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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 16, 2019
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)
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 : June 16, 2024
Estimated Study Completion Date : June 14, 2025

Resource links provided by the National Library of Medicine

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. Duration of overall complete response (DoCR) [ Time Frame: Approximately 16 months ]
  4. Time to response (TTR) [ Time Frame: Approximately 16 months ]
  5. ORR by investigator and in biomarker population [ Time Frame: Approximately 16 months ]
  6. PFS by investigator and in biomarker population [ Time Frame: Approximately 22 months ]
  7. OS in biomarker population [ Time Frame: Up to 59 months ]
  8. Incidence of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation [ 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 [ 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 treatment

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


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 #.

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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
Local Institution Not yet recruiting
Stanford, California, United States, 94305
Contact: Site 0122         
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Theresa Medina, Site 0051    720-848-8845      
United States, Connecticut
Local Institution Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: Site 0065         
United States, Florida
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Jose Lutzky, Site 0017    305674262555862      
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Nikhil Khushalani, Site 0112    813-745-7361      
United States, Georgia
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322-1013
Contact: Melinda Yushak, Site 0012    404-778-4520      
United States, Kentucky
Local Institution Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Site 0019         
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Site 0018         
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      
United States, New York
Local Institution Not yet recruiting
Buffalo, New York, United States, 14263
Contact: Site 0087         
Local Institution Not yet recruiting
New York, New York, United States, 10065
Contact: Site 0141         
United States, Ohio
Local Institution Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Site 0049         
Local Institution Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Site 0037         
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: Matthew Taylor, 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
Local Institution Not yet recruiting
Autonoma, Buenos Aires, Argentina, C118AAT
Contact: Site 0107         
Clinica Adventista Belgrano Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1430
Contact: Aldo Perfetti, Site 0109    5440141500      
Local Institution Not yet recruiting
Caba, Argentina, 1199
Contact: Site 0106         
Instituto Medico Especialazado Alexander Fleming Recruiting
Caba, Argentina, 1426
Contact: Yanina Pfluger, Site 0108    +541132218956      
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 Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Site 0055         
Local Institution Recruiting
Woolloongabba, Queensland, Australia, 4012
Contact: Site 0056         
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 Not yet 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 0 0000 00000      
Local Institution Not yet recruiting
Wien, Austria, 1090
Contact: 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 Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-090
Contact: Site 0125         
Local Institution Not yet 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 Recruiting
Barretos, SAO Paulo, Brazil, 14780-070
Contact: Site 0126         
Canada, Alberta
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0121         
Canada, British Columbia
Local Institution Not yet recruiting
Abbotsford, British Columbia, Canada, V2S 0C2
Contact: Site 0068         
Canada, Newfoundland and Labrador
Local Institution Not yet 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 Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0041         
Canada
Local Institution Recruiting
Quebec, Canada, G1R 2J6
Contact: Site 0069         
Czechia
Local Institution Recruiting
Brno, Czechia, 656 53
Contact: Site 0094         
Local Institution Recruiting
Hradec Kralove, Czechia, 500 05
Contact: Site 0093         
Local Institution Recruiting
Praha 10, Czechia, 100 34
Contact: Site 0091         
Dermatovenerologicka klinika VFN a 1. LF UK Recruiting
Praha 2, Czechia, 128 08
Contact: Ivana Krajsova, Site 0092         
France
Hopital Claude Huriez Recruiting
Lille, France, 59000
Contact: Laurent Mortier, Site 0007         
Hotel Dieu - Chu De Nantes Recruiting
Nantes Cedex 01, France, 44093
Contact: Brigitte Dreno, Site 0003         
Hopital Saint Louis Recruiting
Paris, France, 75475
Contact: Celeste Lebbe, Site 0005         
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69310
Contact: Stephane Dalle, Site 0006         
Hopital Nord - CHU de Saint-Etienne Recruiting
Saint Priest en Jarez, France, 42270
Contact: Jean-Luc Perrot, Site 0009         
Institut Claudius Regaud Recruiting
Toulouse Cedex 9, France, 31059
Contact: Nicolas Meyer, Site 0002    +33531156281      
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Caroline Robert, Site 0004         
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    +492017232325      
Local Institution Not yet recruiting
Goettingen, Germany, 37075
Contact: Site 0030         
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      
Local Institution Not yet recruiting
Kiel, Germany, 24105
Contact: Site 0028         
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: Carola Berking, Site 0021    +4989440056326      
Local Institution Not yet recruiting
Muenster, Germany, 48157
Contact: Site 0027         
Local Institution Not yet recruiting
Regensburg, Germany, 93053
Contact: Site 0060         
Universitaetsklinikum Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Thomas Eigentler, Site 0025    +49070712984503      
Local Institution Not yet recruiting
Wuerzburg, Germany, 97080
Contact: Site 0032         
Greece
Local Institution Not yet recruiting
Athens, Greece, 11526
Contact: Site 0038         
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 Not yet recruiting
Wilton, Cork, Ireland, T12 DC4A
Contact: Site 0136         
Local Institution Not yet recruiting
Dublin 7, Dublin, Ireland
Contact: Site 0129         
Local Institution Not yet recruiting
Dublin, Ireland, 01
Contact: Site 0130         
Local Institution Not yet recruiting
Dublin, Ireland, 4
Contact: Site 0128         
Local Institution Not yet recruiting
Galway, Ireland, ST4 6QG
Contact: Site 0138         
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
Local Institution Not yet recruiting
Bari, Italy, 70124
Contact: Site 0044         
Local Institution Not yet recruiting
Bergamo, Italy, 24127
Contact: Site 0151         
Local Institution Not yet recruiting
Genova, Italy, 16132
Contact: Site 0046         
Local Institution Recruiting
Medola, Italy, 47014
Contact: Site 0113         
Local Institution Not yet recruiting
Milan, Italy, 20141
Contact: Site 0045         
Local Institution Not yet recruiting
Napoli, Italy, 80131
Contact: Site 0043         
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         
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1066CX
Contact: Site 0101         
Local Institution Recruiting
Amsterdam, Netherlands, 1081 HZ
Contact: Site 0102         
Local Institution Not yet 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 Not yet recruiting
Christchurch, New Zealand
Contact: Site 0063         
Local Institution Not yet recruiting
Wellington, New Zealand, 6021
Contact: Site 0062         
Poland
Local Institution Not yet recruiting
Lublin, Poland, 20-090
Contact: Site 0095         
Local Institution Recruiting
Warszawa, Poland, 02-781
Contact: Site 0090         
Local Institution Not yet recruiting
Wroclaw, Poland, 53-413
Contact: Site 0096         
Portugal
Local Institution Not yet recruiting
Lisboa, Portugal, 1649-035
Contact: Site 0134         
Local Institution Not yet recruiting
Porto, Portugal, 4200-072
Contact: Site 0133         
Romania
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 Not yet recruiting
Oradea, Romania, 410469
Contact: Site 0073         
Russian Federation
Local Institution Not yet recruiting
Krasnoyarsk, Russian Federation, 660133
Contact: Site 0149         
Local Institution Not yet recruiting
Moscow, Russian Federation, 105229
Contact: Site 0086         
Local Institution Not yet recruiting
Moscow, Russian Federation, 115478
Contact: Site 0111         
Local Institution Not yet 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      
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    +41442554802      
United Kingdom
Local Institution Not yet recruiting
London, Greater London, United Kingdom, SW17 0RE
Contact: Site 0077         
Local Institution Not yet recruiting
Wirral, Merseyside, United Kingdom, CH63 4JY
Contact: Site 0137         
Local Institution Not yet recruiting
Edinburgh, Midlothian, United Kingdom, EH16 4SB
Contact: Site 0081         
Local Institution Not yet recruiting
Belfast, United Kingdom, BT9 7AB
Contact: Site 0078         
Local Institution Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Site 0076         
Local Institution Not yet recruiting
Cottingham, United Kingdom, HU16 5JQ
Contact: Site 0079         
Local Institution Not yet recruiting
London, United Kingdom, SW3 6JJ
Contact: Site 0074         
Local Institution Recruiting
Manchester, United Kingdom, M20 4GJ
Contact: Site 0075         
Local Institution Not yet recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Site 0132         
Local Institution Not yet 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
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03635983     History of Changes
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 16, 2019
Last Verified: October 2019

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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
Additional relevant MeSH terms:
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Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents