A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:12 - Any
Updated:4/5/2019
Start Date:September 14, 2018
End Date:March 15, 2025
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email

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A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

The purpose of the study is to test the effectiveness (how well the drug works), safety, and
tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus
nivolumab given alone in participants with previously untreated melanoma skin cancer that is
either unable to be surgically removed or has spread


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

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or
older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only)

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

- Treatment-naive participants (ie, no prior systemic anticancer therapy for
unresectable or metastatic melanoma) with the exception of prior adjuvant treatment

Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases

- Uveal melanoma

- Participants with an active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
23
sites
Aurora, Colorado 80045
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-418-1208
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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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Phone: 813-745-7361
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Phone: 404-778-4520
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, GA
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Autonoma, Buenos Aires
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Autonoma,
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Boston, Massachusetts 02111
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Boston, MA
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Buffalo, New York 14215
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Buffalo, NY
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Cleveland, Ohio 44195
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Cleveland, OH
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Easton, Pennsylvania 18045
Phone: 484-503-4152
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Easton, PA
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Fairfax, Virginia 22031
Phone: 703-970-6548
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Fairfax, VA
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Hackensack, New Jersey
Phone: 551-996-5809
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Hackensack, NJ
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Houston, Texas 77030
Phone: 713-792-2538
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Houston, TX
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
Phone: 858-246-1093
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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Los Angeles, California 90095
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Louisville, Kentucky 40202
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Louisville, KY
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Miami Beach, Florida 33140
Phone: 305674262555862
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Miami Beach, FL
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Minneapolis, Minnesota 55416
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Minneapolis, MN
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New Haven, Connecticut 06520
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New Haven, CT
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New York, New York 10016
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New York, NY
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Palo Alto, California 94304
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Palo Alto, CA
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Philadelphia, Pennsylvania 19111
Phone: 215-728-3022
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Philadelphia, PA
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Portland, Oregon 97213
Phone: 503-215-2691
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Portland, OR
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-273-2779
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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