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NCT07218809RecruitingPhase 3

AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer

A Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator's Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01)

Source: ClinicalTrials.gov · Last updated 21 Jul 2026

Brief summary (registry, in English)

The intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1100 (estimated)
First submitted
16 Oct 2025
Start date
29 Dec 2025
Primary completion date
17 Nov 2028
Lead sponsor
AstraZeneca
NCT number
NCT07218809
EU CT number
2025-520466-22-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1100
  • From 29 Dec 2025 to the primary completion date, 17 Nov 2028
  • 262 sites in 24 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

  • Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC.
  • Major surgical procedure within 4 weeks of the first dose of study intervention

Other illness

  • Primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤ 3 months after the last dose of first line platinum-containing chemotherapy.
  • Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring
  • Current signs, symptoms, or clinical investigations consistent with bowel obstruction, including sub-occlusive disease.
  • Participant has non-infectious ILD/pneumonitis or has a history of non-infectious ILD/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.

Other

  • Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour.

Who the study is looking for

  • Participants with confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer.
  • Participants must have platinum-resistant disease:
  • Participants who have only had one prior line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between \> 3 months and ≤ 6 months after the date of the last dose of platinum.
  • Participants who have received 2 or 3 lines of platinum therapy must have progressed ≤ 6 months after the date of the last dose of platinum.
  • Participants must have radiologically progressed on or after their most recent line of therapy.
  • Participants must have received at least one, but no more than 3, prior systemic lines of anti-cancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment
  • Participants with documented BRCA mutation (germline and/or somatic) must have received prior PARPi if the participant is eligible per approved label and standard-of-care institutional guidelines, except in cases of documented contraindication, precaution or intolerance.
  • Provision of an FFPE tumour tissue sample

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

Full criteria on ClinicalTrials.gov

Sites (262)

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

SiteCityCountrySite status
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AdelaideAustraliaRecruiting
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AuchenflowerAustraliaRecruiting
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CampbelltownAustraliaRecruiting
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CamperdownAustraliaNot yet recruiting
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ClaytonAustraliaNot yet recruiting
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CudgenAustraliaNot yet recruiting
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GarranAustraliaRecruiting
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GosfordAustraliaRecruiting
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HeidelbergAustraliaRecruiting
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KogarahAustraliaRecruiting
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MelbourneAustraliaRecruiting
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RichmondAustraliaRecruiting
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St LeonardsAustraliaRecruiting
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WaratahAustraliaRecruiting
Grand Hopital de Charleroi
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CharleroiBelgiumRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Hopital De Libramont
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Libramont-ChevignyBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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NamurBelgiumRecruiting
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BarretosBrazilNot yet recruiting
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Bela VistaBrazilNot yet recruiting
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CuritibaBrazilNot yet recruiting
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GoiâniaBrazilNot yet recruiting
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NatalBrazilNot yet recruiting
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Porto AlegreBrazilNot yet recruiting
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Porto VelhoBrazilNot yet recruiting
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Rio de JaneiroBrazilNot yet recruiting
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São José do Rio PretoBrazilNot yet recruiting
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São PauloBrazilNot yet recruiting
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EdmontonCanadaNot yet recruiting
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HamiltonCanadaNot yet recruiting
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KingstonCanadaNot yet recruiting
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MontrealCanadaNot yet recruiting
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QuébecCanadaNot yet recruiting
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BaselSwitzerlandNot yet recruiting
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MünsterlingenSwitzerlandNot yet recruiting
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Sankt GallenSwitzerlandNot yet recruiting
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ThunSwitzerlandNot yet recruiting
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ZollikerbergSwitzerlandNot yet recruiting
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ZurichSwitzerlandNot yet recruiting
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Port MonttChileNot yet recruiting
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ProvidenciaChileNot yet recruiting
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SantiagoChileNot yet recruiting
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Viña del MarChileNot yet recruiting
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BeijingChinaNot yet recruiting
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BengbuChinaNot yet recruiting
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ChangchunChinaNot yet recruiting
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ChangshaChinaNot yet recruiting
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ChengduChinaNot yet recruiting
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ChongqingChinaNot yet recruiting
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FuzhouChinaNot yet recruiting
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GuangzhouChinaNot yet recruiting
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HangzhouChinaNot yet recruiting
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HarbinChinaNot yet recruiting
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JinanChinaNot yet recruiting
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LanzhouChinaNot yet recruiting
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LinyiChinaNot yet recruiting
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NanchangChinaNot yet recruiting
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NanjingChinaNot yet recruiting
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NanningChinaNot yet recruiting
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ShanghaiChinaNot yet recruiting
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ShenyangChinaNot yet recruiting
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ShijiazhuangChinaNot yet recruiting
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TaiyuanChinaNot yet recruiting
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TianjinChinaNot yet recruiting
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WuhanChinaNot yet recruiting
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Xi'anChinaNot yet recruiting
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ZhanjiangChinaNot yet recruiting
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ZhengzhouChinaNot yet recruiting
Fakultni Nemocnice Brno
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Brno-StredCzechiaNot yet recruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaNot yet recruiting
Nemocnice AGEL Nový Jičín a.s.
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Nový JičínCzechiaNot yet recruiting
University Hospital Olomouc
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OlomoucCzechiaNot yet recruiting
Fakultni nemocnice Bulovka
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PragueCzechiaNot yet recruiting
Fakultni nemocnice v Motole
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PragueCzechiaNot yet recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaNot yet recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Klinikum Lippe GmbH
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DetmoldGermanyRecruiting
Technische Universitaet Dresden
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DresdenGermanyRecruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyRecruiting
Agaplesion Frankfurter Diakonie Kliniken gGmbH
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Frankfurt am MainGermanyRecruiting
Albertinen-Krankenhaus/Albertinen-Haus gGmbH
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HamburgGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Universitaetsklinikum Mannheim GmbH
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MannheimGermanyRecruiting
DIAK Klinikum Landkreis Schwaebisch Hall gGmbH
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Schwaebisch HallGermanyRecruiting
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
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StuttgartGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
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WiesbadenGermanyRecruiting
Aalborg University Hospital
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AalborgDenmarkRecruiting
Region Midtjylland
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Aarhus NDenmarkRecruiting
Odense University Hospital
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Odense CDenmarkRecruiting
Sygehus Lillebaelt - Vejle Sygehus
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VejleDenmarkRecruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Institut Catala d'Oncologia
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BadalonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Hospital Universitario Donostia
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DonostiaSpainRecruiting
Institut Català d'Oncologia
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GironaSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Sainte Catherine Institut Du Cancer Avignon-Provence
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Avignon Cedex 9FranceRecruiting
Centre Hospitalier De Dax Cote D'Argent
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DaxFranceRecruiting
Oncoradio Centre Oncogard
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Nimes Cedex 9FranceRecruiting
Institut Curie
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ParisFranceRecruiting
Centre Hospitalier De Pau
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Pau CedexFranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
CARIO Centre Armoricain de Radiotherapie d'Imagerie medicale et d'Oncologie
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PlerinFranceRecruiting
Institut Godinot
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ReimsFranceRecruiting
Institut De Cancerologie De L Ouest
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Saint-Herblain CedexFranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceRecruiting
Clinique Pasteur
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Toulouse Cedex 3FranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceRecruiting
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Barrow in FurnessUnited KingdomRecruiting
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BirminghamUnited KingdomNot yet recruiting
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CambridgeUnited KingdomNot yet recruiting
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CanterburyUnited KingdomNot yet recruiting
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CardiffUnited KingdomNot yet recruiting
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EdinburghUnited KingdomRecruiting
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Greater LondonUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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NottinghamUnited KingdomRecruiting
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SuttonUnited KingdomRecruiting
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SwanseaUnited KingdomRecruiting
Areteio Hospital
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AthensGreeceRecruiting
General Hospital of Athens - Alexandra
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AthensGreeceRecruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceRecruiting
General Hospital Of Messinia
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KalamataGreeceRecruiting
General Oncological Hospital Of Kifissia Agioi Anargyroi
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KifissiaGreeceRecruiting
Mitera S.A.
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MarousiGreeceRecruiting
General Hospital Of Patras Agios Andreas
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PatrasGreeceRecruiting
General University Hospital Of Patras
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PatrasGreeceRecruiting
St. Luke's Hospital S.A.
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ThessalonikiGreeceRecruiting
Cork University Hospital
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CorkIrelandRecruiting
St Vincent's University Hospital
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Dublin 4IrelandRecruiting
Mater Misericordiae University Hospital
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Dublin 7IrelandRecruiting
St James's Hospital
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Dublin 8IrelandRecruiting
University Hospital Waterford
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WaterfordIrelandRecruiting
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AfulaIsraelNot yet recruiting
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BeershebaIsraelRecruiting
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HaderaIsraelRecruiting
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HaifaIsraelRecruiting
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HolonIsraelRecruiting
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JerusalemIsraelRecruiting
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Kfar SabaIsraelRecruiting
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NahariyaIsraelRecruiting
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Ramat GanIsraelNot yet recruiting
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SofiaIsraelWithdrawn
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Tel AvivIsraelRecruiting
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BhubaneswarIndiaNot yet recruiting
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ChennaiIndiaNot yet recruiting
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DelhiIndiaNot yet recruiting
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Dhanvantari NagarIndiaNot yet recruiting
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KolkataIndiaNot yet recruiting
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NagpurIndiaNot yet recruiting
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NashikIndiaNot yet recruiting
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SuratIndiaNot yet recruiting
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TiruchirappalliIndiaNot yet recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
Azienda Ospedaliera per l Emergenza Cannizzaro
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CataniaItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyRecruiting
Alessandro Manzoni Hospital
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LeccoItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyRecruiting
Humanitas Mirasole S.p.A.
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MilanItalyRecruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Parma
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ParmaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Azienda Ospedaliera Ordine Mauriziano Torino
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TorinoItalyRecruiting
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Akashi-shiJapanNot yet recruiting
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ChūōkuJapanNot yet recruiting
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Hidaka-shiJapanRecruiting
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KashiwaJapanNot yet recruiting
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KobeJapanRecruiting
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KōtokuJapanRecruiting
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Kurume-shiJapanRecruiting
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NagoyaJapanNot yet recruiting
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NiigataJapanRecruiting
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OkayamaJapanNot yet recruiting
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OsakaJapanRecruiting
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Sagamihara-shiJapanRecruiting
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SapporoJapanRecruiting
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SendaiJapanRecruiting
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Shinjuku-kuJapanRecruiting
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Shiwa-gunJapanRecruiting
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Sunto-gunJapanNot yet recruiting
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TsuJapanRecruiting
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BusanSouth KoreaRecruiting
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DaeguSouth KoreaRecruiting
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Goyang-siSouth KoreaRecruiting
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Seongnam-siSouth KoreaRecruiting
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SeoulSouth KoreaRecruiting
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SuwonSouth KoreaRecruiting
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YangsanSouth KoreaRecruiting
Region Oestergoetland
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LinkopingSwedenRecruiting
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LundSwedenRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
Region Vaesterbotten
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UmeaSwedenRecruiting
Uppsala University Hospital
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BangkokThailandNot yet recruiting
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Chiang MaiThailandNot yet recruiting
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DusitThailandNot yet recruiting
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SongkhlaThailandNot yet recruiting
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ChanghuaTaiwanNot yet recruiting
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TaoyuanTaiwanNot yet recruiting
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BillingsUnited StatesRecruiting
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Blue AshUnited StatesRecruiting
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Chapel HillUnited StatesRecruiting
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ChicagoUnited StatesNot yet recruiting
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Little RockUnited StatesNot yet recruiting
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LouisvilleUnited StatesRecruiting
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OmahaUnited StatesRecruiting
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PeoriaUnited StatesRecruiting
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PortlandUnited StatesRecruiting
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RoanokeUnited StatesRecruiting
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Salt Lake CityUnited StatesWithdrawn
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San AntonioUnited StatesRecruiting
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SeattleUnited StatesRecruiting
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SpringfieldUnited StatesRecruiting
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SylvaniaUnited StatesNot yet recruiting
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The BronxUnited StatesNot yet recruiting
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TowsonUnited StatesRecruiting
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TylerUnited StatesRecruiting
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UrbanaUnited StatesRecruiting
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Washington D.C.United StatesRecruiting
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WestonUnited StatesNot yet recruiting
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WorcesterUnited StatesNot yet recruiting
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YorkUnited StatesNot yet recruiting

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