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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635983
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Melanoma Biological: NKTR-214 Biological: Nivolumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 764 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : April 25, 2022
Estimated Study Completion Date : June 16, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Combination
NKTR-214 + Nivolumab
 Biological: NKTR-214
Specified dose on specified days
Other Names:
  • Bempegaldesleukin
  • BMS-986321

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558
Experimental: Monotherapy
Nivolumab
 Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) by Blinded Independent Central Review (BICR) [ Time Frame: Approximately 16 months ]
  2. Progression-free survival (PFS) by BICR [ Time Frame: Approximately 22 months ]
  3. Overall survival (OS) [ Time Frame: Up to 59 months ]

Secondary Outcome Measures :
  1. Clinical benefit rate (CBR) [ Time Frame: Approximately 16 months ]
  2. Duration of response (DoR) [ Time Frame: Approximately 16 months ]
  3. Time to response (TTR) [ Time Frame: Approximately 16 months ]
  4. ORR by investigator and in biomarker population [ Time Frame: Approximately 16 months ]
  5. PFS by investigator and in biomarker population [ Time Frame: Approximately 22 months ]
  6. OS in biomarker population [ Time Frame: Up to 59 months ]
  7. Incidence of participants with non-serious Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  8. Incidence of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  9. Incidence of treatment-related AEs [ Time Frame: Up to 5 years ]
  10. Incidence of treatment-related SAEs [ Time Frame: Up to 5 years ]
  11. Incidence of laboratory abnormalities in blood [ Time Frame: Up to 5 years ]
  12. Incidence of laboratory abnormalities in blood serum [ Time Frame: Up to 5 years ]
  13. Incidence of laboratory abnormalities in urine [ Time Frame: Up to 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 could apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635983


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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United States, California
UC San Diego Moores Cancer Ctr Recruiting
La Jolla, California, United States, 92093-0698
Contact: Gregory Daniels, Site 0014    858-246-1093      
Local Institution Withdrawn
Los Angeles, California, United States, 90095
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305
Contact: Sunil Reddy, Site 0122    650-725-9810      
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Theresa Medina, Site 0051    720-848-8832      
United States, Connecticut
Smilow Cancer Center at Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Sarah Weiss, Site 0065    203-737-5435      
United States, Florida
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Jose Lutzky, Site 0017    305674262555862      
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Jose Lutzky, Site 0153         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Nikhil Khushalani, Site 0112    813-745-5170      
United States, Georgia
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322-1013
Contact: Melinda Yushak, Site 0012    404-778-7215      
United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jason Chesney, Site 0019    502-562-4673      
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Elizabeth Buchbinder, Site 0018    617-632-4503      
United States, Minnesota
Local Institution Withdrawn
Minneapolis, Minnesota, United States, 55407-3799
United States, Missouri
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Leonel Hernandez Aya, Site 0135    314-273-2779      
United States, New Jersey
The Cancer Center At Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07061
Contact: Andrew Pecora, Site 0016    551-996-5809      
Local Institution Not yet recruiting
New Brunswick, New Jersey, United States, 08009
Contact: Site 0185         
United States, New York
Local Institution Withdrawn
Buffalo, New York, United States, 14263
Memorial Sloan Kettering Nassau Recruiting
New York, New York, United States, 10065
Contact: Alexander Shoushtari, Site 0141    646-888-4162      
United States, Ohio
Local Institution Withdrawn
Cleveland, Ohio, United States, 44106
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Pauline Funchain, Site 0037    216-636-5654      
United States, Oregon
Portland Providence Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Brendan Curti, Site 0011    503-215-2691      
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Aimee Kohn, Site 0013    503-418-1208      
United States, Pennsylvania
St. Luke's Hospital & Health Network Recruiting
Easton, Pennsylvania, United States, 18045
Contact: Gary Lu, Site 0052    484-503-4152      
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2412
Contact: Anthony Olszanski, Site 0015    215-728-3022      
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Adi Diab, Site 0001    713-792-2538      
United States, Virginia
Inova Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22031
Contact: Sekwon Jang, Site 0064    703-970-6548      
Argentina
Hospital Aleman Recruiting
Autonoma, Buenos Aires, Argentina, C118AAT
Contact: Gabriela Gatica, Site 0107    1140840034      
Clinica Adventista Belgrano Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1430
Contact: Aldo Perfetti, Site 0109    5440141500      
Local Institution Withdrawn
Caba, Argentina, 1199
Instituto Medico Especialazado Alexander Fleming Recruiting
Caba, Argentina, 1426
Contact: Yanina Pfluger, Site 0108    +541132218956      
Local Institution Recruiting
Cordoba, Argentina, 5000
Contact: Site 0157         
Australia, New South Wales
Local Institution Recruiting
Coffs Harbour, New South Wales, Australia, 2450
Contact: Site 0146         
Local Institution Recruiting
North Sydney, New South Wales, Australia, 2060
Contact: Site 0053         
Australia, Queensland
Local Institution Recruiting
Cairns, Queensland, Australia, 4870
Contact: Site 0058         
Local Institution Active, not recruiting
Greenslopes, Queensland, Australia, 4120
Local Institution Recruiting
Woolloongabba, Queensland, Australia, 4012
Contact: Site 0056         
Australia, South Australia
Local Institution Not yet recruiting
Elizabeth Vale, South Australia, Australia, 5112
Contact: Site 0172         
Australia, Victoria
Local Institution Recruiting
Melbourne, Victoria, Australia, 3000
Contact: Site 0054         
Local Institution Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Site 0143         
Australia, Western Australia
Local Institution Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 0097         
Local Institution Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 0057         
Austria
Med University Graz Dermatology Recruiting
Graz, Austria, 8036
Contact: Erika Richtig, Site 0034         
PMU Salzburg Recruiting
Salzburg, Austria, 5020
Contact: Peter Koelblinger, Site 0035    +435725558269      
Medizinische Universtaet Wien Recruiting
Wien, Austria, 1090
Contact: Christoph Hoeller, Site 0033         
Belgium
Local Institution Recruiting
Brussels, Belgium, 1000
Contact: Site 0083         
Local Institution Recruiting
Hasselt, Belgium, 3500
Contact: Site 0084         
Local Institution Recruiting
Leuven, Belgium, B-300
Contact: Site 0085         
Brazil
Local Institution Not yet recruiting
Fortaleza, Ceara, Brazil, 60130-241
Contact: Site 0168         
Local Institution Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-090
Contact: Site 0125         
Local Institution Recruiting
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Contact: Site 0124         
Local Institution Recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
Contact: Site 0127         
Local Institution Not yet recruiting
Itajai, Santa Catarina, Brazil, 88301-220
Contact: Site 0171         
Local Institution Recruiting
Barretos, SAO Paulo, Brazil, 14780-070
Contact: Site 0126         
Local Institution Not yet recruiting
Rio De Janeiro, Brazil, 20231-050
Contact: Site 0182         
Local Institution Not yet recruiting
Sao Paulo, Brazil, 01509-900
Contact: Site 0169         
Canada, Alberta
Local Institution Recruiting
Edmonton, Alberta, Canada, T6X 1E8
Contact: Site 0121         
Canada, Newfoundland and Labrador
Local Institution Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Site 0139         
Canada, Ontario
Local Institution Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Site 0066         
Local Institution Recruiting
Kitchener, Ontario, Canada, N2G 1G3
Contact: Site 0067         
Local Institution Withdrawn
Toronto, Ontario, Canada, M4N 3M5
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0041         
Canada
Local Institution Not yet recruiting
Abbotsford, Canada, V2S 0C2
Contact: Site 0068         
Local Institution Recruiting
Quebec, Canada, G1R 2J6
Contact: Site 0069         
Chile
Local Institution Not yet recruiting
Santiago, Metropolitana, Chile, 8330024
Contact: Site 0173         
Local Institution Not yet recruiting
Santiago, Metropolitana, Chile, 8420383
Contact: Site 0174         
Czechia
Klinika komplexni onkologicke pece Recruiting
Brno, Czechia, 656 53
Contact: Radek Lakomy, Site 0094    +420543132209      
Klinika onkologie a radioterapie Recruiting
Hradec Kralove, Czechia, 500 05
Contact: Jindrich Kopecky, Site 0093    +420495832176      
Dermatovenerologicka klinika 3. LF UK a FNKV Recruiting
Praha 10, Czechia, 100 34
Contact: Petr Arenberger, Site 0091    +420267163000      
Dermatovenerologicka klinika VFN a 1. LF UK Recruiting
Praha 2, Czechia, 128 08
Contact: Ivana Krajsova, Site 0092    +420224962426      
Finland
Local Institution Not yet recruiting
KYS, Finland, 70029
Contact: Site 0167         
Local Institution Recruiting
Tampere, Finland, 33520
Contact: Site 0166         
Local Institution Recruiting
Turku, Finland, 20520
Contact: Site 0165         
France
Local Institution Recruiting
Bordeaux, France, 33000
Contact: Site 0158         
Hopital Claude Huriez Recruiting
LILLE Cedex, France, 59037
Contact: Laurent Mortier, Site 0007    33320444193      
Hopital Saint Eloi Recruiting
Montpellier Cedex 05, France, 34295
Contact: Olivier Dereure, Site 0008    33467336906      
Hotel Dieu - Chu De Nantes Recruiting
Nantes Cedex 01, France, 44093
Contact: Brigitte DRENO, Site 0003    33240083131      
Chu De Nice Hopital De Cimiez Recruiting
Nice Cedex 1, France, 6003
Contact: Henri Montaudie, Site 0155    33492036667      
Hopital Saint Louis Recruiting
Paris, France, 75475
Contact: Celeste Lebbe, Site 0005    33142494727      
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69310
Contact: Stephane Dalle, Site 0006    33478861679      
Hopital Charles Nicolle C H U Rouen Recruiting
Rouen, France, 76000
Contact: Anne-Benedicte Duval-Modeste, Site 0010    33232886699      
Hopital Nord - CHU de Saint-Etienne Recruiting
Saint Priest en Jarez, France, 42270
Contact: Jean-Luc Perrot, Site 0009    33477120818      
Institut Claudius Regaud Recruiting
Toulouse Cedex 9, France, 31059
Contact: Nicolas Meyer, Site 0002    33531155180      
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Caroline Robert, Site 0004    33142116497      
Germany
Elbe Klinikum Buxtehude Recruiting
Buxtehude, Germany, 21614
Contact: Peter Mohr, Site 0031    +4941617036218      
Universitaetsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Contact: Friedegund Meier, Site 0029    +4935145819782      
Universitaetsklinik Essen Recruiting
Essen, Germany, 45147
Contact: Dirk Schadendorf, Site 0026    +492017233797      
Georg August Universitaet Goettingen Recruiting
Goettingen, Germany, 37075
Contact: Kai-Martin Thoms, Site 0030    +495513963790      
Universitaets-Krankenhaus Eppendorf Recruiting
Hamburg, Germany, 20251
Contact: Christoffer Gebhardt, Site 0023    +4940741022101      
Medizinische Hochschule Hannover (Hannover Medical School) Recruiting
Hannover, Germany, D30625
Contact: Ralf Gutzmer, Site 0024    +495115327662      
Nationales Centrum Fuer Tumorerkrakungen (Nct) Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Jessica Hassel, Site 0020    +4962215636871      
Universitaetsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Contact: Axel Hauschild, Site 0028    +4943150021133      
Universitatsklinikum AoR Klinik fur Dermatologie, Venerologie und Allergologie Recruiting
Leipzig, Germany, 04103
Contact: Jan Simon, Site 0022    +493419718371      
Ludwig-Maximilians-Universitaet Recruiting
Muenchen, Germany, 80337
Contact: Max Schlaak, Site 0021    +4989440056323      
Fachklinik Hornheide Recruiting
Muenster, Germany, 48157
Contact: Michael Fluck, Site 0027    +492513287505      
University Hospital of Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Sebastian Haferkamp, Site 0060    +499419449641      
Universitaetsklinikum Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Thomas Eigentler, Site 0025    +49070712984503      
Univ. Klinikum Wuerzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Bastian Schilling, Site 0032         
Greece
Laiko General Hospital Of Athens Recruiting
Athens, Greece, 11526
Contact: Helen Gogas, Site 0038    +302132060942      
Metropolitan Hospital Recruiting
Neo Faliro, Greece, 18547
Contact: Dimitrios Bafaloukos, Site 0039    +302104809739      
Interbalkan European Medical Center Recruiting
Thessaloniki, Greece, 57001
Contact: Sofia Baka, Site 0040    +302310400368      
Ireland
Local Institution Recruiting
Wilton, Cork, Ireland
Contact: Site 0136         
Local Institution Recruiting
Dublin 7, Dublin, Ireland
Contact: Site 0129         
Local Institution Recruiting
Dublin, Ireland, 01
Contact: Site 0130         
Local Institution Recruiting
Dublin, Ireland, 4
Contact: Site 0128         
Local Institution Withdrawn
Galway, Ireland, ST4 6QG
Israel
Local Institution Recruiting
Beer Sheva, Israel, 84101
Contact: Site 0098         
Local Institution Recruiting
Jerusalem, Israel, 91120
Contact: Site 0088         
Local Institution Recruiting
Ramat-gan, Israel, 52621
Contact: Site 0089         
Italy
IRCCS Giovanni Paolo II Istituto Oncologico Recruiting
Bari, Italy, 70124
Contact: Michele Guida, Site 0044    +390805555111      
Local Institution Recruiting
Bergamo, Italy, 24127
Contact: Site 0151         
Local Institution Recruiting
Forli, Italy, 47014
Contact: Site 0113         
Local Institution Withdrawn
Genova, Italy, 16132
Local Institution Not yet recruiting
Milano, Italy, 20133
Contact: Site 0160         
Local Institution Recruiting
Milan, Italy, 20141
Contact: Site 0045         
Instituto Nazionale Tumori Fondazione G. Pascale Recruiting
Napoli, Italy, 80131
Contact: Paolo Ascierto, Site 0043    +390815903245      
Istituto Oncologico Veneto IOV Recruiting
Padova, Italy, 35128
Contact: Jacopo Pigozzo, Site 0047    +390498215664      
Azienda Ospedaliera Universitaria Senese Recruiting
Siena, Italy, 53100
Contact: Michele Maio, Site 0042    +390577585111      
Local Institution Not yet recruiting
Torino, Italy, 10060
Contact: Site 0170         
Local Institution Not yet recruiting
Torino, Italy, 10126
Contact: Site 0161         
Mexico
Local Institution Not yet recruiting
Ciudad de Mexico, Distrito Federal, Mexico, 03100
Contact: Site 0175         
Local Institution Not yet recruiting
Zapopan, Jalisco, Mexico, 45070
Contact: Site 0176         
Local Institution Not yet recruiting
Monterrey, Nuevo LEON, Mexico, 64460
Contact: Site 0177         
Local Institution Not yet recruiting
Monterrey, Nuevo LEON, Mexico, 64710
Contact: Site 0180         
Local Institution Not yet recruiting
Benito Juarez, Quintana ROO, Mexico, 77500
Contact: Site 0178         
Local Institution Not yet recruiting
Puebla, Mexico, 72424
Contact: Site 0179         
Local Institution Not yet recruiting
San Luis Potosi, Mexico, 78200
Contact: Site 0181         
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1066CX
Contact: Site 0101         
Local Institution Recruiting
Amsterdam, Netherlands, 1081 HZ
Contact: Site 0102         
Local Institution Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Site 0099         
Local Institution Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Site 0100         
Local Institution Recruiting
Untrecht, Netherlands, 3584CX
Contact: Site 0147         
New Zealand
Local Institution Recruiting
Auckland, New Zealand, 1023
Contact: Site 0159         
Local Institution Recruiting
Christchurch, New Zealand
Contact: Site 0063         
Local Institution Recruiting
Wellington, New Zealand, 6021
Contact: Site 0062         
Poland
Local Institution Not yet recruiting
Bialystok, Poland, 15-027
Contact: Site 0184         
Local Institution Recruiting
Bydgoszcz, Poland, 85-796
Contact: Site 0152         
Local Institution Withdrawn
Lublin, Poland, 20-090
Local Institution Recruiting
Warszawa, Poland, 02-781
Contact: Site 0090         
Local Institution Withdrawn
Wroclaw, Poland, 53-413
Portugal
Local Institution Recruiting
Lisboa, Portugal, 1649-035
Contact: Site 0134         
Local Institution Recruiting
Porto, Portugal, 4200-072
Contact: Site 0133         
Romania
Local Institution Recruiting
Bucharest, Romania, 022328
Contact: Site 0162         
Local Institution Recruiting
Cluj-Napoca, Romania, 400015
Contact: Site 0070         
Local Institution Recruiting
Craiova, Romania, 200347
Contact: Site 0071         
Local Institution Recruiting
Floresti, Romania, 407280
Contact: Site 0120         
Local Institution Withdrawn
Oradea, Romania, 410469
Russian Federation
Local Institution Recruiting
Krasnoyarsk, Russian Federation, 660133
Contact: Site 0149         
Local Institution Recruiting
Moscow, Russian Federation, 105229
Contact: Site 0086         
Local Institution Not yet recruiting
Moscow, Russian Federation, 115478
Contact: Site 0111         
Local Institution Recruiting
Moscow, Russian Federation, 121309
Contact: Site 0148         
Spain
H. Univ. Vall dHebron Recruiting
Barcelona, Spain, 08035
Contact: Eva Munoz, Site 0116    +34932746247      
Hospital Clinic I Provincial Recruiting
Barcelona, Spain, 08036
Contact: Ana Arance, Site 0115    +349322754003297      
Hospital Universitario Reina Sofia Recruiting
Cordoba, Spain, 14004
Contact: Pedro Sanchez Maurino, Site 0123    +34957011464      
Complejo Hospitalario de Jaen Recruiting
Jaen, Spain, 23007
Contact: Pedro Lopez Leiva, Site 0118    +34953220306      
Hospital Gral. Univ. Gregorio Maranon Recruiting
Madrid, Spain, 28007
Contact: Ivan Marquez, Site 0114    +34914269070      
Hospital Clinico Univ. de Santiago-CHUS Recruiting
Santiago Compostela, Spain, 15706
Contact: Carmela Rodriguez, Site 0119    +34981951470      
Hospital General Universitario De Valencia Recruiting
Valencia, Spain, 46014
Contact: Alfonso Berrocal, Site 0117    +34961972151      
Sweden
Local Institution Not yet recruiting
Gothenburg, Sweden, 413 45
Contact: Site 0163         
Local Institution Not yet recruiting
Lund, Sweden, 222 42
Contact: Site 0164         
Switzerland
Universitatsspital Bern, Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Robert Hunger, Site 0104    +41316327820      
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, 1011
Contact: Olivier Michielin, Site 0105    +41213414358      
Universitaetsspital Zuerich Recruiting
Zurich, Switzerland, 8091
Contact: Reinhard Dummer, Site 0036    +41442553847      
United Kingdom
Local Institution Recruiting
London, Greater London, United Kingdom, SW17 0RE
Contact: Site 0077         
Local Institution Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Site 0132         
Local Institution Not yet recruiting
Edinburgh, Midlothian, United Kingdom, EH16 4SB
Contact: Site 0081         
Local Institution Recruiting
Belfast, United Kingdom, BT9 7AB
Contact: Site 0078         
Local Institution Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Site 0076         
Local Institution Recruiting
Cottingham, United Kingdom, HU16 5JQ
Contact: Site 0079         
Local Institution Recruiting
Liverpool, United Kingdom, L7 8YA
Contact: Site 0137         
Local Institution Recruiting
London, United Kingdom, SW3 6JJ
Contact: Site 0074         
Local Institution Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Site 0075         
Local Institution Recruiting
Sutton., United Kingdom, SM25PT
Contact: Site 0131         
Local Institution Recruiting
Tauton, United Kingdom, TA1 5DA
Contact: Site 0142         
Sponsors and Collaborators
Bristol-Myers Squibb
Nektar Therapeutics
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03635983    
Other Study ID Numbers: CA045-001
2018-001423-40 ( EudraCT Number )
17-214-08 ( Other Identifier: Nektar Therapeutics )
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
NKTR-214
Nivolumab
Immunotherapy
bempegaldesleukin (BEMPEG: NKTR-214)
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents