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NCT03522246Active, not recruitingPhase 3

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

Source: ClinicalTrials.gov · Last updated 24 Jun 2025

Brief summary (registry, in English)

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1097 (actual)
First submitted
9 Apr 2018
Start date
14 May 2018
Primary completion date
20 May 2024
Lead sponsor
pharmaand GmbH
NCT number
NCT03522246
EU CT number
2024-516662-11-00
EudraCT number
2017-004557-17

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1097
  • From 14 May 2018 to the primary completion date, 20 May 2024
  • 214 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

  • Any prior treatment for ovarian cancer, other than the first-line platinum regimen
  • Condition requiring active systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications

Other illness

  • Active second malignancy
  • Evidence of interstitial lung disease or active pneumonitis
  • Active, known or suspected autoimmune disease

Other

  • Pure sarcomas or borderline tumors or mucinous tumors
  • Known central nervous system brain metastases

Who the study is looking for

  • Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking)
  • Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
  • Sufficient tumor tissue for planned analysis
  • ECOG performance status of 0 or 1
  • Patients must be 20 years of age to consent in Japan, Taiwan and South Korea; in all other participating countries patients must be 18 years of age to consent

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

Full criteria on ClinicalTrials.gov

Sites (214)

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

SiteCityCountrySite status
Royal Brisbane and Women's Hospital
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BrisbaneAustraliaUnknown status
Peter MacCallum Cancer Center
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MelbourneAustraliaUnknown status
Newcastle Private Hospital
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New Lambton HeightsAustraliaUnknown status
Northern Cancer Institute St Leonards
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Saint LeonardsAustraliaUnknown status
St. John of God Subiaco Hospital
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SubiacoAustraliaUnknown status
Prince of Wales Hospital
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SydneyAustraliaUnknown status
Brian Fricker Oncology Centre, Burnside Hospital
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Toorak GardensAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
UZ Leuven
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LeuvenBelgiumCompleted
BC Cancer Abbotsford
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Abbotsford British ColumbiaCanadaUnknown status
Alberta Health Services - University of Calgary
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CalgaryCanadaUnknown status
Alberta Health Services and The University of Alberta
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EdmontonCanadaUnknown status
Nsha-Qeii Hsc
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HalifaxCanadaUnknown status
Juravinski Cancer Center
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HamiltonCanadaUnknown status
BC Cancer - Kelowna
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KelownaCanadaUnknown status
London Health Sciences Center
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LondonCanadaUnknown status
McGill University Health Center
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MontrealCanadaUnknown status
Centre Hospitalier de l'Université de Montréal
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MontrealCanadaUnknown status
Ottawa Hospital Cancer Centre
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OttawaCanadaUnknown status
Centre Integre Universitaire de sante et de service sociaux de l'Estri-Centre hospitalier univeritaire de Sherbrooke
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SherbrookeCanadaUnknown status
BC Cancer Surrey
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SurreyCanadaUnknown status
CancerCare Manitoba
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WinnipegCanadaUnknown status
Masarykuv Onkologicky Ustav
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Brno-StredCzechiaCompleted
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaCompleted
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyCompleted
Universitaetsklinikum Mannheim GmbH
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MannheimGermanyCompleted
Aalborg University Hospital
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AalborgDenmarkCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Consorcio Hospitalario Provincial De Castellon
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Castello De La PlanaSpainCompleted
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Universitario Central De Asturias
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OviedoSpainCompleted
Hospital Son Llatzer
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PalmaSpainCompleted
Hospital Universitario Virgen De Valme
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SevillaSpainCompleted
Kuopio University Hospital
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KuopioFinlandUnknown status
Royal Sussex County Hospital
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BrightonUnited KingdomUnknown status
Bristol Cancer Institute Medical Oncology
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BristolUnited KingdomUnknown status
Addenbrookes Hospital
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CambridgeUnited KingdomUnknown status
East Kent Hospitals University NHS Foundation trust Medical Oncology
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CanterburyUnited KingdomUnknown status
Northampton General Hospital
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CliftonvilleUnited KingdomUnknown status
Western General Hospital
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EdinburghUnited KingdomUnknown status
University Hospitals of Morecambe Bay NHS Foundation Trust
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LancasterUnited KingdomUnknown status
St James University Hospital
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LeedsUnited KingdomUnknown status
Barts and the London NHS Trust
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LondonUnited KingdomUnknown status
Imperial College London
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LondonUnited KingdomUnknown status
Guy's & St Thomas' NHS Foundation Trust (Guy's Cancer Centre)
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LondonUnited KingdomUnknown status
The Royal Marsden NHS Foundation Trust
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LondonUnited KingdomUnknown status
University of College London Hospital
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LondonUnited KingdomUnknown status
The James Cook University Hospital
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MiddlesbroughUnited KingdomUnknown status
Poole Hospital NHS Foundation Trust
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PooleUnited KingdomUnknown status
South West Wales Cancer Centre - Singleton Hospital
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SwanseaUnited KingdomUnknown status
Musgrove Park Hospital
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TauntonUnited KingdomUnknown status
University General Hospital Attikon
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AthensGreeceCompleted
Alexandra Hospital
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AthensGreeceCompleted
Euromedica General Clinic of Thessaloniki
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ThessalonikiGreeceCompleted
Cork University Hospital
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CorkIrelandCompleted
Bon Secours Hospital Cork
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CorkIrelandCompleted
University Hospital Limerick
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LimerickIrelandCompleted
Shaare Zedek Medical Oncology
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JerusalemIsraelUnknown status
Meir Medical Center
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Kfar SabaIsraelUnknown status
Galilee Medical Center
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NahariyaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Ziv Medical Center
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SafedIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Centro di Riferimento Oncologico di Aviano
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AvianoItalyCompleted
Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS
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CandioloItalyCompleted
ARNAS Garibaldi Di Catania
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CataniaItalyCompleted
Universita' Degli Studi G. D'annunzio Di Chieti
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ChietiItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Azienda Unita Locale Socio Sanitaria N 8 Berica
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VicenzaItalyCompleted
Hyogo Cancer Center
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AkashiJapanUnknown status
Osaka International Cancer Institute
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ChuoJapanUnknown status
Saitama Medical University International Medical Center
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HidakaJapanUnknown status
National Cancer Center Hospital East
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KashiwaJapanUnknown status
Nippon Medical School Musashikosugi Hospital
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Kawasaki-shiJapanUnknown status
The Cancer Institute Hospital of JFCR
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Koto-kuJapanUnknown status
Kurume University Hospital
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KurumeJapanUnknown status
Gunma University Hospital
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MaebashiJapanUnknown status
Iwate Medical University
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MoriokaJapanUnknown status
Hiroshima City Hiroshima Citizens Hospital
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NakaJapanUnknown status
Kindai University Hospital
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Ōsaka-sayamaJapanUnknown status
Gunma Prefectural Cancer Center
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Ota-ShiJapanUnknown status
Saitama Cancer Center
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SaitamaJapanUnknown status
Keio University Hospital
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Shinjuku-kuJapanUnknown status
Kagawa Prefectural Central Hospital
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TakamatsuJapanUnknown status
National Defense Medical College Hospital
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TokorozawaJapanUnknown status
National Cancer Center Hospital
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TokyoJapanUnknown status
University of Tsukuba Hospital
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TsukubaJapanUnknown status
Kanagawa Cancer Center
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YokohamaJapanUnknown status
Yokohama City University Hospital
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YokohamaJapanUnknown status
Soonchunhyang University Cheonan Hospital
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CheonanSouth KoreaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
CHA Bundang Medical Center
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Seongnam-siSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Korea University Guro Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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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
Korea Cancer Center Hospital
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SeoulSouth KoreaUnknown status
Konkuk University Medical Center
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
Auckland City Hospital
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AucklandNew ZealandUnknown status
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Waikato Hospital
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HamiltonNew ZealandUnknown status
Palmerston North Hospital
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Palmerston NorthNew ZealandUnknown status
Tauranga Hospital
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TaurangaNew ZealandUnknown status
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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BialystokPolandCompleted
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandCompleted
Szpitale Pomorskie Sp z o o
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GdyniaPolandCompleted
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
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PoznanPolandCompleted
Pomeranian Medical University
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SzczecinPolandCompleted
Mazowiecki Szpital Brodnowski Sp. z o.o.
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WarsawPolandCompleted
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaCompleted
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Bihor
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OradeaRomaniaCompleted
Oncomed S.R.L.
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TimisoaraRomaniaCompleted
Arkhangelsk Clinical Oncological Dispensary
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ArkhangelskRussiaUnknown status
BHI of Omsk region "Clinical Oncology Dispensary"
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OmskRussiaUnknown status
Orenburg Regional Clinical Oncological Dispensary
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OrenburgRussiaUnknown status
SBHI Saint Petersburg Research Center specialized types of medical care (Oncology)
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PesochnyyRussiaUnknown status
SBHI SR Pyatigorsk Interdistrict Oncology Dispensary
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PyatigorskRussiaUnknown status
FSBEI HE I.P. Pavlov SPbSMU MoH Russia
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Saint PetersburgRussiaUnknown status
Limited Liability Company MedPomosch
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Saint PetersburgRussiaUnknown status
Saint-Petersburg State Budget Institution of Healthcare City Clinical Oncology Dispensary
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Saint PetersburgRussiaUnknown status
1st Medical University
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Saint PetersburgRussiaUnknown status
Federa; State Budgetary Educational Institution of Higher Education National Research Ogarev Mordovia State University
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SaranskRussiaUnknown status
State Medical Institution "Oncology Center #2" under the Krasnodar Region Healthcare Department
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SochiRussiaUnknown status
Region Skane Skanes Universitetssjukhus
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LundSwedenCompleted
National University Hospital
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SingaporeSingaporeUnknown status
National Cancer Center Singapore
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SingaporeSingaporeUnknown status
Hualien Tzu Chi Hospital
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Hualien CityTaiwanUnknown status
Kaohsiung Veterans General Hospital
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Kaohsiung CityTaiwanUnknown status
Far Eastern Memorial Hospital
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New Taipei CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
Chi Mei Medical Center (CMMC)
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TainanTaiwanUnknown status
Chi Mei Hospital, Liouying (CMHLY)
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TainanTaiwanUnknown status
Taipei Medical University Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Tri-Service General Hospital
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TaipeiTaiwanUnknown status
MacKay Memorial Hospital
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanUnknown status
Women's Cancer Care Associates
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AlbanyUnited StatesUnknown status
Northside Hospital
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AtlantaUnited StatesUnknown status
Augusta University
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AugustaUnited StatesUnknown status
University of Colorado Cancer Center
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AuroraUnited StatesUnknown status
Texas Oncology - Austin Central
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AustinUnited StatesUnknown status
SKCCC at Johns Hopkins
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BaltimoreUnited StatesUnknown status
Texas Oncology - Bedford
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BedfordUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
MD Anderson Cancer Center at Cooper
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CamdenUnited StatesUnknown status
University of North Carolina
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Chapel HillUnited StatesUnknown status
Rush University Medical Center
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ChicagoUnited StatesUnknown status
Oncology Hematology Care, Inc
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CincinnatiUnited StatesUnknown status
University of Cincinnati
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CincinnatiUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
MD Anderson Cancer Center - Ohio Health
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ColumbusUnited StatesUnknown status
The Ohio State University
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ColumbusUnited StatesUnknown status
John Muir Clinical Research Center
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ConcordUnited StatesUnknown status
Texas Oncology-Dallas Presbyterian Hospital
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DallasUnited StatesUnknown status
Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Oncology Associates of Oregon, P.C.
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EugeneUnited StatesUnknown status
Summit Medical Group
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Florham ParkUnited StatesUnknown status
Florida Gynecologic Oncology
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Fort MyersUnited StatesUnknown status
Texas Oncology, Fort Worth
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Fort WorthUnited StatesUnknown status
Dr. Sudarshan K. Sharma, Ltd - Gynecologic Oncology
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HinsdaleUnited StatesUnknown status
University of Texas - MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Memorial Hermann
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HoustonUnited StatesUnknown status
Community Health Network
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IndianapolisUnited StatesUnknown status
University of Iowa Hospitals
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Iowa CityUnited StatesUnknown status
MD Anderson Cancer Center-Baptist
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JacksonvilleUnited StatesUnknown status
Broome Oncology, LLC
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Johnson CityUnited StatesUnknown status
Northwell Health Monter Cancer Center
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Lake SuccessUnited StatesUnknown status
Rocky Mountain Cancer Centers
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LakewoodUnited StatesUnknown status
Women's Cancer Center of Nevada
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Las VegasUnited StatesUnknown status
University of Kentucky
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LexingtonUnited StatesUnknown status
UCLA Women's Health Clinical Research Unit
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Los AngelesUnited StatesUnknown status
Norton Cancer Institute
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LouisvilleUnited StatesUnknown status
Baptist Health Medical Group Oncology, LLC
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MiamiUnited StatesUnknown status
Froedtert and Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
Ochsner Medical Center
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New OrleansUnited StatesUnknown status
New York University Medical Center
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New YorkUnited StatesUnknown status
Virginia Oncology Associates
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NorfolkUnited StatesUnknown status
University of Oklahoma Health Science Center
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Oklahoma CityUnited StatesUnknown status
Florida Hospital
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OrlandoUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Arizona Oncology Associates, PC- HAL
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PhoenixUnited StatesUnknown status
UPMC-Magee Womens Hospital
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PittsburghUnited StatesUnknown status
Northwest Cancer Specialists, P.C.
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PortlandUnited StatesUnknown status
LMG Gynecologic Oncology
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PortlandUnited StatesUnknown status
Metro-Minnesota Community Oncology Research Consortium
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Saint Louis ParkUnited StatesUnknown status
Huntsman Cancer Institute
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Salt Lake CityUnited StatesUnknown status
Texas Oncology - San Antonio Medical Center
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San AntonioUnited StatesUnknown status
Kaiser Permanente Northern California
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San FranciscoUnited StatesUnknown status
Maine Medical Center
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ScarboroughUnited StatesUnknown status
Avera Gynecologic Oncology
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Sioux FallsUnited StatesUnknown status
Ferrell-Duncan Clinic
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SpringfieldUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Texas Oncology - The Woodlands, Gynecologic Oncology
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The WoodlandsUnited StatesUnknown status
The University of Arizona Cancer Center
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TucsonUnited StatesUnknown status
Arizona Oncology Associates, PC - HOPE
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TucsonUnited StatesUnknown status
Oklahoma Cancer Specialists and Research Institute
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TulsaUnited StatesUnknown status
University of Kansas Cancer Center
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WestwoodUnited StatesUnknown status
Abington Memorial Hospital
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Willow GroveUnited StatesUnknown status
Dr. Abdurrahman Yurtaslan Ankara Women's Health Education and Research Hospital
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AnkaraTurkey (Türkiye)Unknown status
Koc University School of Medicine, Koc University Hospital
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IstanbulTurkey (Türkiye)Unknown status
Istanbul University-cerrahpasa, Cerrahpasa School of Medicine
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IstanbulTurkey (Türkiye)Unknown status
Celal Bayar University Faculty of Medicine
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ManisaTurkey (Türkiye)Unknown status
Baskent University Hospital
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YüreğirTurkey (Türkiye)Unknown status

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