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NCT07106762RecruitingPhase 2/3

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy

IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment

Source: ClinicalTrials.gov · Last updated 29 Jul 2026

Brief summary (registry, in English)

A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
470 (estimated)
First submitted
5 Aug 2025
Start date
30 Sept 2025
Primary completion date
26 Jan 2029
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT07106762

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 470
  • From 30 Sept 2025 to the primary completion date, 26 Jan 2029
  • 163 sites in 22 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

  • Participants must not have platinum-based chemotherapy exposure within 12 months.
  • Participants must not have received \>2 prior regimens irrespective of the setting.
  • Participants must not have prior therapy with topoisomerase 1 inhibitor.

Lab values

  • Participants must not have prior ADC therapy targeting EGFR or HER3.

Other

  • Participants must not have active, untreated brain metastases.
  • Other protocol-defined inclusion/exclusion criteria apply.

Who the study is looking for

  • Participants must have histologically confirmed advanced urothelial carcinoma.
  • Participants must be eligible to receive platinum-based chemotherapy.
  • Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy.
  • Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment.
  • Participants must have ≥ 1 measurable lesion per RECIST v1.1.
  • Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (163)

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

SiteCityCountrySite status
Hospital Italiano de Buenos Aires
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ABBArgentinaRecruiting
Instituto Alexander Fleming
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CABAArgentinaRecruiting
Hospital Británico de Buenos Aires
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CABAArgentinaRecruiting
Asociación de Beneficencia Hospital Sirio Libanés
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Ciudad Autonoma de Buenos AiresArgentinaRecruiting
IONC Instituto Oncologico de Cordoba Fundacion Richardet Longo
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CórdobaArgentinaRecruiting
Fundacion Centro Oncologico de Integracion Regional
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MendozaArgentinaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Klinik Ottakring
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ViennaAustriaRecruiting
Medizinische Universität Wien
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ViennaAustriaRecruiting
Austin Health
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HeidelbergAustraliaRecruiting
Macquarie University
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Macquarie UniversityAustraliaRecruiting
GenesisCare - North Shore
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St LeonardsAustraliaRecruiting
UZ Gent
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GhentBelgiumRecruiting
AZ Maria Middelares
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GhentBelgiumRecruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
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LiègeBelgiumRecruiting
ZAS Augustinus
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WilrijkBelgiumRecruiting
-
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Porto AlegreBrazilNot yet recruiting
-
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Rio de JaneiroBrazilNot yet recruiting
-
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SalvadorBrazilNot yet recruiting
-
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São PauloBrazilNot yet recruiting
-
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EdmontonCanadaNot yet recruiting
McGill University Health Centre
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MontrealCanadaRecruiting
The Ottawa Hospital Cancer Centre
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OttawaCanadaRecruiting
Princess Margaret Cancer Centre
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TorontoCanadaRecruiting
Ospedale Regionale Bellinzona e Valli
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BellinzonaSwitzerlandRecruiting
Kantonsspital Graubunden
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ChurSwitzerlandRecruiting
Cantonal Hospital St Gallen
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Sankt GallenSwitzerlandRecruiting
Universitätsspital Zürich
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ZurichSwitzerlandRecruiting
-
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BeijingChinaNot yet recruiting
-
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BeijingChinaNot yet recruiting
-
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ChangshaChinaNot yet recruiting
Sichuan Cancer Hospital
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ChengduChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
-
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FuzhouChinaNot yet recruiting
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaRecruiting
The First Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaRecruiting
Sun Yat-sen University Cancer Center
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GuangzhouChinaRecruiting
Zhujiang Hospital
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GuangzhouChinaRecruiting
-
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HangzhouChinaNot yet recruiting
Shandong Cancer Hospital
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JinanChinaRecruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaRecruiting
-
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NanjingChinaNot yet recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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NanjingChinaRecruiting
-
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NantongChinaNot yet recruiting
The Affiliated Hospital of Qingdao University
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QingdaoChinaRecruiting
-
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ShanghaiChinaNot yet recruiting
-
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TianjinChinaNot yet recruiting
Tianjin Medical University Cancer Institute & Hospital
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TianjinChinaRecruiting
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
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WuhanChinaRecruiting
-
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XiamenChinaNot yet recruiting
Yantai Yuhuangding Hospital
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YantaiChinaRecruiting
-
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ZhengzhouChinaNot yet recruiting
-
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BrnoCzechiaNot yet recruiting
-
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Hradec KrálovéCzechiaNot yet recruiting
-
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PragueCzechiaNot yet recruiting
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
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BerlinGermanyRecruiting
Universitaetsklinikum Duesseldorf
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DüsseldorfGermanyRecruiting
Krankenhaus Nordwest GmbH
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FrankfurtGermanyRecruiting
Universitaetsklinikum Hamburg-Eppendorf
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HamburgGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
NCT
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HeidelbergGermanyRecruiting
Marienhospital Herne
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HerneGermanyRecruiting
Universitätsklinikum Jena
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JenaGermanyRecruiting
Universitaetsklinikum Schleswig Holstein Campus Kiel
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KielGermanyRecruiting
TUM Klinikum
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MunichGermanyRecruiting
Klinikum Nürnberg Nord
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NurembergGermanyRecruiting
Studienpraxis Urologie
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NürtingenGermanyRecruiting
Caritas-Krankenhaus St. Josef
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RegensburgGermanyRecruiting
Universitaetsklinikum Ulm
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UlmGermanyRecruiting
Hospital Infanta Cristina
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BadajozSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Hospital Universitario Virgen del Rocio
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SevilleSpainRecruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainRecruiting
CHU de Bordeaux Hop St ANDRE
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BordeauxFranceRecruiting
CHRU de Brest
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BrestFranceRecruiting
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
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Clermont-FerrandFranceRecruiting
Centre Leon Berard
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Lyon Cedex08FranceRecruiting
-
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MarseilleFranceWithdrawn
Centre Antoine Lacassagne
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NiceFranceRecruiting
Hôpital Européen Georges Pompidou
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ParisFranceRecruiting
Groupe hospitalier Paris saint Joseph
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ParisFranceRecruiting
Institut de Cancérologie de l'Ouest
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Saint-HerblainFranceRecruiting
CHU Strasbourg-Hautepierre
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StrasbourgFranceRecruiting
Hopital Foch
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SuresnesFranceRecruiting
Gustave Roussy
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VillejuifFranceRecruiting
-
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GlasgowUnited KingdomNot yet recruiting
Royal Marsden Hospital (Sutton)
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LondonUnited KingdomRecruiting
St. Bartholomew's Hospital
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LondonUnited KingdomRecruiting
-
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SheffieldUnited KingdomNot yet recruiting
-
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CorkIrelandNot yet recruiting
Tallaght University Hospital
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DublinIrelandRecruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Hadassah medical Center
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JerusalemIsraelRecruiting
Rabin Medical Center
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Petah TikvaIsraelRecruiting
Yitzhak Shamir Medical Center
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TsrifinIsraelRecruiting
A.O.U.C Policlinico di Bari
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BariItalyRecruiting
Istituto Oncologico Veneto IRCCS
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Castelfranco VenetoItalyRecruiting
IRCCS AOM Azienda Ospedaliera Metropolitana
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GenoaItalyRecruiting
Ospedale San Raffaele
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MilanItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria Federico II
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NaplesItalyRecruiting
Azienda Ospedaliero Universitaria di Parma
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ParmaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Istituto Nazionale Tumori Regina Elena
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RomeItalyRecruiting
-
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Bunkyo-kuJapanNot yet recruiting
-
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KawasakiJapanNot yet recruiting
-
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Koto-kuJapanNot yet recruiting
-
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ToyomaJapanNot yet recruiting
-
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AmsterdamNetherlandsNot yet recruiting
-
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BredaNetherlandsNot yet recruiting
-
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LeeuwardenNetherlandsNot yet recruiting
Akershus universitetssykehus
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LørenskogNorwayRecruiting
Sykehuset Østfold Kalnes
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SarpsborgNorwayRecruiting
Sykehuset i Vestfold
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TønsbergNorwayRecruiting
Institutul Oncologic Cluj
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Cluj-NapocaRomaniaRecruiting
Centrul de Oncologie "Sfântul Nectarie"
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CraiovaRomaniaRecruiting
Institutul Regional de Oncologie
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IașiRomaniaRecruiting
Sahlgrenska Universitetssjukhuset
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GothenburgSwedenRecruiting
-
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MalmöSwedenNot yet recruiting
Karolinska Universitetssjukhuset Solna
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SolnaSwedenRecruiting
Texas Oncology - West Texas
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AbileneUnited StatesRecruiting
-
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AustinUnited StatesNot yet recruiting
Johns Hopkins Hospital
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BaltimoreUnited StatesRecruiting
-
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BostonUnited StatesNot yet recruiting
-
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BuffaloUnited StatesWithdrawn
University of Virginia Health System
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CharlottesvilleUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Fairview Hospital
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ClevelandUnited StatesRecruiting
The James Outpatient Care West Campus
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ColumbusUnited StatesRecruiting
Rocky Mountain Cancer Centers, LLP
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DenverUnited StatesRecruiting
Karmanos Cancer Institute
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DetroitUnited StatesRecruiting
-
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DillonUnited StatesWithdrawn
Shaw Cancer Center
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EdwardsUnited StatesRecruiting
-
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FullertonUnited StatesNot yet recruiting
-
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GilbertUnited StatesNot yet recruiting
University of Kentucky Chandler Medical Center
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LexingtonUnited StatesRecruiting
Cleveland Clinic - Hillcrest Hospital
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Mayfield HeightsUnited StatesRecruiting
Miami Cancer Institute at Baptist Health, Inc.
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MiamiUnited StatesRecruiting
Intermountain Medical Center
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MurrayUnited StatesRecruiting
-
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NashvilleUnited StatesNot yet recruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesRecruiting
-
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NorfolkUnited StatesNot yet recruiting
Palo Alto Center-Palo Alto Medical Foundation Research Institute
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Palo AltoUnited StatesRecruiting
-
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PortlandUnited StatesNot yet recruiting
University of California Davis (UC Davis) Comprehensive Cancer Center
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SacramentoUnited StatesRecruiting
Sutter Health - Sutter Institute for Medical Research
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SacramentoUnited StatesRecruiting
Pacific Hematology Oncology Associates
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San FranciscoUnited StatesRecruiting
Sutter Santa Rosa
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Santa RosaUnited StatesRecruiting
University of Washington Medical Center - Montlake
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SeattleUnited StatesRecruiting
-
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SeattleUnited StatesNot yet recruiting
Fred Hutchinson Cancer Center
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SeattleUnited StatesRecruiting
St George Regional Hospital Cancer Center
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St. GeorgeUnited StatesRecruiting
Sibley Memorial Hospital
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Washington D.C.United StatesRecruiting

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