive Cancer Centers of Nevada
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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The Angeles Clinic & Research Institute
Los Angeles, California 90025
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Los Angeles, CA
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Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Lutherville, Maryland 21093
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Lutherville, MD
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Allina Health
Minneapolis, Minnesota 55407
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Minneapolis, MN
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Atlantic Melanoma Center
Morristown, New Jersey 07960
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Morristown, NJ
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Yale University
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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NYU Clinical Cancer Center
New York, New York 10016
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New York, NY
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Memorial Sloan Kettering Cancer Center
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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Comprehensive Cancer Center At Desert Regional Medical Center
Palm Springs, California 92262
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Palm Springs, CA
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Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
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Pittsburgh, PA
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Providence Cancer Center Oncology and Hematology Care Eastside, Site #194
Portland, Oregon 97213
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Portland, OR
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Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California
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Rancho Mirage, CA
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Washington University School of Medicine
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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Saint Louis, MO
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Huntsman Cancer Institute
Salt Lake City, Utah 84112
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Salt Lake City, UT
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California Pacific Medical Center Research Institute
San Francisco, California 94110
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San Francisco, CA
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Maine Center for Cancer Medicine
Scarborough, Maine
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Scarborough, ME
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University of Arizona Cancer Center
Tucson, Arizona 85724
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Tucson, AZ
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Georgetown University Medical Center
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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MedStar Washington Hospital Center
Washington, District of Columbia
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Washington,
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