Spots Global Cancer Trial Database for Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
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Trial Identification
Brief Title: Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
Official Title: A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)
Study ID: NCT04410445
Study Description
Brief Summary: The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.
Detailed Description: The main purpose of this study is to compare the efficacy, as measured by recurrence-free survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph node \[LN\] metastasis \> 1 mm), Stage IIIB/C/D, or Stage IV (American Joint Committee on Cancer \[AJCC\] 8th edition) cutaneous melanoma with no evidence of disease (NED) who are at high risk for recurrence.
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Honor Health, Scottsdale, Arizona, United States
Banner MD Anderson Cancer Center, Little Rock, Arkansas, United States
Kaiser Foundation Hospital, Inpatient Pharmacy, Anaheim, California, United States
Kaiser Permanente, Fontana, California, United States
St. Joseph Heritage Healthcare, Fullerton, California, United States
Hematology Oncology Medical Group of Orange County, Inc., Orange, California, United States
University of California Irvine, Orange, California, United States
Emad Ibrahim, MD, Inc, Redlands, California, United States
Kaiser Permanente, Riverside, California, United States
Southern California Permanente Medical Group, Riverside, California, United States
San Francisco Oncology Associates, San Francisco, California, United States
California Cancer Associates for Research and Excellence, San Marcos, California, United States
Kaiser Permanente, San Marcos, California, United States
Angeles Clinic and Research Institute, Santa Monica, California, United States
John Wayne Cancer Institute, Santa Monica, California, United States
Rocky Mountain Cancer Centers (Littleton) - USOR, Aurora, Colorado, United States
University of Colorado - Cancer Center - PPDS, Aurora, Colorado, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Orlando Health Cancer Institute, Longwood, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Goshen Center For Cancer Care, Goshen, Indiana, United States
University of Kentucky, Lexington, Kentucky, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Mayo Clinic - PIN, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Frontier Cancer Center and Blood Institute, Billings, Montana, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Atlantic Health System, Morristown, New Jersey, United States
NYU Langone Medical Center, New York, New York, United States
Columbia University Medical Center - PIN, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Duke Cancer Institute, Durham, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
Providence Cancer Institute, Franz Clinic, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Lehigh Valley Physician Group (LVPG) - Hematology Oncology, Allentown, Pennsylvania, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
Jefferson University Hospital, Philadelphia, Pennsylvania, United States
H Lee Moffitt Cancer Center and Research Institute, Pittsburgh, Pennsylvania, United States
Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Prisma Health Cancer Institute, Greenville, South Carolina, United States
SCRI Tennessee Oncology Chattanooga, Chattanooga, Tennessee, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
SCRI Tennessee Oncology Nashville, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Department of Pharmacy Investigational Drug Services, Dallas, Texas, United States
Texas Oncology (Loop) - USOR, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Utah Cancer Specialists (Salt Lake City), Salt Lake City, Utah, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Blue Ridge Cancer Care - USOR, Roanoke, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Northwest Medical Specialties, Tacoma, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
Royal Adelaide Hospital, Adelaide, , Australia
Cairns Hospital, Cairns, , Australia
Icon Cancer Care Wesley, Chermside, , Australia
Gallipoli Medical Research Foundation, Greenslopes, , Australia
Austin Health, Heidelberg, , Australia
Alfred Hospital, Melbourne, , Australia
Affinity Clinical Research, Nedlands, , Australia
Sir Charles Gairdner Hospital, Nedlands, , Australia
Melanoma Institute Australia, North Sydney, , Australia
Gold Coast University Hospital, Southport, , Australia
Tasman Oncology Research, Southport, , Australia
Blacktown Hospital, Westmead, , Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
Medizinische Universität Graz, Graz, , Austria
Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH, Lienz, , Austria
Landeskrankenhaus Feldkirch, Rankweil, , Austria
Salzburger Landeskliniken, Salzburg, , Austria
Universitätsklinikum St. Pölten, St.Pölten, , Austria
Allgemeines Krankenhaus der Stadt Wien, Vienna, , Austria
Mou/Mmci - Ppds, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Králové, , Czechia
Krajska nemocnice Liberec, a.s., Liberec, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Ostrava Poruba, , Czechia
Nemocnice Na Bulovce, Prague, , Czechia
Vseobecna Fakultni Nemocnice V Praze, Praha, , Czechia
Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud, Amiens, , France
CHU Angers, Angers, , France
Hôpital Saint-André, Bordeau, , France
CHRU de Tours, Chambray-lès-Tours, , France
CHU Estaing, Clermont-Ferrand, , France
Hôpital Albert Michallon La Tronche, La Tronche, , France
CHRU Lille, Lille, , France
Hôtel Dieu - Nantes, Nantes, , France
CHU de Nice, Nice, , France
Hôpital Saint Louis, Paris, , France
Groupe Hospitalier Bichat Claude Bernard, Paris, , France
Hospices Civils de Lyon, Pierre-Bénite, , France
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS, Rennes, , France
Hôpital Charles Nicolle, Rouen, , France
Centre Hospitalier Universitaire de Saint Etienne, Saint-Priest-en-Jarez, , France
Institut Gustave Roussy, Villejuif, , France
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Ruhr Universität Bochum, Bochum, , Germany
Elben Klinken Stade - Buxtehude, Buxtehude, , Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden, , Germany
Helios Klinikum Erfurt, Erfurt, , Germany
Universitätsklinikum Essen, Essen, , Germany
SRH Wald-Klinikum Gera GmbH, Gera, , Germany
Universitatsklinikum Halle (Saale), Halle, , Germany
Universitätsklinikum Hamburg Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
University Clinic Heidelberg, Heidelberg, , Germany
SLK Kliniken Heilbronn GmbH, Heilbronn, , Germany
Universitatsklinikum Schleswig-Holstein, Kiel, , Germany
Uniklinik Köln, Köln, , Germany
Universitatsklinikum Leipzig, Leipzig, , Germany
Klinikum der Stadt Ludwigshafen gGmbH, Ludwigshafen, , Germany
Universitätsklinik Magdeburg, Magdeburg, , Germany
Klinikum Mannheim Universitätsklinikum gGmbH, Mannheim, , Germany
Universitatsklinikum Munster, Münster, , Germany
Fachklinik Hornheide, Münster, , Germany
University Clinic Regensburg, Regensburg, , Germany
Helios Klinikum Schwerin, Schwerin, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
Laiko General Hospital of Athens, Ampelokipoi, , Greece
Henry Dunant Hospital, Athens, , Greece
Metropolitan Hospital - First Oncology Clinic, Athens, , Greece
Metropolitan Hospital - Fourth Oncology Clinic, Athens, , Greece
Pepagni Hospital, Heraklion, , Greece
Medical Center of Athens, Maroúsi, , Greece
Interbalkan Medical Center of Thessaloniki, Pylaía, , Greece
Theageneio Anticancer Oncology Hospital of Thessaloniki, Thessaloníki, , Greece
Papageorgiou General Hospital of Thessaloniki, Thessaloníki, , Greece
Bioclinic Thessaloniki (Galinos clinic), Thessaloníki, , Greece
HaEmek Medical Center, Afula, , Israel
Soroka University Medical Centre, Be'er Sheva, , Israel
Rambam Medical Center - PPDS, Haifa, , Israel
Hadassah Medical Center - PPDS, Jerusalem, , Israel
Rabin Medical Center - PPDS, Petah tikva, , Israel
Sheba Medical Center - PPDS, Ramat Gan, , Israel
IRCCS Giovanni Paolo II Istituto Oncologico, Bari, , Italy
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, , Italy
Fondazione del Piemonte per l'Oncologia (IRCCS), Candiolo, , Italy
Ospedale Policlinico San Martino, Genova, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS, Meldola, , Italy
Istituto Europeo Di Oncologia, Milano, , Italy
Istituto Nazionale Dei Tumori, Milano, , Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena, , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale, Napoli, , Italy
Istituto Oncologico Veneto - I.R.C.C.S., Padova, , Italy
Azienda Ospedaliera Universitaria Senese, Siena, , Italy
VU Medisch Centrum, Amsterdam, , Netherlands
Zuyderland Medisch Centrum, Heerlen, , Netherlands
Medisch Centrum Leeuwarden, Leeuwarden, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Radboud University Nijmegen Medical Centre, Nijmegen, , Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Maxima Medisch Centrum, Veldhoven, , Netherlands
Isala Klinieken, Zwolle, , Netherlands
Christchurch Hospital, Christchurch, , New Zealand
Dunedin Hospital, Dunedin, , New Zealand
Auckland City Hospital, Heidelberg, , New Zealand
Tauranga Hospital, Tauranga, , New Zealand
Wellington Hospital, Wellington, , New Zealand
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku, Białystok, , Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz, , Poland
Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska, Lublin, , Poland
Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu, Poznań, , Poland
Centro Hospitalar E Universitário de Coimbra EPE, Coimbra, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisboa, , Portugal
Hospital CUF Tejo, Lisboa, , Portugal
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS, Porto, , Portugal
Affidea Romania SRL, Bucharest, , Romania
S.C. Medisprof SRL, Cluj-Napoca, , Romania
S.C. Onco Clinic Consult SA, Craiova, , Romania
Oncology Center Sfantul Nectarie, Craiova, , Romania
Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk, , Russian Federation
Clinical Oncology Centre #1, Krasnodar, , Russian Federation
Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy, Krasnoyarsk, , Russian Federation
Kursk Regional Oncology Centre, Kursk, , Russian Federation
PMI Euromedservice, Pushkin, , Russian Federation
Ryazan Regional Clinical Oncology Dispensary, Ryazan', , Russian Federation
FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF, Saint Petersburg, , Russian Federation
Railway Clinical Hospital JSC RZhD, Saint Petersburg, , Russian Federation
Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation
Hospital Universitario A Coruña, A Coruña, , Spain
Hospital Universitario Germans Trias i Pujol, Badalona, , Spain
Hospital de La Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Dexeus - Grupo Quironsalud, Barcelona, , Spain
Hospital Universitario Vall d'Hebron - PPDS, Barcelona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals, Córdoba, , Spain
Hospital Universitario Virgen de La Arrixaca, El Palmar, , Spain
Hospital Universitario de Jaen, Jaén, , Spain
C.H. Regional Reina Sofia - PPDS, L'Hospitalet De Llobregat, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario HM Sanchinarro - CIOCC, Madrid, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Consorcio Hospital General Universitario de Valencia, Valencia, , Spain
Addenbrooke's Hospital, Cambridge, , United Kingdom
Castle Hill Hospital, Cottingham, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Contact Details
Name: Study Director
Affiliation: Nektar Therapeutics
Role: STUDY_DIRECTOR
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