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NCT06486441Active, not recruitingPhase 3

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

The goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy, versus the treatment of physician's choice (TPC). The primary objectives of this study are to evaluate the effect of SG compared to TPC on progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
640 (estimated)
First submitted
27 Jun 2024
Start date
28 Aug 2024
Primary completion date
Jun 2029
Lead sponsor
Gilead Sciences
NCT number
NCT06486441
EU CT number
2024-511957-23-00
EudraCT number
2024-511957-23

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 640
  • From 28 Aug 2024 to the primary completion date, Jun 2029
  • 190 sites in 19 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 who are candidates for curative-intent therapy at the time of study enrollment.
  • Participants eligible for rechallenge with platinum-based chemotherapy as determined by the investigator.
  • Received any prior treatment with a Trop-2-directed antibody-drug conjugate (ADC).
  • Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months prior to randomization.

Other illness

  • Have an active second malignancy.
  • Have an active serious infection requiring systemic antimicrobial therapy.

Lab values

  • Have a positive serum pregnancy test or are breastfeeding for participants who are assigned female at birth.
    • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Other

  • Uterine leiomyosarcoma and endometrial stromal sarcomas are excluded.

Who the study is looking for

  • Documented evidence of recurrent/persistent endometrial cancer (endometrial carcinoma or carcinosarcoma).
  • Up to 3 prior lines of systemic therapy for endometrial cancer, including systemic platinum-based chemotherapy and anti-PD-1/PD-L1 therapy, either in combination or separately.
  • Eligible for treatment with either doxorubicin or paclitaxel as determined by the investigator.
  • Radiologically evaluable disease (either measurable or nonmeasurable) by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status score of 0 or 1.
  • Adequate organ function

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

Full criteria on ClinicalTrials.gov

Sites (190)

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

SiteCityCountrySite status
Chris O'Brien Lifehouse
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CamperdownAustraliaUnknown status
Canberra Hospital
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CanberraAustraliaUnknown status
Monash Health
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ClaytonAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
Sir Charles Gairdner Hospital
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MurdochAustraliaUnknown status
Mater Cancer Care Centre
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South BrisbaneAustraliaUnknown status
Clínica de Neoplasias Litoral
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ItajaíBrazilUnknown status
Centro de Pesquisa Clínica do Hospital Moinhos de Vento
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Porto AlegreBrazilUnknown status
Hospital Santa Joana Recife
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RecifeBrazilUnknown status
Instituto D'Or Pesquisa e Ensino
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Rio de JaneiroBrazilUnknown status
Ensino e Terapia de Inovação Clínica AMO - ETICA
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SalvadorBrazilUnknown status
BP - A Beneficência Portuguesa da São Paulo / Hospital BP Mirante
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São PauloBrazilUnknown status
Instituto do Câncer do Estado de São Paulo
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São PauloBrazilUnknown status
AC Camargo Cancer Center, Fundacao Antonio Prudente
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São PauloBrazilUnknown status
DASA - Hospital 9 de Julho
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São PauloBrazilUnknown status
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaUnknown status
London Health Sciences Centre
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LondonCanadaUnknown status
McGill University Health Centre Glen Site
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MontrealCanadaUnknown status
CIC-CHU de Québec-Université Laval- Hôpital de l'Enfant-Jésus
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QuébecCanadaUnknown status
Sunnybrook Research Institute
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TorontoCanadaUnknown status
Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
West China Second Hospital of Sichuan University
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ChengduChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
Guangxi Medical University Affiliated Tumor Hospital
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Guangxi Zhuang Autonomous RegionChinaUnknown status
Sun Yat Sen Memorial Hospital of Sun Yat sen University
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GuangzhouChinaUnknown status
Women's hospital school of medicine Zhejiang University
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HangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Jiangxi maternal and child health hospital
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NanchangChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Shanghai Tenth People's Hospital
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ShanghaiChinaUnknown status
Tianjin Medical University Cancer Institute & Hospital
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TianjinChinaUnknown status
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
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WuhanChinaUnknown status
Tongji Hospital Tongji Medical College of Hust
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WuhanChinaUnknown status
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Nemocnice AGEL Nový Jičín a.s.
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Nový JičínCzechiaActive, not recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaActive, not recruiting
Fakultni nemocnice Bulovka
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PragueCzechiaActive, not recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaActive, not recruiting
Hochtaunus-Kliniken gGmbH
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Bad HomburgGermanyActive, not recruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
Medizinische Hochschule Hannover
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HanoverGermanyActive, not recruiting
Universitaet Leipzig
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LeipzigGermanyActive, not recruiting
Universitat Heidelberg
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MannheimGermanyActive, not recruiting
Klinikum rechts der Isar der TU Muenchen AöR
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MunichGermanyActive, not recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitario Donostia
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DonostiaSpainActive, not recruiting
Hospital Universitario de Jaén
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JaénSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
University Hospital Son Espases
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PalmaSpainActive, not recruiting
Parc Tauli Hospital Universitari
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SabadellSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Centre Francois Baclesse
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Caen Cedex 5FranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Institut De Cancerologie De L Ouest
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Saint-Herblain CedexFranceActive, not recruiting
Institut De Cancerologie De Lorraine
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Vandouvre Les NancyFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Birmingham Heartlands Hospital
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BirminghamUnited KingdomUnknown status
Cambridge University Hospitals NHS Foundation Trust
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CambridgeUnited KingdomUnknown status
Leeds Teaching Hospitals NHS Trust
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LeedsUnited KingdomUnknown status
University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary
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LeicesterUnited KingdomUnknown status
University College London Hospitals
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LondonUnited KingdomUnknown status
East and North Hertfordshire NHS Trust (Mount Vernon Cancer Centre)
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NorthwoodUnited KingdomUnknown status
Areteio Hospital
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AthensGreeceActive, not recruiting
General Hospital Of Messinia
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KalamataGreeceActive, not recruiting
Mitera S.A.
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MarousiGreeceActive, not recruiting
General Hospital Of Patras Agios Andreas
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PatrasGreeceActive, not recruiting
St. Luke's Hospital S.A.
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ThessalonikiGreeceActive, not recruiting
Hong Kong Sanatorium & Hospital
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Happy ValleyHong Kong SAR ChinaUnknown status
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Prince of Wales Hospital
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New TerritoriesHong Kong SAR ChinaUnknown status
Hillel Yaffe Medical Center
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HaderaIsraelUnknown status
Rambam Health Care Campus
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HaifaIsraelUnknown status
Wolfson Medical Center
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HolonIsraelUnknown status
Hadassah medical Center
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JerusalemIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Sourasky T.A.M.C.
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Tel AvivIsraelUnknown status
Centro di Riferimento Oncologico di Aviano
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AvianoItalyActive, not recruiting
Careggi University Hospital
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FlorenceItalyActive, not recruiting
Alessandro Manzoni Hospital
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LeccoItalyActive, not recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyActive, not recruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyActive, not recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Istituto Oncologico Veneto
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PadovaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
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TurinItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Chiba Cancer Center
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ChibaJapanUnknown status
The Jikei University Kashiwa Hospital
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ChibaJapanUnknown status
Hyogo Cancer Center
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HyōgoJapanUnknown status
St Marianna University Hospital
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KanagawaJapanUnknown status
Mie University Hospital
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MieJapanUnknown status
Okayama University Hospital
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OkayamaJapanUnknown status
Saitama Medical University International Medical Center
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SaitamaJapanUnknown status
Shizuoka Cancer Center
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ShizuokaJapanUnknown status
National Cancer Center Hospital
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TokyoJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Keimyung University-Dongsan Medical Center
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Dalseo-guSouth KoreaUnknown status
National Cancer Center - Korea
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Goyang-siSouth KoreaUnknown status
Severance hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Szpitale Pomorskie Sp z o o
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GdyniaPolandActive, not recruiting
Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
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KatowicePolandActive, not recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandActive, not recruiting
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
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SiedlcePolandActive, not recruiting
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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WroclawPolandActive, not recruiting
National University Hospital
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SingaporeSingaporeUnknown status
National Cancer Centre Singapore
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SingaporeSingaporeUnknown status
Kaohsiung Veterans General Hospital
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Kaohsiung CityTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
MacKay Memorial Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Chang Gung Memorial Hospital Linkou
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Taoyuan CityTaiwanUnknown status
University of New Mexico Comprehensive Cancer Center
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AlbuquerqueUnited StatesUnknown status
Winship Cancer Institute, Emory University
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AtlantaUnited StatesUnknown status
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
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AuroraUnited StatesUnknown status
Greater Baltimore Medical Center
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BaltimoreUnited StatesUnknown status
Tufts Medical Center
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BostonUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
MUSC Hollings Cancer Center
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CharlestonUnited StatesUnknown status
University of Virginia Comprehensive Cancer Center
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CharlottesvilleUnited StatesUnknown status
University of Chicago Medical Center
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ChicagoUnited StatesUnknown status
Northwestern Memorial Hospital
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ChicagoUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Ohio Health Research Institute
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ColumbusUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
Florida Cancer Specialists
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Fort MyersUnited StatesUnknown status
Texas Oncology
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Fort WorthUnited StatesUnknown status
University of Florida
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GainesvilleUnited StatesUnknown status
Hartford Healthcare Cancer Institute at Hartford Hospital
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HartfordUnited StatesUnknown status
Alliance Cancer Specialists, PC
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HorshamUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Baylor College of Medicine Medical Center
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HoustonUnited StatesUnknown status
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
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IndianapolisUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Baptist MD Anderson Cancer Center
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JacksonvilleUnited StatesUnknown status
West Michigan Cancer Center
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KalamazooUnited StatesUnknown status
MidAmerica Division Inc., c/o Research Medical Center
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Kansas CityUnited StatesUnknown status
UC San Diego Medical Center
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La JollaUnited StatesUnknown status
Northwell Health Cancer Institute
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Lake SuccessUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
Baptist Health Lexington
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LexingtonUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Norton Cancer Institute
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LouisvilleUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center
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MadisonUnited StatesUnknown status
Froedtert and the Medical College of Wisconsin (MCW)
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MilwaukeeUnited StatesUnknown status
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
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MinneapolisUnited StatesUnknown status
SCRI Oncology Partners
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NashvilleUnited StatesUnknown status
Rutgers Cancer Institute
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New BrunswickUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
Ochsner Clinic Foundation
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New OrleansUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Columbia University Medical Center - Herbert Irving Pavilion
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New YorkUnited StatesUnknown status
Virginia Oncology Associates
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NorfolkUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
Stanford Women's Cancer Center
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Palo AltoUnited StatesUnknown status
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
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PhiladelphiaUnited StatesUnknown status
Providence Cancer Institute Franz Clinic
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PortlandUnited StatesUnknown status
University of Rochester Medical Center
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RochesterUnited StatesUnknown status
Metro Minnesota Community Oncology Research Consortium (MMCORC)
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Saint Louis ParkUnited StatesUnknown status
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System
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SavannahUnited StatesUnknown status
Fred Hutchinson Cancer Center
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SeattleUnited StatesUnknown status
Baystate Medical Center
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SpringfieldUnited StatesUnknown status
SUNY Upstate Medical University
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SyracuseUnited StatesUnknown status
Oklahoma Cancer Specialists and Research Institute - OCSRI - Tulsa
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TulsaUnited StatesUnknown status
Kaiser Permanente Medical Center
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VallejoUnited StatesUnknown status
Atrium Health Wake Forest Baptist
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Winston-SalemUnited StatesUnknown status

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