Expanded Access Program With Nivolumab in Combination With Ipilimumab in Patients With Tumors Unable to be Removed by Surgery or Metastatic Melanoma



Status:Available
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/27/2016
Contact:Please Contact
Email:Clinical.Trials@bms.com

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Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Subjects With Unresectable or Metastatic Melanoma

The purpose of this study is to provide treatment with nivolumab in combination with
ipilimumab to subjects who are anti-(CTLA)-4 and anti-PD-1 treatment-naive and have
unresectable or metastatic melanoma.


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

Inclusion Criteria:

- Men and women 18 years and older

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

- Histologically-confirmed unresectable stage III or stage IV melanoma, as per American
Joint Committee on Cancer (AJCC) staging system, Including mucosal and ocular
melanoma

- Subjects must be anti-CTLA-4 treatment-naive and anti-PD-1 treatment-naive. Subjects
may have had other prior systemic treatment for localized or metastatic disease

- Subjects with brain metastases are eligible if these have been treated and there is
no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks
after treatment is complete 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
equivalent) for at least 2 weeks prior to study drug administration

Exclusion Criteria:

- Active (symptomatic) and not treated brain metastases or leptomeningeal metastases

- Life expectancy < 6 weeks

- Subjects with active, known, or suspected autoimmune disease. Subjects with Type I
diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders
(such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or
conditions not expected to recur in absence of an external trigger are permitted to
enroll

- Subjects with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalents) or other immunosuppressive medications within
14 days of treatment. Inhaled or topical steroids and adrenal replacement steroid
doses > 10 mg daily prednisone equivalent are permitted in the absence of active
autoimmune disease

- Subjects who received prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 or
anti-PD-L2, anti-CT137 (or any other antibody or drug specifically targeting T-cell
costimulation or checkpoint pathways) or subject is expected to require any other
form of systemic antineoplastic therapy while receiving nivolumab
We found this trial at
58
sites
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-1540
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-632-9265
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Phone: 206-288-1004
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Phone: 813-449-8260
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Allentown, Pennsylvania 18105
Phone: 610-402-7880
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Phone: 734-615-4762
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Atlanta, Georgia 30322
Phone: 813-745-8581
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Phone: 720-848-0564
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Austin, Texas 78731
Phone: 512-427-9400
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6501 Truxtun Avenue
Bakersfield, California 93309
Phone: 661-862-7158
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Baltimore, Maryland 21237
Phone: 443-777-7364
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Baltimore, Maryland 21231
Phone: 410-583-2970
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Phone: 301-571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Bethlehem, Pennsylvania 18015
Phone: 610-954-4434
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-4715
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Charlotte, North Carolina 28203
Phone: 520-629-4624
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Detroit, Michigan 48201
Phone: 906-225-3922
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Easley, South Carolina 29640
Phone: 864-679-3926
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Edmonton, Alberta
Phone: (780) 432-8757
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Evanston, Illinois 60201
Phone: 847-570-2515
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Gilbert, Arizona 85234
Phone: 480-256-6444
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Grand Rapids, Michigan 49503
Phone: 616-954-5550
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Hollywood, Florida 33021
Phone: 954-986-6363
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Houston, Texas 77030
Phone: 717-792-2921
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Jacksonville, Florida 32224
Phone: 904-953-2000
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Jacksonville, Florida 32256
Phone: 904-388-2619
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
Phone: 858-822-6196
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Phone: 702-822-5293
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Littleton, Colorado 80120
Phone: 303-388-4876
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Longwood, Florida 32750
Phone: 855-265-4372
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Los Angeles, California 90095
Phone: 818-271-2500
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Louisville, Kentucky 40202
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Madison, Wisconsin 53792
(608) 263-2400
Phone: 608-263-0117
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Miami Beach, Florida 33140
Phone: 305-535-3300
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Midland, Texas 79701
Phone: 303-388-4876
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Morristown, New Jersey 07960
Phone: 973-971-7111
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New Haven, Connecticut 06519
Phone: 203-785-6221
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New York, New York 10016
Phone: 212-731-5431
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4162
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Newnan, Georgia 30265
Phone: 770-400-6335
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Niles, Illinois 60714
Phone: 847-268-8200
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Orlando, Florida 32804
Phone: 407-303-2498
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Paris, Texas 75460
Phone: 903-785-0031
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Phoenix, Arizona 85054
Phone: 480-301-8000
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Portland, Oregon 97213
Phone: 503-239-7767
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514 North Prospect Avenue
Redondo Beach, California 90277
Phone: 310-750-3376
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Richmond, Virginia 23235
Phone: 804-330-7990
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Roanoke, Virginia 24014
Phone: 540-982-0237
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Rochester, Minnesota 55905
Phone: 507-289-5280
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-4819
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Francisco, California 94110
Phone: 713-500-6799
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San Francisco, California 94143
Phone: 415-476-7710
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Santa Monica, California 90404
Phone: 310-231-2121
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1325 South Church Lane
Santa Monica, California 93454
Phone: 805-349-9393
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12697 E 51st Street South
Tulsa, Oklahoma 74146
918-505-3200
Tulsa Cancer Institute, Pllc Now under the new name of Tulsa Cancer Institute, our specialists...
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Washington, District of Columbia 20007
Phone: 202-444-4883
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Winchester, Virginia 22601
Phone: 540-662-1108
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