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| ID | Type | Description | Link |
|---|---|---|---|
| MK-2870-021 | Other Identifier | MSD | |
| GOG-3102 | Other Identifier | Gynecologic Oncology Group | |
| ENGOT-ov85 | Other Identifier | European Network for Gynaecological Oncological Trial groups | |
| U1111-1297-5158 | Registry Identifier | WHO/UTN | |
| 2023-508047-40-00 | Registry Identifier | EU CT | |
| jRCT2031250647 | Registry Identifier | Japan Registry of Clinical Trial (jRCT) |
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Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:
The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sac-TMT +/- Bevacizumab | Experimental | Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses. |
|
| Standard of Care | Active Comparator | Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab tirumotecan | Drug | Administered via intravenous (IV) infusion at a dose of 4mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. | Up to approximately 49 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 78 months |
| Progression-Free Survival 2 (PFS2) | PFS2 as assessed by investigator is defined as the time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first. |
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The main inclusion criteria include but are not limited to the following:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Cancer Center ( Site 0029) | Recruiting | Miami Beach | Florida | 33140 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Bevacizumab | Drug | Administered via IV infusion at a dose of 15mg/kg |
|
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| Rescue Medications | Drug | Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent. |
|
| Up to approximately 78 months |
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | Up to approximately 78 months |
| Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | Up to approximately 78 months |
| Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Combined Score (Items 29 and 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) | EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7- point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented. | Baseline, and at designated time points up to approximately 78 months |
| Change From Baseline in Physical Functioning Combined Score (Items 1 to 5) Using EORTC QLQ-C30 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 5 questions and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 physical functioning combined score will be presented. | Baseline, and at designated time points up to approximately 78 months |
| Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 role functioning combined score will be presented. | Baseline, and at designated time points up to approximately 78 months |
| Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28) | EORTC QLQ-OV28 is an OC-specific module to supplement the EORTC QLQ-C30. Participant responses to the 6 abdominal/GI symptoms scale questions are scored on a 4-point scale (1=not at all, 4=very much). The combined score is computed by averaging the raw scores of the 6 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-OC28 Items 31-36) score will be presented. A lower score indicates a better outcome. | Baseline, and at designated time points up to approximately 78 months |
| Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085) | Recruiting | Orlando | Florida | 32806 | United States |
|
| Winship Cancer Institute of Emory University ( Site 0037) | Recruiting | Atlanta | Georgia | 30308 | United States |
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| Parkview Research Center at Parkview Regional Medical Center ( Site 0055) | Recruiting | Fort Wayne | Indiana | 46845 | United States |
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| Women's Cancer Care ( Site 0018) | Recruiting | Covington | Louisiana | 70433 | United States |
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| Nebraska Methodist Hospital ( Site 0004) | Recruiting | Omaha | Nebraska | 68114 | United States |
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| University Of Nebraska Medical Center ( Site 0035) | Recruiting | Omaha | Nebraska | 68198 | United States |
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| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007) | Recruiting | Tulsa | Oklahoma | 74146 | United States |
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| Women & Infants Hospital ( Site 0001) | Recruiting | Providence | Rhode Island | 02905 | United States |
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| West Cancer Center and Research Institute ( Site 0013) | Recruiting | Germantown | Tennessee | 38138 | United States |
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| University of Tennessee Medical Center ( Site 0087) | Recruiting | Knoxville | Tennessee | 37920 | United States |
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| Hospital Aleman ( Site 2903) | Recruiting | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1119ACN | Argentina |
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| Instituto Alexander Fleming ( Site 2902) | Recruiting | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1426ANZ | Argentina |
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| Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901) | Recruiting | Mar del Plata | Buenos Aires | B7600FZO | Argentina |
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| Fundación Respirar ( Site 2912) | Recruiting | Buenos Aires | Buenos Aires F.D. | C1426AAL | Argentina |
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| Sanatorio Parque - Oncología ( Site 2911) | Recruiting | Rosario | Santa Fe Province | S2000DVC | Argentina |
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| Instituto de Oncologia de Rosario ( Site 2909) | Recruiting | Rosario | Santa Fe Province | S2000KZE | Argentina |
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| Hospital Britanico de Buenos Aires ( Site 2905) | Recruiting | CABA | C1280AEB | Argentina |
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| Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907) | Recruiting | La Rioja | F5300COE | Argentina |
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| Gallipoli Medical Research Ltd ( Site 0204) | Recruiting | Brisbane | Queensland | 4120 | Australia |
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| Epworth Freemasons ( Site 0207) | Recruiting | East Melbourne | Victoria | 3002 | Australia |
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| Medizinische Universitat Wien ( Site 0102) | Recruiting | Vienna | State of Vienna | 1090 | Austria |
|
| Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101) | Recruiting | Innsbruck | Tyrol | 6020 | Austria |
|
| Grand Hopital de Charleroi ( Site 0303) | Recruiting | Charleroi | Hainaut | 6000 | Belgium |
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| AZ Maria Middelares ( Site 0302) | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
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| UZ Leuven ( Site 0301) | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| Liga Norte Riograndense Contra o Cancer ( Site 0417) | Recruiting | Natal | Rio Grande do Norte | 59062-000 | Brazil |
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| Hospital São Lucas da PUCRS ( Site 0415) | Recruiting | Porto Alegre | Rio Grande do Sul | 90610000 | Brazil |
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| Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0414) | Recruiting | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
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| CIUSSS - Saguenay-Lac-Saint-Jean ( Site 0519) | Recruiting | Chicoutimi | Quebec | G7H 5H6 | Canada |
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| McGill University Health Centre ( Site 0516) | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| Fundacion Colombiana de Cancerología Clinica Vida ( Site 0803) | Recruiting | Medellín | Antioquia | 050030 | Colombia |
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| FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801) | Recruiting | Bogotá | Bogota D.C. | 110131 | Colombia |
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| Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0802) | Recruiting | Valledupar | Cesar Department | 200001 | Colombia |
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| Instituto Nacional De Cancerologia ( Site 0808) | Recruiting | Bogota | Cundinamarca | 111151 | Colombia |
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| Oncólogos del Occidente S.A.S. ( Site 0806) | Recruiting | Pereira | Risaralda Department | 660001 | Colombia |
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| Fakultni Nemocnice Brno Bohunice ( Site 3304) | Recruiting | Brno | Brno-mesto | 602 00 | Czechia |
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| Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 3303) | Recruiting | Ostrava-Poruba | Ostrava Mesto | 708 52 | Czechia |
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| Fakultni nemocnice Kralovske Vinohrady ( Site 3306) | Recruiting | Prague | 100 34 | Czechia |
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| Vseobecna fakultni nemocnice v Praze ( Site 3305) | Recruiting | Prague | 128 08 | Czechia |
|
| Fakultni nemocnice motol ( Site 3302) | Recruiting | Prague | 150 06 | Czechia |
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| Herlev Hospital ( Site 0902) | Recruiting | Herlev | Capital Region | 2730 | Denmark |
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| Aalborg Universitetshospital ( Site 0901) | Recruiting | Aalborg | North Denmark | 9000 | Denmark |
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| Aarhus Universitetshospital, Skejby ( Site 0903) | Recruiting | Aarhus | North Denmark | 8200 | Denmark |
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| Odense Universitets Hospital ( Site 0904) | Recruiting | Odense | Region Syddanmark | 9000 | Denmark |
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| Oulun yliopistollinen sairaala ( Site 1003) | Recruiting | Oulu | North Ostrobothnia | 90220 | Finland |
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| Kuopion Yliopistollinen Sairaala ( Site 1004) | Recruiting | Kuopio | Northern Savonia | 70200 | Finland |
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| Tampereen yliopistollinen sairaala ( Site 1002) | Recruiting | Tampere | Pirkanmaa | 33520 | Finland |
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| Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001) | Recruiting | Turku | Southwest Finland | 20520 | Finland |
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| CENTRE LEON BERARD ( Site 1101) | Recruiting | Lyon | Auvergne-Rhône-Alpes | 69008 | France |
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| Hopitaux Universitaires de Strasbourg ( Site 1109) | Recruiting | Strasbourg | Bas-Rhin | 67000 | France |
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| Hôpital Privé Des Côtes d'Armor ( Site 1102) | Recruiting | Plérin | Cotes-d Armor | 22190 | France |
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| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1105) | Recruiting | Tours | Indre-et-Loire | 37044 | France |
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| Centre Oscar Lambret ( Site 1106) | Recruiting | Lille | Nord | 59020 | France |
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| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113) | Recruiting | Clermont-Ferrand | Puy-de-Dome | 63003 | France |
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| Alexandra General Hospital of Athens ( Site 0703) | Recruiting | Athens | Attica | 115 28 | Greece |
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| Agios Loukas Clinic ( Site 0702) | Recruiting | Thessaloniki | 552 36 | Greece |
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| Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910) | Recruiting | Kecskemét | Bács-Kiskun county | 6000 | Hungary |
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| Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 3911) | Recruiting | Győr | Győr-Moson-Sopron | 9024 | Hungary |
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| Országos Onkológiai Intézet-Ngyógyászat ( Site 3913) | Recruiting | Budapest | 1122 | Hungary |
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| Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912) | Recruiting | Debrecen | 4032 | Hungary |
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| Rambam Health Care Campus ( Site 1422) | Recruiting | Haifa | 3109601 | Israel |
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| Edith Wolfson Medical Center ( Site 1423) | Recruiting | Holon | 5810001 | Israel |
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| Sheba Medical Center ( Site 1421) | Recruiting | Ramat Gan | 5265601 | Israel |
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| Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501) | Recruiting | Brescia | 25123 | Italy |
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| Istituto Nazionale dei Tumori ( Site 1504) | Recruiting | Milan | 20133 | Italy |
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| Istituto Europeo di Oncologia ( Site 1503) | Recruiting | Milan | 20141 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510) | Recruiting | Roma | 00168 | Italy |
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| Gunma Prefectural Cancer Center ( Site 1605) | Recruiting | Ōta | Gunma | 373-8550 | Japan |
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| Hokkaido University Hospital ( Site 1609) | Recruiting | Sapporo | Hokkaido | 060-8648 | Japan |
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| Hyogo Cancer Center ( Site 1620) | Recruiting | Akashi | Hyōgo | 673-8558 | Japan |
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| Iwate Medical University Hospital ( Site 1610) | Recruiting | Shiwa-gun | Iwate | 028-3695 | Japan |
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| Saitama Medical University International Medical Center ( Site 1607) | Recruiting | Hidaka | Saitama | 350-1298 | Japan |
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| Cancer Institute Hospital of JFCR ( Site 1614) | Recruiting | Koto | Tokyo | 135-8550 | Japan |
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| Keio University Hospital ( Site 1611) | Recruiting | Shinjyuku | Tokyo | 160-8582 | Japan |
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| Kagoshima City Hospital ( Site 1613) | Recruiting | Kagoshima | 890-8760 | Japan |
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| Niigata Cancer Center Hospital ( Site 1608) | Recruiting | Niigata | 951-8566 | Japan |
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| Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604) | Recruiting | Osaka | 541-8567 | Japan |
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| Stavanger Universitetssjukehus ( Site 2002) | Recruiting | Stavanger | Rogaland | 4068 | Norway |
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| Sorlandet Sykehus Kristiansand ( Site 2003) | Recruiting | Kristiansand | Vest-Agder | 4615 | Norway |
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| Oslo University Hospital ( Site 2001) | Recruiting | Oslo | 0424 | Norway |
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| Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2106) | Recruiting | Poznan | Greater Poland Voivodeship | 60-569 | Poland |
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| Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 2105) | Recruiting | Poznan | Greater Poland Voivodeship | 61-866 | Poland |
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| Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102) | Recruiting | Siedlce | Masovian Voivodeship | 08-110 | Poland |
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| Bialostockie Centrum Onkologii ( Site 2104) | Recruiting | Bialystok | Podlaskie Voivodeship | 15-027 | Poland |
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| Uniwersytecki Szpital Kliniczny nr2 PUM w Szczecinie ( Site 2103) | Recruiting | Szczecin | West Pomeranian Voivodeship | 70-111 | Poland |
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| Severance Hospital ( Site 2302) | Recruiting | Seodaemun-Gu | Seoul | 03722 | South Korea |
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| Keimyung University Dongsan Hospital ( Site 2304) | Recruiting | Daegu | Taegu-Kwangyokshi | 42601 | South Korea |
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| Seoul National University Hospital ( Site 2301) | Recruiting | Seoul | 03080 | South Korea |
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| Asan Medical Center ( Site 2305) | Recruiting | Seoul | 05505 | South Korea |
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| Samsung Medical Center ( Site 2303) | Recruiting | Seoul | 06351 | South Korea |
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| Institut Català d'Oncologia (ICO) - Girona ( Site 2402) | Recruiting | Girona | Gerona | 17007 | Spain |
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| Complejo Hospitalario Universitario A Coruna ( Site 2412) | Recruiting | A Coruña | La Coruna | 15006 | Spain |
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| Clinica Universidad de Navarra ( Site 2407) | Recruiting | Madrid | Madrid, Comunidad de | 28027 | Spain |
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| Instituto Valenciano de Oncologia - IVO ( Site 2411) | Recruiting | Valencia | Valenciana, Comunitat | 46009 | Spain |
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| Hospital Vall D Hebron ( Site 2403) | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Clinic I Provincial de Barcelona ( Site 2409) | Recruiting | Barcelona | 08036 | Spain |
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| ICO L Hospitalet ( Site 2408) | Recruiting | Barcelona | 08907 | Spain |
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| Hospital Universitario Reina Sofia ( Site 2406) | Recruiting | Córdoba | 14004 | Spain |
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| Hospital Ramon y Cajal ( Site 2405) | Recruiting | Madrid | 28034 | Spain |
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| Hospital Clinico San Carlos... ( Site 2410) | Recruiting | Madrid | 28040 | Spain |
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| Hospital Universitario La Paz-Oncología Médica ( Site 2404) | Recruiting | Madrid | 28046 | Spain |
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| Karolinska Universitetssjukhuset Solna ( Site 2502) | Recruiting | Stockholm | Stockholm County | 171 76 | Sweden |
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| Inselspital Bern ( Site 3504) | Recruiting | Bern | Canton of Bern | 3010 | Switzerland |
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| Ospedale Regionale Bellinzona e Valli ( Site 3501) | Recruiting | Bellinzona | Canton Ticino | 6500 | Switzerland |
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| Kantonsspital Graubünden ( Site 3503) | Recruiting | Chur | Kanton Graubünden | 7000 | Switzerland |
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| Hôpitaux Universitaires de Genève (HUG) ( Site 3502) | Recruiting | Geneva | 1205 | Switzerland |
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| Taichung Veterans General Hospital ( Site 2603) | Recruiting | Taichung | 40705 | Taiwan |
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| National Cheng Kung University Hospital ( Site 2602) | Recruiting | Tainan | 704302 | Taiwan |
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| National Taiwan University Hospital ( Site 2601) | Recruiting | Taipei | 10002 | Taiwan |
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| Mackay Memorial Hospital ( Site 2604) | Recruiting | Taipei | 104 | Taiwan |
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| Linkou Chang Gung Memorial Hospital ( Site 2605) | Recruiting | Taoyuan | 333 | Taiwan |
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| Ramathibodi Hospital. ( Site 3402) | Recruiting | Bangkok | Bangkok | 10400 | Thailand |
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| Faculty of Medicine Siriraj Hospital ( Site 3401) | Recruiting | Bangkoknoi | Bangkok | 10700 | Thailand |
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| Faculty of Medicine - Khon Kaen University ( Site 3403) | Recruiting | Muang | Changwat Khon Kaen | 40002 | Thailand |
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| Addenbrookes Hospital ( Site 2802) | Recruiting | Cambridge | Cambridgeshire | CB2 2QQ | United Kingdom |
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| University Hospitals of Leicester NHS Trust ( Site 2805) | Recruiting | Leicester | Leicestershire | LE3 9QP | United Kingdom |
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| The Christie NHS Foundation Trust ( Site 2804) | Recruiting | Manchester | m20 4bx | United Kingdom |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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Not provided