Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Years and Over |
Gender | All |
Inclusion Criteria:
- - Male or female patients, age 12 years or older at the time of signing the informed consent form (age 18 years or older where local regulations, countries, and/or institutional policies do not allow for patients < 18 years of age (adolescents) to participate).
- - Histologically confirmed Stage IIIA (LN metastasis > 1 mm), IIIB/C/D, or IV (M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has been completely surgically resected within 12 weeks prior to randomization.
- - Tumor tissue available from biopsy or resected disease must be provided to central laboratory for PD-L1 status analysis.
- - Disease-free status documented by a complete physical examination and imaging studies within 28 days prior to randomization.
Exclusion Criteria:
- - History of ocular/uveal melanoma or mucosal melanoma.
- - Active, known or suspected autoimmune disease.
- - Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.
- - Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions.
- - Prior therapy with interferon, talimogene laherparepvec (Imylgic®), interleukin-2 (IL-2) directed therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte-associated protein 4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways).
- - Prior malignancy active within the previous 3 years except for locally potentially curable cancers that have been apparently cured.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04410445 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Nektar Therapeutics |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Study Director |
Principal Investigator Affiliation | Nektar Therapeutics |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Active, not recruiting |
Countries | Australia, Austria, Czechia, France, Germany, Greece, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma, Melanoma Stage III, Melanoma Stage IV, Melanoma (Skin) |
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.
Arms
Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab
Arm A: Participants will receive bempegaldesleukin (NKTR-214) IV in combination with nivolumab every 3 weeks.
Active Comparator: Nivolumab
Arm B: Participants will receive nivolumab IV alone every 4 weeks.
Interventions
Biological: - Bempegaldesleukin
Specified dose on specified days
Biological: - Nivolumab
Specified dose on specified days
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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Address
Honor Health
Scottsdale, Arizona, 85258
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Address
Banner MD Anderson Cancer Center
Little Rock, Arkansas, 72205
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Address
Kaiser Foundation Hospital, Inpatient Pharmacy
Anaheim, California, 92805
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Address
Kaiser Permanente
Fontana, California, 92335
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Address
St. Joseph Heritage Healthcare
Fullerton, California, 92835
Status
Address
Hematology Oncology Medical Group of Orange County, Inc.
Orange, California, 92868
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University of California Irvine
Orange, California, 92868
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Address
Emad Ibrahim, MD, Inc
Redlands, California, 92373
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Kaiser Permanente
Riverside, California, 92505
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Address
Southern California Permanente Medical Group
Riverside, California, 92505
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San Francisco Oncology Associates
San Francisco, California, 94115
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California Cancer Associates for Research and Excellence
San Marcos, California, 92069
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Kaiser Permanente
San Marcos, California, 92078
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Angeles Clinic and Research Institute
Santa Monica, California, 90404
Status
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John Wayne Cancer Institute
Santa Monica, California, 90404
Status
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Rocky Mountain Cancer Centers (Littleton) - USOR
Aurora, Colorado, 80012
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University of Colorado - Cancer Center - PPDS
Aurora, Colorado, 80045
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MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
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Orlando Health Cancer Institute
Longwood, Florida, 32750
Status
Address
Rush University Medical Center
Chicago, Illinois, 60612
Status
Address
Goshen Center For Cancer Care
Goshen, Indiana, 46526
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Address
University of Kentucky
Lexington, Kentucky, 40536
Status
Address
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
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Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
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Mayo Clinic - PIN
Rochester, Minnesota, 55905
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Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
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Address
Frontier Cancer Center and Blood Institute
Billings, Montana, 59102
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Address
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
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Address
Nebraska Methodist Hospital
Omaha, Nebraska, 68130
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Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
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Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
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Address
Atlantic Health System
Morristown, New Jersey, 07960
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Address
NYU Langone Medical Center
New York, New York, 10016
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Address
Columbia University Medical Center - PIN
New York, New York, 10021
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Address
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
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Address
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 32750
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Address
Duke Cancer Institute
Durham, North Carolina, 27710
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Address
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
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Address
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Status
Address
Providence Cancer Institute, Franz Clinic
Portland, Oregon, 97213
Status
Address
Oregon Health and Science University
Portland, Oregon, 97216
Status
Address
Lehigh Valley Physician Group (LVPG) - Hematology Oncology
Allentown, Pennsylvania, 18103
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Address
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
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Address
Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
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Address
H Lee Moffitt Cancer Center and Research Institute
Pittsburgh, Pennsylvania, 15232
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Address
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
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Address
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
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Address
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404
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Address
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
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SCRI Tennessee Oncology Nashville
Nashville, Tennessee, 37203
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Status
Address
Department of Pharmacy Investigational Drug Services
Dallas, Texas, 75235
Status
Address
Texas Oncology (Loop) - USOR
Dallas, Texas, 75246
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Address
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
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MD Anderson Cancer Center
Houston, Texas, 77030
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Utah Cancer Specialists (Salt Lake City)
Salt Lake City, Utah, 90603
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University of Virginia Cancer Center
Charlottesville, Virginia, 22903
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Inova Schar Cancer Institute
Fairfax, Virginia, 22031
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Address
Blue Ridge Cancer Care - USOR
Roanoke, Virginia, 24014
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Address
Seattle Cancer Care Alliance
Seattle, Washington, 98109
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Address
Northwest Medical Specialties
Tacoma, Washington, 98405
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Address
University of Wisconsin
Madison, Wisconsin, 53792
International Sites
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Royal Adelaide Hospital
Adelaide, , 5000
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Cairns Hospital
Cairns, , 4870
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Icon Cancer Care Wesley
Chermside, , 4032
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Gallipoli Medical Research Foundation
Greenslopes, , 4120
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Austin Health
Heidelberg, , 3084
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Alfred Hospital
Melbourne, , 3004
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Affinity Clinical Research
Nedlands, , 6009
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Sir Charles Gairdner Hospital
Nedlands, , 6009
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Melanoma Institute Australia
North Sydney, , 2000
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Address
Gold Coast University Hospital
Southport, , 4215
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Tasman Oncology Research
Southport, , 4215
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Blacktown Hospital
Westmead, , 2145
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Princess Alexandra Hospital
Woolloongabba, , 4102
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Medizinische Universität Graz
Graz, , 8036
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Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH
Lienz, ,
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Landeskrankenhaus Feldkirch
Rankweil, , 6830
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Salzburger Landeskliniken
Salzburg, ,
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Universitätsklinikum St. Pölten
St.Pölten, , 3100
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Allgemeines Krankenhaus der Stadt Wien
Vienna, , 1090
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Mou/Mmci - Ppds
Brno, , 65653
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Fakultni nemocnice Hradec Kralove
Hradec Králové, ,
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Krajska nemocnice Liberec, a.s.
Liberec, , 46063
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Fakultni nemocnice Olomouc
Olomouc, , 79900
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Fakultni nemocnice Ostrava
Ostrava Poruba, , 70852
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Nemocnice Na Bulovce
Prague, , 16000
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Address
Vseobecna Fakultni Nemocnice V Praze
Praha, , 12808
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Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud
Amiens, , 80054
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CHU Angers
Angers, , 49100
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Hôpital Saint-André
Bordeau, ,
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CHRU de Tours
Chambray-lès-Tours, ,
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CHU Estaing
Clermont-Ferrand, , 63003
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Hôpital Albert Michallon La Tronche
La Tronche, , 38043
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CHRU Lille
Lille, , 59037
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Hôtel Dieu - Nantes
Nantes, , 44093
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CHU de Nice
Nice, , 6202
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Hôpital Saint Louis
Paris, , 75475
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Groupe Hospitalier Bichat Claude Bernard
Paris, , 75877
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Hospices Civils de Lyon
Pierre-Bénite, , 69310
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EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
Rennes, , 35042
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Hôpital Charles Nicolle
Rouen, , 76031
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Centre Hospitalier Universitaire de Saint Etienne
Saint-Priest-en-Jarez, , 42055
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Institut Gustave Roussy
Villejuif, , 94801
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Charité - Universitätsmedizin Berlin
Berlin, , 10117
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Ruhr Universität Bochum
Bochum, , 44791
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Elben Klinken Stade - Buxtehude
Buxtehude, , 21614
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Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , 81307
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Helios Klinikum Erfurt
Erfurt, , 99089
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Universitätsklinikum Essen
Essen, , 45147
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SRH Wald-Klinikum Gera GmbH
Gera, , 7548
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Universitatsklinikum Halle (Saale)
Halle, , 6097
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Universitätsklinikum Hamburg Eppendorf
Hamburg, , 20246
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Medizinische Hochschule Hannover
Hannover, , 30625
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University Clinic Heidelberg
Heidelberg, , 69120
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SLK Kliniken Heilbronn GmbH
Heilbronn, , 74078
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Address
Universitatsklinikum Schleswig-Holstein
Kiel, , 24105
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Uniklinik Köln
Köln, , 50937
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Universitatsklinikum Leipzig
Leipzig, , 04103
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Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, , 67063
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Universitätsklinik Magdeburg
Magdeburg, , 39014
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Klinikum Mannheim Universitätsklinikum gGmbH
Mannheim, , 76297
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Universitatsklinikum Munster
Münster, , 48149
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Fachklinik Hornheide
Münster, , 48157
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University Clinic Regensburg
Regensburg, , 93053
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Helios Klinikum Schwerin
Schwerin, , 19049
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Universitätsklinikum Tübingen
Tübingen, , 76297
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Universitätsklinikum Ulm
Ulm, , 89081
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Universitätsklinikum Würzburg
Würzburg, , 97080
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Address
Laiko General Hospital of Athens
Ampelokipoi, , 11526
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Address
Henry Dunant Hospital
Athens, , 11526
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Address
Metropolitan Hospital - First Oncology Clinic
Athens, , 18547
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Address
Metropolitan Hospital - Fourth Oncology Clinic
Athens, , 18547
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Address
Pepagni Hospital
Heraklion, , 71110
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Address
Medical Center of Athens
Maroúsi, , 15125
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Address
Interbalkan Medical Center of Thessaloniki
Pylaía, , TK57001
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Address
Theageneio Anticancer Oncology Hospital of Thessaloniki
Thessaloníki, , 54645
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Address
Papageorgiou General Hospital of Thessaloniki
Thessaloníki, , 56429
Status
Address
Bioclinic Thessaloniki (Galinos clinic)
Thessaloníki, , 86
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Address
HaEmek Medical Center
Afula, , 18101
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Address
Soroka University Medical Centre
Be'er Sheva, , 8410501
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Rambam Medical Center - PPDS
Haifa, , 31096
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Address
Hadassah Medical Center - PPDS
Jerusalem, , 9574425
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Rabin Medical Center - PPDS
Petah tikva, , 49100
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Sheba Medical Center - PPDS
Ramat Gan, ,
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Address
IRCCS Giovanni Paolo II Istituto Oncologico
Bari, , 70124
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Address
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, ,
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Address
Fondazione del Piemonte per l'Oncologia (IRCCS)
Candiolo, , 10060
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Address
Ospedale Policlinico San Martino
Genova, ,
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Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola, , 47014
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Istituto Europeo Di Oncologia
Milano, , 20141
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Istituto Nazionale Dei Tumori
Milano, ,
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Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, , 41100
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Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli, , 80131
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Address
Istituto Oncologico Veneto - I.R.C.C.S.
Padova, , 35128
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Address
Azienda Ospedaliera Universitaria Senese
Siena, , 53100
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Address
VU Medisch Centrum
Amsterdam, , 1081HV
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Address
Zuyderland Medisch Centrum
Heerlen, , 6419
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Address
Medisch Centrum Leeuwarden
Leeuwarden, , 8934
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Address
Leiden University Medical Center
Leiden, , 2333ZA
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Address
Radboud University Nijmegen Medical Centre
Nijmegen, , 6525GA
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Address
Universitair Medisch Centrum Utrecht
Utrecht, , 3584
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Maxima Medisch Centrum
Veldhoven, ,
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Address
Isala Klinieken
Zwolle, , 8025AB
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Address
Christchurch Hospital
Christchurch, , 8140
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Address
Dunedin Hospital
Dunedin, , 9054
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Address
Auckland City Hospital
Heidelberg, , 3084
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Address
Tauranga Hospital
Tauranga, , 3143
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Address
Wellington Hospital
Wellington, , 6021
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Address
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
Białystok, , 15-027
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Address
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, , 85796
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Address
Uniwersyteckie Centrum Kliniczne
Gdańsk, , 80952
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Address
NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
Lublin, , 20064
Status
Address
Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu
Poznań, , 60780
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Address
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, , 3004-561
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Address
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisboa, , 1649-035
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Address
Hospital CUF Tejo
Lisboa, , 1649-035
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Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon, , 1099-023
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Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto, , 4200-072
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Address
Onco Clinic Consult SA
Bucharest, , 022328
Status
Address
Oncology Center Sfantul Nectarie
Cluj-Napoca, , 400641
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Address
Medisprof SRL
Craiova, , 200396
Status
Address
Affidea Romania SRL
Dolj, , 200008
Status
Address
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, , 454087
Status
Address
Clinical Oncology Centre #1
Krasnodar, , 350040
Status
Address
Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy
Krasnoyarsk, , 660133
Status
Address
Kursk Regional Oncology Centre
Kursk, , 305524
Status
Address
PMI Euromedservice
Pushkin, , 196603
Status
Address
Ryazan Regional Clinical Oncology Dispensary
Ryazan', , 390011
Status
Address
FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF
Saint Petersburg, , 191758
Status
Address
Railway Clinical Hospital JSC RZhD
Saint Petersburg, , 195271
Status
Address
Regional Clinical Oncology Hospital
Yaroslavl, , 150040
Status
Address
Hospital Universitario A Coruña
A Coruña, , 15006
Status
Address
Hospital Universitario Germans Trias i Pujol
Badalona, , 08911
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Address
Hospital de La Santa Creu i Sant Pau
Barcelona, , 08025
Status
Address
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona, , 08028
Status
Address
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , 08035
Status
Address
ICO l'Hospitalet - Hospital Duran i Reynals
Córdoba, , 14004
Status
Address
Hospital Universitario Virgen de La Arrixaca
El Palmar, ,
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Address
Hospital Universitario de Jaen
Jaén, , 23007
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Address
C.H. Regional Reina Sofia - PPDS
L'Hospitalet De Llobregat, , 08904
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Address
Hospital Universitario 12 de Octubre
Madrid, , 28041
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Hospital Universitario HM Sanchinarro - CIOCC
Madrid, , 28050
Status
Address
Hospital General Universitario Gregorio Maranon
Madrid, , 4628007
Status
Address
Hospital Universitario Virgen de la Victoria
Málaga, , 29789
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Hospital Universitario Virgen Macarena
Sevilla, , 41009
Status
Address
Consorcio Hospital General Universitario de Valencia
Valencia, ,
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Address
Addenbrooke's Hospital
Cambridge, , CB20QQ
Status
Address
Castle Hill Hospital
Cottingham, , HU165JQ
Status
Address
Leicester Royal Infirmary
Leicester, , LE15WW
Status
Address
Nottingham City Hospital
Nottingham, , BG72UH
Status
Address
Royal Cornwall Hospital
Truro, , TR13LJ