New hope for endometrial cancer: targeted drug BNT323 faces chemo in phase 3 trial
NCT ID NCT06340568
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 8 times
Summary
This Phase 3 trial tests whether the drug BNT323 (trastuzumab pamirtecan) works better than standard chemotherapy for people with recurrent endometrial cancer that expresses HER2. About 480 participants will be split into two groups based on their HER2 levels. The study measures how long the cancer stays under control and whether tumors shrink. It is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BNT323 (trastuzumab pamirtecan)
- What this could lead to
- If it works, this could offer a new treatment option for people with recurrent endometrial cancer that has not responded to prior therapy.
- What could go wrong
- This is a Phase 3 trial, but results are not guaranteed. The drug may not improve survival or could have side effects. It is only for certain HER2 levels.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 480 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent). * Have histologically confirmed endometrial cancer that: * Is recurrent, * Has a HER2 IHC score of 1+, 2+ (Cohort 1), or 3+ (Cohort 2) as determined by central laboratory testing for HER2 expression, and * Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma is allowed. * Have measurable disease defined by RECIST v1.1. * Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2. * Have recurrent endometrial cancer and meet any of the following: * developed recurrence \<12 months from completing platinum-based chemotherapy given as adjuvant therapy for Stage I to III disease, or * developed recurrence after platinum-based chemotherapy in the recurrent/metastatic setting. * Have received prior ICI treatment (i.e., anti-programmed death 1/anti-programmed death-ligand 1) * Have a life expectancy of ≥12 weeks at screening. Key Exclusion Criteria: * Are ineligible for all options in the investigator's choice of chemotherapy arm, per local prescribing information and institutional guidelines (applicable to Cohort 1 only). * Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior the first dose of study treatment. * Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events. * Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal shunt within 2 weeks prior to the first dose of study treatment. * Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Participants with prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses of less than 10 mg/day of prednisone or equivalent, and topical corticosteroids. Participants receiving corticosteroids may continue if the dose is stable upon giving main informed consent. * Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to the first dose of study treatment, severe asthma, chronic obstructive pulmonary disorder with moderate acute exacerbations, restrictive lung disease, pulmonary fibrosis, radiation pneumonitis, significant pleural effusion etc.), or any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and/or prior pneumonectomy (complete). * Have uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose of study treatment. * Have unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than alopecia, fatigue, or endocrinopathies that are well controlled) not yet resolved to Grade ≤1 or baseline. * Are pregnant or breastfeeding or are planning pregnancy during the study or within 7 months after the last dose of study treatment. * Have a history of allergies, hypersensitivities, or intolerance to study treatments (investigational medicinal products and auxiliary medicinal product) including any excipients thereof or to other monoclonal antibodies. Participants who have successfully undergone a desensitization process and are able to tolerate the drug are eligible. * Had prior treatment with topoisomerase I inhibitors, including ADCs. * Have left ventricular ejection fraction \<55% by either echocardiography or multiple-gated acquisition within 28 days prior to the first dose of study treatment. This includes participants with tissue doppler E/e' ratio \>15. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Endometrial cancer are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
191 sites in 26 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AZ Groeninge VZW
RECRUITINGKortrijk, 8500, Belgium
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Aalborg Universit Hospital
RECRUITINGAalborg, 9000, Denmark
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Addenbrooke's Hospital
RECRUITINGCambridge, CB2 0QQ, United Kingdom
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Adelaide Oncology & Haematology
RECRUITINGAdelaide, 5000, Australia
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Affiliated Hospital of Jining Medical University
RECRUITINGJining, Shandong, 272029, China
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Akademiska Sjukhuset
RECRUITINGUppsala, 75185, Sweden
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Alexandra General Hospital of Athens
RECRUITINGAthens, 11528, Greece
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Anhui Provincial Hospital
RECRUITINGHefei, Anhui, 230001, China
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Aretaieio Hospital
RECRUITINGAthens, 11528, Greece
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Azienda Ospedaliera Cannizzaro - Oncologia
RECRUITINGCatania, 95126, Italy
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Azienda Ospedaliera Ordine Mauriziano Umberto I di Torino
RECRUITINGTorino, 10128, Italy
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Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
RECRUITINGBologna, 40138, Italy
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Baskent University Adana Application and Research Center
RECRUITINGAdana, 01120, Turkey (Türkiye)
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Baskent University Ankara Hospital
RECRUITINGAnkara, 06490, Turkey (Türkiye)
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Beijing Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China
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Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
RECRUITINGIstanbul, 34093, Turkey (Türkiye)
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Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie
RECRUITINGBialystok, 15-027, Poland
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Bristol Haematology and Oncology Centre
RECRUITINGBristol, BS2 8ED, United Kingdom
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Broward Health Medical Center
RECRUITINGFort Lauderdale, Florida, 33316, United States
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Bács-Kiskun Vármegyei Oktatókórház
RECRUITINGKecskemét, 6000, Hungary
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CHA Bundang Medical Center
RECRUITINGSeongnam-si, 13496, South Korea
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CHU Besançon Service Oncologie
RECRUITINGBesançon, 25000, France
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CHU UCL Namur-Sainte-Elisabeth
RECRUITINGNamur, B5000, Belgium
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Cancer Hospital of Shandong First Medical University
RECRUITINGJinan, Shandong, 250117, China
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Cancer Hospital of Shantou University Medical College
RECRUITINGShantou, Guangdong, 515063, China
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Cancer Research SA
RECRUITINGAdelaide, 5000, Australia
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Carle Cancer Institute
RECRUITINGUrbana, Illinois, 61801, United States
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Castle Hill Hospital
RECRUITINGCottingham, HU165JQ, United Kingdom
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Centre François Baclesse
RECRUITINGCaen, 14000, France
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Centro Oncológico de Excelencia
RECRUITINGSan Juan, 5400, Argentina
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Centro de Investigaciones Medicas Mar del Plata
RECRUITINGBuenos Aires, B7600FYK, Argentina
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Centro de Oncologia Dr. Doreski - Fundación Respirar
RECRUITINGBuenos Aires, 01426, Argentina
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Charité - Campus Virchow-Klinikum
RECRUITINGBerlin, 13353, Germany
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China Medical University Hospital
RECRUITINGTaichung, 40447, Taiwan
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Clinique Victor Hugo - Centre Jean Bernard
RECRUITINGLe Mans, 72000, France
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Cliniques Universitaires Saint-Luc
RECRUITINGBrussels, 1200, Belgium
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Debreceni Egyetem
RECRUITINGDebrecen, 4032, Hungary
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Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
RECRUITINGAnkara, 06200, Turkey (Türkiye)
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Erasmus Medisch Centrum
RECRUITINGRotterdam, 3015 AA, Netherlands
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Ewha Womans University Seoul Hospital
RECRUITINGSeoul, 07804, South Korea
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Fakultní nemocnice Bulovka
RECRUITINGPrague, 18081, Czechia
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Fakultní nemocnice Motol a Homolka
RECRUITINGPrague, 15000, Czechia
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Fakultní nemocnice Ostrava
RECRUITINGOstrava, 01790, Czechia
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First Affiliated Hospital of Xiamen University
RECRUITINGXiamen, Fujian, 361003, China
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITINGRoma, 00168, Italy
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Frankston Hospital
RECRUITINGMelbourne, VIC 3199, Australia
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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Fujian Provincial Cancer Hospital
RECRUITINGFuzhou, Fujian, 350014, China
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Fundação Faculdade Regional de Medicina de São José do Rio Petro
RECRUITINGSão José do Rio Preto, 15090-000, Brazil
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Fundação Sao Francisco Xavier
RECRUITINGIpatinga, 35162-189, Brazil
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Gangnam Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, 06273, South Korea
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Gansu Provincial Maternity and Child-care Hospital
RECRUITINGLanzhou, Gansu, 730050, China
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General Hospital of Kalamata
RECRUITINGKalamata, 24100, Greece
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Gosford Hospital
RECRUITINGGosford, 2250, Australia
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Guangxi Medical University Affiliated Tumor Hospital
RECRUITINGNanning, Guangxi, 530200, China
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Guy's Hospital
RECRUITINGLondon, SE1 9RT, United Kingdom
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Gynekologicko-porodnická klinika, Fakultni nemocnice Brno
RECRUITINGBrno, 60200, Czechia
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HPT São Lucas da PUCRS - UBEA
RECRUITINGPorto Alegre, 90610-000, Brazil
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Hacettepe University
RECRUITINGAnkara, 06230, Turkey (Türkiye)
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Hadassah Ein Kerem Medical Center
RECRUITINGJerusalem, 9112001, Israel
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Harbin Medical University Cancer Hospital
RECRUITINGHarbin, Heilongjiang, 150091, China
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Health Sciences Centre
RECRUITINGSt. John's, A1V 3V6, Canada
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Herlev og Gentofte Hospital
RECRUITINGHerlev, 2730, Denmark
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Hospital Británico de Buenos Aires
RECRUITINGBuenos Aires, C1280AEB, Argentina
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Hospital Clinic de Barcelona
RECRUITINGBarcelona, 08036, Spain
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Hospital Provincial del Centenario
RECRUITINGRosario, S2002KDS, Argentina
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Hospital Sirio Libanês
RECRUITINGSão Paulo, 01308-050, Brazil
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Hospital Universitar Donostia
RECRUITINGDonostia / San Sebastian, 20014, Spain
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Hospital Universitari Vall, d'Hebron
RECRUITINGBarcelona, 08035, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, 28041, Spain
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Hospital Universitario La Paz
RECRUITINGMadrid, 28046, Spain
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Hospital Universitario Ramón y Cajal
RECRUITINGMadrid, 28034, Spain
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Hospital Universitario Reina Sofia
RECRUITINGCórdoba, 14004, Spain
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Hospital de Clínicas de Passo Fundo
RECRUITINGPasso Fundo, 99010-260, Brazil
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Hospital de Clínicas de Porto Alegre
RECRUITINGPorto Alegre, 90035-903, Brazil
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Hubei Cancer Hospital
RECRUITINGWuhan, Hubei, 430079, China
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Humanitas San Pio X
RECRUITINGMilan, 20159, Italy
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Hôpital Nord Bâtiment Mistral
RECRUITINGMarseille, 13015, France
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Hôpital Saint Louis
RECRUITINGParis, 75010, France
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IASO General Clinic
RECRUITINGMarousi, 151 23, Greece
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ICO - Site Paul Papin
RECRUITINGAngers, 49055, France
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ICO - Site René Gauducheau
RECRUITINGSaint-Herblain, 44800, France
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IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST)
RECRUITINGMeldola, 47014, Italy
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Inst D'Or de Pesquisa E Ensino
RECRUITINGSão Paulo, 01401-002, Brazil
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Institut Català d'Oncologia (ICO) Hospital Universitari de Girona Dr. Josep Trueta
RECRUITINGGirona, 17007, Spain
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Institut Jules Bordet
RECRUITINGBrussels, 1070, Belgium
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Institut de Cancérologie de Strasbourg Europe - ICANS
RECRUITINGStrasbourg, 67000, France
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Instituto Valenciano de Oncología - Valencia
RECRUITINGValencia, 46009, Spain
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Instituto de Pesquisa Clínica - Hospital Moinhos de Vento
RECRUITINGPorto Alegre, 90035-000, Brazil
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Intermountain Healthcare
RECRUITINGMurray, Utah, 84107-5701, United States
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Investigaciones CORI S.R.L.
RECRUITINGLa Rioja, F5300COE, Argentina
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Irmandade da Santa Casa de Misericórdia de Porto Alegre
RECRUITINGPorto Alegre, 90050-170, Brazil
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Istanbul University Istanbul Medical Faculty
RECRUITINGIstanbul, 34093, Turkey (Türkiye)
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Istituto Europeo di Oncologia
RECRUITINGMilan, 20141, Italy
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Istituto Nazionale Tumori Fondazione G. Pascale
RECRUITINGNaples, 80131, Italy
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Istituto Nazionale dei Tumori
RECRUITINGMilan, 20133, Italy
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Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
RECRUITINGBari, 70124, Italy
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Jewish General Hospital
RECRUITINGMontreal, H3T 1E2, Canada
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Jiangxi Maternal and Child Health Hospital
RECRUITINGNanchang, Jiangxi, 330006, China
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Karolinska University Hospital
RECRUITINGStockholm, 17176, Sweden
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Keimyung Univty Dongsan Hospital
RECRUITINGDaegu, 42601, South Korea
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Kliniken Essen-Mitte
RECRUITINGEssen, 45136, Germany
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Klinkum Kassel
RECRUITINGKassel, 34125, Germany
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Korea University Anam Hospital
RECRUITINGSeoul, 02841, South Korea
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Kuang Tien General Hospital
RECRUITINGTaichung, 433004, Taiwan
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Kuopio University HPT
RECRUITINGKuopio, 70210, Finland
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LMU-Campus Innenstadt
RECRUITINGMünchen, 81377, Germany
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Lady Davis Carmel Medical Center
RECRUITINGHaifa, 3436212, Israel
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Linyi Cancer Hospital
RECRUITINGLinyi, Shandong, 276001, China
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MacKay Memorial Hospital_ Taipei Branch
RECRUITINGTaipei, 10449, Taiwan
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Mater Hospital Brisbane
RECRUITINGSouth Brisbane, 4001, Australia
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MedStar Washington Hospital Center
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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Miami Valley Hospital South
RECRUITINGCenterville, Ohio, 45459, United States
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Monash Health Clinical Trial Center
RECRUITINGClayton, 3168, Australia
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Mount Vermont Cancer Center
RECRUITINGMiddlesex, HA6 2RN, United Kingdom
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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NYU Langone Hospital - Long Island
RECRUITINGMineola, New York, 11501, United States
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National Cancer Center
RECRUITINGGoyang, 10408, South Korea
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National Cancer Centre Singapore
RECRUITINGSingapore, 168583, Singapore
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National Cheng Kung University Hospital
RECRUITINGTainan, 70457, Taiwan
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Nottingham University Hospitals NHS Trust
RECRUITINGNottingham, NG5 1PB, United Kingdom
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OSF Saint Francis Medical Center
RECRUITINGPeoria, Illinois, 61637, United States
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OYS Naisten poliklinikka
RECRUITINGOulu, 90029, Finland
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Obstetrics & Gynecology Hospital of Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200011, China
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Odense University Hospital
RECRUITINGOdense, 5000, Denmark
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Ohio State University
RECRUITINGHilliard, Ohio, 43026, United States
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OncoCare Cancer Centre
RECRUITINGSingapore, 258499, Singapore
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Országos Onkológiai Intézet
RECRUITINGBudapest, 1122, Hungary
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Oslo University Hospital
RECRUITINGOslo, 0379, Norway
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Ospedale San Raffaele
RECRUITINGMilan, 20132, Italy
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Peggy & Charles Stephenson Oklahoma Cancer Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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Peter MacCallum Cancer Centre
RECRUITINGMelbourne, 3000, Australia
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Princess Margaret Cancer C
RECRUITINGToronto, M5G 2M9, Canada
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Rabin Medical Center-Beilinson Campus
RECRUITINGPetah Tikva, 4941492, Israel
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Radboud UMC
RECRUITINGNijmegen, 6525 GA, Netherlands
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Rigshospitalet
RECRUITINGCopenhagen, 2100, Denmark
-
Royal Cornwall Hospital
RECRUITINGTruro, TR1 3LJ, United Kingdom
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Royal Devon & Exeter HPT
RECRUITINGExeter, EX2 5DW, United Kingdom
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Royal Sussex County Hospital
RECRUITINGBrighton, BN2 1ES, United Kingdom
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SUNY Upstate Medical University
RECRUITINGSyracuse, New York, 13210, United States
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Samsung Changwon Hospital
RECRUITINGChangwon, 51353, South Korea
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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Sanford Cancer Center
RECRUITINGSioux Falls, South Dakota, 57104, United States
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Semmelweis Egyetem
RECRUITINGBudapest, 1088, Hungary
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Seoul National University Bundang Hospital
RECRUITINGSeongnam, 13620, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
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Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, 03722, South Korea
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Shaare Zedek
RECRUITINGJerusalem, 9103102, Israel
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Shaare Zedek Medical Center
RECRUITINGJerusalem, 9103102, Israel
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Sheba Medical Center
RECRUITINGRamat Gan, 5265601, Israel
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Shoalhaven Cancer Care Centre
RECRUITINGNowra, 2541, Australia
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Sichuan Provincial People's Hospital
RECRUITINGChengdu, Sichuan, 610072, China
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Siedleckie Centrum Onkologii
RECRUITINGSiedlce, 08-110, Poland
-
Singleton Hospital
RECRUITINGSwansea, SA2 8QA, United Kingdom
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Skånes Universitetssjukhus Lund
RECRUITINGLund, 222 42, Sweden
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Sourasky Medical Centre
RECRUITINGTel Aviv, 642390, Israel
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Stavanger University Hospital
RECRUITINGStavanger, 4011, Norway
-
Sunshine Hospital
RECRUITINGSaint Albans, 3021, Australia
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Taichung Veterans General Hospital
RECRUITINGTaichung, 40705, Taiwan
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Taipei Veterans General Hospital
RECRUITINGTaipei, 11217, Taiwan
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Texas Oncology, P.A.
RECRUITINGTyler, Texas, 75702, United States
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The Affiliated Hospital of Nanjing University Medical School
RECRUITINGNanjing, Jiangsu, 210008, China
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The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITINGSeoul, 06591, South Korea
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The Center of Hope Reno
RECRUITINGReno, Nevada, 89511, United States
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The First Affiliated Hospital of Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510080, China
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The First Affiliated Hospital of Wenzhou Medical University
RECRUITINGWenzhou, Zhejiang, 325015, China
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The First Affiliated Hospital of Xian Jiaotong University
RECRUITINGXi'an, Shaanxi, 710061, China
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The First Hospital of Jilin University
RECRUITINGChangchun, Jilin, 130021, China
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The Second Affiliated Hospital of Chongqing Medical University
RECRUITINGChongqing, Chongqing Municipality, 400010, China
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The Second Affiliated Hospital of Zhengzhou University
RECRUITINGZhengzhou, Henan, 450014, China
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Tianjin Medical University Cancer Institute & Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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Turun yliopistollinen keskussairaala
RECRUITINGTurku, 20521, Finland
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UZ Leuven
RECRUITINGLeuven, 3000, Belgium
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Universitaets-Frauenklinik, Tübingen
RECRUITINGTübingen, 72076, Germany
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Universitair Ziekenhuis Antwerpen (UZA)
RECRUITINGEdegem, 2650, Belgium
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Universitair Ziekenhuis Gent
RECRUITINGGhent, 9000, Belgium
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University College London Hospitals
RECRUITINGLondon, NW1 2PG, United Kingdom
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University General Hospital Attikon
RECRUITINGChaïdári, 124 62, Greece
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University Hospital Olomouc - Onkologická klinika- Fakultni
RECRUITINGOlomouc, 77900, Czechia
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Vseobecna fakultni nemocnice v Praze
RECRUITINGPrague, 12808, Czechia
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WK Cancer Center
RECRUITINGShreveport, Louisiana, 71103, United States
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Warwick Hospital
RECRUITINGCoventry, CV2 2DX, United Kingdom
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Western General Hospital
RECRUITINGEdinburgh, EH4 2XU, United Kingdom
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Wollongong Hospital
RECRUITINGWollongong, 2500, Australia
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Xiangyang Central Hospital
RECRUITINGXiangyang, Hubei, 441138, China
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Yale University School of Medicine
RECRUITINGNew Haven, Connecticut, 06520, United States
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Yantai Yuhuangding Hospital
RECRUITINGYantai, Shandong, 264000, China
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Zala Varmegyei Szent Rafael Korhaz
RECRUITINGZalaegerszeg, 8900, Hungary
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Zhejiang Cancer Hospital
RECRUITINGHangzhou, Zhejiang, 310022, China
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İzmir City Hospital
RECRUITINGBayraklı, 35540, Turkey (Türkiye)
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