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Recruiting Phase 3 NCT06459180

A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)

Phase 3 – large-scale trial before approval
Conditions: Cervical Cancer

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion. The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.
Who can participate
Inclusion Criteria: * Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix * Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens * Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions * Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent * Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion * Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated * HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion) * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Has adequate organ function Exclusion Criteria: * Has Grade ≥2 peripheral neuropathy * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. * Received prior systemic anticancer therapy * Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed * Has other histological subtypes of cervical cancer apart from squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma), or has a diagnosis of nonepithelial cancer (eg, sarcoma, neuroendocrine tumors) of the cervix. * Known additional malignancy that is progressing or has required active treatment within the past 3 years * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Active infection requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Concurrent active Hepatitis B and active Hepatitis C virus infection * Severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy * Participants who have not adequately recovered from major surgery or have ongoing surgical complications * Has a history of (noninfectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD
Interventions
Sacituzumab Tirumotecan
BIOLOGICAL
Pemetrexed
DRUG
Tisotumab Vedotin
BIOLOGICAL
Topotecan
DRUG
Vinorelbine
DRUG
Gemcitabine
DRUG
Irinotecan
DRUG
Locations 240
Argentina (8)
Instituto de Oncología Angel H. Roffo ( Site 0103)
Buenos Aires , Buenos Aires F.D.
Study Coordinator
Instituto Alexander Fleming ( Site 0108)
Buenos Aires , Buenos Aires F.D.
Study Coordinator
Hospital Aleman-Oncology ( Site 0100)
Buenos Aires
COMPLETED
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0109)
CABA
Study Coordinator
Hospital Británico de Buenos Aires-Oncology ( Site 0102)
Ciudad Autónoma de Buenos Aires , Buenos Aires
Study Coordinator
Sanatorio Allende - Cerro-Oncology ( Site 0106)
Córdoba , Córdoba Province
Study Coordinator
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0104)
La Rioja
ACTIVE_NOT_RECRUITING
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107)
Mar del Plata , Buenos Aires
Study Coordinator
Australia (6)
Monash Health-Oncology Research ( Site 3002)
Clayton , Victoria
Study Coordinator
Royal Brisbane and Women's Hospital ( Site 3001)
Herston , Queensland
Study Coordinator
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 3005)
Melbourne , Victoria
COMPLETED
Sir Charles Gairdner Hospital ( Site 3003)
Nedlands , Western Australia
ACTIVE_NOT_RECRUITING
Blacktown Hospital ( Site 3006)
Sydney , New South Wales
Study Coordinator
Campbelltown Hospital-Macarthur Cancer Therapy Centre Medical Oncology ( Site 3000)
Sydney , New South Wales
Study Coordinator
Austria (4)
Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 1003)
Graz , Styria
Study Coordinator
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1000)
Innsbruck , Tyrol
Study Coordinator
Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1002)
Linz , Upper Austria
Study Coordinator
Medizinische Universität Wien ( Site 1001)
Vienna
Study Coordinator
Belgium (5)
AZORG Campus Aalst-Moorselbaan ( Site 2905)
Aalst , Oost-Vlaanderen
Study Coordinator
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman-Medical Oncology ( Site 2904)
Belgium , Wallonne, Region
COMPLETED
UZ Gent-Medical oncology ( Site 2901)
Ghent , Oost-Vlaanderen
ACTIVE_NOT_RECRUITING
UZ Leuven-Gynecologic Oncology ( Site 2900)
Leuven , Vlaams-Brabant
Study Coordinator
CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 2902)
Namur
Study Coordinator
Brazil (7)
Instituto do Câncer e Transplante de Curitiba ( Site 0205)
Curitiba , Paraná
Study Coordinator
Centro de Hematologia e Oncologia ( Site 0203)
Joinville , Santa Catarina
Study Coordinator
Hospital Moinhos de Vento-Centro de Pesquisa Clínica ( Site 0204)
Porto Alegre , Rio Grande do Sul
Study Coordinator
Hospital do Câncer Mãe de Deus ( Site 0201)
Porto Alegre , Rio Grande do Sul
COMPLETED
Americas Centro de Oncologia Integrado ( Site 0202)
Rio de Janeiro
Study Coordinator
IBCC - Instituto Brasileiro de Controle do Câncer-Centro de Pesquisa Clínica ( Site 0200)
São Paulo , São Paulo
Study Coordinator
Hospital Paulistano ( Site 0209)
São Paulo
Study Coordinator
Bulgaria (3)
MBAL Uni Hospital-Department of Medical Oncology ( Site 1104)
Panagyurishte , Pazardzhik
Study Coordinator
MHAT - Heart and Brain ( Site 1100)
Pleven
Study Coordinator
Complex Oncology Center - Plovdiv EOOD ( Site 1102)
Plovdiv
Study Coordinator
Canada (8)
Royal Victoria Regional Health Centre ( Site 4009)
Barrie , Ontario
Study Coordinator
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 4003)
Hamilton , Ontario
Study Coordinator
BC Cancer Kelowna ( Site 4007)
Kelowna , British Columbia
Study Coordinator
Centre Hospitalier de l'Université de Montréal ( Site 4001)
Montreal , Quebec
Study Coordinator
McGill University Health Centre ( Site 4000)
Montreal , Quebec
Study Coordinator
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 4002)
Québec , Quebec
Study Coordinator
BC Cancer Surrey ( Site 4006)
Surrey , British Columbia
Study Coordinator
BC Cancer Victoria ( Site 4008)
Victoria , British Columbia
Study Coordinator
Chile (3)
FALP-UIDO ( Site 0300)
Santiago , Region M. de Santiago
Study Coordinator
Pontificia Universidad Catolica de Chile ( Site 0302)
Santiago , Region M. de Santiago
Study Coordinator
ONCOCENTRO APYS-ACEREY ( Site 0303)
Viña del Mar , Valparaiso
ACTIVE_NOT_RECRUITING
China (32)
Beijing Peking Union Medical College Hospital ( Site 5045)
Beijing , Beijing Municipality
Study Coordinator
Jilin Province Tumor Hospital ( Site 5036)
Changchun , Jilin
Study Coordinator
Hunan Cancer Hospital ( Site 5021)
Changsha , Hunan
Study Coordinator
Xiangya Hospital Central South University ( Site 5009)
Changsha , Hunan
Study Coordinator
West China Second University Hospital, Sichuan University ( Site 5017)
Chengdu , Sichuan
Study Coordinator
Sichuan Cancer hospital-Oncology ( Site 5030)
Chengdu , Sichuan
ACTIVE_NOT_RECRUITING
Chongqing University Cancer Hospital ( Site 5003)
Chongqing , Chongqing Municipality
Study Coordinator
Fujian Provincial Cancer Hospial ( Site 5012)
Fuzhou , Fujian
ACTIVE_NOT_RECRUITING
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 5001)
Guangzhou , Guangdong
ACTIVE_NOT_RECRUITING
Sun Yat-sen University Cancer Center-Internal medicine ( Site 5006)
Guangzhou , Guangdong
COMPLETED
Hainan General Hospital ( Site 5032)
Haikou , Hainan
ACTIVE_NOT_RECRUITING
Women s Hospital School of Medicine Zhejiang University ( Site 5022)
Hangzhou , Zhejiang
Study Coordinator
Zhejiang Cancer Hospital ( Site 5008)
Hangzhou , Zhejiang
Study Coordinator
Harbin Medical University Cancer Hospital ( Site 5010)
Harbin , Heilongjiang
COMPLETED
Anhui Provincial Cancer Hospital-Gynecological Oncology ( Site 5040)
Hefei , Anhui
Study Coordinator
Anhui Provincial Hospital ( Site 5011)
Hefei , Anhui
Study Coordinator
Shandong Cancer Hospital ( Site 5014)
Jinan , Shandong
ACTIVE_NOT_RECRUITING
Yunnan Province Cancer Hospital-Gynecology Department ( Site 5005)
Kunming , Yunnan
ACTIVE_NOT_RECRUITING
LinYi Cancer Hospital-Gastrology department ( Site 5039)
Linyi , Shandong
COMPLETED
Jiangxi Maternal and Child Health Hospital ( Site 5031)
Nanchang , Jiangxi
Study Coordinator
Jiangsu Province Hospital-Oncology Department ( Site 5018)
Nanjing , Jiangsu
COMPLETED
Guangxi Medical University Affiliated Tumor Hospital ( Site 5016)
Nanning , Guangxi
Study Coordinator
Obstetrics & Gynecology Hospital of Fudan University ( Site 5015)
Shanghai , Shanghai Municipality
ACTIVE_NOT_RECRUITING
Shanxi Cancer Hospital ( Site 5043)
Taiyuan , Shanxi
Study Coordinator
The First Affiliated Hospital of Wenzhou Medical University ( Site 5033)
Wenzhou , Zhejiang
ACTIVE_NOT_RECRUITING
Wuhan Union Hospital ( Site 5020)
Wuhan , Hubei
Study Coordinator
Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 5019)
Wuhan , Hubei
Study Coordinator
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 5007)
Xi'an , Shaanxi
ACTIVE_NOT_RECRUITING
The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 5027)
Xiamen , Fujian
ACTIVE_NOT_RECRUITING
The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 5041)
Xinxiang , Henan
Study Coordinator
Affiliated Hospital of Guangdong Medical University ( Site 5004)
Zhanjiang , Guangdong
Study Coordinator
Henan Cancer Hospital ( Site 5026)
Zhengzhou , Henan
Study Coordinator
Colombia (6)
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0403)
Bogotá , Bogota D.C.
ACTIVE_NOT_RECRUITING
Instituto Nacional De Cancerologia-Oncología Clínica ( Site 0404)
Bogota , Cundinamarca
ACTIVE_NOT_RECRUITING
Fundación Valle del Lili ( Site 0406)
Cali , Valle del Cauca Department
ACTIVE_NOT_RECRUITING
IMAT S.A.S ( Site 0402)
Montería , Departamento de Córdoba
COMPLETED
Oncologos del Occidente ( Site 0405)
Pereira , Risaralda Department
ACTIVE_NOT_RECRUITING
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0401)
Valledupar , Cesar Department
ACTIVE_NOT_RECRUITING
Denmark (3)
Aarhus Universitetshospital, Skejby ( Site 1301)
Aarhus , Central Jutland
ACTIVE_NOT_RECRUITING
Rigshospitalet-Dept. of Oncology ( Site 1300)
Copenhagen , Capital Region
ACTIVE_NOT_RECRUITING
Odense Universitetshospital-Department of oncology ( Site 1302)
Odense C , Region Syddanmark
ACTIVE_NOT_RECRUITING
Finland (3)
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1400)
Helsinki , Uusimaa
ACTIVE_NOT_RECRUITING
Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1404)
Tampere , Pirkanmaa
COMPLETED
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1401)
Turku , Southwest Finland
ACTIVE_NOT_RECRUITING
France (12)
CHU Besançon ( Site 1507)
Besançon , Franche-Comte
Study Coordinator
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1503)
Bordeaux , Aquitaine
ACTIVE_NOT_RECRUITING
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1508)
Clermont-Ferrand , Auvergne
ACTIVE_NOT_RECRUITING
CENTRE LEON BERARD ( Site 1505)
Lyon Cedex08 , Auvergne-Rhône-Alpes
Study Coordinator
Institut Paoli-Calmettes ( Site 1504)
Marseille , Bouches-du-Rhone
Study Coordinator
Institut Regional du Cancer Montpellier ( Site 1511)
Montpellier , Herault
ACTIVE_NOT_RECRUITING
Hôpital privé du Confluent SAS ( Site 1509)
Nantes , Loire-Atlantique
ACTIVE_NOT_RECRUITING
Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1506)
Paris
Study Coordinator
Hôpital Privé Des Côtes d'Armor ( Site 1510)
Plérin , Cotes-d Armor
ACTIVE_NOT_RECRUITING
Hopitaux Universitaires de Strasbourg ( Site 1501)
Strasbourg , Bas-Rhin
Study Coordinator
Oncopole Claudius Regaud ( Site 1502)
Toulouse , Haute-Garonne
ACTIVE_NOT_RECRUITING
Gustave Roussy ( Site 1512)
Villejuif , Île-de-France Region
Study Coordinator
Germany (11)
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1607)
Düsseldorf , North Rhine-Westphalia
Study Coordinator
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Gynäkologie und Gynäkologische Onko ( Site 1600)
Essen , North Rhine-Westphalia
Study Coordinator
Universitaetsklinikum Essen ( Site 1613)
Essen , North Rhine-Westphalia
Study Coordinator
Universitaetsklinikum Hamburg-Eppendorf-Department of Gynecology ( Site 1611)
Hamburg
Study Coordinator
Universitaetsklinikum Heidelberg Nationales Centrum fuer Tumorerkrankungen ( Site 1612)
Heidelberg , Baden-Wurttemberg
Study Coordinator
SLK-Kliniken Heilbronn ( Site 1617)
Heilbronn , Baden-Wurttemberg
Study Coordinator
Universitaetsklinikum des Saarlandes ( Site 1618)
Homburg , Saarland
Study Coordinator
Universitätsklinikum Marburg ( Site 1604)
Marburg , Hesse
Study Coordinator
Klinikum der Universität München Großhadern-Klinik und Poliklinik für Frauenheilkunde und Geburtshi ( Site 1605)
Munich , Bavaria
Study Coordinator
Diakonie-Klinikum Schwaebisch-Hall gGmbH Frauenklinik ( Site 1614)
Schwäbisch Hall , Baden-Wurttemberg
Study Coordinator
Klinikum Worms ( Site 1619)
Worms , Rhineland-Palatinate
Study Coordinator
Greece (4)
Aretaieio Hospital ( Site 1700)
Athens , Attica
Study Coordinator
Mitera Hospital ( Site 1702)
Athens , Attica
Study Coordinator
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1703)
Chaïdári , Attica
Study Coordinator
Agios Andreas Hospital Patras ( Site 1701)
Patras , Peloponnese
Study Coordinator
Ireland (3)
Cork University Hospital ( Site 1900)
Cork
ACTIVE_NOT_RECRUITING
Mater Misericordiae University Hospital ( Site 1901)
Dublin
ACTIVE_NOT_RECRUITING
St. James's Hospital-Cancer clinical trials office ( Site 1902)
Dublin
COMPLETED
Israel (4)
Rambam Health Care Campus ( Site 2002)
Haifa
Study Coordinator
Edith Wolfson Medical Center ( Site 2003)
Holon
Study Coordinator
Hadassah Medical Center ( Site 2000)
Jerusalem
Study Coordinator
Sheba Medical Center ( Site 2001)
Ramat Gan
Study Coordinator
Italy (13)
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-DEPARTMENT OF EXPERIMENTAL, DIAGNOSTIC ( Site 2105)
Bologna , Emilia-Romagna
Study Coordinator
Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2110)
Brescia
Study Coordinator
Ospedale Cannizzaro ( Site 2104)
Catania
Study Coordinator
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 2107)
Milan , Lombardy
COMPLETED
Ospedale Humanitas San Pio X ( Site 2113)
Milan , Lombardy
Study Coordinator
Ospedale San Raffaele. ( Site 2106)
Milan
Study Coordinator
Istituto Europeo di Oncologia IRCCS ( Site 2108)
Milan
Study Coordinator
Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2111)
Monza , Lombardy
Study Coordinator
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2103)
Naples
Study Coordinator
Istituto Oncologico Veneto IRCCS ( Site 2109)
Padova
Study Coordinator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2102)
Roma
Study Coordinator
Humanitas University ( Site 2112)
Rozzano , Milano
Study Coordinator
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 2100)
Turin , Piedmont
Study Coordinator
Japan (19)
National Cancer Center Hospital ( Site 5108)
Chūō , Tokyo
ACTIVE_NOT_RECRUITING
National Hospital Organization Kyushu Cancer Center ( Site 5104)
Fukuoka
ACTIVE_NOT_RECRUITING
Saitama Medical University International Medical Center ( Site 5117)
Hidaka , Saitama
ACTIVE_NOT_RECRUITING
Kagoshima City Hospital ( Site 5115)
Kagoshima
COMPLETED
National Cancer Center Hospital East ( Site 5113)
Kashiwa , Chiba
COMPLETED
Cancer Institute Hospital of JFCR ( Site 5111)
Koto , Tokyo
Study Coordinator
Kurume University Hospital ( Site 5105)
Kurume , Fukuoka
Study Coordinator
National Hospital Organization Shikoku Cancer Center ( Site 5109)
Matsuyama , Ehime
ACTIVE_NOT_RECRUITING
The Jikei University Hospital ( Site 5118)
Minato , Tokyo
Study Coordinator
Aichi Cancer Center ( Site 5110)
Nagoya , Aichi-ken
ACTIVE_NOT_RECRUITING
Niigata Cancer Center Hospital ( Site 5100)
Niigata
Study Coordinator
Gunma Prefectural Cancer Center ( Site 5116)
Ohta , Gunma
Study Coordinator
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 5103)
Osaka
Study Coordinator
Hokkaido University Hospital ( Site 5106)
Sapporo , Hokkaido
Study Coordinator
Keio University Hospital ( Site 5101)
Shinjyuku , Tokyo
ACTIVE_NOT_RECRUITING
Iwate Medical University Hospital ( Site 5112)
Shiwa-gun , Iwate
Study Coordinator
Shizuoka Cancer Center ( Site 5107)
Sunto-gun, , Shizuoka
COMPLETED
Ehime University Hospital ( Site 5102)
Tōon , Ehime
ACTIVE_NOT_RECRUITING
University of Tsukuba Hospital ( Site 5114)
Tsukuba , Ibaraki
ACTIVE_NOT_RECRUITING
Malaysia (4)
Pantai Hospital Kuala Lumpur ( Site 3100)
Kuala Lumpur
Study Coordinator
University Malaya Medical Centre ( Site 3102)
Lembah Pantai , Kuala Lumpur
ACTIVE_NOT_RECRUITING
Sunway Medical Centre ( Site 3105)
Petaling Jaya , Selangor
ACTIVE_NOT_RECRUITING
Penang Adventist Hospital ( Site 3101)
Pulau Pinang
ACTIVE_NOT_RECRUITING
Mexico (5)
Centro de Investigación Oncológica Galerías SC ( Site 0508)
Aguascalientes
Study Coordinator
CENEIT Oncologicos ( Site 0507)
Mexico City , Mexico City
Study Coordinator
Centro de Investigacion Clinica de Oaxaca ( Site 0505)
Oaxaca City , Oaxaca
Study Coordinator
Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0506)
San Luis Potosí City
Study Coordinator
Oncare - Unidad Valle ( Site 0509)
San Pedro Garza García , Nuevo León
ACTIVE_NOT_RECRUITING
Netherlands (5)
Amsterdam UMC, locatie VUmc ( Site 2201)
Amsterdam , North Holland
Study Coordinator
Catharina Ziekenhuis-Oncology ( Site 2203)
Eindhoven , North Brabant
Study Coordinator
University Medical Center Groningen ( Site 2204)
Groningen
Study Coordinator
Radboudumc-Medical Oncology ( Site 2202)
Nijmegen , Gelderland
Study Coordinator
Erasmus Medisch Centrum-Medical Oncology ( Site 2200)
Rotterdam , South Holland
Study Coordinator
Norway (1)
Oslo universitetssykehus, Radiumhospitalet ( Site 2300)
Oslo
ACTIVE_NOT_RECRUITING
Poland (3)
Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2402)
Bialystok , Podlaskie Voivodeship
COMPLETED
Uniwersytecki Szpital Kliniczny w Poznaniu-Klinika Ginekologii Onkologicznej ( Site 2404)
Poznan , Greater Poland Voivodeship
ACTIVE_NOT_RECRUITING
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2400)
Warsaw , Masovian Voivodeship
ACTIVE_NOT_RECRUITING
Puerto Rico (1)
UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0601)
San Juan
Study Coordinator
Singapore (2)
National University Hospital ( Site 3301)
Singapore , Central Singapore
ACTIVE_NOT_RECRUITING
National Cancer Centre Singapore ( Site 3300)
Singapore , Central Singapore
Study Coordinator
South Korea (4)
Seoul National University Hospital ( Site 3403)
Seoul
ACTIVE_NOT_RECRUITING
Severance Hospital, Yonsei University Health System ( Site 3402)
Seoul
ACTIVE_NOT_RECRUITING
Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3401)
Seoul
COMPLETED
Samsung Medical Center ( Site 3400)
Seoul
ACTIVE_NOT_RECRUITING
Spain (11)
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2509)
Barcelona , Catalonia
ACTIVE_NOT_RECRUITING
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2500)
Barcelona
ACTIVE_NOT_RECRUITING
Hospital Universitario Reina Sofia-Oncologia Medica ( Site 2501)
Córdoba
ACTIVE_NOT_RECRUITING
Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 2507)
Girona , Gerona
COMPLETED
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2508)
L'Hospitalet de Llobregat , Catalonia
ACTIVE_NOT_RECRUITING
Clinica Universidad de Navarra ( Site 2510)
Madrid , Madrid, Comunidad de
ACTIVE_NOT_RECRUITING
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2502)
Madrid , Madrid, Comunidad de
ACTIVE_NOT_RECRUITING
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2506)
Madrid , Madrid, Comunidad de
ACTIVE_NOT_RECRUITING
Hospital Universitario La Paz-Oncología Médica ( Site 2504)
Madrid
ACTIVE_NOT_RECRUITING
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2503)
Valencia , Valenciana, Comunitat
ACTIVE_NOT_RECRUITING
HOSPITAL CLINICO DE VALENCIA ( Site 2505)
Valencia , Valenciana, Comunitat
ACTIVE_NOT_RECRUITING
Sweden (4)
Universitetssjukhuset i Linköping ( Site 2600)
Linköping , Östergötland County
Study Coordinator
Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2602)
Lund , Skåne County
Study Coordinator
Karolinska Universitetssjukhuset Solna ( Site 2601)
Stockholm , Stockholm County
ACTIVE_NOT_RECRUITING
Akademiska sjukhuset ( Site 2603)
Uppsala , Uppsala County
ACTIVE_NOT_RECRUITING
Switzerland (2)
University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 2701)
Basel , Canton of Basel-City
COMPLETED
Inselspital Bern-Oncology ( Site 2700)
Bern
ACTIVE_NOT_RECRUITING
United Kingdom (6)
Gartnavel General Hospital-Clinical Trials Unit ( Site 2800)
Glasgow , Glasgow City
ACTIVE_NOT_RECRUITING
St James's University Hospital ( Site 2804)
Leeds
Study Coordinator
ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 2807)
London , England
Study Coordinator
University College London Hospital ( Site 2805)
London , London, City of
Study Coordinator
The Christie NHS Foundation Trust-Research and Development ( Site 2802)
Manchester
Study Coordinator
Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 2801)
Sutton , England
ACTIVE_NOT_RECRUITING
United States (38)
Optimum Clinical Research Group ( Site 4138)
Albuquerque , New Mexico
Study Coordinator
Providence Alaska Medical Center ( Site 4137)
Anchorage , Alaska
Study Coordinator
Northside Hospital ( Site 4127)
Atlanta , Georgia
COMPLETED
Georgia Cancer Center at Augusta University ( Site 4112)
Augusta , Georgia
ACTIVE_NOT_RECRUITING
Texas Oncology - Central/South Texas ( Site 8010)
Austin , Texas
Study Coordinator
University of Virginia Cancer Center ( Site 4123)
Charlottesville , Virginia
Study Coordinator
University of Cincinnati Medical Center ( Site 4128)
Cincinnati , Ohio
Study Coordinator
Duke Cancer Institute ( Site 4120)
Durham , North Carolina
Study Coordinator
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
Eugene , Oregon
Study Coordinator
Inova Schar Cancer Institute ( Site 4139)
Fairfax , Virginia
Study Coordinator
Texas Oncology - DFW ( Site 8003)
Fort Worth , Texas
Study Coordinator
The West Clinic, PLLC dba West Cancer Center ( Site 4108)
Germantown , Tennessee
Study Coordinator
The Ohio State University ( Site 4103)
Hilliard , Ohio
Study Coordinator
Houston Methodist Hospital OB/GYN ( Site 4102)
Houston , Texas
Study Coordinator
Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125)
La Jolla , California
Study Coordinator
UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105)
Los Angeles , California
Study Coordinator
Mount Sinai Comprehensive Cancer Center ( Site 4143)
Miami Beach , Florida
Study Coordinator
Perlmutter Cancer Center NYU Langone Hospital - Long Island ( Site 4145)
Mineola , New York
Study Coordinator
USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)
Mobile , Alabama
Study Coordinator
University Medical Center New Orleans ( Site 4132)
New Orleans , Louisiana
Study Coordinator
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 4121)
New York , New York
Study Coordinator
Hoag Memorial Hospital Presbyterian ( Site 4104)
Newport Beach , California
Study Coordinator
Advent Health ( Site 4140)
Orlando , Florida
Study Coordinator
Sidney Kimmel Cancer Center - Jefferson Health ( Site 4142)
Philadelphia , Pennsylvania
Study Coordinator
HonorHealth (HH) ( Site 8002)
Phoenix , Arizona
Study Coordinator
Legacy Good Samaritan Medical Center-Oncology Clinical Research ( Site 4115)
Portland , Oregon
Study Coordinator
The Center of Hope ( Site 4106)
Reno , Nevada
Study Coordinator
Texas Oncology - San Antonio ( Site 8006)
San Antonio , Texas
Study Coordinator
Lewis Cancer and Research Pavilion ( Site 4114)
Savannah , Georgia
Study Coordinator
Swedish Medical Center-Swedish Cancer Institute ( Site 4134)
Seattle , Washington
Study Coordinator
Willis Knighton Medical Center ( Site 4101)
Shreveport , Louisiana
Study Coordinator
Holy Name Medical Center ( Site 4117)
Teaneck , New Jersey
Study Coordinator
Arizona Oncology Associates - HOPE ( Site 8001)
Tucson , Arizona
COMPLETED
Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research ( Site 4116)
Tulsa , Oklahoma
Study Coordinator
Texas Oncology - Northeast Texas ( Site 8009)
Tyler , Texas
Study Coordinator
Texas Oncology - Gulf Coast ( Site 8008)
Webster , Texas
Study Coordinator
Florida Cancer Specialists East ( Site 7001)
West Palm Beach , Florida
Study Coordinator
Asplundh Cancer Pavilion ( Site 4113)
Willow Grove , Pennsylvania
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
24.07.2024
Completion date
15.06.2028
Registry ID
NCT06459180
Source
clinicaltrials.gov
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