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

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

783

Study ID:

NCT03635983

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 163 Locations for this study

See Locations Near You

Local Institution - 0187
Tucson Arizona, 85724, United States
UC San Diego Moores Cancer Ctr
La Jolla California, 92093, United States
Local Institution - 0122
Stanford California, 94305, United States
University Of Colorado
Aurora Colorado, 80045, United States
Local Institution - 0065
New Haven Connecticut, 06510, United States
Local Institution - 0017
Miami Beach Florida, 33140, United States
Local Institution - 0153
Miami Florida, 33136, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Local Institution - 0019
Louisville Kentucky, 40202, United States
Local Institution - 0018
Boston Massachusetts, 02215, United States
Local Institution - 0188
Ann Arbor Michigan, 48109, United States
Allina Health dba Virginia Piper Cancer Institute Fridley
Fridley Minnesota, 55432, United States
Washington University School Of Medicine
Saint Louis Missouri, 63110, United States
Local Institution - 0016
Hackensack New Jersey, 07601, United States
Local Institution - 0185
New Brunswick New Jersey, 08903, United States
Local Institution - 0141
New York New York, 10065, United States
Local Institution - 0037
Cleveland Ohio, 44195, United States
Local Institution - 0011
Portland Oregon, 97213, United States
Local Institution - 0013
Portland Oregon, 97239, United States
St. Luke's Hospital & Health Network
Easton Pennsylvania, 18045, United States
Local Institution - 0015
Philadelphia Pennsylvania, 19111, United States
Local Institution - 0001
Houston Texas, 77030, United States
Local Institution - 0064
Fairfax Virginia, 22031, United States
Hospital Aleman
Autonoma Buenos Aires, C118A, Argentina
Local Institution - 0109
Ciudad Autonoma de Buenos Aires Buenos Aires, 1430, Argentina
Local Institution
Buenos Aires Distrito Federal, C1017, Argentina
Instituto Medico Especialazado Alexander Fleming
Caba , 1426, Argentina
Local Institution - 0157
Cordoba , 5000, Argentina
Local Institution - 0146
Coffs Harbour New South Wales, 2450, Australia
Local Institution - 0053
North Sydney New South Wales, 2060, Australia
Local Institution - 0058
Cairns Queensland, 4870, Australia
Local Institution
Greenslopes Queensland, 4120, Australia
Local Institution - 0056
Woolloongabba Queensland, 4102, Australia
Local Institution - 0172
Elizabeth Vale South Australia, 5112, Australia
Local Institution
Melbourne Victoria, 3000, Australia
Local Institution - 0143
Melbourne Victoria, 3004, Australia
Local Institution - 0057
Nedlands Western Australia, 6009, Australia
Local Institution - 0097
Nedlands Western Australia, 6009, Australia
Local Institution - 0034
Graz , 8036, Austria
PMU Salzburg
Salzburg , 5020, Austria
Local Institution - 0033
Wien , 1090, Austria
Local Institution
Brussels , 1000, Belgium
Local Institution - 0084
Hasselt , 3500, Belgium
Local Institution
Leuven , B-300, Belgium
Local Institution - 0168
Fortaleza Ceara, 60130, Brazil
Local Institution - 0125
Belo Horizonte Minas Gerais, 30130, Brazil
Local Institution - 0124
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0127
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Local Institution - 0171
Itajai Santa Catarina, 88301, Brazil
Local Institution - 0126
Barretos Sao Paulo, 14780, Brazil
Local Institution - 0182
Rio De Janeiro , 20231, Brazil
Local Institution - 0169
Sao Paulo , 01509, Brazil
Local Institution - 0068
Abbotsford British Columbia, V2S 0, Canada
Local Institution - 0139
St. John's Newfoundland and Labrador, A1B 3, Canada
Local Institution
Hamilton Ontario, L8V 5, Canada
Local Institution - 0067
Kitchener Ontario, N2G 1, Canada
Local Institution
Toronto Ontario, M5G 2, Canada
Local Institution - 0121
Edmonton , T6X 1, Canada
Local Institution
Quebec , G1R 2, Canada
Local Institution - 0174
Recoleta Metropolitana, 0, Chile
Local Institution
Santiago Metropolitana, 83300, Chile
Local Institution - 0094
Brno , 656 5, Czechia
Klinika onkologie a radioterapie
Hradec Kralove , 500 0, Czechia
Dermatovenerologicka klinika 3. LF UK a FNKV
Praha 10 , 100 3, Czechia
Local Institution - 0092
Praha 2 , 128 0, Czechia
Local Institution - 0166
Tampere Oulun Lääni, FI-33, Finland
Local Institution - 0167
KYS , 70029, Finland
Local Institution
Turku , 20520, Finland
Local Institution - 0158
Bordeaux , 33075, France
Local Institution - 0007
Lille , 59000, France
Hopital Saint Eloi
Montpellier Cedex 05 , 34295, France
Local Institution - 0003
Nantes Cedex 1 , 44093, France
Local Institution - 0155
Nice , 06200, France
Local Institution - 0005
Paris , 75475, France
Centre Hospitalier Lyon Sud
Pierre Benite , 69310, France
Hopital Charles Nicolle C H U Rouen
Rouen , 76000, France
Local Institution - 0009
Saint Priest en Jarez , 42270, France
Local Institution - 0002
Toulouse Cedex 9 , 31059, France
Local Institution - 0004
Villejuif , 94805, France
Elbe Klinikum Buxtehude
Buxtehude , 21614, Germany
Local Institution - 0029
Dresden , 01307, Germany
Helios Klinikum Erfurt
Erfurt , 99089, Germany
Local Institution - 0026
Essen , 45147, Germany
Georg August Universitaet Goettingen
Goettingen , 37075, Germany
Universitaets-Krankenhaus Eppendorf
Hamburg , 20251, Germany
Local Institution - 0024
Hannover , D3062, Germany
Nationales Centrum Fuer Tumorerkrakungen (Nct) Heidelberg
Heidelberg , 69120, Germany
Universitatsklinikum Schleswig-Holstein
Kiel , 24105, Germany
Local Institution - 0022
Leipzig , 04103, Germany
Local Institution - 0021
Muenchen , 80337, Germany
Local Institution - 0027
Muenster , 48157, Germany
Local Institution - 0060
Regensburg , 93053, Germany
Local Institution - 0025
Tuebingen , 72076, Germany
Local Institution - 0032
Wuerzburg , 97080, Germany
Local Institution - 0038
Athens , 11526, Greece
Metropolitan Hospital
Neo Faliro , 18547, Greece
Local Institution - 0040
Thessaloniki , 57001, Greece
Local Institution - 0136
Wilton Cork, 0, Ireland
Local Institution - 0129
Dublin 7 Dublin, 0, Ireland
Local Institution - 0128
Dublin , 4, Ireland
Local Institution - 0130
Dublin , Dubli, Ireland
Local Institution - 0098
Beer Sheva , 84101, Israel
Local Institution
Jerusalem , 91120, Israel
Local Institution - 0089
Ramat-gan , 52621, Israel
Istituto Europeo Di Oncologia
Milan Lombardia, 20141, Italy
IRCCS Giovanni Paolo II Istituto Oncologico
Bari , 70124, Italy
ASST Papa Giovanni XXIII
Bergamo , 24127, Italy
IRST Meldola
Meldola (fc) , 47014, Italy
IRCCS Istituto Nazionale Tumori Milano
Milano , 20133, Italy
Instituto Nazionale Tumori Fondazione G. Pascale
Napoli , 80131, Italy
Istituto Oncologico Veneto IOV
Padova , 35128, Italy
Azienda Ospedaliera Universitaria Senese
Siena , 53100, Italy
Istituto di Candiolo
Torino , 10060, Italy
Azienda Ospedaliera Citta della Salute e della Scienza
Torino , 10126, Italy
Local Institution - 0175
Ciudad de Mexico Distrito Federal, 03100, Mexico
Local Institution - 0176
Zapopan Jalisco, 45070, Mexico
Local Institution - 0177
Monterrey Nuevo LEON, 64460, Mexico
Local Institution
Monterrey Nuevo LEON, 64710, Mexico
Local Institution
Cancun Quintana ROO, 77500, Mexico
Local Institution - 0179
Puebla , 72424, Mexico
Local Institution - 0181
San Luis Potosi , 78200, Mexico
Local Institution - 0101
Amsterdam , 1066C, Netherlands
Local Institution - 0102
Amsterdam , 1081 , Netherlands
Local Institution - 0099
Leiden , 2333 , Netherlands
Local Institution - 0100
Nijmegen , 6525 , Netherlands
Local Institution
Untrecht , 3584C, Netherlands
Local Institution
Auckland , 1023, New Zealand
Local Institution - 0063
Christchurch , 8011, New Zealand
Local Institution - 0062
Wellington , 6021, New Zealand
Local Institution
Bydgoszcz , 85-79, Poland
Local Institution - 0090
Warszawa , 02-78, Poland
Local Institution
Lisboa , 1649-, Portugal
Local Institution - 0133
Porto , 4200-, Portugal
Local Institution - 0162
Bucharest , 02232, Romania
Local Institution - 0070
Cluj-Napoca , 40001, Romania
Local Institution - 0071
Craiova , 20034, Romania
Local Institution - 0120
Floresti , 40728, Romania
Local Institution - 0149
Krasnoyarsk , 66013, Russian Federation
Local Institution - 0086
Moscow , 10522, Russian Federation
Local Institution - 0111
Moscow , 11547, Russian Federation
Local Institution - 0148
Moscow , 12130, Russian Federation
Local Institution - 0116
Barcelona , 08035, Spain
Local Institution - 0115
Barcelona , 08036, Spain
Local Institution - 0123
Cordoba , 14004, Spain
Local Institution
Doniostia - San Sebastian , 20014, Spain
Local Institution
Donostia , 20014, Spain
Local Institution - 0118
Jaén , 23007, Spain
Hospital Gral. Univ. Gregorio Maranon
Madrid , 28007, Spain
Local Institution - 0119
Santiago Compostela , 15706, Spain
Local Institution - 0117
Valencia , 46014, Spain
Local Institution - 0163
Gothenburg , 413 4, Sweden
Local Institution - 0164
Lund , 222 4, Sweden
Universitatsspital Bern, Inselspital
Bern , 3010, Switzerland
Local Institution - 0105
Lausanne , 1011, Switzerland
Local Institution - 0036
Zuerich , 8091, Switzerland
Local Institution - 0132
Southampton Hampshire, SO16 , United Kingdom
Local Institution
Edinburgh Midlothian, EH16 , United Kingdom
Local Institution - 0131
Sutton. Surrey, SM25P, United Kingdom
Local Institution
Belfast , BT9 7, United Kingdom
Local Institution
Cambridge , CB2 0, United Kingdom
Local Institution - 0079
Cottingham , HU16 , United Kingdom
Local Institution - 0137
Liverpool , L7 8Y, United Kingdom
Local Institution - 0077
London , SW17 , United Kingdom
Local Institution - 0074
London , SW36J, United Kingdom
Local Institution
Manchester , M20 4, United Kingdom
Local Institution
Tauton , TA1 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

783

Study ID:

NCT03635983

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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