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NCT04211337Active, not recruitingPhase 3

A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer

A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)

Source: ClinicalTrials.gov · Last updated 19 Mar 2026

Brief summary (registry, in English)

The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
291 (actual)
First submitted
24 Dec 2019
Start date
11 Feb 2020
Primary completion date
22 May 2023
Lead sponsor
Loxo Oncology, Inc.
NCT number
NCT04211337
EU CT number
2023-506782-56-00
EudraCT number
2019-001978-28

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 291
  • From 11 Feb 2020 to the primary completion date, 22 May 2023
  • 123 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Other malignancy unless nonmelanoma skin cancer, carcinoma in situ or malignancy diagnosed ≥2 years previously and not currently active. Participants with multiple endocrine neoplasia type 2 (MEN2) associated pheochromocytoma may be eligible.

Other illness

  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months, history of Torsades de pointes, or prolongation of the QTcF \>470 milliseconds on more than one electrocardiogram (ECG) during screening. Participants who are intended to receive vandetanib if randomized to the control arm are ineligible if QTcF is \>450 milliseconds.
  • Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing uncontrolled intercurrent illness.
  • Active hemorrhage or at significant risk for hemorrhage.

Other

  • An additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment. Examples include, but are not limited to RAS or BRAF gene mutations and NTRK gene fusions.
  • Symptomatic central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.

Criteria the registry did not label

  • At least 18 years of age (participants as young as 12 years of age will be allowed if permitted by local regulatory authorities).
  • Histologically or cytologically confirmed, unresectable, locally advanced and/or metastatic MTC and no prior history of treatment with kinase inhibitors for advanced/metastatic disease.
  • Radiographic progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at screening compared with a previous image taken within the prior 14 months as assessed by the BICR. Participants with measurable or non-measurable but evaluable disease are eligible; however, participants with non-measurable disease may not have disease limited to bone sites only.
  • A defined/acceptable RET gene alteration identified in a tumor, germline deoxyribonucleic acid (DNA) or blood sample.
    • Tumor tissue in sufficient quantity to allow for retrospective central analysis of RET mutation status
  • Eastern Cooperative Oncology Group performance status score of 0 to 2.
  • Adequate hematologic, hepatic, and renal function and electrolytes.
  • Men and women of childbearing potential must agree to use a highly effective contraceptive method during treatment with study drug and for 4 months following the last dose of study drug.
  • Ability to swallow capsules.

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (123)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Alfred Hospital
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MelbourneAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
Sir Charles Gairdner Hospital
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PerthAustraliaUnknown status
Royal North Shore Hospital
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St LeonardsAustraliaUnknown status
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumCompleted
Fundação Pio XII - Hospital de Câncer de Barretos
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BarretosBrazilUnknown status
Oncocentro
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Belo HorizonteBrazilUnknown status
Centro de Pesquisa Sao Lucas
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CampinasBrazilUnknown status
Hospital de Cancer de Londrina
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LondrinaBrazilUnknown status
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
Hospital de Clínicas de Ribeirão Preto
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Ribeirão PretoBrazilUnknown status
Grupo COI - Clínicas Oncológicas Integradas
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Rio de JaneiroBrazilUnknown status
Grupo Oncoclínicas Botafogo
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Rio de JaneiroBrazilUnknown status
Instituto Nacional de Câncer - INCA
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Rio de JaneiroBrazilUnknown status
Icesp - Instituto Do Câncer Do Estado de São Paulo
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São PauloBrazilUnknown status
Hospital Sirio Libanes
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São PauloBrazilUnknown status
Centro Paulista de Oncologia Clínica
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São PauloBrazilUnknown status
Instituto D'Or de Pesquisa e Ensino (IDOR)
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São PauloBrazilUnknown status
Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
Beijing Tongren Hospital affiliated to Capital Medical University
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BeijingChinaUnknown status
Jilin Cancer Hospital
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ChangchunChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
Sun Yat-Sen University Cancer Centre
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GuangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital
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HangzhouChinaUnknown status
Zhejiang Provincial People's Hospital
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Anhui Provincial Hospital
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HefeiChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
First Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
Gansu Cancer Hospital
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LanzhouChinaUnknown status
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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NanjingChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Univerzita Karlova 2 Lekarska Fakulta
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Prague 5CzechiaCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Universitaetsklinikum - Essen
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EssenGermanyCompleted
Medizinische Hochschule Hannover
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HanoverGermanyCompleted
Universitaetsklinikum Magdeburg AöR
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MagdeburgGermanyCompleted
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyCompleted
München Campus Großhadern - Medizinische Klinik und Poliklinik IV
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MünchenGermanyCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Centre Hospitalier Universitaire D'Angers
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AngersFranceCompleted
Institut Bergonie
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BordeauxFranceCompleted
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
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Bouches-du-RhôneFranceCompleted
Centre Francois Baclesse
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Caen Cedex 5FranceCompleted
Centre Jean Perrin
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Clermont Ferrand Cedex1FranceCompleted
Centr Georges Francois Leclerc
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DijonFranceCompleted
Hopital Claude Huriez - CHU de Lille
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LilleFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
University Hospitals Pitie Salpetriere - Charles Foix
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ParisFranceCompleted
Centre Paul Strauss
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STRASBOURG, AlsaceFranceCompleted
Institut Universitaire Du Cancer Toulouse-Oncopole
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Toulouse Cedex 9FranceCompleted
Institut Gustave Roussy
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VillejuifFranceCompleted
Velindre Cancer Centre
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CardiffUnited KingdomUnknown status
Gartnavel General Hospital
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GlasgowUnited KingdomUnknown status
University College London Hospital
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LondonUnited KingdomUnknown status
Royal Marsden Hospital (Sutton)
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LondonUnited KingdomUnknown status
Royal Marsden Hospital (Chelsea)
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LondonUnited KingdomUnknown status
Weston Park Hospital
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SheffieldUnited KingdomUnknown status
Alexandra Hospital
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AthensGreeceCompleted
Hadassah medical Center
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JerusalemIsraelUnknown status
Rabin Medical Center
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Petah TikvaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Post Graduate Institute of Medical Education & Research (PGIMER)
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ChandigarhIndiaUnknown status
Apollo Gleneagles Hospitals Kolkata
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KolkataIndiaUnknown status
HCG Manavata Cancer Centre
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NashikIndiaUnknown status
Deenanath Mangeshkar Hospital & Research Centre
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PuneIndiaUnknown status
Grant Medical Foundation Ruby Hall Clinic
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PuneIndiaUnknown status
Regional Cancer Centre - Thiruvananthapuram
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ThiruvananthapuramIndiaUnknown status
Istituto Auxologico Italiano
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MilanoItalyCompleted
Azienda Ospedaliero Universitaria Pisana
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PisaItalyCompleted
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyCompleted
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyCompleted
National Hospital Organization Kyushu Medical Center
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FukuokaJapanUnknown status
National Cancer Center Hospital East
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KashiwaJapanUnknown status
Kobe University Hospital
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KobeJapanUnknown status
Japanese Foundation for Cancer Research
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KotoJapanUnknown status
Aichi Cancer Center Hospital
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NagoyaJapanUnknown status
Hokkaido University Hospital
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SapporoJapanUnknown status
Osaka University Hospital
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SuitaJapanUnknown status
Yokohama City University Hospital
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YokohamaJapanUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
Chungbuk National University Hospital
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JungbukSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeongnamSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Netherlands Cancer Institute
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AmsterdamNetherlandsCompleted
Universitair Medisch Centrum Groningen
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GroningenNetherlandsCompleted
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsCompleted
University Hospital Maastricht
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MaastrichtNetherlandsCompleted
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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GliwicePolandActive, not recruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandActive, not recruiting
Clinic Evimed
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ChelyabinskRussiaUnknown status
Endocrinology Research Center of Rosmedtechnologies
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MoscowRussiaUnknown status
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
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MoscowRussiaUnknown status
A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological
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ObninskRussiaUnknown status
Saint Petersburg State University
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Saint PetersburgRussiaUnknown status
Saint-Petersburg city clinical oncology dispensary
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Saint PetersburgRussiaUnknown status
University of Michigan
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Ann ArborUnited StatesUnknown status
Emory University
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AtlantaUnited StatesUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
University of Chicago Medical Center
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ChicagoUnited StatesUnknown status
University of Cincinnati Medical Center
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CincinnatiUnited StatesUnknown status
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
City of Hope National Medical Center
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DuarteUnited StatesUnknown status
University of Texas - MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
UCLA Hematology/Oncology - Westwood (Building 100)
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Los AngelesUnited StatesUnknown status
University of Wisconsin Hospitals and Clinics
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MadisonUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
University of Pennsylvania Hospital
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PhiladelphiaUnited StatesUnknown status
University of California Davis (UC Davis) Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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TorranceUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.