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

NCT ID: NCT03635983

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 783 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-21
• Study Completion Date: 2024-03-19

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

Conditions

Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination

NKTR-214 + Nivolumab

Group Type: EXPERIMENTAL

NKTR-214

Intervention Type: BIOLOGICAL

Specified dose on specified days

Nivolumab

Intervention Type: BIOLOGICAL

Specified dose on specified days

Monotherapy

Nivolumab

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: BIOLOGICAL

Specified dose on specified days

Interventions

NKTR-214

Specified dose on specified days

Intervention Type: BIOLOGICAL

Nivolumab

Specified dose on specified days

Intervention Type: BIOLOGICAL

Other Intervention Names

Bempegaldesleukin; BMS-986321; Opdivo; BMS-936558

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nektar Therapeutics

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 0187

Tucson, Arizona, United States

Local Institution - 0014

La Jolla, California, United States

Local Institution - 0122

Stanford, California, United States

Local Institution - 0051

Aurora, Colorado, United States

Local Institution - 0065

New Haven, Connecticut, United States

Local Institution - 0153

Miami, Florida, United States

Local Institution - 0017

Miami Beach, Florida, United States

Local Institution - 0112

Tampa, Florida, United States

Local Institution - 0012

Atlanta, Georgia, United States

Local Institution - 0019

Louisville, Kentucky, United States

Local Institution - 0018

Boston, Massachusetts, United States

Local Institution - 0188

Ann Arbor, Michigan, United States

Local Institution - 0186

Fridley, Minnesota, United States

Local Institution - 0135

St Louis, Missouri, United States

Local Institution - 0016

Hackensack, New Jersey, United States

Local Institution - 0185

New Brunswick, New Jersey, United States

Local Institution - 0141

New York, New York, United States

Local Institution - 0037

Cleveland, Ohio, United States

Local Institution - 0011

Portland, Oregon, United States

Local Institution - 0013

Portland, Oregon, United States

St. Luke's Hospital & Health Network

Easton, Pennsylvania, United States

Local Institution - 0015

Philadelphia, Pennsylvania, United States

Local Institution - 0001

Houston, Texas, United States

Local Institution - 0064

Fairfax, Virginia, United States

Local Institution - 0109

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0107

Buenos Aires, Buenos Aires F.D., Argentina

Local Institution - 0183

Buenos Aires, Distrito Federal, Argentina

Local Institution - 0108

CABA, , Argentina

Local Institution - 0157

Córdoba, , Argentina

Local Institution - 0146

Coffs Harbour, New South Wales, Australia

Local Institution - 0053

North Sydney, New South Wales, Australia

Local Institution - 0058

Cairns, Queensland, Australia

Local Institution

Greenslopes, Queensland, Australia

Local Institution - 0056

Woolloongabba, Queensland, Australia

Local Institution - 0172

Elizabeth Vale, South Australia, Australia

Local Institution - 0054

Melbourne, Victoria, Australia

Local Institution - 0143

Melbourne, Victoria, Australia

Local Institution - 0057

Nedlands, Western Australia, Australia

Local Institution - 0097

Nedlands, Western Australia, Australia

Local Institution - 0034

Graz, , Austria

Local Institution - 0035

Salzburg, , Austria

Local Institution - 0033

Vienna, , Austria

Local Institution - 0083

Brussels, , Belgium

Local Institution - 0084

Hasselt, , Belgium

Local Institution - 0085

Leuven, , Belgium

Local Institution - 0168

Fortaleza, Ceará, Brazil

Local Institution - 0125

Belo Horizonte, Minas Gerais, Brazil

Local Institution - 0124

Ijuí, Rio Grande do Sul, Brazil

Local Institution - 0127

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0171

Itajaí, Santa Catarina, Brazil

Local Institution - 0126

Barretos, São Paulo, Brazil

Local Institution - 0182

Rio de Janeiro, , Brazil

Local Institution - 0169

São Paulo, , Brazil

Local Institution - 0068

Abbotsford, British Columbia, Canada

Local Institution - 0139

St. John's, Newfoundland and Labrador, Canada

Local Institution - 0066

Hamilton, Ontario, Canada

Local Institution - 0067

Kitchener, Ontario, Canada

Local Institution - 0041

Toronto, Ontario, Canada

Local Institution

Québec, Quebec, Canada

Local Institution - 0121

Edmonton, , Canada

Local Institution - 0174

Recoleta, Santiago Metropolitan, Chile

Local Institution - 0173

Santiago, Santiago Metropolitan, Chile

Local Institution - 0094

Brno, , Czechia

Local Institution - 0093

Hradec Králové, , Czechia

Local Institution - 0091

Prague, , Czechia

Local Institution - 0092

Prague, , Czechia

Local Institution - 0166

Tampere, Oulun Lääni, Finland

Local Institution - 0167

KYS, , Finland

Local Institution - 0165

Turku, , Finland

Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre

Bordeaux, , France

Hopital Claude Huriez

Lille, , France

Hopital Saint Eloi

Montpellier, , France

Local Institution - 0003

Nantes, , France

Local Institution - 0155

Nice, , France

Hopital Saint Louis

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

CHU Charles Nicolle

Rouen, , France

Local Institution - 0009

Saint-Priest-en-Jarez, , France

Local Institution - 0002

Toulouse, , France

Institute Gustave Roussy

Villejuif, , France

Local Institution - 0031

Buxtehude, , Germany

Local Institution - 0029

Dresden, , Germany

Local Institution - 0192

Erfurt, , Germany

Local Institution - 0026

Essen, , Germany

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Göttingen, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Kiel, , Germany

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Leipzig, , Germany

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München, , Germany

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Münster, , Germany

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Regensburg, , Germany

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Tübingen, , Germany

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Würzburg, , Germany

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Athens, , Greece

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Neo Faliro, , Greece

Local Institution - 0040

Thessaloniki, , Greece

Local Institution - 0136

Wilton, CORK, Ireland

Local Institution - 0129

Dublin, Dublin, Ireland

Local Institution - 0128

Dublin, , Ireland

Local Institution - 0130

Dublin, , Ireland

Local Institution - 0098

Beersheba, , Israel

Local Institution - 0088

Jerusalem, , Israel

Local Institution - 0089

Ramat Gan, , Israel

Local Institution - 0045

Milan, Lombardy, Italy

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Turin, Piedmont, Italy

Local Institution - 0044

Bari, , Italy

ASST Papa Giovanni XXIII

Bergamo, , Italy

Local Institution - 0113

Meldola (FC), , Italy

IRCCS Istituto Nazionale Tumori Milano

Milan, , Italy

Local Institution - 0043

Napoli, , Italy

Istituto Oncologico Veneto IOV

Padua, , Italy

Local Institution - 0042

Siena, , Italy

Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

Torino, , Italy

Local Institution - 0176

Zapopan, Jalisco, Mexico

Local Institution - 0175

Mexico City, Mexico City, Mexico

Local Institution - 0177

Monterrey, Nuevo León, Mexico

Local Institution - 0180

Monterrey, Nuevo León, Mexico

Local Institution - 0178

Cancún, Quintana Roo, Mexico

Local Institution - 0179

Puebla City, , Mexico

Local Institution - 0181

San Luis Potosí City, , Mexico

Local Institution - 0101

Amsterdam, , Netherlands

Local Institution - 0102

Amsterdam, , Netherlands

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Leiden, , Netherlands

Local Institution - 0100

Nijmegen, , Netherlands

Local Institution - 0147

Untrecht, , Netherlands

Local Institution - 0159

Auckland, , New Zealand

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Christchurch, , New Zealand

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Wellington, , New Zealand

Local Institution - 0152

Bydgoszcz, , Poland

Local Institution - 0090

Warsaw, , Poland

Local Institution - 0134

Lisbon, , Portugal

Local Institution - 0133

Porto, , Portugal

Local Institution - 0162

Bucharest, , Romania

Local Institution - 0070

Cluj-Napoca, , Romania

Local Institution - 0071

Craiova, , Romania

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Floreşti, , Romania

Local Institution - 0149

Krasnoyarsk, , Russia

Local Institution - 0086

Moscow, , Russia

Local Institution - 0111

Moscow, , Russia

Local Institution - 0148

Moscow, , Russia

Local Institution - 0116

Barcelona, , Spain

Local Institution - 0115

Barcelona, , Spain

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Córdoba, , Spain

Local Institution - 0190

Doniostia - San Sebastian, , Spain

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Donostia / San Sebastian, , Spain

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Jaén, , Spain

Local Institution - 0114

Madrid, , Spain

Local Institution - 0119

Santiago Compostela, , Spain

Local Institution - 0117

Valencia, , Spain

Local Institution - 0163

Gothenburg, , Sweden

Local Institution - 0164

Lund, , Sweden

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Bern, , Switzerland

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Lausanne, , Switzerland

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Zurich, , Switzerland

Local Institution - 0132

Southampton, Hampshire, United Kingdom

Local Institution

Edinburgh, Midlothian, United Kingdom

Local Institution - 0131

Sutton, Surrey, United Kingdom

Local Institution - 0078

Belfast, , United Kingdom

Local Institution - 0076

Cambridge, , United Kingdom

Local Institution - 0079

Cottingham, , United Kingdom

Local Institution - 0137

Liverpool, , United Kingdom

Local Institution - 0077

London, , United Kingdom

Local Institution - 0074

London, , United Kingdom

Local Institution - 0075

Manchester, , United Kingdom

Local Institution - 0142

Tauton, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Chile; Czechia; Finland; France; Germany; Greece; Ireland; Israel; Italy; Mexico; Netherlands; New Zealand; Poland; Portugal; Romania; Russia; Spain; Sweden; Switzerland; United Kingdom

References

Diab A, Gogas H, Sandhu S, Long GV, Ascierto PA, Larkin J, Sznol M, Franke F, Ciuleanu TE, Pereira C, Munoz Couselo E, Bronzon Damian F, Schenker M, Perfetti A, Lebbe C, Quereux G, Meier F, Curti BD, Rojas C, Arriaga Y, Yang H, Zhou M, Ravimohan S, Statkevich P, Tagliaferri MA, Khushalani NI. Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results. J Clin Oncol. 2023 Oct 20;41(30):4756-4767. doi: 10.1200/JCO.23.00172. Epub 2023 Aug 31.

Reference Type: DERIVED

PMID: 37651676 (View on PubMed)

Khushalani NI, Diab A, Ascierto PA, Larkin J, Sandhu S, Sznol M, Koon HB, Jarkowski A, Zhou M, Statkevich P, Geese WJ, Long GV. Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design. Future Oncol. 2020 Oct;16(28):2165-2175. doi: 10.2217/fon-2020-0351. Epub 2020 Jul 29.

Reference Type: DERIVED

PMID: 32723187 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

2018-001423-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17-214-08

Identifier Type: OTHER

Identifier Source: secondary_id

CA045-001

Identifier Type: -

Identifier Source: org_study_id