AzTrials
AzTrials

Ovarian NeoplasmsPhase 3TroFuse-021NCT07318558

A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)

A Phase 3 study testing Sacituzumab tirumotecan, Bevacizumab and Rescue Medications in people with Ovarian Neoplasms and Ovarian Cancer, run by Merck Sharp & Dohme LLC at 167 sites in 30 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial summary

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms, Ovarian Cancer
What is being tested?
Sacituzumab tirumotecan, Bevacizumab and Rescue Medications
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
167 sitesin 30 countries
Study dates
16 Feb 2026to 25 Feb 2033
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

The main inclusion criteria include but are not limited to the following:

  • Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (>50%) Grade 3 features are present.
  • Has completed primary debulking surgery or interval debulking surgery.
  • Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.
  • Has provided tumor tissue that is not previously irradiated.
  • Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV
  • Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
  • Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.

The main exclusion criteria include but are not limited to the following:

  • Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has a history of severe eye disease.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.
  • Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria.
  • Had a live or live-attenuated vaccine within 30 days of randomization.
  • Has a known additional malignancy that is progressing or required active treatment within the past 3 years.
  • Has active infection requiring systemic therapy.
  • Has concurrent and active HBV and HCV infections.
  • Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease.
  • Has not recovered from major surgery or has ongoing surgical complications.
  • Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.
  • Active or ongoing stomatitis of any grade.

Trial locations and contacts

167 sites in 30 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

167 sites in 30 countries

United States27 sites, 27 recruiting

  • Womens Cancer Care Associates, LLC ( Site 0023)

    Albany, New York, 12208-1743

    Study Coordinator, 518-458-1390

    Recruiting

  • Illinois Cancer Specialists (ICS) ( Site 8009)

    Arlington Heights, Illinois, 60005

    Study Coordinator, 847-259-4482

    Recruiting

  • Winship Cancer Institute of Emory University ( Site 0037)

    Atlanta, Georgia, 30308

    Study Coordinator, 404-778-1900

    Recruiting

  • University of Alabama - Birmingham ( Site 0058)

    Birmingham, Alabama, 35233

    Study Coordinator, 205-934-4986

    Recruiting

  • University of Cincinnati Medical Center ( Site 0042)

    Cincinnati, Ohio, 45219

    Study Coordinator, 513-584-1000

    Recruiting

  • Maryland Oncology Hematology (MOH) ( Site 8002)

    Columbia, Maryland, 21044

    Study Coordinator, 410-964-2212

    Recruiting

  • Women's Cancer Care ( Site 0018)

    Covington, Louisiana, 70433

    Study Coordinator, 985-892-2252

    Recruiting

  • Duke Cancer Center ( Site 0012)

    Durham, North Carolina, 27710

    Study Coordinator, 919-681-6900

    Recruiting

  • Virginia Cancer Specialists (VCS) ( Site 8012)

    Fairfax, Virginia, 22031

    Study Coordinator, 703-280-5390

    Recruiting

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0055)

    Fort Wayne, Indiana, 46845

    Study Coordinator, 206-266-7701

    Recruiting

  • West Cancer Center and Research Institute ( Site 0013)

    Germantown, Tennessee, 38138

    Study Coordinator, 901-683-0055

    Recruiting

  • Franciscan Health Indianapolis ( Site 0081)

    Indianapolis, Indiana, 46237

    Study Coordinator, 317-528-5000

    Recruiting

  • University of Tennessee Medical Center ( Site 0087)

    Knoxville, Tennessee, 37920

    Study Coordinator, 865-305-9000

    Recruiting

  • Mount Sinai Cancer Center ( Site 0029)

    Miami Beach, Florida, 33140

    Study Coordinator, 305-674-2625

    Recruiting

  • Henry-Joyce Cancer Clinic ( Site 0011)

    Nashville, Tennessee, 37232

    Study Coordinator, 615-936-4585

    Recruiting

  • Memorial Sloan Kettering Cancer Center ( Site 0072)

    New York, New York, 10022

    Study Coordinator, 347-923-8746

    Recruiting

  • Virginia Oncology Associates (VOA) ( Site 8013)

    Norfolk, Virginia, 23502

    Study Coordinator, 757-466-8663

    Recruiting

  • Nebraska Methodist Hospital ( Site 0004)

    Omaha, Nebraska, 68114

    Study Coordinator, 402-354-7939

    Recruiting

  • University Of Nebraska Medical Center ( Site 0035)

    Omaha, Nebraska, 68198

    Study Coordinator, 402-559-2000

    Recruiting

  • Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)

    Orlando, Florida, 32806

    Study Coordinator, 321-841-8393

    Recruiting

  • Hospital of the University of Pennsylvania ( Site 0071)

    Philadelphia, Pennsylvania, 19104

    Study Coordinator, 215-662-4000

    Recruiting

  • Kaiser Permanente Interstate Medical Office - Central ( Site 0089)

    Portland, Oregon, 97227

    Study Coordinator, 503-335-2400

    Recruiting

  • Women & Infants Hospital ( Site 0001)

    Providence, Rhode Island, 02905

    Study Coordinator, 401-274-1122x48181

    Recruiting

  • The Center of Hope ( Site 0025)

    Reno, Nevada, 89511

    Study Coordinator, 775-327-4673

    Recruiting

  • Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060)

    Scarborough, Maine, 04074

    Study Coordinator, 207-883-0069

    Recruiting

  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)

    Tulsa, Oklahoma, 74146

    Study Coordinator, 918-505-3200

    Recruiting

  • John Muir Health Cancer Center ( Site 0069)

    Walnut Creek, California, 94598

    Study Coordinator, 925-692-5603

    Recruiting

Other trials in United States

Japan15 sites, 15 recruiting

  • Hyogo Cancer Center ( Site 1620)

    Akashi, Hyōgo, 673-8558

    Study Coordinator, +81-78-929-1151

    Recruiting

  • National Hospital Organization Kyushu Cancer Center ( Site 1603)

    Fukuoka, 811-1395

    Study Coordinator, +81-92-541-3231

    Recruiting

  • Saitama Medical University International Medical Center ( Site 1607)

    Hidaka, Saitama, 350-1298

    Study Coordinator, +81-42-984-4111

    Recruiting

  • Kagoshima City Hospital ( Site 1613)

    Kagoshima, 890-8760

    Study Coordinator, +81-99-230-7000

    Recruiting

  • Cancer Institute Hospital of JFCR ( Site 1614)

    Koto, Tokyo, 135-8550

    Study Coordinator, +81-3-3520-0111

    Recruiting

  • Kurume University Hospital ( Site 1615)

    Kurume, Fukuoka, 830-0011

    Study Coordinator, +81-942-35-3311

    Recruiting

  • Aichi Cancer Center ( Site 1601)

    Nagoya, Aichi-ken, 464-8681

    Study Coordinator, +81-52-762-6111

    Recruiting

  • Niigata Cancer Center Hospital ( Site 1608)

    Niigata, 951-8566

    Study Coordinator, +81-25-266-5111

    Recruiting

  • Okayama University Hospital ( Site 1619)

    Okayama, 700-8558

    Study Coordinator, +81-86-223-7151

    Recruiting

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604)

    Osaka, 541-8567

    Study Coordinator, +81-6-6945-1181

    Recruiting

  • Gunma Prefectural Cancer Center ( Site 1605)

    Ōta, Gunma, 373-8550

    Study Coordinator, +81-276-38-0771

    Recruiting

  • Hokkaido University Hospital ( Site 1609)

    Sapporo, Hokkaido, 060-8648

    Study Coordinator, +81-11-716-1161

    Recruiting

  • Keio University Hospital ( Site 1611)

    Shinjyuku, Tokyo, 160-8582

    Study Coordinator, +81-3-3353-1211

    Recruiting

  • Iwate Medical University Hospital ( Site 1610)

    Shiwa-gun, Iwate, 028-3695

    Study Coordinator, +81-19-613-7111

    Recruiting

  • Shizuoka Cancer Center ( Site 1618)

    Sunto-gun,, Shizuoka, 411-8777

    Study Coordinator, +81-55-989-5222

    Recruiting

Other trials in Japan

Spain11 sites, 11 recruiting

  • Complejo Hospitalario Universitario A Coruna ( Site 2412)

    A Coruña, La Coruna, 15006

    Study Coordinator, 34981178353

    Recruiting

  • Hospital Vall D Hebron ( Site 2403)

    Barcelona, 08035

    Study Coordinator, +34934894350

    Recruiting

  • Hospital Clinic I Provincial de Barcelona ( Site 2409)

    Barcelona, 08036

    Study Coordinator, +34932275402

    Recruiting

  • ICO L Hospitalet ( Site 2408)

    Barcelona, 08907

    Study Coordinator, +34932607744

    Recruiting

  • Hospital Universitario Reina Sofia ( Site 2406)

    Córdoba, 14004

    Study Coordinator, +34957011456

    Recruiting

  • Institut Català d'Oncologia (ICO) - Girona ( Site 2402)

    Girona, Gerona, 17007

    Study Coordinator, +34972225834

    Recruiting

  • Clinica Universidad de Navarra ( Site 2407)

    Madrid, Madrid, Comunidad de, 28027

    Study Coordinator, +34913531920/ 7513

    Recruiting

  • Hospital Ramon y Cajal ( Site 2405)

    Madrid, 28034

    Study Coordinator, +34913368263

    Recruiting

  • Hospital Clinico San Carlos... ( Site 2410)

    Madrid, 28040

    Study Coordinator, 34913303000 x484811

    Recruiting

  • Hospital Universitario La Paz-Oncología Médica ( Site 2404)

    Madrid, 28046

    Study Coordinator, +34679927508

    Recruiting

  • Instituto Valenciano de Oncologia - IVO ( Site 2411)

    Valencia, Valenciana, Comunitat, 46009

    Study Coordinator, +34961114229

    Recruiting

Other trials in Spain

France10 sites, 10 recruiting

  • CHRU de Brest - Hopital de la Cavale Blanche ( Site 1104)

    Brest, Finistere, 29200

    Study Coordinator, +33230338161

    Recruiting

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)

    Clermont-Ferrand, Puy-de-Dome, 63003

    Study Coordinator, +33473278080

    Recruiting

  • Centre Oscar Lambret ( Site 1106)

    Lille, Nord, 59020

    Study Coordinator, +33320295606

    Recruiting

  • Centre Hospitalier Universitaire Dupuytren ( Site 1112)

    Limoges, Haute-Vienne, 87042

    Study Coordinator, +33555056268

    Recruiting

  • CENTRE LEON BERARD ( Site 1101)

    Lyon, Auvergne-Rhône-Alpes, 69008

    Study Coordinator, +33478782888

    Recruiting

  • Institut Paoli Calmettes ( Site 1111)

    Marseille, Bouches-du-Rhone, 13273

    Study Coordinator, +33491223333

    Recruiting

  • Hôpital Privé Des Côtes d'Armor ( Site 1102)

    Plérin, Cotes-d Armor, 22190

    Study Coordinator, +33296752216

    Recruiting

  • Hopitaux Universitaires de Strasbourg ( Site 1109)

    Strasbourg, Bas-Rhin, 67000

    Study Coordinator, 0368767141

    Recruiting

  • LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1114)

    Toulouse, Haute-Garonne, 31059

    Study Coordinator, +33531155101

    Recruiting

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1105)

    Tours, Indre-et-Loire, 37044

    Study Coordinator, +33247478261

    Recruiting

Other trials in France

Argentina8 sites, 8 recruiting

  • Fundación Respirar ( Site 2912)

    Buenos Aires, Buenos Aires F.D., C1426AAL

    Study Coordinator, +541147815331

    Recruiting

  • Hospital Britanico de Buenos Aires ( Site 2905)

    CABA, C1280AEB

    Study Coordinator, +5411 4309 4469

    Recruiting

  • Hospital Aleman ( Site 2903)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1119ACN

    Study Coordinator, +5491148277000

    Recruiting

  • Instituto Alexander Fleming ( Site 2902)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

    Study Coordinator, 5411 3221 8900

    Recruiting

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907)

    La Rioja, F5300COE

    Study Coordinator, +54 380 4336443

    Recruiting

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)

    Mar del Plata, Buenos Aires, B7600FZO

    Study Coordinator, +54 223 496 3224

    Recruiting

  • Sanatorio Parque - Oncología ( Site 2911)

    Rosario, Santa Fe Province, S2000DVC

    Study Coordinator, +543412987413

    Recruiting

  • Instituto de Oncologia de Rosario ( Site 2909)

    Rosario, Santa Fe Province, S2000KZE

    Study Coordinator, +543414218909

    Recruiting

Other trials in Argentina

Italy7 sites, 7 recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501)

    Brescia, 25123

    Study Coordinator, +390303998428

    Recruiting

  • ASST DI LECCO ( Site 1509)

    Lecco, 23900

    Study Coordinator, 0039 0341489167

    Recruiting

  • Istituto Nazionale dei Tumori ( Site 1504)

    Milan, 20133

    Study Coordinator, +390223903619

    Recruiting

  • Istituto Europeo di Oncologia ( Site 1503)

    Milan, 20141

    Study Coordinator, 390257489543

    Recruiting

  • Istituto Oncologico Veneto ( Site 1506)

    Padova, 35128

    Study Coordinator, 0039 0498215729

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510)

    Roma, 00168

    Study Coordinator, +390630157004

    Recruiting

  • Ospedale Mauriziano ( Site 1507)

    Torino, 10128

    Study Coordinator, 0039 0115082764

    Recruiting

Other trials in Italy

Brazil6 sites, 6 recruiting

  • ANIMI - Unidade de Tratamento Oncologico ( Site 0421)

    Lages, Santa Catarina, 88501-001

    Study Coordinator, +554933805200

    Recruiting

  • Liga Norte Riograndense Contra o Cancer ( Site 0417)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +558440095595

    Recruiting

  • Hospital São Lucas da PUCRS ( Site 0415)

    Porto Alegre, Rio Grande do Sul, 90610000

    Study Coordinator, +555133396039

    Recruiting

  • Obras Sociais Irma Dulce ( Site 0427)

    Salvador, Estado de Bahia, 41680-430

    Study Coordinator, +55 71 3310-1978

    Recruiting

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0414)

    São José do Rio Preto, São Paulo, 15090-000

    Study Coordinator, 55 17 32015054

    Recruiting

  • IBCC - Núcleo de Pesquisa e Ensino ( Site 0416)

    São Paulo, 04014-002

    Study Coordinator, +551144500360

    Recruiting

Other trials in Brazil

Chile6 sites, 6 recruiting

  • Clinica Puerto Montt ( Site 0606)

    Port Montt, Los Lagos Region, 5507642

    Study Coordinator, 56961687093

    Recruiting

  • Fundación Arturo López Pérez ( Site 0607)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224205098

    Recruiting

  • Clínica Alemana de Santiago ( Site 0610)

    Santiago, Region M. de Santiago, 7650568

    Study Coordinator, +56996197211

    Recruiting

  • Pontificia Universidad Catolica de Chile ( Site 0602)

    Santiago, Region M. de Santiago, 8330073

    Study Coordinator, +56934331806

    Recruiting

  • Bradfordhill ( Site 0601)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +5622949070

    Recruiting

  • ONCOCENTRO APYS-ACEREY ( Site 0603)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, +56323320850

    Recruiting

Other trials in Chile

Czechia6 sites, 6 recruiting

  • Fakultni Nemocnice Brno Bohunice ( Site 3304)

    Brno, Brno-mesto, 602 00

    Study Coordinator, 420532233843

    Recruiting

  • Fakultni nemocnice Hradec Kralove ( Site 3307)

    Hradec Králové, 500 05

    Study Coordinator, +420 495 831 111

    Recruiting

  • Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 3303)

    Ostrava-Poruba, Ostrava Mesto, 708 52

    Study Coordinator, +420597371804

    Recruiting

  • Fakultni nemocnice Kralovske Vinohrady ( Site 3306)

    Prague, 100 34

    Study Coordinator, +420267161111

    Recruiting

  • Vseobecna fakultni nemocnice v Praze ( Site 3305)

    Prague, 128 08

    Study Coordinator, +420224967451

    Recruiting

  • Fakultni nemocnice motol ( Site 3302)

    Prague, 150 06

    Study Coordinator, +420224431111

    Recruiting

Other trials in Czechia

Colombia5 sites, 5 recruiting

  • Instituto Nacional De Cancerologia ( Site 0808)

    Bogota, Cundinamarca, 111151

    Study Coordinator, +5714320160

    Recruiting

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)

    Bogotá, Bogota D.C., 110131

    Study Coordinator, +573044921963

    Recruiting

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 0803)

    Medellín, Antioquia, 050030

    Study Coordinator, +576044480016

    Recruiting

  • Oncólogos del Occidente S.A.S. ( Site 0806)

    Pereira, Risaralda Department, 660001

    Study Coordinator, +573002558656

    Recruiting

  • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0802)

    Valledupar, Cesar Department, 200001

    Study Coordinator, 605 5804141

    Recruiting

Other trials in Colombia

Hungary5 sites, 5 recruiting

  • Semmelweis Egyetem I. Szamu Szuleszeti es Nogyogyaszati Klinika ( Site 3915)

    Budapest, 1088

    Study Coordinator, +36 1 266 0473

    Recruiting

  • Országos Onkológiai Intézet-Ngyógyászat ( Site 3913)

    Budapest, 1122

    Study Coordinator, +3612248600

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912)

    Debrecen, 4032

    Study Coordinator, 0652255705

    Recruiting

  • Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 3911)

    Győr, Győr-Moson-Sopron, 9024

    Study Coordinator, +3696418244

    Recruiting

  • Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910)

    Kecskemét, Bács-Kiskun county, 6000

    Study Coordinator, +3676516719

    Recruiting

Other trials in Hungary

Poland5 sites, 5 recruiting

  • Bialostockie Centrum Onkologii ( Site 2104)

    Bialystok, Podlaskie Voivodeship, 15-027

    Study Coordinator, +48856646732

    Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2106)

    Poznan, Greater Poland Voivodeship, 60-569

    Study Coordinator, +48618549014

    Recruiting

  • Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 2105)

    Poznan, Greater Poland Voivodeship, 61-866

    Study Coordinator, +48 61 8850 557

    Recruiting

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)

    Siedlce, Masovian Voivodeship, 08-110

    Study Coordinator, +48256403485

    Recruiting

  • Uniwersytecki Szpital Kliniczny nr2 PUM w Szczecinie ( Site 2103)

    Szczecin, West Pomeranian Voivodeship, 70-111

    Study Coordinator, +48 91 466 10 00

    Recruiting

Other trials in Poland

South Korea5 sites, 5 recruiting

  • Keimyung University Dongsan Hospital ( Site 2304)

    Daegu, Taegu-Kwangyokshi, 42601

    Study Coordinator, +82532586671

    Recruiting

  • Severance Hospital ( Site 2302)

    Seodaemun-Gu, Seoul, 03722

    Study Coordinator, +82222277969

    Recruiting

  • Seoul National University Hospital ( Site 2301)

    Seoul, 03080

    Study Coordinator, +82260724984

    Recruiting

  • Asan Medical Center ( Site 2305)

    Seoul, 05505

    Study Coordinator, +82230103640

    Recruiting

  • Samsung Medical Center ( Site 2303)

    Seoul, 06351

    Study Coordinator, +82234101382

    Recruiting

Other trials in South Korea

Taiwan5 sites, 5 recruiting

  • Taichung Veterans General Hospital ( Site 2603)

    Taichung, 40705

    Study Coordinator, 886-4-23592525x5822

    Recruiting

  • National Cheng Kung University Hospital ( Site 2602)

    Tainan, 704302

    Study Coordinator, +8862353535

    Recruiting

  • National Taiwan University Hospital ( Site 2601)

    Taipei, 10002

    Study Coordinator, 886-223123456x271563

    Recruiting

  • Mackay Memorial Hospital ( Site 2604)

    Taipei, 104

    Study Coordinator, +886225433535

    Recruiting

  • Linkou Chang Gung Memorial Hospital ( Site 2605)

    Taoyuan, 333

    Study Coordinator, 886-33281200x8258

    Recruiting

Other trials in Taiwan

United Kingdom5 sites, 5 recruiting

  • Royal United Hospital Bath NHS Foundation Trust ( Site 2808)

    Bath, Bath And North East Somerset, BA1 3NG

    Study Coordinator, +441225821778

    Recruiting

  • Addenbrookes Hospital ( Site 2802)

    Cambridge, Cambridgeshire, CB2 2QQ

    Study Coordinator, +441223805000

    Recruiting

  • University Hospitals of Leicester NHS Trust ( Site 2805)

    Leicester, Leicestershire, LE3 9QP

    Study Coordinator, +443003031573

    Recruiting

  • University College London Hospitals ( Site 2801)

    London, London, City of, NW1 2PG

    Study Coordinator, +4402034477807

    Recruiting

  • The Christie NHS Foundation Trust ( Site 2804)

    Manchester, m20 4bx

    Study Coordinator, 0161 918 7690

    Recruiting

Other trials in United Kingdom

Denmark4 sites, 4 recruiting

  • Aalborg Universitetshospital ( Site 0901)

    Aalborg, North Denmark, 9000

    Study Coordinator, +4597660000

    Recruiting

  • Aarhus Universitetshospital, Skejby ( Site 0903)

    Aarhus, North Denmark, 8200

    Study Coordinator, +4578450000

    Recruiting

  • Herlev Hospital ( Site 0902)

    Herlev, Capital Region, 2730

    Study Coordinator, +4538689255

    Recruiting

  • Odense Universitets Hospital ( Site 0904)

    Odense, Region Syddanmark, 9000

    Study Coordinator, +4523604974

    Recruiting

Other trials in Denmark

Finland4 sites, 4 recruiting

  • Kuopion Yliopistollinen Sairaala ( Site 1004)

    Kuopio, Northern Savonia, 70200

    Study Coordinator, +35844 7176780

    Recruiting

  • Oulun yliopistollinen sairaala ( Site 1003)

    Oulu, North Ostrobothnia, 90220

    Study Coordinator, +358 8 3153108

    Recruiting

  • Tampereen yliopistollinen sairaala ( Site 1002)

    Tampere, Pirkanmaa, 33520

    Study Coordinator, +358331166203

    Recruiting

  • Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)

    Turku, Southwest Finland, 20520

    Study Coordinator, +358 2 313 0000

    Recruiting

Other trials in Finland

Switzerland4 sites, 4 recruiting

  • Ospedale Regionale Bellinzona e Valli ( Site 3501)

    Bellinzona, Canton Ticino, 6500

    Study Coordinator, 41918118194

    Recruiting

  • Inselspital Bern ( Site 3504)

    Bern, Canton of Bern, 3010

    Study Coordinator, 41316326416

    Recruiting

  • Kantonsspital Graubünden ( Site 3503)

    Chur, Kanton Graubünden, 7000

    Study Coordinator, +41 81 256 6646

    Recruiting

  • Hôpitaux Universitaires de Genève (HUG) ( Site 3502)

    Geneva, 1205

    Study Coordinator, +41795534976

    Recruiting

Other trials in Switzerland

Australia3 sites, 3 recruiting

  • Gallipoli Medical Research Ltd ( Site 0204)

    Brisbane, Queensland, 4120

    Study Coordinator, +610733947807

    Recruiting

  • Epworth Freemasons ( Site 0207)

    East Melbourne, Victoria, 3002

    Study Coordinator, +61385595000

    Recruiting

  • Westmead Hospital ( Site 0201)

    Westmead, New South Wales, 2145

    Study Coordinator, 0288909518

    Recruiting

Other trials in Australia

Belgium3 sites, 3 recruiting

  • Grand Hopital de Charleroi ( Site 0303)

    Charleroi, Hainaut, 6000

    Study Coordinator, +3260 11 06 04

    Recruiting

  • AZ Maria Middelares ( Site 0302)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +32 9 246 95 19

    Recruiting

  • UZ Leuven ( Site 0301)

    Leuven, Vlaams-Brabant, 3000

    Study Coordinator, +32 16 34 74 19

    Recruiting

Other trials in Belgium

Canada3 sites, 3 recruiting

  • CIUSSS - Saguenay-Lac-Saint-Jean ( Site 0519)

    Chicoutimi, Quebec, G7H 5H6

    Study Coordinator, 418 541-1000

    Recruiting

  • Centre Hospitalier de l'Université de Montréal ( Site 0518)

    Montreal, Quebec, H2X 3H8

    Study Coordinator, 514-890-8000

    Recruiting

  • McGill University Health Centre ( Site 0516)

    Montreal, Quebec, H4A 3J1

    Study Coordinator, 514-934-1934 x31975

    Recruiting

Other trials in Canada

Greece3 sites, 3 recruiting

  • Alexandra General Hospital of Athens ( Site 0703)

    Athens, Attica, 115 28

    Study Coordinator, +302132162543

    Recruiting

  • Evgenidion Clinic Agia Trias S.A ( Site 0701)

    Athens, Attica, 115 28

    Study Coordinator, +302107286444

    Recruiting

  • Agios Loukas Clinic ( Site 0702)

    Thessaloniki, 552 36

    Study Coordinator, +302310390972

    Recruiting

Other trials in Greece

Israel3 sites, 3 recruiting

  • Rambam Health Care Campus ( Site 1422)

    Haifa, 3109601

    Study Coordinator, +97247772688

    Recruiting

  • Edith Wolfson Medical Center ( Site 1423)

    Holon, 5810001

    Study Coordinator, +97235028211

    Recruiting

  • Sheba Medical Center ( Site 1421)

    Ramat Gan, 5265601

    Study Coordinator, +97235303030

    Recruiting

Other trials in Israel

Norway3 sites, 3 recruiting

  • Sorlandet Sykehus Kristiansand ( Site 2003)

    Kristiansand, Vest-Agder, 4615

    Study Coordinator, +4738073070

    Recruiting

  • Oslo University Hospital ( Site 2001)

    Oslo, 0424

    Study Coordinator, +47-48512384

    Recruiting

  • Stavanger Universitetssjukehus ( Site 2002)

    Stavanger, Rogaland, 4068

    Study Coordinator, 4751518000

    Recruiting

Other trials in Norway

Thailand3 sites, 3 recruiting

  • Ramathibodi Hospital. ( Site 3402)

    Bangkok, Bangkok, 10400

    Study Coordinator, +6622011451

    Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 3401)

    Bangkoknoi, Bangkok, 10700

    Study Coordinator, +6624194488

    Recruiting

  • Faculty of Medicine - Khon Kaen University ( Site 3403)

    Muang, Changwat Khon Kaen, 40002

    Study Coordinator, +6643348382

    Recruiting

Other trials in Thailand

Austria2 sites, 2 recruiting

  • Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)

    Innsbruck, Tyrol, 6020

    Study Coordinator, +4351250483105

    Recruiting

  • Medizinische Universitat Wien ( Site 0102)

    Vienna, State of Vienna, 1090

    Study Coordinator, +43 1 4040061030

    Recruiting

Other trials in Austria

Ireland2 sites, 2 recruiting

  • Cork University Hospital ( Site 1303)

    Cork, T12 DC4A

    Study Coordinator, +350214922000

    Recruiting

  • St James Hospital ( Site 1302)

    Dublin, D08 E9P6

    Study Coordinator, +353014103000

    Recruiting

Other trials in Ireland

Peru2 sites, 2 recruiting

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)

    Lima, 15036

    Study Coordinator, +51 951 881 870

    Recruiting

  • Clínica San Felipe ( Site 3603)

    Lima, 15072

    Study Coordinator, +5112190000 Ext 8327

    Recruiting

Other trials in Peru

Germany1 site, 1 recruiting

  • Universitätsklinikum Jena ( Site 1211)

    Jena, Thuringia, 07747

    Study Coordinator, +49 36419329101

    Recruiting

Other trials in Germany

Sweden1 site, 1 recruiting

  • Karolinska Universitetssjukhuset Solna ( Site 2502)

    Stockholm, Stockholm County, 171 76

    Study Coordinator, +460812370000

    Recruiting

Other trials in Sweden

About this study

Official title: A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:

  • Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.
  • Observation, which is watching to see if cancer grows or worsens

The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

Being tested
Sacituzumab tirumotecan, Bevacizumab, Rescue Medications
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab tirumotecanDrug

    Also called sac-TMT, MK-2870, SKB264

    Administered via intravenous (IV) infusion at a dose of 4mg/kg

  • BevacizumabDrug

    Also called Avastin, Altuzan, MVASI

    Administered via IV infusion at a dose of 15mg/kg

  • Rescue MedicationsDrug

    Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent.

Study groups in NCT07318558
Study groupRoleWhat they receive
Sac-TMT +/- BevacizumabExperimentalParticipants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.
Receives: Drug: Sacituzumab tirumotecan; Drug: Bevacizumab; Drug: Rescue Medications
Standard of CareActive comparatorParticipants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab.
Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

    Measured: Up to approximately 49 months

Secondary outcomes (8)

  1. Overall Survival (OS)

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

    Measured: Up to approximately 78 months

  2. Progression-Free Survival 2 (PFS2)

    PFS2 as assessed by investigator is defined as the time from randomization to the documented subsequent objective disease progression after initiation of new anticancer therapy or death due to any cause, whichever occurs first.

    Measured: Up to approximately 78 months

  3. Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 78 months

  4. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 78 months

  5. Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Combined Score (Items 29 and 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)

    EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7- point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.

    Measured: Baseline and up to approximately 78 months

  6. Change From Baseline in Physical Functioning Combined Score (Items 1 to 5) Using EORTC QLQ-C30

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 5 questions and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 physical functioning combined score will be presented.

    Measured: Baseline and up to approximately 78 months

  7. Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. The change from baseline in the EORTC QLQ-C30 role functioning combined score will be presented.

    Measured: Baseline and up to approximately 78 months

  8. Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)

    EORTC QLQ-OV28 is an OC-specific module to supplement the EORTC QLQ-C30. Participant responses to the 6 abdominal/GI symptoms scale questions are scored on a 4-point scale (1=not at all, 4=very much). The combined score is computed by averaging the raw scores of the 6 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-OC28 Items 31-36) score will be presented. A lower score indicates a better outcome.

    Measured: Baseline and up to approximately 78 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start16 Feb 2026
  3. Primary completion25 Feb 2033 (estimated)
  4. Study completion25 Feb 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07318558
Sponsor's protocol ID
2870-021
Other IDs
MK-2870-021, GOG-3102, ENGOT-ov85, U1111-1297-5158, 2023-508047-40-00, jRCT2031250647, 2023
Acronym
TroFuse-021
Status last verified
Oct 2026
First submitted
2 Jan 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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