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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. 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
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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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

Resource links provided by the National Library of Medicine

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

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




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 ]


Information from the National Library of Medicine

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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


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


Locations
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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
Sponsors and Collaborators
Bristol-Myers Squibb
Nektar Therapeutics
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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: January 20, 2022
Last Verified: January 2022

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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
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action