Melanoma Clinical Trial
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
Summary
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
Eligibility Criteria
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 and/or neoadjuvant treatment for melanoma with approved agents
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 apply
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There are 163 Locations for this study
Tucson Arizona, 85724, United States
La Jolla California, 92093, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
Miami Beach Florida, 33140, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Louisville Kentucky, 40202, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Fridley Minnesota, 55432, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
New Brunswick New Jersey, 08903, United States
New York New York, 10065, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97213, United States
Portland Oregon, 97239, United States
Easton Pennsylvania, 18045, United States
Philadelphia Pennsylvania, 19111, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Autonoma Buenos Aires, C118A, Argentina
Ciudad Autonoma de Buenos Aires Buenos Aires, 1430, Argentina
Buenos Aires Distrito Federal, C1017, Argentina
Caba , 1426, Argentina
Cordoba , 5000, Argentina
Coffs Harbour New South Wales, 2450, Australia
North Sydney New South Wales, 2060, Australia
Cairns Queensland, 4870, Australia
Greenslopes Queensland, 4120, Australia
Woolloongabba Queensland, 4102, Australia
Elizabeth Vale South Australia, 5112, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3004, Australia
Nedlands Western Australia, 6009, Australia
Nedlands Western Australia, 6009, Australia
Graz , 8036, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Brussels , 1000, Belgium
Hasselt , 3500, Belgium
Leuven , B-300, Belgium
Fortaleza Ceara, 60130, Brazil
Belo Horizonte Minas Gerais, 30130, Brazil
Ijui RIO Grande DO SUL, 98700, Brazil
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Itajai Santa Catarina, 88301, Brazil
Barretos Sao Paulo, 14780, Brazil
Rio De Janeiro , 20231, Brazil
Sao Paulo , 01509, Brazil
Abbotsford British Columbia, V2S 0, Canada
St. John's Newfoundland and Labrador, A1B 3, Canada
Hamilton Ontario, L8V 5, Canada
Kitchener Ontario, N2G 1, Canada
Toronto Ontario, M5G 2, Canada
Edmonton , T6X 1, Canada
Quebec , G1R 2, Canada
Recoleta Metropolitana, 0, Chile
Santiago Metropolitana, 83300, Chile
Brno , 656 5, Czechia
Hradec Kralove , 500 0, Czechia
Praha 10 , 100 3, Czechia
Praha 2 , 128 0, Czechia
Tampere Oulun Lääni, FI-33, Finland
KYS , 70029, Finland
Turku , 20520, Finland
Bordeaux , 33075, France
Lille , 59000, France
Montpellier Cedex 05 , 34295, France
Nantes Cedex 1 , 44093, France
Nice , 06200, France
Paris , 75475, France
Pierre Benite , 69310, France
Rouen , 76000, France
Saint Priest en Jarez , 42270, France
Toulouse Cedex 9 , 31059, France
Villejuif , 94805, France
Buxtehude , 21614, Germany
Dresden , 01307, Germany
Erfurt , 99089, Germany
Essen , 45147, Germany
Goettingen , 37075, Germany
Hamburg , 20251, Germany
Hannover , D3062, Germany
Heidelberg , 69120, Germany
Kiel , 24105, Germany
Leipzig , 04103, Germany
Muenchen , 80337, Germany
Muenster , 48157, Germany
Regensburg , 93053, Germany
Tuebingen , 72076, Germany
Wuerzburg , 97080, Germany
Athens , 11526, Greece
Neo Faliro , 18547, Greece
Thessaloniki , 57001, Greece
Wilton Cork, 0, Ireland
Dublin 7 Dublin, 0, Ireland
Dublin , 4, Ireland
Dublin , Dubli, Ireland
Beer Sheva , 84101, Israel
Jerusalem , 91120, Israel
Ramat-gan , 52621, Israel
Milan Lombardia, 20141, Italy
Bari , 70124, Italy
Bergamo , 24127, Italy
Meldola (fc) , 47014, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Siena , 53100, Italy
Torino , 10060, Italy
Torino , 10126, Italy
Ciudad de Mexico Distrito Federal, 03100, Mexico
Zapopan Jalisco, 45070, Mexico
Monterrey Nuevo LEON, 64460, Mexico
Monterrey Nuevo LEON, 64710, Mexico
Cancun Quintana ROO, 77500, Mexico
Puebla , 72424, Mexico
San Luis Potosi , 78200, Mexico
Amsterdam , 1066C, Netherlands
Amsterdam , 1081 , Netherlands
Leiden , 2333 , Netherlands
Nijmegen , 6525 , Netherlands
Untrecht , 3584C, Netherlands
Auckland , 1142, New Zealand
Christchurch , 8011, New Zealand
Wellington , 6021, New Zealand
Bydgoszcz , 85-79, Poland
Warszawa , 02-78, Poland
Lisboa , 1649-, Portugal
Porto , 4200-, Portugal
Bucharest , 02232, Romania
Cluj-Napoca , 40001, Romania
Craiova , 20034, Romania
Floresti , 40728, Romania
Krasnoyarsk , 66013, Russian Federation
Moscow , 10522, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 12130, Russian Federation
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Cordoba , 14004, Spain
Doniostia - San Sebastian , 20014, Spain
Donostia , 20014, Spain
Jaén , 23007, Spain
Madrid , 28007, Spain
Santiago Compostela , 15706, Spain
Valencia , 46014, Spain
Gothenburg , 413 4, Sweden
Lund , 222 4, Sweden
Bern , 3010, Switzerland
Lausanne , 1011, Switzerland
Zuerich , 8091, Switzerland
Southampton Hampshire, SO16 , United Kingdom
Edinburgh Midlothian, EH16 , United Kingdom
Sutton. Surrey, SM25P, United Kingdom
Belfast , BT9 7, United Kingdom
Cambridge , CB2 0, United Kingdom
Cottingham , HU16 , United Kingdom
Liverpool , L7 8Y, United Kingdom
London , SW17 , United Kingdom
London , SW36J, United Kingdom
Manchester , M20 4, United Kingdom
Tauton , TA1 5, United Kingdom
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