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

NCT06132958 | Active Not Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: 2870-0052023-504816-14-00U1111-1288-7581jRCT2031240041
• Study Type: interventional
• Target: 710
• Locations: 30 countries
• Sites: 239

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.

Conditions

Endometrial Cancer

Keywords

Endometrial cancer; Antibody-drug conjugate (ADC); Trophoblast cell-surface antigen 2 (TROP2)

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

  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.

  Up to approximately 4 years

• Overall Survival (OS)

  OS is defined as the time from randomization to death due to any cause.

  Up to approximately 4 years

Secondary Outcomes (5)

• Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR

  Up to approximately 4 years

• Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

  Up to approximately 4 years

• Number of Participants Who Experience One or More Adverse Events (AEs)

  Up to approximately 4 years

• Number of Participants Who Discontinue Study Intervention Due to an AE

  Up to approximately 4 years

• 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

Study Arms (2)

Sacituzumab tirumotecan

EXPERIMENTAL

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.

Biological: Sacituzumab tirumotecan

Chemotherapy

ACTIVE COMPARATOR

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.

Drug: Doxorubicin; Drug: Paclitaxel; Drug: Nab-paclitaxel

Interventions

Paclitaxel DRUG

80 mg/m\^2 of paclitaxel by IV infusion

Also known as: TAXOL®

Chemotherapy

Nab-paclitaxel DRUG

100 mg/m\^2 of nab-paclitaxel by IV infusion

Also known as: Abraxane

Chemotherapy

Doxorubicin DRUG

60 mg/m\^2 of doxorubicin by IV Infusion

Also known as: ADRIAMYCIN®

Chemotherapy

Sacituzumab tirumotecan BIOLOGICAL

4 mg/kg of sacituzumab tirumotecan by IV infusion

Also known as: SKB264 MK-2870

Sacituzumab tirumotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• European Network for Gynaecological Oncological Trial groups(ENGOT): collaborator
• GOG Foundation: collaborator
• Merck Sharp & Dohme LLC: lead

Study Sites (241)

USA Mitchell Cancer Institute ( Site 4142)

Mobile, Alabama, 36604, United States

Location

Alaska Womens Cancer Care ( Site 4122)

Anchorage, Alaska, 99508, United States

Location

HonorHealth (HH) ( Site 8000)

Phoenix, Arizona, 85016, United States

Location

Arizona Oncology Associates - HOPE ( Site 8002)

Tucson, Arizona, 85711, United States

Location

UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4131)

Los Angeles, California, 90095, United States

Location

California Pacific Medical Center - Van Ness Campus ( Site 4129)

San Francisco, California, 94109, United States

Location

Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114)

New Haven, Connecticut, 06511, United States

Location

MedStar Washington Hospital Center ( Site 4108)

Washington D.C., District of Columbia, 20010, United States

Location

Mount Sinai Cancer Center ( Site 4117)

Miami Beach, Florida, 33140, United States

Location

AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 4113)

Orlando, Florida, 32804, United States

Location

Florida Cancer Specialists - East ( Site 7000)

West Palm Beach, Florida, 33401, United States

Location

Northside Hospital ( Site 4112)

Atlanta, Georgia, 30342, United States

Location

Augusta University ( Site 4116)

Augusta, Georgia, 30912, United States

Location

Centricity Research Columbus Cancer Center ( Site 4154)

Columbus, Georgia, 31904, United States

Location

NorthShore University HealthSystem - Evanston Hospital ( Site 4110)

Evanston, Illinois, 60201, United States

Location

Parkview Research Center at Parkview Regional Medical Center ( Site 4132)

Fort Wayne, Indiana, 46845, United States

Location

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 4150)

Edgewood, Kentucky, 41017, United States

Location

University Medical Center New Orleans ( Site 4133)

New Orleans, Louisiana, 70112, United States

Location

TRIALS 365 ( Site 4105)

Shreveport, Louisiana, 71103, United States

Location

University of Massachusetts Memorial Medical Center ( Site 4103)

Worcester, Massachusetts, 01605, United States

Location

Washington University School of Medicine-Obstetrics & Gynecology ( Site 4146)

St Louis, Missouri, 63110, United States

Location

The Center of Hope ( Site 4109)

Reno, Nevada, 89511, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center ( Site 4118)

Hackensack, New Jersey, 07601, United States

Location

Atlantic Health System Morristown Medical Center ( Site 4135)

Morristown, New Jersey, 07960, United States

Location

Holy Name Medical Center ( Site 4115)

Teaneck, New Jersey, 07666, United States

Location

New York - Presbyterian Brooklyn Methodist Hospital ( Site 4134)

Brooklyn, New York, 11215, United States

Location

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 4156)

Mineola, New York, 11501, United States

Location

Laura and Isaac Perlmutter Cancer Center ( Site 4106)

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai-Department of Obstetrics, Gynecology, and Reproductive Scie ( Site 4128)

New York, New York, 10029, United States

Location

Good Samaritan Hospital Medical Center ( Site 4139)

West Islip, New York, 11795, United States

Location

Duke Cancer Institute ( Site 4120)

Durham, North Carolina, 27710, United States

Location

Sanford Health Roger Maris Cancer Center ( Site 4158)

Fargo, North Dakota, 58102, United States

Location

University of Cincinnati Medical Center ( Site 4136)

Cincinnati, Ohio, 45219, United States

Location

Sidney Kimmel Cancer Center - Jefferson Health ( Site 4157)

Philadelphia, Pennsylvania, 19107, United States

Location

AHN West Penn Hospital-Gynecologic Oncology ( Site 4111)

Pittsburgh, Pennsylvania, 15244, United States

Location

Asplundh Cancer Pavilion ( Site 4107)

Willow Grove, Pennsylvania, 19090, United States

Location

Women & Infants Hospital ( Site 4138)

Providence, Rhode Island, 02905, United States

Location

Sanford Cancer Center-Gynecologic Oncology ( Site 4121)

Sioux Falls, South Dakota, 57104, United States

Location

The West Clinic, PLLC dba West Cancer Center ( Site 4102)

Germantown, Tennessee, 38138, United States

Location

Houston Methodist Hospital-Obstetrics and Gynecology ( Site 4130)

Houston, Texas, 77030, United States

Location

Texas Oncology - San Antonio ( Site 8005)

San Antonio, Texas, 78240, United States

Location

Texas Oncology - Gulf Coast ( Site 8006)

The Woodlands, Texas, 77380, United States

Location

Hospital Británico de Buenos Aires-Oncology ( Site 1002)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

Location

Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1008)

Buenos Aires, Buenos Aires F.D., C1122AAL, Argentina

Location

Instituto Alexander Fleming-Alexander Fleming ( Site 1007)

Buenos Aires, Buenos Aires F.D., C1426ANZ, Argentina

Location

Hospital Aleman-Oncology ( Site 1001)

Buenos Aires, C1118AAT, Argentina

Location

Instituto de Oncología Angel H. Roffo ( Site 1003)

Buenos Aires, C1417DTB, Argentina

Location

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1004)

Buenos Aires, C1431FWO, Argentina

Location

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1006)

La Rioja, F5300COE, Argentina

Location

GenesisCare North Shore ( Site 1103)

St Leonards, New South Wales, 2065, Australia

Location

Blacktown Hospital ( Site 1101)

Sydney, New South Wales, 2148, Australia

Location

Royal Brisbane and Women's Hospital ( Site 1102)

Brisbane, Queensland, 4029, Australia

Location

Epworth Freemasons ( Site 1104)

East Melbourne, Victoria, 3002, Australia

Location

Frankston Hospital ( Site 1105)

Frankston, Victoria, 3199, Australia

Location

Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1201)

Innsbruck, Tyrol, 6020, Austria

Location

Medizinische Universität Wien ( Site 1202)

Vienna, 1090, Austria

Location

AZ Maria Middelares-IKG ( Site 1305)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Gent-Medical oncology ( Site 1303)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven-Gynecologic Oncology ( Site 1301)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Delta vzw-Oncology ( Site 1302)

Roeselare, West-Vlaanderen, 8800, Belgium

Location

CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 1304)

Namur, 5000, Belgium

Location

Hospital São Domingos ( Site 1365)

São Luís, Maranhão, 65060-645, Brazil

Location

Centro Oncologico do Triangulo ( Site 1360)

Uberlândia, Minas Gerais, 38408-150, Brazil

Location

Hospital Moinhos de Vento ( Site 1359)

Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

Location

Instituto Joinvilense de Hematologia e Oncologia ( Site 1353)

Joinville, Santa Catarina, 89201260, Brazil

Location

Instituto de Ensino e Pesquisa ( Site 1355)

Sorocaba, São Paulo, 18052-775, Brazil

Location

Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 1352)

Rio de Janeiro, 20775-001, Brazil

Location

Hospital Samaritano De Sao Paulo ( Site 1367)

São Paulo, 01232-010, Brazil

Location

A. C. Camargo Cancer Center ( Site 1351)

São Paulo, 01509-010, Brazil

Location

IBCC - Núcleo de Pesquisa e Ensino ( Site 1366)

São Paulo, 04014-002, Brazil

Location

Arthur J.E. Child Comprehensive Cancer Centre ( Site 1413)

Calgary, Alberta, T2N 5G2, Canada

Location

Cross Cancer Institute ( Site 1414)

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer Vancouver ( Site 1415)

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Trillium Health Partners - Credit Valley Hospital ( Site 1410)

Mississauga, Ontario, L5M 2N1, Canada

Location

CIUSSS- saguenay-Lac-Saint-Jean ( Site 1408)

Chicoutimi, Quebec, G7H 5H6, Canada

Location

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 1405)

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hospitalier de l'Université de Montréal ( Site 1403)

Montreal, Quebec, H2X 0C1, Canada

Location

McGill University Health Centre ( Site 1404)

Montreal, Quebec, H4A 3J1, Canada

Location

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1505)

Santiago, Region M. de Santiago, 7500653, Chile

Location

Pontificia Universidad Catolica de Chile ( Site 1503)

Santiago, Region M. de Santiago, 8330024, Chile

Location

Bradfordhill-Clinical Area ( Site 1501)

Santiago, Region M. de Santiago, 8420383, Chile

Location

James Lind Centro de Investigacion del Cancer ( Site 1504)

Temuco, Región de la Araucanía, 4800827, Chile

Location

Second Affiliated hospital of Anhui Medical University-Oncology ( Site 1635)

Hefei, Anhui, 230000, China

Location

Beijing Obstetric and Gynecology Hospital ( Site 1653)

Beijing, Beijing Municipality, 100006, China

Location

Fujian Cancer Hospital-Gynecological Oncology Surgery ( Site 1627)

Fuzhou, Fujian, 350014, China

Location

The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 1613)

Xiamen, Fujian, 361003, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1634)

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-sen University Cancer Center ( Site 1604)

Guangzhou, Guangdong, 510555, China

Location

Cancer Hospital of Shantou University Medical College ( Site 1642)

Shantou, Guangdong, 515041, China

Location

Affiliated Hospital of Guangdong Medical University ( Site 1614)

Zhanjiang, Guangdong, 524004, China

Location

Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 1622)

Nanning, Guangxi, 530021, China

Location

Hainan General Hospital ( Site 1636)

Haikou, Hainan, 570311, China

Location

Harbin Medical University Cancer Hospital-Gynecological Radiotherapy Department ( Site 1652)

Harbin, Heilongjiang, 150000, China

Location

Henan Cancer Hospital ( Site 1618)

Zhengzhou, Henan, 450008, China

Location

The Second Affiliated Hospital of Zhengzhou University ( Site 1640)

Zhengzhou, Henan, 450014, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1621)

Wuhan, Hubei, 430022, China

Location

Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 1607)

Wuhan, Hubei, 430079, China

Location

Xiangya Hospital Central South University-Gynecology ( Site 1603)

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital ( Site 1623)

Changsha, Hunan, 410013, China

Location

Nanjing First Hospital ( Site 1649)

Nanjing, Jiangsu, 210006, China

Location

Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 1625)

Nanchang, Jiangxi, 330000, China

Location

LinYi Cancer Hospital-Gastrology department ( Site 1630)

Linyi, Shandong, 276000, China

Location

Obstetrics & Gynecology Hospital of Fudan University ( Site 1617)

Shanghai, Shanghai Municipality, 200011, China

Location

Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1626)

Shanghai, Shanghai Municipality, 201204, China

Location

West China Second University Hospital, Sichuan University ( Site 1602)

Chengdu, Sichuan, 610000, China

Location

Sichuan Cancer hospital-Oncology ( Site 1650)

Chengdu, Sichuan, 610042, China

Location

Xinjiang Medical University Cancer Hospital - Urumqi ( Site 1648)

Ürümqi, Xinjiang, 830000, China

Location

Yunnan Province Cancer Hospital-Gynecology Department ( Site 1641)

Kunming, Yunnan, 650107, China

Location

The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 1609)

Hangzhou, Zhejiang, 310006, China

Location

Zhejiang Cancer Hospital-Oncology ( Site 1601)

Hangzhou, Zhejiang, 310022, China

Location

Taizhou Hospital of Zhejiang Province ( Site 1633)

Linhai, Zhejiang, 317000, China

Location

The First Affiliated Hospital of Wenzhou Medical University ( Site 1615)

Wenzhou, Zhejiang, 325015, China

Location

Fakultní Nemocnice Brno-Gynekologicko-porodnicka klinika ( Site 1704)

Brno, Brno-mesto, 602 00, Czechia

Location

Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 1703)

Ostrava, Moravskoslezský kraj, 708 52, Czechia

Location

Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 1706)

Nový Jiín, Novy Jicin, 741 01, Czechia

Location

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1702)

Olomouc, Olomoucký kraj, 779 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady ( Site 1707)

Prague, Praha 10, 100 34, Czechia

Location

Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1705)

Prague, Praha 2, 12808, Czechia

Location

Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 1701)

Prague, Praha 8, 180 00, Czechia

Location

Herlev and Gentofte Hospital-Department of Oncology ( Site 1801)

Copenhagen, Capital Region, 2730, Denmark

Location

Rigshospitalet-Dept. of Oncology ( Site 1803)

Copenhagen, Capital Region, DK-2100, Denmark

Location

Aarhus Universitetshospital, Skejby ( Site 1802)

Aarhus, Central Jutland, 8200, Denmark

Location

Kuopion Yliopistollinen Sairaala ( Site 1904)

Kuopio, Northern Savonia, 70210, Finland

Location

Tampereen yliopistollinen sairaala ( Site 1901)

Tampere, Pirkanmaa, 33520, Finland

Location

Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1903)

Turku, Southwest Finland, 20520, Finland

Location

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1902)

Helsinki, Uusimaa, 00029, Finland

Location

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 2002)

Bordeaux, Aquitaine, 33076, France

Location

CENTRE LEON BERARD ( Site 2004)

Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France

Location

ROC37 ( Site 2010)

Chambray-lès-Tours, Centre-Val de Loire, 37170, France

Location

Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 2001)

Plérin, Cotes-d Armor, 22190, France

Location

CHU Besançon ( Site 2009)

Besançon, Doubs, 25000, France

Location

Institut Claudius Regaud ( Site 2006)

Toulouse, Haute-Garonne, 31059, France

Location

Centre Oscar Lambret ( Site 2007)

Lille, Hauts-de-France, 59020, France

Location

Institut Regional du Cancer Montpellier ( Site 2008)

Montpellier, Herault, 34298, France

Location

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2003)

Rennes, Ille-et-Vilaine, 35042, France

Location

Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 2005)

Paris, 75020, France

Location

SLK-Kliniken Heilbronn ( Site 2107)

Heilbronn, Baden-Wurttemberg, 74078, Germany

Location

Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 2101)

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum ( Site 2110)

Ravensburg, Baden-Wurttemberg, 88212, Germany

Location

Universitaetsklinikum Tuebingen ( Site 2111)

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinikum der Universität München Großhadern-Klinik und Poliklinik für Frauenheilkunde und Geburtshi ( Site 2109)

Munich, Bavaria, 81337, Germany

Location

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 2104)

Essen, North Rhine-Westphalia, 45136, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur ( Site 2103)

Dresden, Saxony, 01307, Germany

Location

Charité Campus Virchow-Klinikum ( Site 2102)

Berlin, 13353, Germany

Location

Agios Andreas Hospital Patras ( Site 2201)

Pátrai, Achaia, 263 35, Greece

Location

Aretaieio Hospital Oncology Unit ( Site 2206)

Athens, Attica, 115 28, Greece

Location

Metropolitan Hospital-2nd Oncology Dept ( Site 2202)

Athens, Attica, 185 47, Greece

Location

Hygeia Hospital ( Site 2204)

Marousi, Attica, 151 23, Greece

Location

Cork University Hospital ( Site 2402)

Cork, T12 DC4A, Ireland

Location

Mater Misericordiae University Hospital ( Site 2403)

Dublin, D07 R2WY, Ireland

Location

St. James's Hospital-Cancer clinical trials office ( Site 2401)

Dublin, D08 E9P6, Ireland

Location

Rambam Health Care Campus-Gyneco-oncology unit ( Site 2502)

Haifa, 3109601, Israel

Location

Edith Wolfson Medical Center ( Site 2501)

Holon, 5810001, Israel

Location

Shaare Zedek Medical Center ( Site 2503)

Jerusalem, 9103102, Israel

Location

Rabin Medical Center ( Site 2505)

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center ( Site 2504)

Ramat Gan, 5265601, Israel

Location

Sourasky Medical Center ( Site 2506)

Tel Aviv, 6423906, Israel

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-SSD Oncologia medica Addarii ( Site 2603)

Bologna, Emilia-Romagna, 40138, Italy

Location

CRO-IRCCS ( Site 2609)

Aviano, Friuli Venezia Giulia, 33081, Italy

Location

AOU Policlinico Umberto I ( Site 2606)

Rome, Lazio, 00161, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 2605)

Milan, Lombardy, 20133, Italy

Location

Istituto Europeo di Oncologia IRCCS ( Site 2607)

Milan, Lombardy, 20141, Italy

Location

Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 2610)

Rozzano, Milano, 20089, Italy

Location

Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'O-Day Hospital Oncologico Multidisciplin ( Site 2613)

Candiolo, Torino, 10060, Italy

Location

Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 2604)

Bari, 70124, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2611)

Brescia, 25123, Italy

Location

Humanitas San Pio X Hospital ( Site 2614)

Milan, 20159, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 2602)

Naples, 80131, Italy

Location

Arcispedale Santa Maria Nuova ( Site 2612)

Reggio Emilia, 42123, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2601)

Roma, 00168, Italy

Location

Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 2608)

Torino, 10128, Italy

Location

Aichi Cancer Center ( Site 2714)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Hospital Organization Shikoku Cancer Center ( Site 2705)

Matsuyama, Ehime, 791-0280, Japan

Location

Ehime University Hospital ( Site 2709)

Tōon, Ehime, 791-0295, Japan

Location

Kurume University Hospital ( Site 2703)

Kurume, Fukuoka, 830-0011, Japan

Location

Gunma Prefectural Cancer Center ( Site 2708)

Otashi, Gunma, 373-8550, Japan

Location

Hokkaido University Hospital ( Site 2707)

Sapporo, Hokkaido, 060-8648, Japan

Location

University of Tsukuba Hospital ( Site 2713)

Tsukuba, Ibaraki, 305-8576, Japan

Location

Iwate Medical University Hospital ( Site 2712)

Shiwa-gun, Iwate, 028-3695, Japan

Location

Niigata Cancer Center Hospital ( Site 2701)

Niigata, Niigata, 951-8566, Japan

Location

Saitama Medical University International Medical Center ( Site 2710)

Hidaka, Saitama, 350-1298, Japan

Location

Shizuoka Cancer Center ( Site 2716)

Sunto-gun,, Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital ( Site 2715)

Chuo-ku, Tokyo, 104-0045, Japan

Location

Cancer Institute Hospital of JFCR ( Site 2706)

Koto, Tokyo, 135-8550, Japan

Location

Showa Medical University Hospital ( Site 2719)

Shinagawa, Tokyo, 142-8666, Japan

Location

Keio University Hospital ( Site 2702)

Shinjuku, Tokyo, 160-8582, Japan

Location

National Hospital Organization Kyushu Cancer Center ( Site 2711)

Fukuoka, 811-1395, Japan

Location

Kagoshima City Hospital ( Site 2717)

Kagoshima, 890-8760, Japan

Location

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2718)

Osaka, 541-8567, Japan

Location

Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2803)

Kuala Lumpur, 59100, Malaysia

Location

University Malaya Medical Centre ( Site 2801)

Kuala Lumpur, 59100, Malaysia

Location

COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 2902)

Coyoacán, Mexico City, 04700, Mexico

Location

Higiea Oncologia ( Site 2905)

Mexico City, Mexico City, 11819, Mexico

Location

Oncare - Unidad Valle ( Site 2906)

San Pedro Garza García, Nuevo León, 66220, Mexico

Location

CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 2901)

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

Centro de Investigacion Clinica de Oaxaca ( Site 2907)

Oaxaca City, Oaxaca, 68020, Mexico

Location

Radboudumc-Medical Oncology ( Site 3003)

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Amsterdam UMC - locatie VUmc ( Site 3004)

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Leids Universitair Medisch Centrum-Medical Oncology ( Site 3002)

Leiden, South Holland, 2333 ZA, Netherlands

Location

Stavanger Universitetssykehus ( Site 3103)

Stavanger, Rogaland, 4011, Norway

Location

Universitetssykehuset Nord-Norge HF ( Site 3101)

Tromsø, Troms, 9038, Norway

Location

Sorlandet Sykehus Kristiansand ( Site 3104)

Kristiansand, Vest-Agder, 4615, Norway

Location

Oslo universitetssykehus, Radiumhospitalet ( Site 3102)

Oslo, 0379, Norway

Location

Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie-Oddział Radioterapii i Onkologii Ginek ( Site 3202)

Poznan, Greater Poland Voivodeship, 61-866, Poland

Location

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3201)

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 3203)

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 3204)

Bialystok, Podlaskie Voivodeship, 15-027, Poland

Location

Ad-Vance Medical Research-Research ( Site 3302)

Ponce, 00717, Puerto Rico

Location

Pan American Center for Oncology Trials - Ciudadela ( Site 3301)

San Juan, 00909, Puerto Rico

Location

UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 3304)

San Juan, 00935, Puerto Rico

Location

National Cancer Centre Singapore-Medical Oncology ( Site 3401)

Singapore, Central Singapore, 168583, Singapore

Location

Seoul National University Bundang Hospital-Obstetrics and Gynecology ( Site 3505)

Seongnam, Kyonggi-do, 13620, South Korea

Location

Seoul National University Hospital ( Site 3502)

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 3503)

Seoul, 03722, South Korea

Location

Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3501)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 3504)

Seoul, 06351, South Korea

Location

Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 3608)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 3606)

Girona, Gerona, 17007, Spain

Location

Clinica Universidad de Navarra ( Site 3603)

Madrid, Madrid, Comunidad de, 28027, Spain

Location

Hospital Universitario 12 de Octubre-Medical Oncology ( Site 3607)

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Hospital Universitario La Paz-Oncología Médica ( Site 3604)

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 3605)

Valencia, Valenciana, Comunitat, 46009, Spain

Location

HOSPITAL CLINICO DE VALENCIA ( Site 3609)

Valencia, Valenciana, Comunitat, 46010, Spain

Location

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 3602)

Barcelona, 08035, Spain

Location

Hospital Universitario Reina Sofia-Oncologia Medica ( Site 3601)

Córdoba, 14004, Spain

Location

Skånes Universitetssjukhus Lund ( Site 3702)

Lund, Skåne County, 22185, Sweden

Location

Karolinska Universitetssjukhuset Solna ( Site 3701)

Stockholm, Stockholm County, 171 76, Sweden

Location

University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 3808)

Basel, Canton of Basel-City, 4031, Switzerland

Location

Ospedale Regionale Bellinzona e Valli ( Site 3802)

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Kantonsspital Graubünden-Medizin ( Site 3803)

Chur, Kanton Graubünden, 7000, Switzerland

Location

Inselspital Bern-Oncology ( Site 3801)

Bern, 3010, Switzerland

Location

University Hospitals Sussex NHS Foundation Trust ( Site 4006)

East Sussex, Brighton And Hove, BN2 1ES, United Kingdom

Location

Royal Derby Hospital ( Site 4007)

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 4002)

London, England, SW3 6JJ, United Kingdom

Location

The Royal Cornwall Hospital ( Site 4009)

Truro, England, TR1 3LJ, United Kingdom

Location

University College London Hospital-Cancer Clinical Trials Unit ( Site 4004)

London, London, City of, NW1 2PG, United Kingdom

Location

Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 4008)

London, London, City of, SE1 9RT, United Kingdom

Location

Hammersmith Hospital ( Site 4001)

London, London, City of, W12 OHS, United Kingdom

Location

The Beatson West of Scotland Cancer Centre ( Site 4005)

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 4010)

London, Sutton, SW3 6JJ, United Kingdom

Location

The Christie NHS Foundation Trust-Medical Oncology ( Site 4003)

Manchester, m20 4bx, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Doxorubicin; Paclitaxel; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: December 6, 2023
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): January 10, 2028
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

DK (3); US (42); MY (2); AR (7); CZ (7); NL (3); PL (4); PR (3); ES (9); CL (4); BR (9); GB (10); FR (10); IL (6); NO (4); CA (8); JP (18); DE (8); IE (3); SG (1); CN (30); IT (14); FI (4); AU (5); SE (2); BE (5); CH (4); GR (4); ME (5); KR (5)