A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract
NCT ID: NCT07218380
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2025-12-12
2033-05-31
Brief Summary
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Vepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab.
Study participation could last up to approximately 6 years.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vepugratinib + EV + Pembrolizumab (Safety Lead In)
Vepugratinib administered orally with EV + pembrolizumab administered IV
Vepugratinib
Administered orally
EV
Administered by IV infusion
Pembrolizumab
Administered by IV infusion
Vepugratinib + Enfortumab Vedotin (EV) + Pembrolizumab
Vepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion.
Vepugratinib
Administered orally
EV
Administered by IV infusion
Pembrolizumab
Administered by IV infusion
Placebo + EV + Pembrolizumab
Placebo administered orally, and EV + pembrolizumab administered by IV infusion.
Placebo
Administered orally
EV
Administered by IV infusion
Pembrolizumab
Administered by IV infusion
Interventions
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Vepugratinib
Administered orally
Placebo
Administered orally
EV
Administered by IV infusion
Pembrolizumab
Administered by IV infusion
Eligibility Criteria
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Inclusion Criteria
* Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer.
* Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Have adequate laboratory parameters
Exclusion Criteria
* Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events (\[CTCAE\] version 5.0) from prior neoadjuvant or adjuvant systemic therapy.
* Have ongoing sensory or motor neuropathy of Grade 2 or higher
* Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.
* Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Clearview Cancer Institute
Huntsville, Alabama, United States
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
TRIO-US (Translational Research in Oncology-US)
Los Angeles, California, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer (TMPN)
Torrance, California, United States
AdventHealth Medical Group - Porter
Denver, Colorado, United States
Colorado West Healthcare System - Grand Valley Oncology
Grand Junction, Colorado, United States
AdventHealth Orlando
Orlando, Florida, United States
St. Luke's Cancer Institute: Boise
Boise, Idaho, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Franciscan Health
Indianapolis, Indiana, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Columbia University Irving Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Lancaster General Hospital - Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Avera Cancer Institute- Research
Sioux Falls, South Dakota, United States
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
USO-Texas Oncology-Central/South Texas
Austin, Texas, United States
World Research Link
Baytown, Texas, United States
Parkland Health and Hospital System
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Nova Oncology
McAllen, Texas, United States
US Oncology Research Network
The Woodlands, Texas, United States
USO - Texas Oncology - Northeast Texas
Tyler, Texas, United States
USO - Virginia Oncology Associates
Norfolk, Virginia, United States
Box Hill Hospital
Box Hill, , Australia
Mater Misericordiae Limited
Brisbane, , Australia
GenesisCare - Campbelltown
Campbelltown, , Australia
Austin Health
Heidelberg, , Australia
Macquarie University
Macquarie University, , Australia
Sir Charles Gairdner Hospital
Perth, , Australia
Prince of Wales Hospital
Randwick, , Australia
Western Health-Sunshine & Footscray Hospitals
St Albans, , Australia
Calvary Mater Newcastle
Waratah, , Australia
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, , Brazil
CPAM - Centro de Pesquisas da Amazônia
Belém, , Brazil
Oncocentro de Minas Gerais
Belo Horizonte, , Brazil
Hospital Mario Penna
Belo Horizonte, , Brazil
Hospital Tacchini
Bento Gonçalves, , Brazil
Centro Integrado de Oncologia de Curitiba
Curitiba, , Brazil
IOP Pesquisa
Curitiba, , Brazil
Centro Paraibano De Oncologia - Oncoclínicas
João Pessoa, , Brazil
Hospital de Cancer de Londrina
Londrina, , Brazil
Liga Norte Riograndense Contra o Câncer
Natal, , Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Porto Alegre, , Brazil
Hospital São Lucas da PUCRS
Porto Alegre, , Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, , Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Rio de Janeiro, , Brazil
Instituto D'Or Pesquisa e Ensino
Rio de Janeiro, , Brazil
Nucleo de Oncologia da Bahia
Salvador, , Brazil
Clinica Amo - Rio Vermelho
Salvador, , Brazil
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, , Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, , Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, , Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, , Brazil
Hospital BP
São Paulo, , Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, , Brazil
Centro Paulista de Oncologia Clínica
São Paulo, , Brazil
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, , Brazil
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, , Canada
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, , Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, , Canada
BC Cancer Vancouver
Vancouver, , Canada
Peking University First Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Beijing Cancer hospital
Beijing, , China
Beijing GoBroad Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Xiangya Hospital Central South University
Changsha, , China
Hunan Cancer Hospital
Changsha, , China
West China Hospital, Sichuan University
Chengdu, , China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Chongqing University Cancer Hospital
Chongqing, , China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Zhujiang Hospital
Guangzhou, , China
Sun Yat-Sen University Cancer Centre
Guangzhou, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
Sir Run Run Shaw Hospital
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, , China
Ningbo First Hospital
Ningbo, , China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Huashan Hospital, Fudan University
Shanghai, , China
Shanghai Tenth People's Hospital
Shanghai, , China
The Second Hospital of Tianjin Medical University
Tianjin, , China
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, , China
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Fakultni Thomayerova nemocnice
Prague, , Czechia
Fakultni nemocnice Motol
Prague, , Czechia
Aalborg Universitetshospital, Syd
Aalborg, , Denmark
Aarhus Universitetshospital, Skejby
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Herlev and Gentofte Hospital
Copenhagen, , Denmark
Næstved Sygehus
Næstved, , Denmark
Institut de Cancérologie de l'Ouest
Angers, , France
CHU de Bordeaux Hop St ANDRE
Bordeaux, , France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, , France
CHRU de Brest
Brest, , France
Centre François Baclesse
Caen, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon Cedex08, , France
Institut Paoli-Calmettes
Marseille, , France
Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire Carém -T
Nîmes, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Oncopole Claudius Regaud
Toulouse, , France
Gustave Roussy
Villejuif, , France
Helios Klinikum Bad Saarow
Bad Saarow, , Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, , Germany
Evangelisches Krankenhaus Bielefeld - Johannesstift
Bielefeld, , Germany
Johanniter-Krankenhaus
Bonn, , Germany
Studienzentrum Bayenthal Urologische Partnerschaft Köln
Cologne, , Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, , Germany
Urologicum Duisburg Fachärztesozietät - Walsum
Duisburg, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Krankenhaus Nordwest GmbH
Frankfurt, , Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
NCT
Heidelberg, , Germany
InVO Institut für Versorgungsforschung in der Onkologie
Koblenz, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Klinikum Rechts Der Isar Der Technischen Universität München
Munich, , Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, , Germany
Klinikum Nürnberg Nord
Nuremberg, , Germany
Studienpraxis Urologie
Nürtingen, , Germany
Universitätsmedizin Rostock
Rostock, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Országos Onkológiai Intézet
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
Nyíregyháza, , Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, , Hungary
Instituto Tumori Giovanni Paolo II
Bari, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Istituto Oncologico Veneto IRCCS
Padua, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Istituto Nazionale Tumori Regina Elena
Rome, , Italy
National Cancer Center Hospital
Chūōku, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Hirosaki University Hospital
Hirosaki, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
National Cancer Center Hospital East
Kashiwa, , Japan
St. Marianna University Hospital
Kawasaki, , Japan
Kagawa University Hospital
Kita-ku, , Japan
Kobe City Medical Center General Hospital
Kobe, , Japan
The Cancer Institute Hospital of JFCR
Kōtoku, , Japan
Kyoto University Hospital
Kyoto, , Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, , Japan
Aichi Cancer Center Hospital
Nagoya, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Gunma Prefectural Cancer Center
Otashi, , Japan
Hokkaido University Hospital
Sapporo, , Japan
Tohoku University Hospital
Sendai, , Japan
Iwate Medical University Hospital
Shiwa-gun Yahaba-cho, , Japan
Tokushima University Hospital
Tokushima, , Japan
Tsukuba University Hospital
Tsukuba, , Japan
Amsterdam UMC, locatie VUmc
Amsterdam, , Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
IN VIVO
Bydgoszcz, , Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie
Koszalin, , Poland
Pratia MCM Krakow
Krakow, , Poland
AIDPORT Sp. z o.o.
Skórzewo, , Poland
GYNCENTRUM Szpital
Sosnowiec, , Poland
Luxmed Onkologia sp. z o. o.
Warsaw, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, , Poland
WSD MEDI
Warsaw, , Poland
Medical Concierge Centrum Medyczne
Warsaw, , Poland
Szpital Grochowski im. dr med. Rafała Masztaka SPZOZ
Warsaw, , Poland
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wrocaw, , Poland
National Cancer Center
Goyang-si, , South Korea
Chungnam national university hospital
Junggu, , South Korea
Gachon University Gil Medical Center
Namdong-gu, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Hospital Infanta Cristina
Badajoz, , Spain
Institut Català d'Oncologia (ICO) - Badalona
Badalona, , Spain
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital General Universitario de Elche
Elche, , Spain
Institut Català d'Oncologia (ICO) - Girona
Girona, , Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Hospitalet, , Spain
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, , Spain
Hospital La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
H.R.U Málaga - Hospital General
Málaga, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, , Spain
Hospital Universitari Sant Joan de Reus
Reus, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Arnau de Vilanova
Valencia, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Chi Mei Medical Center
Tainan, , Taiwan
Chi Mei Hospital - Liouying Branch
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
National Taiwan University Cancer Center (NTUCC)
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Adana Medical Park Seyhan Hastanesi
Adana, , Turkey (Türkiye)
Sakarya University School of Medicine
Adapazarı, , Turkey (Türkiye)
Ankara University Health Practice and Research Hospitals
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi
Ankara, , Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi
Antalya, , Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, , Turkey (Türkiye)
Trakya University
Edirne, , Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, , Turkey (Türkiye)
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi
Izmir, , Turkey (Türkiye)
Huddersfield Royal Infirmary
Huddersfield, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Royal Marsden Hospital (Sutton)
London, , United Kingdom
Royal Marsden Hospital (Chelsea)
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
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Related Links
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Lilly Trials site
Other Identifiers
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J4G-MC-JZVD
Identifier Type: OTHER
Identifier Source: secondary_id
2025-522855-25-00
Identifier Type: CTIS
Identifier Source: secondary_id
27333
Identifier Type: -
Identifier Source: org_study_id
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