AzTrials
AzTrials

Ovarian CancerPhase 3NCT06824467

A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

A Phase 3 study testing Sacituzumab tirumotecan, Bevacizumab and H1 receptor antagonist in people with Ovarian Cancer and Fallopian Tube Cancer, run by Merck Sharp & Dohme LLC at 198 sites in 29 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

The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Sacituzumab tirumotecan, Bevacizumab and H1 receptor antagonist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
770 participants
Where
198 sitesin 29 countries
Study dates
9 Apr 2025to 9 Nov 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Has locally advanced or metastatic, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies
  • Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 to 8 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)
  • Has platinum-sensitive epithelial OC
  • Has provided tissue of a tumor lesion that was not previously irradiated
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
  • Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)
  • Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  • Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)

Who cannot join

  • Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma
  • Has platinum-resistant OC or platinum-refractory OC
  • Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening
Show all 14Show fewer
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received more than 2 prior lines of systemic therapy for OC
  • Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)
  • Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids
  • Has an additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active infection requiring systemic therapy
  • Has active or ongoing stomatitis

Trial locations and contacts

198 sites in 29 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

198 sites in 29 countries

United States38 sites, 37 recruiting

  • University of New Mexico Comprehensive Cancer Center ( Site 0055)

    Albuquerque, New Mexico, 87131

    Study Coordinator, 505-272-4946

    Recruiting

  • Alaska Women's Cancer Care ( Site 0096)

    Anchorage, Alaska, 99508

    Study Coordinator, 907-562-4673

    Recruiting

  • Winship Cancer Institute of Emory University ( Site 0086)

    Atlanta, Georgia, 30322

    Study Coordinator, 404-778-1900

    Recruiting

  • Augusta University - Georgia Cancer Center ( Site 0066)

    Augusta, Georgia, 30912

    Study Coordinator, 706-721-6744

    Recruiting

  • Texas Oncology - Central/South Texas ( Site 8009)

    Austin, Texas, 78758

    Study Coordinator, 512-873-8900

    Recruiting

  • University of Alabama at Birmingham ( Site 0006)

    Birmingham, Alabama, 35249

    Study Coordinator, (205) 934-7442

    Recruiting

  • University of Cincinnati Medical Center ( Site 0090)

    Cincinnati, Ohio, 45219

    Study Coordinator, 513-584-1958

    Recruiting

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0054)

    Columbus, Ohio, 43210

    Study Coordinator, 614-293-3300

    Recruiting

  • Women's Cancer Care ( Site 0067)

    Covington, Louisiana, 70433

    Study Coordinator, 985-892-2252

    Recruiting

  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010)

    Eugene, Oregon, 97401

    Study Coordinator, 541-683-5001

    Recruiting

  • Virginia Cancer Specialists (VCS) ( Site 8011)

    Fairfax, Virginia, 22031

    Study Coordinator, (571) 350-8400

    Recruiting

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0003)

    Fort Wayne, Indiana, 46845

    Study Coordinator, 260-425-6981

    Recruiting

  • Texas Oncology - DFW ( Site 8001)

    Fort Worth, Texas, 76104

    Study Coordinator, 817-413-1500

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081)

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-5855

    Recruiting

  • City of Hope Lennar Foundation Cancer Center ( Site 0024)

    Irvine, California, 92618

    Study Coordinator, 626-256-4673

    Recruiting

  • St. Dominic's Hospital ( Site 0064)

    Jackson, Mississippi, 39216

    Active, not recruiting

  • Minnesota Oncology Hematology (MNO) ( Site 8002)

    Maplewood, Minnesota, 55109

    Study Coordinator, 615-693-2574

    Recruiting

  • Mount Sinai Braman Comprehensive Cancer Center ( Site 0078)

    Miami Beach, Florida, 33140

    Study Coordinator, 305-674-2625

    Recruiting

  • NYU Langone Hospital - Long Island ( Site 0015)

    Mineola, New York, 11501

    Study Coordinator, 516-663-0333

    Recruiting

  • Henry-Joyce Cancer Clinic ( Site 0060)

    Nashville, Tennessee, 37232

    Study Coordinator, 615-936-8422

    Recruiting

  • Rutgers Cancer Institute of New Jersey ( Site 0071)

    New Brunswick, New Jersey, 08901

    Study Coordinator, 732-235-7258

    Recruiting

  • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)

    New Haven, Connecticut, 06510

    Study Coordinator, 203-785-5702

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center ( Site 0076)

    New York, New York, 10016

    Study Coordinator, 212-731-6000

    Recruiting

  • Nebraska Methodist Hospital ( Site 0053)

    Omaha, Nebraska, 68114

    Study Coordinator, 402-354-8534

    Recruiting

  • FirstHealth Cancer Center ( Site 0079)

    Pinehurst, North Carolina, 28374

    Study Coordinator, 910-715-8684

    Recruiting

  • Allegheny Health Network West Penn Hospital ( Site 0099)

    Pittsburgh, Pennsylvania, 15224

    Study Coordinator, 412-578-5000

    Recruiting

  • Women & Infants Hospital ( Site 0050)

    Providence, Rhode Island, 02905

    Study Coordinator, 401-274-1100

    Recruiting

  • University Of Texas Health Science Center -San Antonio ( Site 0095)

    San Antonio, Texas, 78229

    Study Coordinator, 210-567-7000

    Recruiting

  • Texas Oncology - San Antonio ( Site 8005)

    San Antonio, Texas, 78240

    Study Coordinator, 210-595-5300

    Recruiting

  • UCSF Medical Center at Mission Bay ( Site 0013)

    San Francisco, California, 94158

    Study Coordinator, 415-353-3000

    Recruiting

  • Sarasota Memorial Hospital ( Site 0075)

    Sarasota, Florida, 34239

    Study Coordinator, 941-917-2225

    Recruiting

  • Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)

    Scarborough, Maine, 04074

    Study Coordinator, 207-883-0069

    Recruiting

  • Washington University School of Medicine ( Site 0052)

    St Louis, Missouri, 63110

    Study Coordinator, 314-454-6215

    Recruiting

  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)

    Tulsa, Oklahoma, 74146

    Study Coordinator, 918-505-3200

    Recruiting

  • John Muir Health Cancer Center ( Site 0016)

    Walnut Creek, California, 94598

    Study Coordinator, 925-692-5603

    Recruiting

  • Texas Oncology - Gulf Coast ( Site 8003)

    Webster, Texas, 77598

    Study Coordinator, 281-332-7505

    Recruiting

  • Florida Cancer Specialists East ( Site 7000)

    West Palm Beach, Florida, 33401

    Study Coordinator, 561-366-4100

    Recruiting

  • The University of Kansas Cancer Center - Westwood ( Site 0002)

    Westwood, Kansas, 66205

    Study Coordinator, 913-588-6215

    Recruiting

Other trials in United States

Japan16 sites, 16 recruiting

  • National Hospital Organization Kyushu Cancer Center ( Site 1628)

    Fukuoka, 811-1395

    Study Coordinator, +81-92-541-3231

    Recruiting

  • Saitama Medical University International Medical Center ( Site 1632)

    Hidaka, Saitama, 350-1298

    Study Coordinator, +81-42-984-4111

    Recruiting

  • Kagoshima City Hospital ( Site 1638)

    Kagoshima, 890-8760

    Study Coordinator, +81-99-230-7000

    Recruiting

  • National Cancer Center Hospital East ( Site 1641)

    Kashiwa, Chiba, 277-8577

    Study Coordinator, +81-4-7133-1111

    Recruiting

  • Cancer Institute Hospital of JFCR ( Site 1639)

    Koto, Tokyo, 135-8550

    Study Coordinator, +81-3-3520-0111

    Recruiting

  • Kurume University Hospital ( Site 1640)

    Kurume, Fukuoka, 830-0011

    Study Coordinator, +81-942-35-3311

    Recruiting

  • National Hospital Organization Shikoku Cancer Center ( Site 1631)

    Matsuyama, Ehime, 791-0280

    Study Coordinator, +81-89-999-1111

    Recruiting

  • Aichi Cancer Center ( Site 1626)

    Nagoya, Aichi-ken, 464-8681

    Study Coordinator, +81-52-762-6111

    Recruiting

  • Niigata Cancer Center Hospital ( Site 1633)

    Niigata, 951-8566

    Study Coordinator, +81-25-266-5111

    Recruiting

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1629)

    Osaka, 541-8567

    Study Coordinator, +81-6-6945-1181

    Recruiting

  • Gunma Prefectural Cancer Center ( Site 1630)

    Ōta, Gunma, 373-8550

    Study Coordinator, +81-276-38-0771

    Recruiting

  • Hokkaido University Hospital ( Site 1634)

    Sapporo, Hokkaido, 060-8648

    Study Coordinator, +81-11-716-1161

    Recruiting

  • Keio University Hospital ( Site 1636)

    Shinjyuku, Tokyo, 160-8582

    Study Coordinator, +81-3-3353-1211

    Recruiting

  • Iwate Medical University Hospital ( Site 1635)

    Shiwa-gun, Iwate, 028-3695

    Study Coordinator, +81-19-613-7111

    Recruiting

  • Shizuoka Cancer Center ( Site 1643)

    Sunto-gun,, Shizuoka, 411-8777

    Study Coordinator, +81-55-989-5222

    Recruiting

  • Ehime University Hospital ( Site 1637)

    Tōon, Ehime, 791-0295

    Study Coordinator, +81-89-964-5111

    Recruiting

Other trials in Japan

Spain12 sites, 12 recruiting

  • Hospital Vall D Hebron ( Site 2403)

    Barcelona, 08035

    Study Coordinator, +34932746085

    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, +34957011464

    Recruiting

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

    Girona, Gerona, 17007

    Study Coordinator, +34972225828

    Recruiting

  • Hospital General Gregorio Maranon de Madrid ( Site 2412)

    Madrid, Madrid, Comunidad de, 28007

    Study Coordinator, +34915860860

    Recruiting

  • Clinica Universidad de Navarra ( Site 2407)

    Madrid, Madrid, Comunidad de, 28027

    Study Coordinator, +34913531920

    Recruiting

  • Hospital Ramon y Cajal ( Site 2405)

    Madrid, 28034

    Study Coordinator, +3491336 82 63

    Recruiting

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

    Madrid, 28040

    Study Coordinator, 34 913303000 x484811

    Recruiting

  • Hospital Universitario 12 de Octubre ( Site 2411)

    Madrid, 28041

    Study Coordinator, +34913908626

    Recruiting

  • Hospital Universitario La Paz ( Site 2404)

    Madrid, 28046

    Study Coordinator, +34 679927508

    Recruiting

  • Hosp Clinico Universitario de Valencia ( Site 2401)

    Valencia, Valenciana, Comunitat, 46010

    Study Coordinator, 34 961973500

    Recruiting

Other trials in Spain

France11 sites, 11 recruiting

  • Sainte Catherine Institut du Cancer Avignon Provence ( Site 1105)

    Avignon, Vaucluse, 84918

    Study Coordinator, +33490276161

    Recruiting

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1101)

    Bordeaux, Aquitaine, 33076

    Study Coordinator, +33556333333

    Recruiting

  • Centre Francois Baclesse ( Site 1108)

    Caen, Calvados, 14076

    Study Coordinator, +33231459700

    Recruiting

  • Pôle Santé Léonard de Vinci ( Site 1112)

    Chambray-lès-Tours, Indre-et-Loire, 37170

    Study Coordinator, +33247602060

    Recruiting

  • Centre Oscar Lambret ( Site 1104)

    Lille, Ain, 59020

    Study Coordinator, +33320295959

    Recruiting

  • Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1111)

    Paris, Paris, 75014

    Study Coordinator, +33158411439

    Recruiting

  • Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1102)

    Paris, 75020

    Study Coordinator, +33 1 44 74 11 53

    Recruiting

  • Centre Hopitalier Lyon Sud ( Site 1110)

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69310

    Study Coordinator, +33478864318

    Recruiting

  • Hôpital Privé Des Côtes d'Armor ( Site 1106)

    Plérin, Cotes-d Armor, 22190

    Study Coordinator, +33257240243

    Recruiting

  • Institut De Cancerologie De L Ouest ( Site 1107)

    Saint-Herblain, Pays de la Loire Region, 44805

    Study Coordinator, +33 2 40 67 99 00

    Recruiting

  • LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1109)

    Toulouse, Haute-Garonne, 31059

    Study Coordinator, +33531155101

    Recruiting

Other trials in France

Italy11 sites, 11 recruiting

  • CRO-IRCCS ( Site 1510)

    Aviano, Friuli Venezia Giulia, 33081

    Study Coordinator, +390434659474

    Recruiting

  • Instituto Tumori Giovanni Paolo II ( Site 1505)

    Bari, 70124

    Study Coordinator, +390805555355

    Recruiting

  • Istituto Ospedaliero,Fondazione Poliambulanza ( Site 1511)

    Brescia, 25124

    Study Coordinator, +390303518503

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1507)

    Milan, Milano, 20133

    Study Coordinator, 39 0223903479

    Recruiting

  • Istituto Europeo di Oncologia ( Site 1506)

    Milan, 20141

    Study Coordinator, +390257482540

    Recruiting

  • Humanitas San Pio X Hospital ( Site 1503)

    Milan, 20159

    Study Coordinator, +390269516354

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1501)

    Naples, 80131

    Study Coordinator, +390815903637

    Recruiting

  • Istituto Oncologico Veneto IRCCS ( Site 1508)

    Padova, 35128

    Study Coordinator, +390498215729

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana ( Site 1504)

    Pisa, Tuscany, 56126

    Study Coordinator, +39050992371

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 1502)

    Roma, 00168

    Study Coordinator, +390630157004

    Recruiting

  • Ospedale Mauriziano ( Site 1509)

    Torino, 10128

    Study Coordinator, +39 0115082277

    Recruiting

Other trials in Italy

Mexico9 sites, 9 recruiting

  • Centro de Investigación Oncológica Galerías SC ( Site 1720)

    Aguascalientes, 20124

    Study Coordinator, +525527280926

    Recruiting

  • Cryptex Investigación Clínica S.A. de C.V. ( Site 1715)

    Cuauhtémoc, 6100

    Study Coordinator, +525555743589

    Recruiting

  • CIO - Centro de Inmuno-Oncología de Occidente ( Site 1719)

    Guadalajara, Jalisco, 44630

    Study Coordinator, +523313587270

    Recruiting

  • Higiea Oncologia ( Site 1713)

    Mexico City, Mexico City, 11819

    Study Coordinator, +525554137773

    Recruiting

  • COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 1717)

    Mexico City, 04700

    Study Coordinator, +525554248970x4016

    Recruiting

  • Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 1711)

    Monterrey, Nuevo León, 64460

    Study Coordinator, +528115443345

    Recruiting

  • I CAN ONCOLOGY CENTER S.A. DE C.V. ( Site 1716)

    Monterrey, Nuevo León, 64710

    Study Coordinator, +528125558165

    Recruiting

  • Servicios de Oncología Médica Integral - Monterrey ( Site 1712)

    Monterrey, Nuevo León, 66220

    Study Coordinator, +5218118213989

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 1714)

    Oaxaca City, 68020

    Study Coordinator, +529516035559

    Recruiting

Other trials in Mexico

United Kingdom8 sites, 8 recruiting

  • Queen Elizabeth Hospital Birmingham ( Site 2804)

    Birmingham, B15 2TH

    Study Coordinator, 0121 371 8766

    Recruiting

  • Cambridge University Hospital ( Site 2803)

    Cambridge, Cambridgeshire, CB2 2QQ

    Study Coordinator, 01223 216083

    Recruiting

  • Western General Hospital ( Site 2806)

    Edinburgh, Edinburgh, City of, EH4 2XU

    Study Coordinator, +441315371000

    Recruiting

  • Leicester Royal Infirmary ( Site 2808)

    Leicester, LE1 5WW

    Study Coordinator, 0300 303 1573

    Recruiting

  • Clatterbridge Cancer Centre - Liverpool ( Site 2805)

    Liverpool, L7 8YA

    Study Coordinator, 0151 556 5000

    Recruiting

  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2801)

    London, London, City of, SW3 6JJ

    Study Coordinator, 02089156899

    Recruiting

  • Royal Preston Hospital ( Site 2807)

    Preston, Lancashire, PR2 9HT

    Study Coordinator, 01772 524656

    Recruiting

  • Royal Marsden Hospital (Sutton) ( Site 2802)

    Sutton, London, City of, SM2 5PT

    Study Coordinator, 02089156899

    Recruiting

Other trials in United Kingdom

Brazil7 sites, 7 recruiting

  • ANIMI - Unidade de Tratamento Oncologico ( Site 0419)

    Lages, Santa Catarina, 88501-001

    Study Coordinator, +554933805200

    Recruiting

  • Liga Norte Riograndense Contra o Cancer ( Site 0423)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +558440095600

    Recruiting

  • Hospital São Lucas da PUCRS ( Site 0425)

    Porto Alegre, Rio Grande do Sul, 90610000

    Study Coordinator, +555133203000

    Recruiting

  • Instituto Nacional de Câncer - INCA ( Site 0422)

    Rio de Janeiro, 20220-410

    Study Coordinator, +552132072985

    Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0413)

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

    Study Coordinator, +55 17 32015054

    Recruiting

  • Hospital Paulistano ( Site 0421)

    São Paulo, 01321-001

    Study Coordinator, +551130161000

    Recruiting

  • IBCC - Núcleo de Pesquisa e Ensino ( Site 0424)

    São Paulo, 04014-002

    Study Coordinator, +551134744264

    Recruiting

Other trials in Brazil

Argentina6 sites, 6 recruiting

  • Fundación Respirar ( Site 2912)

    Buenos Aires, Buenos Aires F.D., C1426AAL

    Study Coordinator, +5491167281601

    Recruiting

  • Hospital Aleman ( Site 2903)

    CABA, C1118AAT

    Study Coordinator, +541148277000

    Recruiting

  • Instituto Alexander Fleming ( Site 2909)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

    Study Coordinator, 5411 3221 8900

    Recruiting

  • Hospital Italiano de Cordoba ( Site 2908)

    Córdoba, 5000

    Study Coordinator, +543517078224

    Recruiting

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

    Mar del Plata, Buenos Aires, B7600FZO

    Study Coordinator, +54 223 496 3224

    Recruiting

  • Instituto de Oncologia de Rosario ( Site 2910)

    Rosario, Santa Fe Province, S2000KZE

    Study Coordinator, +543414218909

    Recruiting

Other trials in Argentina

Canada6 sites, 6 recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0512)

    Calgary, Alberta, T2N 5G2

    Study Coordinator, 5872315594

    Recruiting

  • Health Sciences North Research Institute ( Site 0517)

    Greater Sudbury, Ontario, P3E 5J1

    Study Coordinator, 7055237100

    Recruiting

  • Trillium Health Partners - Credit Valley Hospital ( Site 0508)

    Mississauga, Ontario, L5M 2N1

    Study Coordinator, 905-813-2200

    Recruiting

  • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0505)

    Montreal, Quebec, H1T 2M4

    Study Coordinator, 514-252-3400

    Recruiting

  • McGill University Health Centre ( Site 0502)

    Montreal, Quebec, H4A 3J1

    Study Coordinator, 514-934-1934

    Recruiting

  • Princess Margaret Cancer Centre ( Site 0518)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, (416) 946-4501

    Recruiting

Other trials in Canada

Peru6 sites, 6 recruiting

  • Unidad de Investigacion Oncologia Clínica Piura ( Site 3606)

    Castilla, Piura, 20001

    Study Coordinator, +51969618109

    Recruiting

  • Hospital Guillermo Almenara Irigoyen ( Site 3608)

    Lima, 15001

    Study Coordinator, +51999903343

    Recruiting

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

    Lima, 15036

    Study Coordinator, +51 951 881 870

    Recruiting

  • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 3601)

    Lima, 15038

    Study Coordinator, +51 940 238 282

    Recruiting

  • Clínica San Felipe ( Site 3603)

    Lima, 15072

    Study Coordinator, +5112190000 Ext 8327

    Recruiting

  • Hospital Cayetano Heredia ( Site 3607)

    Lima, 15102

    Study Coordinator, +51 922 371 048

    Recruiting

Other trials in Peru

Belgium5 sites, 5 recruiting

  • Antwerp University Hospital ( Site 0304)

    Edegem, Antwerpen, 2650

    Study Coordinator, + 32 3 821 47 19

    Recruiting

  • AZ Sint-Lucas ( Site 0305)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +32 9 224 66 20

    Recruiting

  • UZ Leuven ( Site 0301)

    Leuven, Vlaams-Brabant, 3000

    Study Coordinator, +32 16 34 74 19

    Recruiting

  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0306)

    Liège, Liege, 4000

    Study Coordinator, +32 4 323 5332

    Recruiting

  • CHU UCL Namur/Site Sainte Elisabeth ( Site 0302)

    Namur, 5000

    Study Coordinator, +32 (0)81 70 28 44

    Recruiting

Other trials in Belgium

Chile5 sites, 5 recruiting

  • Clinica Puerto Montt ( Site 0615)

    Port Montt, Los Lagos Region, 5507642

    Study Coordinator, 56961687093

    Recruiting

  • Fundación Arturo López Pérez ( Site 0616)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224205098

    Recruiting

  • Pontificia Universidad Catolica de Chile ( Site 0611)

    Santiago, Region M. de Santiago, 8330032

    Study Coordinator, 56934331806

    Recruiting

  • Bradfordhill-Clinical Area ( Site 0610)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, 56229490970

    Recruiting

  • ONCOCENTRO APYS-ACEREY ( Site 0612)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, +56323320860

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Hungary5 sites, 5 recruiting

  • Semmelweis Egyetem ( Site 3925)

    Budapest, Pest County, 1088

    Study Coordinator, +3612660473/54243

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  • Országos Onkológiai Intézet-Ngyógyászat ( Site 3923)

    Budapest, Pest County, 1122

    Study Coordinator, +3612248600 Ext 3616

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  • Debreceni Egyetem Klinikai Kozpont ( Site 3922)

    Debrecen, Hajdú-Bihar, 4032

    Study Coordinator, 0652255705

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  • Bacs-Kiskun Megyei Korhaz ( Site 3920)

    Kecskemét, Bács-Kiskun county, 6000

    Study Coordinator, +3676516719

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  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 3924)

    Szeged, Csongrád megye, 6720

    Study Coordinator, +36 62 544 596

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Israel5 sites, 5 recruiting

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    Hadera, 3810101

    Study Coordinator, +972544512396

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    Haifa, 3109601

    Study Coordinator, +97247772688

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  • Shaare Zedek Medical Center ( Site 1405)

    Jerusalem, 9103102

    Study Coordinator, +97226555424

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  • Meir Medical Center. ( Site 1403)

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    Study Coordinator, 972-9-7471575

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  • Sheba Medical Center ( Site 1401)

    Ramat Gan, 5265601

    Study Coordinator, 972-3-5303157

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    Bialystok, Podlaskie Voivodeship, 15-027

    Study Coordinator, 0048856646728

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  • Swietokrzyskie Centrum Onkologii. ( Site 2105)

    Kielce, Świętokrzyskie Voivodeship, 25-734

    Study Coordinator, 0048413674128

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  • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2106)

    Poznan, Greater Poland Voivodeship, 61-848

    Study Coordinator, +48618549049

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  • Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie ( Site 2103)

    Szczecin, West Pomeranian Voivodeship, 70-111

    Study Coordinator, +48914661332

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  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 2101)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, 0048225462295

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Romania5 sites, 5 recruiting

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    Bucharest, 011132

    Study Coordinator, +40213188930

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    Bucharest, 013975

    Study Coordinator, +40722927377

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  • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2215)

    Cluj-Napoca, Cluj, 400015

    Study Coordinator, +40264598362

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  • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2211)

    Craiova, Dolj, 200746

    Study Coordinator, +40731604432

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  • Cabinet Medical Oncomed ( Site 2217)

    Timișoara, Timiș County, 300239

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South Korea5 sites, 5 recruiting

  • National Cancer Center ( Site 2305)

    Goyang-si, Kyonggi-do, 10408

    Study Coordinator, 82-31-920-1760

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  • Severance Hospital ( Site 2302)

    Seodaemun-Gu, Seoul, 03722

    Study Coordinator, 82-2-2227-7969

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  • Seoul National University Hospital ( Site 2301)

    Seoul, 03080

    Study Coordinator, 82-2-2072-3511

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  • Samsung Medical Center ( Site 2303)

    Seoul, 06351

    Study Coordinator, 82-2-3410-0866

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  • Asan Medical Center ( Site 2304)

    Songpa-gu, Seoul, 05505

    Study Coordinator, +82-2-3010-3640

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Taiwan5 sites, 5 recruiting

  • Taichung Veterans General Hospital ( Site 2603)

    Taichung, 40705

    Study Coordinator, 886423592525x5822

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  • National Cheng Kung University Hospital ( Site 2602)

    Tainan, 704302

    Study Coordinator, +88662353535x5222

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  • National Taiwan University Hospital ( Site 2601)

    Taipei, 10002

    Study Coordinator, 886-223123456x271563

    Recruiting

  • Mackay Memorial Hospital ( Site 2604)

    Taipei, 104

    Study Coordinator, +886225433535x3941

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  • Chang Gung Memorial Hospital - Linkou Branch ( Site 2605)

    Taoyuan, 333

    Study Coordinator, +886-33281200x8258

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Australia4 sites, 4 recruiting

  • Gallipoli Medical Research Ltd ( Site 0214)

    Brisbane, Queensland, 4120

    Study Coordinator, +61733947284

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  • Epworth Freemasons ( Site 0217)

    East Melbourne, Victoria, 3002

    Study Coordinator, +61385595000

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  • Frankston Hospital ( Site 0216)

    Frankston, Victoria, 3199

    Study Coordinator, +61409848084

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  • Blacktown Hospital ( Site 0211)

    Sydney, New South Wales, 2148

    Study Coordinator, +61286705071

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Czechia4 sites, 4 recruiting

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    Brno, Brno-mesto, 602 00

    Study Coordinator, 420532233843

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  • Fakultni nemocnice Ostrava ( Site 3323)

    Ostrava-Poruba, Ostrava Mesto, 708 52

    Study Coordinator, +420597371804

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  • Vseobecna fakultni nemocnice v Praze ( Site 3325)

    Prague, 128 08

    Study Coordinator, +420224967451

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  • Fakultni nemocnice v Motole ( Site 3322)

    Prague, 150 06

    Study Coordinator, +420224434749

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Denmark4 sites, 4 recruiting

  • Aalborg Universitetshospital ( Site 0901)

    Aalborg, North Denmark, 9000

    Study Coordinator, 97661400

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  • Rigshospitalet ( Site 0904)

    Copenhagen, Capital Region, 2100

    Study Coordinator, +45 35453545

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  • Herlev Hospital ( Site 0903)

    Herlev, Capital Region, 2730

    Study Coordinator, +45 38683868

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  • Vejle Sygehus ( Site 0902)

    Vejle, Region Syddanmark, 7100

    Study Coordinator, 79406088

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Austria3 sites, 3 recruiting

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

    Innsbruck, Tyrol, 6020

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Colombia3 sites, 3 recruiting

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Finland3 sites, 3 recruiting

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Portugal2 sites, 2 recruiting

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Thailand2 sites, 2 recruiting

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About this study

Official title: A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)

The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.

Being tested
Sacituzumab tirumotecan, Bevacizumab, H1 receptor antagonist, H2 receptor antagonist, Acetaminophen (or equivalent)
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

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

  • Sacituzumab tirumotecanBiological

    Also called MK-2870, sac-TMT, SKB264

    IV Infusion

  • BevacizumabBiological

    Also called Avastin, Altusan, MVASI

    IV Infusion

  • H1 receptor antagonistDrug

    Rescue medication taken per approved product label before sacituzumab tirumotecan

  • H2 receptor antagonistDrug

    Rescue medication taken per approved product label before sacituzumab tirumotecan

  • Acetaminophen (or equivalent)Drug

    Rescue medication taken per approved product label before sacituzumab tirumotecan

  • Dexamethasone (or equivalent)Drug

    Rescue medication taken per approved product label before sacituzumab tirumotecan

  • Steroid mouthwash (dexamethasone or equivalent)Drug

    Rescue medication taken orally 2-4 times daily

Study groups in NCT06824467
Study groupRoleWhat they receive
Part 1: Sacituzumab tirumotecan + BevacizumabExperimentalParticipants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks
Receives: Biological: Sacituzumab tirumotecan; Biological: Bevacizumab; Drug: H1 receptor antagonist; Drug: H2 receptor antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid mouthwash (dexamethasone or equivalent)
Part 2: Sacituzumab tirumotecanExperimentalParticipants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion for up to approximately 2 years or until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.
Receives: Biological: Sacituzumab tirumotecan; Biological: Bevacizumab; Drug: H1 receptor antagonist; Drug: H2 receptor antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid mouthwash (dexamethasone or equivalent)
Part 2: Standard of care (SOC)Active comparatorParticipants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.
Receives: Biological: Bevacizumab

What is being measured

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

  1. Part 1: Number of Participants With One or More Adverse Events (AEs)

    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 6 weeks

  2. Part 1: Number of Participants Who Discontinue Study Intervention 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 6 weeks

  3. Part 2: Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.

    Measured: Up to approximately 4 years

Secondary outcomes (7)

  1. Part 2: Overall Survival (OS)

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

    Measured: Up to approximately 6 years

  2. Part 2: Number of Participants With One or More AEs

    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 4 years

  3. Part 2: Number of Participants Who Discontinue Study Intervention 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 4 years

  4. Part 2: Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score

    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to Item 30 (""How would you rate your overall quality of life during the past week?") is 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 value indicates a better level of function. The change from baseline in EORTC QLQ-C30 Item 30 score will be reported.

    Measured: Baseline and up to approximately 4 years

  5. Part 2: Change From Baseline in EORTC QLQ-C30 Physical Functioning Score

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.

    Measured: Baseline and up to approximately 4 years

  6. Part 2: Change From Baseline in EORTC QLQ-C30 Role Functioning Score

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate a more impaired level of role functioning. Change from baseline in the role functioning score will be presented.

    Measured: Baseline and up to approximately 4 years

  7. Part 2: Change From Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 (QLQ-OV28) abdominal/gastrointestinal (GI) symptom scale

    The EORTC QLQ-OV28 is an OC-specific, and psychometrically and clinically validated module to supplement the EORTC QLQ-C30. The EORTC QLQ-OV28 abdominal/GI symptom scale is scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much).

    Measured: Baseline and up to approximately 4 years

Timeline

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

  1. First posted13 Feb 2025
  2. Study start9 Apr 2025
  3. Primary completion27 Apr 2029 (estimated)
  4. Study completion9 Nov 2032 (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
None (open label)
Enrolment
770 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06824467
Sponsor's protocol ID
2870-022
Other IDs
MK-2870-022, TroFuse-022, 2023-508015-23-00, U1111-1297-4489, GOG-3103, ENGOT-ov84, jRCT2031240722, 2023
Status last verified
Oct 2026
First submitted
7 Feb 2025
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab tirumotecan, Bevacizumab and H1 receptor antagonist in people with Ovarian Cancer and Fallopian Tube Cancer, run by Merck Sharp & Dohme LLC at 198 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 198 sites in United States, Japan, Spain, France, Italy and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants With One or More Adverse Events (AEs) (time frame: Up to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06824467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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