Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence

PHASE3TerminatedINTERVENTIONAL
Enrollment

765

Participants

Timeline

Start Date

July 27, 2020

Primary Completion Date

September 22, 2022

Study Completion Date

September 22, 2022

Conditions
MelanomaMelanoma Stage IIIMelanoma Stage IVMelanoma (Skin)
Interventions
BIOLOGICAL

Bempegaldesleukin

Specified dose on specified days

BIOLOGICAL

Nivolumab

Specified dose on specified days

Trial Locations (212)

86

Bioclinic Thessaloniki (Galinos clinic), Thessaloniki

1090

Allgemeines Krankenhaus der Stadt Wien, Vienna

2000

Melanoma Institute Australia, North Sydney

2145

Blacktown Hospital, Westmead

3004

Alfred Hospital, Melbourne

3084

Austin Health, Heidelberg

Auckland City Hospital, Heidelberg

3100

Universitätsklinikum St. Pölten, Sankt Pölten

3143

Tauranga Hospital, Tauranga

3584

Universitair Medisch Centrum Utrecht, Utrecht

4032

Icon Cancer Care Wesley, Chermside

4102

Princess Alexandra Hospital, Woolloongabba

4120

Gallipoli Medical Research Foundation, Greenslopes

4215

Gold Coast University Hospital, Southport

Tasman Oncology Research, Southport

4870

Cairns Hospital, Cairns

5000

Royal Adelaide Hospital, Adelaide

6009

Affinity Clinical Research, Nedlands

Sir Charles Gairdner Hospital, Nedlands

6021

Wellington Hospital, Wellington

6097

Universitatsklinikum Halle (Saale), Halle

6202

CHU de Nice, Nice

6419

Zuyderland Medisch Centrum, Heerlen

6830

Landeskrankenhaus Feldkirch, Rankweil

7548

SRH Wald-Klinikum Gera GmbH, Gera

8036

Medizinische Universität Graz, Graz

8140

Christchurch Hospital, Christchurch

8934

Medisch Centrum Leeuwarden, Leeuwarden

9054

Dunedin Hospital, Dunedin

10016

NYU Langone Medical Center, New York

10021

Columbia University Medical Center - PIN, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10060

Fondazione del Piemonte per l'Oncologia (IRCCS), Candiolo

10117

Charité - Universitätsmedizin Berlin, Berlin

11526

Laiko General Hospital of Athens, Ampelokipoi

Henry Dunant Hospital, Athens

12808

Vseobecna Fakultni Nemocnice V Praze, Prague

14004

ICO l'Hospitalet - Hospital Duran i Reynals, Córdoba

15006

Hospital Universitario A Coruña, A Coruña

15125

Medical Center of Athens, Marousi

15232

H Lee Moffitt Cancer Center and Research Institute, Pittsburgh

Hillman Cancer Center, Pittsburgh

16000

Nemocnice Na Bulovce, Prague

17033

Penn State Milton S Hershey Medical Center, Hershey

18101

HaEmek Medical Center, Afula

18103

Lehigh Valley Physician Group (LVPG) - Hematology Oncology, Allentown

18547

Metropolitan Hospital - First Oncology Clinic, Athens

Metropolitan Hospital - Fourth Oncology Clinic, Athens

19049

Helios Klinikum Schwerin, Schwerin

19107

Jefferson University Hospital, Philadelphia

20007

MedStar Georgetown University Hospital, Washington D.C.

20064

NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska, Lublin

20141

Istituto Europeo Di Oncologia, Milan

20246

Universitätsklinikum Hamburg Eppendorf, Hamburg

21614

Elben Klinken Stade - Buxtehude, Buxtehude

22031

Inova Schar Cancer Institute, Fairfax

22903

University of Virginia Cancer Center, Charlottesville

23007

Hospital Universitario de Jaen, Jaén

24014

Blue Ridge Cancer Care - USOR, Roanoke

24105

Universitatsklinikum Schleswig-Holstein, Kiel

27710

Duke Cancer Institute, Durham

28041

Hospital Universitario 12 de Octubre, Madrid

28050

Hospital Universitario HM Sanchinarro - CIOCC, Madrid

29605

Prisma Health Cancer Institute, Greenville

29789

Hospital Universitario Virgen de la Victoria, Málaga

30625

Medizinische Hochschule Hannover, Hanover

31096

Rambam Medical Center - PPDS, Haifa

32750

Orlando Health Cancer Institute, Longwood

University of North Carolina at Chapel Hill, Chapel Hill

35042

EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS, Rennes

35128

Istituto Oncologico Veneto - I.R.C.C.S., Padua

37203

SCRI Tennessee Oncology Nashville, Nashville

37232

Vanderbilt University Medical Center, Nashville

37404

SCRI Tennessee Oncology Chattanooga, Chattanooga

37920

University of Tennessee Medical Center, Knoxville

38043

Hôpital Albert Michallon La Tronche, La Tronche

39014

Universitätsklinik Magdeburg, Magdeburg

40536

University of Kentucky, Lexington

41009

Hospital Universitario Virgen Macarena, Seville

41100

Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena

42055

Centre Hospitalier Universitaire de Saint Etienne, Saint-Priest-en-Jarez

44093

Hôtel Dieu - Nantes, Nantes

44106

University Hospitals Cleveland Medical Center, Cleveland

44195

The Cleveland Clinic Foundation, Cleveland

44791

Ruhr Universität Bochum, Bochum

45147

Universitätsklinikum Essen, Essen

46063

Krajska nemocnice Liberec, a.s., Liberec

46526

Goshen Center For Cancer Care, Goshen

47014

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS, Meldola

48149

Universitatsklinikum Munster, Münster

48157

Fachklinik Hornheide, Münster

49100

CHU Angers, Angers

Rabin Medical Center - PPDS, Petah Tikva

50937

Uniklinik Köln, Cologne

53100

Azienda Ospedaliera Universitaria Senese, Siena

53792

University of Wisconsin, Madison

54645

Theageneio Anticancer Oncology Hospital of Thessaloniki, Thessaloniki

55905

Mayo Clinic - PIN, Rochester

56429

Papageorgiou General Hospital of Thessaloniki, Thessaloniki

59037

CHRU Lille, Lille

59102

Frontier Cancer Center and Blood Institute, Billings

60612

Rush University Medical Center, Chicago

60780

Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu, Poznan

63003

CHU Estaing, Clermont-Ferrand

63110

Washington University School of Medicine, St Louis

65653

Mou/Mmci - Ppds, Brno

67063

Klinikum der Stadt Ludwigshafen gGmbH, Ludwigshafen

68130

Nebraska Cancer Specialists, Omaha

Nebraska Methodist Hospital, Omaha

68198

University of Nebraska Medical Center, Omaha

69120

University Clinic Heidelberg, Heidelberg

69310

Hospices Civils de Lyon, Pierre-Bénite

70121

Ochsner Clinic Foundation, New Orleans

70124

IRCCS Giovanni Paolo II Istituto Oncologico, Bari

70852

Fakultni nemocnice Ostrava, Ostrava Poruba

71110

Pepagni Hospital, Heraklion

72205

Banner MD Anderson Cancer Center, Little Rock

74078

SLK Kliniken Heilbronn GmbH, Heilbronn

75235

Department of Pharmacy Investigational Drug Services, Dallas

75246

Texas Oncology (Loop) - USOR, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

75475

Hôpital Saint Louis, Paris

75877

Groupe Hospitalier Bichat Claude Bernard, Paris

76031

Hôpital Charles Nicolle, Rouen

76297

Klinikum Mannheim Universitätsklinikum gGmbH, Mannheim

Universitätsklinikum Tübingen, Tübingen

77030

MD Anderson Cancer Center, Houston

79900

Fakultni nemocnice Olomouc, Olomouc

80012

Rocky Mountain Cancer Centers (Littleton) - USOR, Aurora

80045

University of Colorado - Cancer Center - PPDS, Aurora

80054

Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud, Amiens

80131

Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale, Napoli

80952

Uniwersyteckie Centrum Kliniczne, Gdansk

81307

Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden

85258

Honor Health, Scottsdale

85796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz

89081

Universitätsklinikum Ulm, Ulm

90404

Angeles Clinic and Research Institute, Santa Monica

John Wayne Cancer Institute, Santa Monica

90603

Utah Cancer Specialists (Salt Lake City), Salt Lake City

92069

California Cancer Associates for Research and Excellence, San Marcos

92078

Kaiser Permanente, San Marcos

92335

Kaiser Permanente, Fontana

92373

Emad Ibrahim, MD, Inc, Redlands

92505

Kaiser Permanente, Riverside

Southern California Permanente Medical Group, Riverside

92805

Kaiser Foundation Hospital, Inpatient Pharmacy, Anaheim

92835

St. Joseph Heritage Healthcare, Fullerton

92868

Hematology Oncology Medical Group of Orange County, Inc., Orange

University of California Irvine, Orange

93053

University Clinic Regensburg, Regensburg

94115

San Francisco Oncology Associates, San Francisco

94801

Institut Gustave Roussy, Villejuif

97080

Universitätsklinikum Würzburg, Würzburg

97213

Providence Cancer Institute, Franz Clinic, Portland

97216

Oregon Health and Science University, Portland

98109

Seattle Cancer Care Alliance, Seattle

98405

Northwest Medical Specialties, Tacoma

99089

Helios Klinikum Erfurt, Erfurt

150040

Regional Clinical Oncology Hospital, Yaroslavl

191758

FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF, Saint Petersburg

195271

Railway Clinical Hospital JSC RZhD, Saint Petersburg

196603

PMI Euromedservice, Pushkin

200094

S.C. Onco Clinic Consult SA, Craiova

200347

Oncology Center Sfantul Nectarie, Craiova

305524

Kursk Regional Oncology Centre, Kursk

350040

Clinical Oncology Centre #1, Krasnodar

390011

Ryazan Regional Clinical Oncology Dispensary, Ryazan

400641

S.C. Medisprof SRL, Cluj-Napoca

454087

Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk

660133

Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy, Krasnoyarsk

4628007

Hospital General Universitario Gregorio Maranon, Madrid

8410501

Soroka University Medical Centre, Beersheba

9574425

Hadassah Medical Center - PPDS, Jerusalem

02114

Massachusetts General Hospital, Boston

07601

Hackensack University Medical Center, Hackensack

07960

Atlantic Health System, Morristown

Unknown

Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH, Lienz

Salzburger Landeskliniken, Salzburg

Fakultni nemocnice Hradec Kralove, Hradec Králové

Hôpital Saint-André, Bordeau

CHRU de Tours, Chambray-lès-Tours

Sheba Medical Center - PPDS, Ramat Gan

ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

Ospedale Policlinico San Martino, Genova

Istituto Nazionale Dei Tumori, Milan

Maxima Medisch Centrum, Veldhoven

Hospital Universitario Virgen de La Arrixaca, El Palmar

Consorcio Hospital General Universitario de Valencia, Valencia

04103

Universitatsklinikum Leipzig, Leipzig

TK57001

Interbalkan Medical Center of Thessaloniki, Pylaia

1081HV

VU Medisch Centrum, Amsterdam

2333ZA

Leiden University Medical Center, Leiden

6525GA

Radboud University Nijmegen Medical Centre, Nijmegen

8025AB

Isala Klinieken, Zwolle

15-027

Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku, Bialystok

3004-561

Centro Hospitalar E Universitário de Coimbra EPE, Coimbra

1099-023

Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon

1649-035

Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon

Hospital CUF Tejo, Lisbon

4200-072

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS, Porto

022328

Affidea Romania SRL, Bucharest

08911

Hospital Universitario Germans Trias i Pujol, Badalona

08025

Hospital de La Santa Creu i Sant Pau, Barcelona

08028

Hospital Universitari Dexeus - Grupo Quironsalud, Barcelona

08035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

08904

C.H. Regional Reina Sofia - PPDS, L'Hospitalet de Llobregat

CB20QQ

Addenbrooke's Hospital, Cambridge

HU165JQ

Castle Hill Hospital, Cottingham

LE15WW

Leicester Royal Infirmary, Leicester

BG72UH

Nottingham City Hospital, Nottingham

TR13LJ

Royal Cornwall Hospital, Truro

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Nektar Therapeutics

INDUSTRY