Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)

Phase 3

Recruiting

• Conditions: Endometrial Cancer
• Interventions: Biological: Sacituzumab tirumotecan; Drug: Doxorubicin; Drug: Paclitaxel; Drug: Nab-paclitaxel

• Registration Number: NCT06132958
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-15
• Study Start: 2023-12-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11
• Primary Completion: 2028-01-10
• Study Completion: 2028-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 710

Inclusion Criteria

• Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
• Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
• Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.

Exclusion Criteria

• Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas
• Has a 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
• Has had a recurrence of endometrial carcinoma or carcinosarcoma more than >12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. Note: 1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
• Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
• Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
• Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
• Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
• Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
• Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sacituzumab tirumotecan	Sacituzumab tirumotecan	Participants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Day 1 of each 14-day cycle. Additionally, participants receive diphenhydramine (or equivalent), a Histamine (H2 antagonist) of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.
Chemotherapy	Doxorubicin	Participants will receive 60 mg/m\^2 of doxorubicin by IV infusion on Day 1 of each 21-day cycle; or 80 mg/m\^2 of paclitaxel by IV infusion on Days 1, 8, and 15 of each 28-day cycle. Participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive Nab-paclitaxel.
Chemotherapy	Paclitaxel	Participants will receive 60 mg/m\^2 of doxorubicin by IV infusion on Day 1 of each 21-day cycle; or 80 mg/m\^2 of paclitaxel by IV infusion on Days 1, 8, and 15 of each 28-day cycle. Participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive Nab-paclitaxel.
Chemotherapy	Nab-paclitaxel	Participants will receive 60 mg/m\^2 of doxorubicin by IV infusion on Day 1 of each 21-day cycle; or 80 mg/m\^2 of paclitaxel by IV infusion on Days 1, 8, and 15 of each 28-day cycle. Participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive Nab-paclitaxel.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)	Up to approximately 4 years	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
Overall Survival (OS)	Up to approximately 4 years	OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Discontinue Study Intervention Due to an AE	Up to approximately 4 years	An AE is defined as 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.
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR	Up to approximately 4 years	ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. based on BICR.
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR	Up to approximately 4 years	For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Number of Participants Who Experience One or More Adverse Events (AEs)	Up to approximately 4 years	An AE is defined as 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.
Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30])	Baseline, up to approximately 4 years	The EORTC QLQ-C30 is a questionnaire to assess the overall health status and quality of life of cancer patients. Participant responses to the questions, "How would you rate your overall health during the past week (Item 29)?" and "How would you rate your overall quality of life during the past week (Item 30)?" 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 and quality of life. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.

Trial Locations

Locations (240)

Shaare Zedek Medical Center ( Site 2503); 🇮🇱 Jerusalem, Israel

Rabin Medical Center ( Site 2505); 🇮🇱 Petah Tikva, Israel

Sheba Medical Center ( Site 2504); 🇮🇱 Ramat Gan, Israel

National Hospital Organization Kyushu Cancer Center ( Site 2711); 🇯🇵 Fukuoka, Japan

Kagoshima City Hospital ( Site 2717); 🇯🇵 Kagoshima, Japan

TRIALS 365 ( Site 4105); 🇺🇸 Shreveport, Louisiana, United States

Osaka International Cancer Institute ( Site 2718); 🇯🇵 Osaka, Japan

Hospital São Domingos ( Site 1365); 🇧🇷 Sao Luis, Maranhao, Brazil

Rambam Health Care Campus-Gyneco-oncology unit ( Site 2502); 🇮🇱 Haifa, Israel

University Medical Center New Orleans ( Site 4133); 🇺🇸 New Orleans, Louisiana, United States

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 4150); 🇺🇸 Edgewood, Kentucky, United States

USA Mitchell Cancer Institute ( Site 4142); 🇺🇸 Mobile, Alabama, United States

Alaska Womens Cancer Care ( Site 4122); 🇺🇸 Anchorage, Alaska, United States

HonorHealth (HH) ( Site 8000); 🇺🇸 Phoenix, Arizona, United States

Arizona Oncology Associates - HOPE ( Site 8002); 🇺🇸 Tucson, Arizona, United States

UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc; 🇺🇸 Los Angeles, California, United States

California Pacific Medical Center - Van Ness Campus ( Site 4129); 🇺🇸 San Francisco, California, United States

Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114); 🇺🇸 New Haven, Connecticut, United States

MedStar Washington Hospital Center ( Site 4108); 🇺🇸 Washington, District of Columbia, United States

Mount Sinai Cancer Center ( Site 4117); 🇺🇸 Miami Beach, Florida, United States

AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 4113); 🇺🇸 Orlando, Florida, United States

Florida Cancer Specialists - East ( Site 7000); 🇺🇸 West Palm Beach, Florida, United States

Northside Hospital ( Site 4112); 🇺🇸 Atlanta, Georgia, United States

Augusta University ( Site 4116); 🇺🇸 Augusta, Georgia, United States

Centricity Research Columbus Cancer Center ( Site 4154); 🇺🇸 Columbus, Georgia, United States

NorthShore University HealthSystem - Evanston Hospital ( Site 4110); 🇺🇸 Evanston, Illinois, United States

Parkview Research Center at Parkview Regional Medical Center ( Site 4132); 🇺🇸 Fort Wayne, Indiana, United States

University of Massachusetts Memorial Medical Center ( Site 4103); 🇺🇸 Worcester, Massachusetts, United States

Washington University School of Medicine-Obstetrics & Gynecology ( Site 4146); 🇺🇸 Saint Louis, Missouri, United States

The Center of Hope ( Site 4109); 🇺🇸 Reno, Nevada, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 4118); 🇺🇸 Hackensack, New Jersey, United States

Atlantic Health System Morristown Medical Center ( Site 4135); 🇺🇸 Morristown, New Jersey, United States

Holy Name Medical Center ( Site 4115); 🇺🇸 Teaneck, New Jersey, United States

New York - Presbyterian Brooklyn Methodist Hospital ( Site 4134); 🇺🇸 Brooklyn, New York, United States

Hospital Aleman-Oncology ( Site 1001); 🇦🇷 Buenos Aires, Argentina

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 4156); 🇺🇸 Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center ( Site 4106); 🇺🇸 New York, New York, United States

Icahn School of Medicine at Mount Sinai-Department of Obstetrics, Gynecology, and Reproductive Scie; 🇺🇸 New York, New York, United States

Good Samaritan Hospital Medical Center ( Site 4139); 🇺🇸 West Islip, New York, United States

Duke Cancer Institute ( Site 4120); 🇺🇸 Durham, North Carolina, United States

Sanford Health Roger Maris Cancer Center ( Site 4158); 🇺🇸 Fargo, North Dakota, United States

University of Cincinnati Medical Center ( Site 4136); 🇺🇸 Cincinnati, Ohio, United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C; 🇺🇸 Columbus, Ohio, United States

Sidney Kimmel Cancer Center - Jefferson Health ( Site 4157); 🇺🇸 Philadelphia, Pennsylvania, United States

AHN West Penn Hospital-Gynecologic Oncology ( Site 4111); 🇺🇸 Pittsburgh, Pennsylvania, United States

Asplundh Cancer Pavilion ( Site 4107); 🇺🇸 Willow Grove, Pennsylvania, United States

Women & Infants Hospital ( Site 4138); 🇺🇸 Providence, Rhode Island, United States

Sanford Cancer Center-Gynecologic Oncology ( Site 4121); 🇺🇸 Sioux Falls, South Dakota, United States

The West Clinic, PLLC dba West Cancer Center ( Site 4102); 🇺🇸 Germantown, Tennessee, United States

Houston Methodist Hospital-Obstetrics and Gynecology ( Site 4130); 🇺🇸 Houston, Texas, United States

Texas Oncology - San Antonio ( Site 8005); 🇺🇸 San Antonio, Texas, United States

Texas Oncology - Gulf Coast ( Site 8006); 🇺🇸 The Woodlands, Texas, United States

Hospital Británico de Buenos Aires-Oncology ( Site 1002); 🇦🇷 Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1008); 🇦🇷 Buenos Aires, Caba, Argentina

Instituto Alexander Fleming-Alexander Fleming ( Site 1007); 🇦🇷 Ciudad Autónoma de Buenos Aires, Caba, Argentina

Instituto de Oncología Angel H. Roffo ( Site 1003); 🇦🇷 Buenos Aires, Argentina

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1004); 🇦🇷 Buenos Aires, Argentina

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1006); 🇦🇷 La Rioja, Argentina

GenesisCare North Shore ( Site 1103); 🇦🇺 St Leonards, New South Wales, Australia

Blacktown Hospital ( Site 1101); 🇦🇺 Sydney, New South Wales, Australia

Royal Brisbane and Women's Hospital ( Site 1102); 🇦🇺 Brisbane, Queensland, Australia

Epworth Freemasons ( Site 1104); 🇦🇺 East Melbourne, Victoria, Australia

Frankston Hospital ( Site 1105); 🇦🇺 Frankston, Victoria, Australia

Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1201); 🇦🇹 Innsbruck, Tirol, Austria

Medizinische Universität Wien ( Site 1202); 🇦🇹 Wien, Austria

AZ Maria Middelares-IKG ( Site 1305); 🇧🇪 Gent, Oost-Vlaanderen, Belgium

UZ Gent-Medical oncology ( Site 1303); 🇧🇪 Gent, Oost-Vlaanderen, Belgium

UZ Leuven-Gynecologic Oncology ( Site 1301); 🇧🇪 Leuven, Vlaams-Brabant, Belgium

AZ Delta vzw-Oncology ( Site 1302); 🇧🇪 Roeselare, West-Vlaanderen, Belgium

CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 1304); 🇧🇪 Namur, Belgium

Centro Oncologico do Triangulo ( Site 1360); 🇧🇷 Uberlândia, Minas Gerais, Brazil

Hospital Moinhos de Vento ( Site 1359); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Instituto Joinvilense de Hematologia e Oncologia ( Site 1353); 🇧🇷 Joinville, Santa Catarina, Brazil

Instituto de Ensino e Pesquisa ( Site 1355); 🇧🇷 Sorocaba, Sao Paulo, Brazil

Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 1352); 🇧🇷 Rio de Janeiro, Brazil

Hospital Samaritano De Sao Paulo ( Site 1367); 🇧🇷 Sao Paulo, Brazil

A. C. Camargo Cancer Center ( Site 1351); 🇧🇷 Sao Paulo, Brazil

IBCC - Núcleo de Pesquisa e Ensino ( Site 1366); 🇧🇷 Sao Paulo, Brazil

Arthur J.E. Child Comprehensive Cancer Centre ( Site 1413); 🇨🇦 Calgary, Alberta, Canada

Cross Cancer Institute ( Site 1414); 🇨🇦 Edmonton, Alberta, Canada

BC Cancer Vancouver ( Site 1415); 🇨🇦 Vancouver, British Columbia, Canada

Trillium Health Partners - Credit Valley Hospital ( Site 1410); 🇨🇦 Mississauga, Ontario, Canada

CIUSSS- saguenay-Lac-Saint-Jean ( Site 1408); 🇨🇦 Chicoutimi, Quebec, Canada

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 1405); 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier de l'Université de Montréal ( Site 1403); 🇨🇦 Montréal, Quebec, Canada

McGill University Health Centre ( Site 1404); 🇨🇦 Montréal, Quebec, Canada

James Lind Centro de Investigacion del Cancer ( Site 1504); 🇨🇱 Temuco, Araucania, Chile

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1505); 🇨🇱 Santiago, Region M. De Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 1503); 🇨🇱 Santiago, Region M. De Santiago, Chile

Bradfordhill-Clinical Area ( Site 1501); 🇨🇱 Santiago, Region M. De Santiago, Chile

Second Affiliated hospital of Anhui Medical University-Oncology ( Site 1635); 🇨🇳 Hefei, Anhui, China

Beijing Obstetric and Gynecology Hospital ( Site 1653); 🇨🇳 Beijing, Beijing, China

Edith Wolfson Medical Center ( Site 2501); 🇮🇱 Holon, Israel

Fujian Cancer Hospital-Gynecological Oncology Surgery ( Site 1627); 🇨🇳 Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 1613); 🇨🇳 Xiamen, Fujian, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1634); 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center ( Site 1604); 🇨🇳 Guangzhou, Guangdong, China

Cancer Hospital of Shantou University Medical College ( Site 1642); 🇨🇳 Shantou, Guangdong, China

Affiliated Hospital of Guangdong Medical University ( Site 1614); 🇨🇳 Zhanjiang, Guangdong, China

Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 1622); 🇨🇳 Nanning, Guangxi, China

Hainan General Hospital ( Site 1636); 🇨🇳 Haikou, Hainan, China

Harbin Medical University Cancer Hospital-Gynecological Radiotherapy Department ( Site 1652); 🇨🇳 Harbin, Heilongjiang, China

Henan Cancer Hospital ( Site 1618); 🇨🇳 Zhengzhou, Henan, China

The Second Affiliated Hospital of Zhengzhou University ( Site 1640); 🇨🇳 Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1621); 🇨🇳 Wuhan, Hubei, China

Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 1607); 🇨🇳 Wuhan, Hubei, China

Xiangya Hospital Central South University-Gynecology ( Site 1603); 🇨🇳 Changsha, Hunan, China

Hunan Cancer Hospital ( Site 1623); 🇨🇳 Changsha, Hunan, China

Nanjing First Hospital ( Site 1649); 🇨🇳 Nanjing, Jiangsu, China

Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 1625); 🇨🇳 Nanchang, Jiangxi, China

LinYi Cancer Hospital-Gastrology department ( Site 1630); 🇨🇳 Linyi, Shandong, China

Obstetrics & Gynecology Hospital of Fudan University ( Site 1617); 🇨🇳 Shanghai, Shanghai, China

Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1626); 🇨🇳 Shanghai, Shanghai, China

West China Second University Hospital, Sichuan University ( Site 1602); 🇨🇳 Chengdu, Sichuan, China

Sichuan Cancer hospital-Oncology ( Site 1650); 🇨🇳 Chengdu, Sichuan, China

Xinjiang Medical University Cancer Hospital - Urumqi ( Site 1648); 🇨🇳 Urumqi, Xinjiang, China

Yunnan Province Cancer Hospital-Gynecology Department ( Site 1641); 🇨🇳 Kunming, Yunnan, China

The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 1609); 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital-Oncology ( Site 1601); 🇨🇳 Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province ( Site 1633); 🇨🇳 Linhai, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University ( Site 1615); 🇨🇳 Wenzhou, Zhejiang, China

Fakultní Nemocnice Brno-Gynekologicko-porodnicka klinika ( Site 1704); 🇨🇿 Brno, Brno-mesto, Czechia

Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 1703); 🇨🇿 Ostrava, Moravskoslezsky Kraj, Czechia

Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 1706); 🇨🇿 Nový Jiín, Novy Jicin, Czechia

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1702); 🇨🇿 Olomouc, Olomoucky Kraj, Czechia

Fakultni nemocnice Kralovske Vinohrady ( Site 1707); 🇨🇿 Praha, Praha 10, Czechia

Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1705); 🇨🇿 Praha, Praha 2, Czechia

Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 1701); 🇨🇿 Praha, Praha 8, Czechia

Herlev and Gentofte Hospital-Department of Oncology ( Site 1801); 🇩🇰 Copenhagen, Hovedstaden, Denmark

Rigshospitalet-Dept. of Oncology ( Site 1803); 🇩🇰 Copenhagen, Hovedstaden, Denmark

Aarhus Universitetshospital, Skejby ( Site 1802); 🇩🇰 Aarhus, Midtjylland, Denmark

Tampereen yliopistollinen sairaala ( Site 1901); 🇫🇮 Tampere, Pirkanmaa, Finland

Kuopion Yliopistollinen Sairaala ( Site 1904); 🇫🇮 Kuopio, Pohjois-Savo, Finland

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1902); 🇫🇮 Helsinki, Uusimaa, Finland

Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1903); 🇫🇮 Turku, Varsinais-Suomi, Finland

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 2002); 🇫🇷 Bordeaux, Aquitaine, France

ROC37 ( Site 2010); 🇫🇷 Chambray Les Tours, Centre, France

Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 2001); 🇫🇷 Plerin, Cotes-d Armor, France

CHU Besançon ( Site 2009); 🇫🇷 Besançon, Doubs, France

Institut Claudius Regaud ( Site 2006); 🇫🇷 Toulouse, Haute-Garonne, France

Institut Regional du Cancer Montpellier ( Site 2008); 🇫🇷 Montpellier, Herault, France

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2003); 🇫🇷 Rennes, Ille-et-Vilaine, France

Centre Oscar Lambret ( Site 2007); 🇫🇷 Lille, Nord-Pas-de-Calais, France

CENTRE LEON BERARD ( Site 2004); 🇫🇷 Lyon Cedex08, Rhone-Alpes, France

Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 2005); 🇫🇷 Paris, France

SLK-Kliniken Heilbronn ( Site 2107); 🇩🇪 Heilbronn, Baden-Wurttemberg, Germany

Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 2101); 🇩🇪 Mannheim, Baden-Wurttemberg, Germany

MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum ( Site 2110); 🇩🇪 Ravensburg, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen ( Site 2111); 🇩🇪 Tübingen, Baden-Wurttemberg, Germany

Klinikum der Universität München Großhadern-Klinik und Poliklinik für Frauenheilkunde und Geburtshi; 🇩🇪 Munich, Bayern, Germany

Charité Campus Virchow-Klinikum ( Site 2102); 🇩🇪 Berlin, Germany

Agios Andreas Hospital Patras ( Site 2201); 🇬🇷 Patras, Achaia, Greece

Aretaieio Hospital Oncology Unit ( Site 2206); 🇬🇷 Athens, Attiki, Greece

Metropolitan Hospital-2nd Oncology Dept ( Site 2202); 🇬🇷 Athens, Attiki, Greece

Hygeia Hospital ( Site 2204); 🇬🇷 Marousi, Attiki, Greece

Cork University Hospital ( Site 2402); 🇮🇪 Cork, Ireland

Mater Misericordiae University Hospital ( Site 2403); 🇮🇪 Dublin, Ireland

St. James's Hospital-Cancer clinical trials office ( Site 2401); 🇮🇪 Dublin, Ireland

Sourasky Medical Center ( Site 2506); 🇮🇱 Tel Aviv, Israel

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-SSD Oncologia medica Addarii ( Site 260; 🇮🇹 Bologna, Emilia-Romagna, Italy

CRO-IRCCS ( Site 2609); 🇮🇹 Aviano, Friuli-Venezia Giulia, Italy

AOU Policlinico Umberto I ( Site 2606); 🇮🇹 Roma, Lazio, Italy

Istituto Europeo di Oncologia IRCCS ( Site 2607); 🇮🇹 Milano, Lombardia, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 260; 🇮🇹 Milan, Lombardia, Italy

Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 2610); 🇮🇹 Rozzano, Milano, Italy

Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'O-Day Hospital Oncologico Multidisciplin; 🇮🇹 Candiolo, Torino, Italy

Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 2604); 🇮🇹 Bari, Italy

Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2611); 🇮🇹 Brescia, Italy

Humanitas San Pio X Hospital ( Site 2614); 🇮🇹 Milano, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 2; 🇮🇹 Napoli, Italy

Arcispedale Santa Maria Nuova ( Site 2612); 🇮🇹 Reggio Emilia, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2601); 🇮🇹 Roma, Italy

Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 2608); 🇮🇹 Torino, Italy

Aichi Cancer Center ( Site 2714); 🇯🇵 Nagoya, Aichi, Japan

National Hospital Organization Shikoku Cancer Center ( Site 2705); 🇯🇵 Matsuyama, Ehime, Japan

Ehime University Hospital ( Site 2709); 🇯🇵 Toon, Ehime, Japan

Kurume University Hospital ( Site 2703); 🇯🇵 Kurume, Fukuoka, Japan

Gunma Prefectural Cancer Center ( Site 2708); 🇯🇵 Otashi, Gunma, Japan

Hokkaido University Hospital ( Site 2707); 🇯🇵 Sapporo, Hokkaido, Japan

University of Tsukuba Hospital ( Site 2713); 🇯🇵 Tsukuba, Ibaraki, Japan

Iwate Medical University Hospital ( Site 2712); 🇯🇵 Shiwa-gun, Iwate, Japan

Niigata Cancer Center Hospital ( Site 2701); 🇯🇵 Niigata-shi, Niigata, Japan

Saitama Medical University International Medical Center ( Site 2710); 🇯🇵 Hidaka, Saitama, Japan

Shizuoka Cancer Center ( Site 2716); 🇯🇵 Sunto-gun,, Shizuoka, Japan

National Cancer Center Hospital ( Site 2715); 🇯🇵 Chuo-ku, Tokyo, Japan

Cancer Institute Hospital of JFCR ( Site 2706); 🇯🇵 Koto, Tokyo, Japan

Showa Medical University Hospital ( Site 2719); 🇯🇵 Shinagawa, Tokyo, Japan

Keio University Hospital ( Site 2702); 🇯🇵 Shinjuku, Tokyo, Japan

Seoul National University Bundang Hospital-Obstetrics and Gynecology ( Site 3505); 🇰🇷 Seongnam, Kyonggi-do, Korea, Republic of

Seoul National University Hospital ( Site 3502); 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 3503); 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3501); 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center ( Site 3504); 🇰🇷 Seoul, Korea, Republic of

Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2803); 🇲🇾 Kuala Lumpur, Malaysia

University Malaya Medical Centre ( Site 2801); 🇲🇾 Kuala Lumpur, Malaysia

COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 2902); 🇲🇽 Coyoacan, Distrito Federal, Mexico

Higiea Oncologia ( Site 2905); 🇲🇽 Mexico City, Distrito Federal, Mexico

CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 2901); 🇲🇽 San Pedro Garza Garcia, Nuevo Leon, Mexico

Oncare - Unidad Valle ( Site 2906); 🇲🇽 San Pedro Garza García, Nuevo Leon, Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 2907); 🇲🇽 Oaxaca de Juarez, Oaxaca, Mexico

Radboudumc-Medical Oncology ( Site 3003); 🇳🇱 Nijmegen, Gelderland, Netherlands

Amsterdam UMC - locatie VUmc ( Site 3004); 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Leids Universitair Medisch Centrum-Medical Oncology ( Site 3002); 🇳🇱 Leiden, Zuid-Holland, Netherlands

Stavanger Universitetssykehus ( Site 3103); 🇳🇴 Stavanger, Rogaland, Norway

Universitetssykehuset Nord-Norge HF ( Site 3101); 🇳🇴 Tromsø, Troms, Norway

Sorlandet Sykehus Kristiansand ( Site 3104); 🇳🇴 Kristiansand, Vest-Agder, Norway

Oslo universitetssykehus, Radiumhospitalet ( Site 3102); 🇳🇴 Oslo, Norway

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3201); 🇵🇱 Siedlce, Mazowieckie, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit; 🇵🇱 Warszawa, Mazowieckie, Poland

Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 3204); 🇵🇱 Bialystok, Podlaskie, Poland

Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie-Oddział Radioterapii i Onkologii Ginek; 🇵🇱 Poznan, Wielkopolskie, Poland

Ad-Vance Medical Research-Research ( Site 3302); 🇵🇷 Ponce, Puerto Rico

Pan American Center for Oncology Trials - Ciudadela ( Site 3301); 🇵🇷 San Juan, Puerto Rico

UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 3304); 🇵🇷 San Juan, Puerto Rico

National Cancer Centre Singapore-Medical Oncology ( Site 3401); 🇸🇬 Singapore, Central Singapore, Singapore

Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 3608); 🇪🇸 L Hospitalet, Barcelona, Spain

Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 3606); 🇪🇸 Girona, Gerona, Spain

Clinica Universidad de Navarra ( Site 3603); 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Hospital Universitario 12 de Octubre-Medical Oncology ( Site 3607); 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Hospital Universitario La Paz-Oncología Médica ( Site 3604); 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 3605); 🇪🇸 Valencia, Valenciana, Comunitat, Spain

HOSPITAL CLINICO DE VALENCIA ( Site 3609); 🇪🇸 Valencia, Valenciana, Comunitat, Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 3602); 🇪🇸 Barcelona, Spain

Hospital Universitario Reina Sofia-Oncologia Medica ( Site 3601); 🇪🇸 Cordoba, Spain

Skånes Universitetssjukhus Lund ( Site 3702); 🇸🇪 Lund, Skane Lan, Sweden

Karolinska Universitetssjukhuset Solna ( Site 3701); 🇸🇪 Stockholm, Stockholms Lan, Sweden

University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 3808); 🇨🇭 Basel, Basel-Stadt, Switzerland

Kantonsspital Graubünden-Medizin ( Site 3803); 🇨🇭 Chur, Grisons, Switzerland

Ospedale Regionale Bellinzona e Valli ( Site 3802); 🇨🇭 Bellinzona, Ticino, Switzerland

Inselspital Bern-Oncology ( Site 3801); 🇨🇭 Berne, Switzerland

University Hospitals Sussex NHS Foundation Trust ( Site 4006); 🇬🇧 East Sussex, Brighton And Hove, United Kingdom

Royal Derby Hospital ( Site 4007); 🇬🇧 Derby, Derbyshire, United Kingdom

ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 4002); 🇬🇧 London, England, United Kingdom

The Royal Cornwall Hospital ( Site 4009); 🇬🇧 Truro, England, United Kingdom

University College London Hospital-Cancer Clinical Trials Unit ( Site 4004); 🇬🇧 London, London, City Of, United Kingdom

Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 4008); 🇬🇧 London, London, City Of, United Kingdom

Hammersmith Hospital ( Site 4001); 🇬🇧 London, London, City Of, United Kingdom

The Beatson West of Scotland Cancer Centre ( Site 4005); 🇬🇧 Glasgow, Scotland, United Kingdom

Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 4010); 🇬🇧 London, Sutton, United Kingdom

The Christie NHS Foundation Trust-Medical Oncology ( Site 4003); 🇬🇧 Manchester, United Kingdom