A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03635983 |
Recruitment Status :
Active, not recruiting
First Posted : August 17, 2018
Last Update Posted : January 20, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Melanoma | Biological: NKTR-214 Biological: Nivolumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 781 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 21, 2018 |
Estimated Primary Completion Date : | April 25, 2022 |
Estimated Study Completion Date : | June 16, 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Combination
NKTR-214 + Nivolumab
|
Biological: NKTR-214
Specified dose on specified days
Other Names:
Biological: Nivolumab Specified dose on specified days
Other Names:
|
Experimental: Monotherapy
Nivolumab
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
|
- Overall response rate (ORR) by Blinded Independent Central Review (BICR) [ Time Frame: Approximately 16 months ]
- Progression-free survival (PFS) by BICR [ Time Frame: Approximately 22 months ]
- Overall survival (OS) [ Time Frame: Up to 59 months ]
- Clinical benefit rate (CBR) [ Time Frame: Approximately 16 months ]
- Duration of response (DoR) [ Time Frame: Approximately 16 months ]
- Time to response (TTR) [ Time Frame: Approximately 16 months ]
- ORR by investigator and in biomarker population [ Time Frame: Approximately 16 months ]
- PFS by investigator and in biomarker population [ Time Frame: Approximately 22 months ]
- OS in biomarker population [ Time Frame: Up to 59 months ]
- Incidence of participants with non-serious Adverse Events (AEs) [ Time Frame: Up to 5 years ]
- Incidence of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
- Incidence of treatment-related AEs [ Time Frame: Up to 5 years ]
- Incidence of treatment-related SAEs [ Time Frame: Up to 5 years ]
- Incidence of laboratory abnormalities in blood [ Time Frame: Up to 5 years ]
- Incidence of laboratory abnormalities in blood serum [ Time Frame: Up to 5 years ]
- Incidence of laboratory abnormalities in urine [ Time Frame: Up to 5 years ]

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

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

United States, Arizona | |
The University of Arizona Cancer Center - North Campus-University of Arizona Cancer Center | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
UC San Diego Moores Cancer Ctr | |
La Jolla, California, United States, 92093-0698 | |
Stanford Cancer Center | |
Stanford, California, United States, 94305 | |
United States, Colorado | |
University Of Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Connecticut | |
Smilow Cancer Center at Yale New Haven Hospital | |
New Haven, Connecticut, United States, 06520 | |
United States, Florida | |
Mount Sinai Comprehensive Cancer Center | |
Miami Beach, Florida, United States, 33140 | |
Sylvester Comprehensive Cancer Center | |
Miami, Florida, United States, 33136 | |
Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Georgia | |
Winship Cancer Institute, Emory University | |
Atlanta, Georgia, United States, 30322-1013 | |
United States, Kentucky | |
University of Louisville Hospital | |
Louisville, Kentucky, United States, 40202 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
University Of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Minnesota | |
Allina Health dba Virginia Piper Cancer Institute Fridley | |
Fridley, Minnesota, United States, 55432 | |
United States, Missouri | |
Washington University School Of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
The Cancer Center At Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
Rutgers Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08903 | |
United States, New York | |
Local Institution | |
New York, New York, United States, 10065 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Portland Providence Medical Center | |
Portland, Oregon, United States, 97213 | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
St. Luke's Hospital & Health Network | |
Easton, Pennsylvania, United States, 18045 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111-2412 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Inova Schar Cancer Institute | |
Fairfax, Virginia, United States, 22031 | |
Argentina | |
Hospital Aleman | |
Autonoma, Buenos Aires, Argentina, C118AAT | |
Clinica Adventista Belgrano | |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1430 | |
Local Institution | |
Buenos Aires, Distrito Federal, Argentina, C1017 | |
Instituto Medico Especialazado Alexander Fleming | |
Caba, Argentina, 1426 | |
Local Institution | |
Cordoba, Argentina, 5000 | |
Australia, New South Wales | |
Local Institution | |
Coffs Harbour, New South Wales, Australia, 2450 | |
Local Institution | |
North Sydney, New South Wales, Australia, 2060 | |
Australia, Queensland | |
Local Institution | |
Cairns, Queensland, Australia, 4870 | |
Local Institution | |
Greenslopes, Queensland, Australia, 4120 | |
Local Institution | |
Woolloongabba, Queensland, Australia, 4102 | |
Australia, South Australia | |
Calvary Central Districts Hospital | |
Elizabeth Vale, South Australia, Australia, 5112 | |
Australia, Victoria | |
Local Institution | |
Melbourne, Victoria, Australia, 3000 | |
Local Institution | |
Melbourne, Victoria, Australia, 3004 | |
Australia, Western Australia | |
Local Institution | |
Nedlands, Western Australia, Australia, 6009 | |
Austria | |
Med University Graz Dermatology | |
Graz, Austria, 8036 | |
PMU Salzburg | |
Salzburg, Austria, 5020 | |
Medizinische Universtaet Wien | |
Wien, Austria, 1090 | |
Belgium | |
Local Institution | |
Brussels, Belgium, 1000 | |
Local Institution | |
Hasselt, Belgium, 3500 | |
Local Institution | |
Leuven, Belgium, B-3000 | |
Brazil | |
Oncocentro Servico Medicos e Hospitalares Ltda | |
Fortaleza, Ceara, Brazil, 60130-241 | |
PERSONAL Oncologia de Precisao e Personalizada | |
Belo Horizonte, Minas Gerais, Brazil, 30130-090 | |
ONCOSITE - Centro de Pesquisa Clinica em Oncologia | |
Ijui, RIO Grande DO SUL, Brazil, 98700-000 | |
Hospital Sao Lucas Da Pucrs | |
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000 | |
Centro De Novos Tratamentos Itajai | |
Itajai, Santa Catarina, Brazil, 88301-220 | |
Fundacao Pio XII - Hospital De Cancer De Barretos | |
Barretos, Sao Paulo, Brazil, 14780-070 | |
Local Institution | |
Rio De Janeiro, Brazil, 20231-050 | |
Fundacao Antonio Prudente-Hospital Ac Camargo | |
Sao Paulo, Brazil, 01509-900 | |
Canada, Alberta | |
Local Institution | |
Edmonton, Alberta, Canada, T6X 1E8 | |
Canada, British Columbia | |
Local Institution | |
Abbotsford, British Columbia, Canada, V2S 0C2 | |
Canada, Newfoundland and Labrador | |
Local Institution | |
St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
Canada, Ontario | |
Local Institution | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Local Institution | |
Kitchener, Ontario, Canada, N2G 1G3 | |
Local Institution | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada | |
Local Institution | |
Quebec, Canada, G1R 2J6 | |
Chile | |
Local Institution | |
Recoleta, Metropolitana, Chile | |
Local Institution | |
Santiago, Metropolitana, Chile, 8330024 | |
Czechia | |
Klinika komplexni onkologicke pece | |
Brno, Czechia, 656 53 | |
Klinika onkologie a radioterapie | |
Hradec Kralove, Czechia, 500 05 | |
Dermatovenerologicka klinika 3. LF UK a FNKV | |
Praha 10, Czechia, 100 34 | |
Dermatovenerologicka klinika VFN a 1. LF UK | |
Praha 2, Czechia, 128 08 | |
Finland | |
Local Institution | |
KYS, Finland, 70029 | |
Local Institution | |
Tampere, Finland, 33520 | |
Local Institution | |
Turku, Finland, 20520 | |
France | |
Local Institution | |
Bordeaux, France, 33000 | |
Hopital Claude Huriez | |
LILLE Cedex, France, 59037 | |
Hopital Saint Eloi | |
Montpellier Cedex 05, France, 34295 | |
Hotel Dieu - Chu De Nantes | |
Nantes Cedex 01, France, 44093 | |
Chu De Nice Hopital De Cimiez | |
Nice, France, 06202 | |
Hopital Saint Louis | |
Paris, France, 75475 | |
Centre Hospitalier Lyon Sud | |
Pierre Benite, France, 69310 | |
Hopital Charles Nicolle C H U Rouen | |
Rouen, France, 76000 | |
Hopital Nord - CHU de Saint-Etienne | |
Saint Priest en Jarez, France, 42270 | |
Institut Claudius Regaud | |
Toulouse Cedex 9, France, 31059 | |
Institut Gustave Roussy | |
Villejuif, France, 94805 | |
Germany | |
Elbe Klinikum Buxtehude | |
Buxtehude, Germany, 21614 | |
Universitaetsklinikum Carl Gustav Carus | |
Dresden, Germany, 01307 | |
Helios Klinikum Erfurt | |
Erfurt, Germany, 99089 | |
Universitaetsklinik Essen | |
Essen, Germany, 45147 | |
Georg August Universitaet Goettingen | |
Goettingen, Germany, 37075 | |
Universitaets-Krankenhaus Eppendorf | |
Hamburg, Germany, 20251 | |
Medizinische Hochschule Hannover (Hannover Medical School) | |
Hannover, Germany, D30625 | |
Nationales Centrum Fuer Tumorerkrakungen (Nct) Heidelberg | |
Heidelberg, Germany, 69120 | |
Universitatsklinikum Schleswig-Holstein | |
Kiel, Germany, 24105 | |
Universitatsklinikum AoR Klinik fur Dermatologie, Venerologie und Allergologie | |
Leipzig, Germany, 04103 | |
Ludwig-Maximilians-Universitaet | |
Muenchen, Germany, 80337 | |
Fachklinik Hornheide | |
Muenster, Germany, 48157 | |
University Hospital of Regensburg | |
Regensburg, Germany, 93053 | |
Universitaetsklinikum Tuebingen | |
Tuebingen, Germany, 72076 | |
Univ. Klinikum Wuerzburg | |
Wuerzburg, Germany, 97080 | |
Greece | |
Laiko General Hospital Of Athens | |
Athens, Greece, 11526 | |
Metropolitan Hospital | |
Neo Faliro, Greece, 18547 | |
Interbalkan European Medical Center | |
Thessaloniki, Greece, 57001 | |
Ireland | |
Local Institution | |
Wilton, Cork, Ireland | |
Local Institution | |
Dublin 7, Dublin, Ireland | |
Local Institution | |
Dublin, Ireland, 01 | |
Local Institution | |
Dublin, Ireland, 4 | |
Israel | |
Local Institution | |
Beer Sheva, Israel, 84101 | |
Local Institution | |
Jerusalem, Israel, 91120 | |
Local Institution | |
Ramat-gan, Israel, 52621 | |
Italy | |
IRCCS Giovanni Paolo II Istituto Oncologico | |
Bari, Italy, 70124 | |
Local Institution | |
Bergamo, Italy, 24127 | |
Local Institution | |
Meldola (fc), Italy, 47014 | |
Local Institution | |
Milano, Italy, 20133 | |
Local Institution | |
Milan, Italy, 20141 | |
Instituto Nazionale Tumori Fondazione G. Pascale | |
Napoli, Italy, 80131 | |
Istituto Oncologico Veneto IOV | |
Padova, Italy, 35128 | |
Azienda Ospedaliera Universitaria Senese | |
Siena, Italy, 53100 | |
Local Institution | |
Torino, Italy, 10060 | |
Local Institution | |
Torino, Italy, 10126 | |
Mexico | |
Local Institution | |
Ciudad de Mexico, Distrito Federal, Mexico, 03100 | |
Local Institution | |
Zapopan, Jalisco, Mexico, 45070 | |
Local Institution | |
Monterrey, Nuevo LEON, Mexico, 64460 | |
Local Institution | |
Monterrey, Nuevo LEON, Mexico, 64710 | |
Local Institution | |
Cancun, Quintana ROO, Mexico, 77500 | |
Local Institution | |
Puebla, Mexico, 72424 | |
Local Institution | |
San Luis Potosi, Mexico, 78200 | |
Netherlands | |
Local Institution | |
Amsterdam, Netherlands, 1066CX | |
Local Institution | |
Amsterdam, Netherlands, 1081 HV | |
Local Institution | |
Leiden, Netherlands, 2333 ZA | |
Local Institution | |
Nijmegen, Netherlands, 6525 GA | |
Local Institution | |
Untrecht, Netherlands, 3584CX | |
New Zealand | |
Local Institution | |
Auckland, New Zealand, 1023 | |
Local Institution | |
Christchurch, New Zealand, 8011 | |
Local Institution | |
Wellington, New Zealand, 6021 | |
Poland | |
Local Institution | |
Bydgoszcz, Poland, 85-796 | |
Local Institution | |
Warszawa, Poland, 02-781 | |
Portugal | |
Local Institution | |
Lisboa, Portugal, 1649-035 | |
Local Institution | |
Porto, Portugal, 4200-072 | |
Romania | |
Local Institution | |
Bucharest, Romania, 022328 | |
Local Institution | |
Cluj-Napoca, Romania, 400015 | |
Local Institution | |
Craiova, Romania, 200347 | |
Local Institution | |
Floresti, Romania, 407280 | |
Russian Federation | |
Local Institution | |
Krasnoyarsk, Russian Federation, 660133 | |
Local Institution | |
Moscow, Russian Federation, 105229 | |
Local Institution | |
Moscow, Russian Federation, 115478 | |
Local Institution | |
Moscow, Russian Federation, 121309 | |
Spain | |
H. Univ. Vall dHebron | |
Barcelona, Spain, 08035 | |
Hospital Clinic I Provincial | |
Barcelona, Spain, 08036 | |
Hospital Universitario Reina Sofia | |
Cordoba, Spain, 14004 | |
Local Institution | |
Doniostia - San Sebastian, Spain, 20014 | |
Local Institution | |
Donostia, Spain, 20014 | |
Complejo Hospitalario de Jaen | |
Jaen, Spain, 23007 | |
Hospital Gral. Univ. Gregorio Maranon | |
Madrid, Spain, 28007 | |
Hospital Clinico Univ. de Santiago-CHUS | |
Santiago Compostela, Spain, 15706 | |
Hospital General Universitario De Valencia | |
Valencia, Spain, 46014 | |
Sweden | |
Local Institution | |
Gothenburg, Sweden, 413 45 | |
Local Institution | |
Lund, Sweden, 222 42 | |
Switzerland | |
Universitatsspital Bern, Inselspital | |
Bern, Switzerland, 3010 | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland, 1011 | |
Universitaetsspital Zuerich | |
Zuerich, Switzerland, 8091 | |
United Kingdom | |
Local Institution | |
London, Greater London, United Kingdom, SW17 0RE | |
Local Institution | |
Southampton, Hampshire, United Kingdom, SO16 6YD | |
Local Institution | |
Edinburgh, Midlothian, United Kingdom, EH16 4SB | |
Local Institution | |
Belfast, United Kingdom, BT9 7AB | |
Local Institution | |
Cambridge, United Kingdom, CB2 0QQ | |
Local Institution | |
Cottingham, United Kingdom, HU16 5JQ | |
Local Institution | |
Liverpool, United Kingdom, L7 8YA | |
Local Institution | |
London, United Kingdom, SW3 6JJ | |
Local Institution | |
Manchester, United Kingdom, M20 4BX | |
Local Institution | |
Sutton., United Kingdom, SM25PT | |
Local Institution | |
Tauton, United Kingdom, TA1 5DA |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | January 20, 2022 |
Last Verified: | January 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
NKTR-214 Nivolumab Immunotherapy bempegaldesleukin (BEMPEG: NKTR-214) |
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 Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |