New drug duo aims to keep ovarian cancer at bay longer
NCT ID NCT06819007
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding trastuzumab deruxtecan (T-DXd) to standard bevacizumab maintenance therapy can delay cancer progression better than bevacizumab alone in people with HER2-expressing advanced ovarian cancer. About 582 adults whose cancer has a specific protein (HER2) will receive either the combination or single drug after initial chemotherapy. The study is currently recruiting.
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 582 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jan 2032
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: 1. Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures. \*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures. 2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old. 3. Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous). 4. Is newly diagnosed FIGO Stage III or IV. 5. Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing. \*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \[IHC 3+/2+/1+\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results. 6. Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination. \*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment. 7. Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable. 8. Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion. Key Exclusion Criteria: 1. Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin. 2. Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor. 3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows: * HRD negative * HRD positive with SD as best response after platinum * HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea * HRD tested, but inconclusive * HRD positive but safety concern (safety concern to be specified). 4. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies. 5. Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization. \*Note: For participants enrolled from the Republic of Korea, 6. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy). 7. Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization. 8. Evidence of active or ongoing bowel obstruction. 9. Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV). Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction. 10. Has a corrected QT interval prolongation to \>480 msec based on average of the Screening triplicate 12-lead ECG. 11. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced high-grade epithelial ovarian cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
208 sites in 25 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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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AZ Sint-Lucas
RECRUITINGGhent, Belgium
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Aarhus University Hospital
RECRUITINGAarhus, Denmark
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Addenbrooke's Hospital
RECRUITINGCambridge, United Kingdom
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AdventHealth Cancer Institute
RECRUITINGOrlando, Florida, 32804, United States
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Affiliated Hospital (Suzhou First People's Hospital)
RECRUITINGSuzhou, China
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Aichi Cancer Center Hospital
RECRUITINGNagoya, Japan
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Akademiska Sjukhuset (Uppsala University Hospital)
RECRUITINGUppsala, 75185, Sweden
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Ann B Barshinger Cancer Institute
RECRUITINGLancaster, Pennsylvania, 17601, United States
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Aretaieio Hospital
RECRUITINGAthens, 11528, Greece
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Asan Medical Center
RECRUITINGSeoul, South Korea
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Avera Medical Group Gynecologic
RECRUITINGSioux Falls, South Dakota, 57105, United States
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Azienda Ospedaliera Per Lemergenza Cannizzaro
RECRUITINGCatania, Italy
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Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
RECRUITINGBologna, Italy
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Azienda Ospedaliera Universitaria Policlinico Umberto
RECRUITINGRoma, 00161, Italy
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Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
RECRUITINGTorino, 10126, Italy
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Azienda Ospedaliero Universitaria Pisana
RECRUITINGPisa, Italy
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Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
RECRUITINGMonza, Italy
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BP A Beneficencia Portuguesa de Sao Paulo
RECRUITINGSão Paulo, Brazil
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Barts Health NHS Trust
RECRUITINGLondon, United Kingdom
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Beijing Cancer Hospital
RECRUITINGBeijing, China
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Broward Health Medical Center
RECRUITINGFort Lauderdale, Florida, 33316, United States
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CHA Bundang Medical Center, CHA University
RECRUITINGSeongnam-si, South Korea
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CHU Montpellier, Saint Eloi
RECRUITINGMontpellier, France
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CHU Saint Etienne
RECRUITINGSaint-Etienne, France
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CHU UCL Namur
RECRUITINGNamur, Belgium
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CRLCC Eugene Marquis
RECRUITINGRennes, France
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Cancer Institute Hospital of JFCR
RECRUITINGKōtoku, 135-8550, Japan
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Centre Georges Francois Leclerc
RECRUITINGDijon, France
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Centre Leon Berard
RECRUITINGLyon, France
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Centro De Pesquisas Clinica Reichow
RECRUITINGBlumenau, Brazil
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Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Hospital Mae de Deus
RECRUITINGPorto Alegre, Brazil
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Ceon Pesquisas
RECRUITINGSanto André, Brazil
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Chang Gung Memorial Hospital
RECRUITINGLinkou Taoyuan, Taiwan
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Chongqing Cancer Hospital
RECRUITINGChongqing, China
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Clinica Universidad de Navarra (Calle Marquesado de Santa Marta)
RECRUITINGSan Blas-Canillejas, Spain
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Clinica Universidad de Navarra (MAD)
RECRUITINGPamplona, Spain
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Cliniques Universitaires Saint-LUC
RECRUITINGWoluwe-Saint-Lambert, Belgium
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Columbia University
RECRUITINGNew York, New York, 10032, United States
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Complejo Hospitalario Universitario A Coruna
RECRUITINGA Coruña, Spain
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Complex Oncology Center- Plovdiv EOOD
RECRUITINGPlovdiv, Bulgaria
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Corewell Health
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Debreceni Egyetem
RECRUITINGDebrecen, 4032, Hungary
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Disney Family Cancer Center
RECRUITINGBurbank, California, 91505, United States
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Endeavor Health Evanston Kellogg Cancer Care Center
RECRUITINGEvanston, Illinois, 60201, United States
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Fakultni Nemocnice Bulovka
RECRUITINGPrague, Czechia
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Fakultni Nemocnice Kralovske Vinohrady
RECRUITINGPrague, Czechia
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Fakultni Nemocnice Ostrava
RECRUITINGOstrava-Poruba, Czechia
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Fakultni Nemocnice V Motole
RECRUITINGPrague, Czechia
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITINGRoma, Italy
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai Shi, 200032, China
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Fujian Cancer Hospital
RECRUITINGFuzhou, China
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Fukushima Medical University Hospital
RECRUITINGFukushima, 960-1295, Japan
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Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto
RECRUITINGSao Jose Rio, Brazil
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Fundação Doutor Amaral Carvalho
RECRUITINGJaú, Brazil
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Gangnam Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, South Korea
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General Hospital of Athens Alexandra
RECRUITINGAthens, 11528, Greece
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Genesis Care North Shore (Oncology)
RECRUITINGSt Leonards, Australia
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Genesis Care, Beaumont House
RECRUITINGOxford, OX4 6LB, United Kingdom
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Genesiscare St Andrews Hospital
RECRUITINGAdelaide, Australia
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Gral Medical S.R.L
RECRUITINGBucharest, Romania
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Greater Baltimore Medical Center
RECRUITINGTowson, Maryland, 21204, United States
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Groupe Sante CHC/Clinique du MontLegia
RECRUITINGLiège, Belgium
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Guangxi Medical University Cancer Hopstial
RECRUITINGNanning, China
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Gujarat Cancer & Research Institute
RECRUITINGAhmedabad, India
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Guys Hospital Cancer Centre
RECRUITINGLondon, SE1 9RT, United Kingdom
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Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
RECRUITINGGyőr, 9024, Hungary
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HCG Cancer Centre Vadodara
RECRUITINGVadodara, India
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HCG Manavata Cancer Centre
RECRUITINGNashik, India
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HOSPITAL KUALA LUMPUR(HKL) Kuala
RECRUITINGLumpur, Malaysia
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Hainan General Hospital
RECRUITINGHaikou, China
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Harbin Medical University - Tumor Hospital
RECRUITINGHaerbing, China
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Henan Cancer Hospital
RECRUITINGZhengzhou, China
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Hopital Claude Huriez- CHU Lille
RECRUITINGLille, France
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Hopital Prive Du Confluent
RECRUITINGNantes, France
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Hopital Saint Joseph- Paris
RECRUITINGParis, France
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Hospital Clinic De Barcelona
RECRUITINGBarcelona, Spain
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Hospital Clinico Universitario De Valencia
RECRUITINGValencia, Spain
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Hospital Europeen Georges Pompidou
RECRUITINGParis, France
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Hospital Sultan
RECRUITINGJohor Bahru, Malaysia
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Hospital Universitari I Politecnic La Fe
RECRUITINGValencia, Spain
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Hospital Universitari Son Espases
RECRUITINGPalma, Spain
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Hospital Universitari Vall D'Hebron
RECRUITINGBarcelona, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, Spain
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Hospital Universitario Donostia
RECRUITINGPlanta Baja, Spain
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Hospital Universitario La Paz
RECRUITINGMadrid, Spain
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Hospital Universitario Ramon y Cajal
RECRUITINGMadrid, Spain
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Hospital Universitario Reina Sofia
RECRUITINGCórdoba, Spain
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Hospital Universitario Virgen De La Arrixaca
RECRUITINGEl Palmar, Spain
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Hospital Universitario Virgen del Rocio
RECRUITINGSeville, Spain
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Hubei Cancer Hospital
RECRUITINGWuhan, China
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Humanitas San Pio X
RECRUITINGMilan, Italy
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Hunan Cancer Hospital
RECRUITINGChangsha, 410006, China
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Hyogo Cancer Center
RECRUITINGAkashi, 673-8558, Japan
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IEO Istituto Europeo Di Oncologia
RECRUITINGMilan, Italy
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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Icon Cancer Centre Hobart
RECRUITINGHobart, Australia
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Icon Cancer Centre Wesley
RECRUITINGAuchenflower, Australia
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Indiana University
RECRUITINGIndianapolis, Indiana, 46202, United States
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Institut Bergonie
RECRUITINGBordeaux, France
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Irmandade Da Santa Casa De Misericordia De Porto Alegre
RECRUITINGPorto Alegre, Brazil
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Istituto Nazionale Tumori Fondazione G. Pascale
RECRUITINGNaples, Italy
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Istituto Nazionale Tumori Regina Elena Irccs
RECRUITINGRoma, Italy
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Istituto Tumori Giovanni Paolo II Irccs Ospedale Oncologico Bari
RECRUITINGBari, Italy
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Iwate Medical University Hospital
RECRUITINGShiwa-Gun, 028-3695, Japan
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Jiangxi Maternal and Child Health Hospital
RECRUITINGNanchang, China
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Jupiter Medical Center
RECRUITINGJupiter, Florida, 33458, United States
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Kaohsiung Chang Gung Memorial Hospital
RECRUITINGKaohsiung City, Taiwan
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Karolinska Universitet Ssjukhuset
RECRUITINGSolna, Sweden
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Keimyung University Dongsan Hospital
RECRUITINGDaegu, South Korea
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Kindai University Hospital
RECRUITINGOsakasayama-shi, Japan
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King George Hospital
RECRUITINGVisakhapatnam, India
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Kurume University Hospital
RECRUITINGKurume-shi, Japan
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Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITINGNew York, New York, 10016, United States
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Legacy Medical Group Gynecologic Oncology
RECRUITINGPortland, Oregon, 97210, United States
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Liaoning Cancer Hospital & Institute
RECRUITINGShenyang, China
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Liga Norte-Rio-Grandense Contra o Cancer
RECRUITINGNatal, Brazil
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MHAT Park Hospital EOOD
RECRUITINGPlovdiv, Bulgaria
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MHAT Serdika EOOD
RECRUITINGSofia, Bulgaria
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MacKay Memorial Hospital- Taipei Branch
RECRUITINGTaipei, Taiwan
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Mahamana Pandit Madan Mohan Malaviya Cancer Centre
RECRUITINGVaranasi, 221005, India
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Mazowiecki Szpital Wojewodzki W Siedlcach SP Zoo
RECRUITINGSiedlce, Poland
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Medeuropa SRL
RECRUITINGBucharest, Romania
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Medeuropa SRL
RECRUITINGOradea, Romania
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Medizinische Universitat Innsbruck
RECRUITINGInnsbruck, Austria
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Meir Medical Center
RECRUITINGKfar Saba, Israel
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Memorial Healthcare International SRL
RECRUITINGBucharest, Romania
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Metropolitan Hospital
RECRUITINGNeo Faliro, 18547, Greece
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Miami Valley Hospital South
RECRUITINGCenterville, Ohio, 45459, United States
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Mie University Hospital
RECRUITINGTsu, 514-8507, Japan
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Minnesota Oncology Hematology PA
RECRUITINGMinneapolis, Minnesota, 55404, United States
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Mount Sinai Medical Center
RECRUITINGMiami Beach, Florida, 33140, United States
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NHO Hokkaido Cancer Center
RECRUITINGSapporo, 003-0804, Japan
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Nancy N. & J.C Lewis Cancer & Research Pavillion- St. Josephs/ Candler Health System
RECRUITINGSavannah, Georgia, 31405, United States
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National And Hapodistrian University of Athens (University General Hospital Attikon)
RECRUITINGAthens, 12462, Greece
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National Cancer Center
RECRUITINGGoyang-si, South Korea
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National Cancer Center Hospital
RECRUITINGChūōku, 104-0045, Japan
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National Cancer Centre Singapore
RECRUITINGSingapore, 168583, Singapore
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National Cancer Institute / Institut Kanser Negara
RECRUITINGPutrajaya, Malaysia
-
National Cancer Institute Nagpur
RECRUITINGNagpur, India
-
National Cheng Kung University Hospital
RECRUITINGTainan, Taiwan
-
National Taiwan University Hospital
RECRUITINGTaipei, Taiwan
-
National University Hospital
RECRUITINGSingapore, Singapore
-
Niigata Cancer Center Hospital
RECRUITINGNiigata, Japan
-
Nuovo Ospedale Degli Infermi
RECRUITINGPonderano, Italy
-
Okayama University Hosptial
RECRUITINGOkayama, 700-8558, Japan
-
Oncocentro Belo Horizonte
RECRUITINGBelo Horizonte, Brazil
-
Osaka International Cancer Institute
RECRUITINGOsaka, Japan
-
Palo Alto Medical Foundation
RECRUITINGPalo Alto, California, 94301, United States
-
Providence Cancer Center Oncology
RECRUITINGPortland, Oregon, 97213, United States
-
Rabin Medical Center-Beilinson Campus
RECRUITINGPetah Tikva, Israel
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Rigshospitalet
RECRUITINGCopenhagen, 2100, Denmark
-
Ruby Hall Clinic
RECRUITINGPune, India
-
Saitama Medical University International Medical Center
RECRUITINGHidaka-Shi, 350-1298, Japan
-
Samsung Medical Center
RECRUITINGSeoul, South Korea
-
Sarah Cannon Research Institute (Oncology Associates of Oregon PC)
RECRUITINGNashville, Tennessee, 37203, United States
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Sarawak General Hospital
RECRUITINGKuching, Malaysia
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Saroj Gupta Cancer Center and Research Institute SGCC&RI
RECRUITINGKolkata, India
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Scripps Clinic
RECRUITINGLa Jolla, California, 92037, United States
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Seoul National University Bundang Hospital
RECRUITINGSeongnam-si, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, South Korea
-
Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, South Korea
-
Shaare Zedek
RECRUITINGJerusalem, Israel
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Shandong Cancer Hospital
RECRUITINGJinan, China
-
Shanxi Cancer Hospital
RECRUITINGTaiyuan, China
-
Sheba Medical Center
RECRUITINGTel Litwinsky, Israel
-
Shizuoka Cancer Center
RECRUITINGSunto-gun, Japan
-
Sichuan University West China Second University Hospital
RECRUITINGChengdu, China
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Sjællands Universitet Hospital
RECRUITINGRoskilde, Denmark
-
Skanes Universitetssjukhus Lund
RECRUITINGLund, Sweden
-
St Luke's Hospital
RECRUITINGThessaloniki, 55236, Greece
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St. Lukes University Health Network
RECRUITINGBethlehem, Pennsylvania, 18015, United States
-
St. Vincent Gynecologic Oncology
RECRUITINGBillings, Montana, 59102, United States
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Sun Yat-Sen University Cancer Center
RECRUITINGGuangzhou, China
-
Taichung Veterans General Hospital
RECRUITINGTaichung, Taiwan
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Taipei Veterans General Hospital
RECRUITINGTaipei, Taiwan
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Tata Memorial Hospital
RECRUITINGMumbai, 400012, India
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Tel Aviv Sourasky Medical Center
RECRUITINGTel Aviv, Israel
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The Catholic University of Korea, Seoul St. Mary'S Hospital
RECRUITINGSeoul, South Korea
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The Christie Hospital
RECRUITINGManchester, United Kingdom
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The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITINGXi'an, China
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The First Hospital of Jilin University
RECRUITINGChangchun, China
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The Lady Davis Carmel Medical Center
RECRUITINGHaifa, Israel
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The Second Hospital of Dalian Medical University
RECRUITINGDalian, China
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Tianjin Medical University Cancer Institute & Hospital
RECRUITINGTianjin, China
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Tongji Hospital Tongji Medical College of HUST
RECRUITINGWuhan, China
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Townsville University Hospital Cancer Centre
RECRUITINGTownsville, 4814, Australia
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Trials365 LLC
RECRUITINGShreveport, Louisiana, 71103, United States
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Trinity Health St. Joseph Mercy Ann Arbor
RECRUITINGAnn Arbor, Michigan, 48106, United States
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UMHAT Sofiamed EOOD
RECRUITINGSofia, Bulgaria
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UMHAT Tsaritsa Yoanna ISUL EAD
RECRUITINGSofia, Bulgaria
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UNC Hospital
RECRUITINGChapel Hill, North Carolina, 27599, United States
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UZ Leuven
RECRUITINGLeuven, Belgium
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Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITINGPoznan, 61848, Poland
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Ushato Prof Ivan Chernozemski Ead
RECRUITINGSofia, Bulgaria
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Utah Cancer Specialists Network
RECRUITINGSalt Lake City, Utah, 84106, United States
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Valley Health System
RECRUITINGParamus, New Jersey, 07652, United States
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Vseobecna Fakultni Nemocnice V Praze
RECRUITINGPrague, Czechia
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Westmead Hospital
RECRUITINGSydney, Australia
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Weston Park Hospital
RECRUITINGSheffield, S10 2SB, United Kingdom
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Woman's Care FL
RECRUITINGSt. Petersburg, Florida, 33713, United States
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Women's Hospital School of Medicine Zhejiang University
RECRUITINGHangzhoushi, China
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Yamagata University Hospital
RECRUITINGYamagata, 990-9585, Japan
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Yantai Yuhuangding Hospital
RECRUITINGYantai, China
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Yunnan Cancer Hospital
RECRUITINGKunming, China
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Zhejiang Cancer Hospital
RECRUITINGHangzhou, China
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Zhong Da Hospital, Southeast University
RECRUITINGNanjing, China
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