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

• ClinicalTrials.gov Identifier: NCT03635983
• Recruitment Status: Active, not recruiting
• First Posted: August 17, 2018
• Last Update Posted: January 20, 2022
• Sponsor: Bristol-Myers Squibb
• Collaborator: Nektar Therapeutics
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

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

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information 

BMS Clinical Trial Patient Recruiting 

Investigator Inquiry Form 

FDA Safety Alerts and Recalls 

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

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.

• 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
• 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

Keywords provided by Bristol-Myers Squibb:

NKTR-214; Nivolumab; Immunotherapy; bempegaldesleukin (BEMPEG: NKTR-214)

Additional relevant MeSH terms:

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