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)

June 11, 2026 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

770

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • CABA, Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman ( Site 2903)
        • Contact:
          • Study Coordinator
          • Phone Number: +541148277000
      • Córdoba, Argentina, 5000
        • Recruiting
        • Hospital Italiano de Cordoba ( Site 2908)
        • Contact:
          • Study Coordinator
          • Phone Number: +543517078224
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming ( Site 2909)
        • Contact:
          • Study Coordinator
          • Phone Number: 5411 3221 8900
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Recruiting
        • Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 223 496 3224
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1426AAL
        • Recruiting
        • Fundación Respirar ( Site 2912)
        • Contact:
          • Study Coordinator
          • Phone Number: +5491167281601
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000KZE
        • Recruiting
        • Instituto de Oncologia de Rosario ( Site 2910)
        • Contact:
          • Study Coordinator
          • Phone Number: +543414218909
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2148
        • Recruiting
        • Blacktown Hospital ( Site 0211)
        • Contact:
          • Study Coordinator
          • Phone Number: +61286705071
    • Queensland
      • Brisbane, Queensland, Australia, 4120
        • Recruiting
        • Gallipoli Medical Research Ltd ( Site 0214)
        • Contact:
          • Study Coordinator
          • Phone Number: +61733947284
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Epworth Freemasons ( Site 0217)
        • Contact:
          • Study Coordinator
          • Phone Number: +61385595000
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Frankston Hospital ( Site 0216)
        • Contact:
          • Study Coordinator
          • Phone Number: +61409848084
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: + 32 3 821 47 19
    • Liege
      • Liège, Liege, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 4 323 5332
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • CHU UCL Namur/Site Sainte Elisabeth ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 (0)81 70 28 44
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • AZ Sint-Lucas ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 9 224 66 20
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 16 34 74 19
  • Brazil
      • Rio de Janeiro, Brazil, 20220-410
        • Recruiting
        • Instituto Nacional de Câncer - INCA ( Site 0422)
        • Contact:
          • Study Coordinator
          • Phone Number: +552132072985
      • São Paulo, Brazil, 04014-002
        • Recruiting
        • IBCC - Núcleo de Pesquisa e Ensino ( Site 0424)
        • Contact:
          • Study Coordinator
          • Phone Number: +551134744264
      • São Paulo, Brazil, 01321-001
        • Recruiting
        • Hospital Paulistano ( Site 0421)
        • Contact:
          • Study Coordinator
          • Phone Number: +551130161000
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Recruiting
        • Liga Norte Riograndense Contra o Cancer ( Site 0423)
        • Contact:
          • Study Coordinator
          • Phone Number: +558440095600
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610000
        • Recruiting
        • Hospital São Lucas da PUCRS ( Site 0425)
        • Contact:
          • Study Coordinator
          • Phone Number: +555133203000
    • Santa Catarina
      • Lages, Santa Catarina, Brazil, 88501-001
        • Recruiting
        • ANIMI - Unidade de Tratamento Oncologico ( Site 0419)
        • Contact:
          • Study Coordinator
          • Phone Number: +554933805200
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0413)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 17 32015054
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre ( Site 0518)
        • Contact:
          • Study Coordinator
          • Phone Number: (416) 946-4501
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-934-1934
  • Chile
    • Los Lagos Region
      • Port Montt, Los Lagos Region, Chile, 5507642
        • Recruiting
        • Clinica Puerto Montt ( Site 0615)
        • Contact:
          • Study Coordinator
          • Phone Number: 56961687093
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS-ACEREY ( Site 0612)
        • Contact:
          • Study Coordinator
          • Phone Number: +56323320860
  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110131
        • Recruiting
        • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0806)
        • Contact:
          • Study Coordinator
          • Phone Number: +576015948650
      • Bogotá, Bogota D.C., Colombia, 111511
        • Recruiting
        • Instituto Nacional De Cancerologia ( Site 0807)
        • Contact:
          • Study Coordinator
          • Phone Number: +573154208007
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660001
        • Recruiting
        • Oncologos Del Occidente ( Site 0805)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3187715522
  • Czechia
      • Prague, Czechia, 128 08
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze ( Site 3325)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224967451
      • Prague, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole ( Site 3322)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224434749
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 602 00
        • Recruiting
        • Fakultni Nemocnice Brno Bohunice ( Site 3324)
        • Contact:
          • Study Coordinator
          • Phone Number: 420532233843
    • Ostrava Mesto
      • Ostrava-Poruba, Ostrava Mesto, Czechia, 708 52
        • Recruiting
        • Fakultni nemocnice Ostrava ( Site 3323)
        • Contact:
          • Study Coordinator
          • Phone Number: +420597371804
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Recruiting
        • Rigshospitalet ( Site 0904)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 35453545
      • Herlev, Capital Region, Denmark, 2730
        • Recruiting
        • Herlev Hospital ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 38683868
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: 97661400
    • Region Syddanmark
      • Vejle, Region Syddanmark, Denmark, 7100
        • Recruiting
        • Vejle Sygehus ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: 79406088
  • Finland
    • North Ostrobothnia
      • Oulu, North Ostrobothnia, Finland, 90220
        • Recruiting
        • Oulun yliopistollinen sairaala ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +358505794505
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70200
        • Recruiting
        • Kuopion Yliopistollinen Sairaala ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: +358447174617
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampereen yliopistollinen sairaala ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: +358407274241
  • France
      • Paris, France, 75020
        • Recruiting
        • Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 1 44 74 11 53
    • Ain
      • Lille, Ain, France, 59020
        • Recruiting
        • Centre Oscar Lambret ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +33320295959
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Recruiting
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +33556333333
    • Auvergne-Rhône-Alpes
      • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69310
        • Recruiting
        • Centre Hopitalier Lyon Sud ( Site 1110)
        • Contact:
          • Study Coordinator
          • Phone Number: +33478864318
    • Calvados
      • Caen, Calvados, France, 14076
        • Recruiting
        • Centre Francois Baclesse ( Site 1108)
        • Contact:
          • Study Coordinator
          • Phone Number: +33231459700
    • Cotes-d Armor
      • Plérin, Cotes-d Armor, France, 22190
        • Recruiting
        • Hôpital Privé Des Côtes d'Armor ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: +33257240243
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • Oncopole Claudius Regaud ( Site 1109)
        • Contact:
          • Study Coordinator
          • Phone Number: +33531155101
    • Indre-et-Loire
      • Chambray-lès-Tours, Indre-et-Loire, France, 37170
        • Recruiting
        • Pôle Santé Léonard de Vinci ( Site 1112)
        • Contact:
          • Study Coordinator
          • Phone Number: +33247602060
    • Paris
      • Paris, Paris, France, 75014
        • Recruiting
        • Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1111)
        • Contact:
          • Study Coordinator
          • Phone Number: +33158411439
    • Pays de la Loire Region
      • Saint-Herblain, Pays de la Loire Region, France, 44805
        • Recruiting
        • Institut De Cancerologie De L Ouest ( Site 1107)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 2 40 67 99 00
    • Vaucluse
      • Avignon, Vaucluse, France, 84918
        • Recruiting
        • Sainte Catherine Institut du Cancer Avignon Provence ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: +33490276161
  • Greece
    • Attica
      • Athens, Attica, Greece, 115 28
        • Recruiting
        • Aretaieio Hospital ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: +302107286444
      • Chaïdári, Attica, Greece, 12462
        • Recruiting
        • ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: +302105831643
  • Hungary
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Recruiting
        • Bacs-Kiskun Megyei Korhaz ( Site 3920)
        • Contact:
          • Study Coordinator
          • Phone Number: +3676516719
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6720
        • Recruiting
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 3924)
        • Contact:
          • Study Coordinator
          • Phone Number: +36 62 544 596
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont ( Site 3922)
        • Contact:
          • Study Coordinator
          • Phone Number: 0652255705
    • Pest County
      • Budapest, Pest County, Hungary, 1122
        • Recruiting
        • Országos Onkológiai Intézet-Ngyógyászat ( Site 3923)
        • Contact:
          • Study Coordinator
          • Phone Number: +3612248600 Ext 3616
  • Ireland
      • Dublin, Ireland, DO8 NHY1
        • Recruiting
        • St James Hospital ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +35314103747
  • Israel
      • Hadera, Israel, 3810101
        • Recruiting
        • Hillel Yaffe Medical Center ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +972544512396
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247772688
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 1405)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226555424
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center. ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-9-7471575
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-3-5303157
  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Instituto Tumori Giovanni Paolo II ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +390805555355
      • Brescia, Italy, 25124
        • Recruiting
        • Istituto Ospedaliero,Fondazione Poliambulanza ( Site 1511)
        • Contact:
          • Study Coordinator
          • Phone Number: +390303518503
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia ( Site 1506)
        • Contact:
          • Study Coordinator
          • Phone Number: +390257482540
      • Milan, Italy, 20159
        • Recruiting
        • Humanitas San Pio X Hospital ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: +390269516354
      • Naples, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: +390815903637
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS ( Site 1508)
        • Contact:
          • Study Coordinator
          • Phone Number: +390498215729
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630157004
      • Torino, Italy, 10128
        • Recruiting
        • Ospedale Mauriziano ( Site 1509)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0115082277
    • Friuli Venezia Giulia
      • Aviano, Friuli Venezia Giulia, Italy, 33081
        • Recruiting
        • CRO-IRCCS ( Site 1510)
        • Contact:
          • Study Coordinator
          • Phone Number: +390434659474
    • Milano
      • Milan, Milano, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: 39 0223903479
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: +39050992371
  • Japan
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center ( Site 1628)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-541-3231
      • Kagoshima, Japan, 890-8760
        • Recruiting
        • Kagoshima City Hospital ( Site 1638)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-99-230-7000
      • Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital ( Site 1633)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-25-266-5111
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1629)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center ( Site 1626)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-762-6111
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Recruiting
        • National Hospital Organization Shikoku Cancer Center ( Site 1631)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-999-1111
      • Tōon, Ehime, Japan, 791-0295
        • Recruiting
        • Ehime University Hospital ( Site 1637)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-964-5111
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital ( Site 1640)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-942-35-3311
    • Gunma
      • Ōta, Gunma, Japan, 373-8550
        • Recruiting
        • Gunma Prefectural Cancer Center ( Site 1630)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-276-38-0771
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital ( Site 1634)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-716-1161
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Recruiting
        • Iwate Medical University Hospital ( Site 1635)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-19-613-7111
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Recruiting
        • Saitama Medical University International Medical Center ( Site 1632)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-42-984-4111
    • Shizuoka
      • Sunto-gun,, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center ( Site 1643)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-55-989-5222
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR ( Site 1639)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
      • Shinjyuku, Tokyo, Japan, 160-8582
        • Recruiting
        • Keio University Hospital ( Site 1636)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3353-1211
  • Mexico
      • Aguascalientes, Mexico, 20124
        • Recruiting
        • Centro de Investigación Oncológica Galerías SC ( Site 1720)
        • Contact:
          • Study Coordinator
          • Phone Number: +525527280926
      • Cuauhtémoc, Mexico, 6100
        • Recruiting
        • Cryptex Investigación Clínica S.A. de C.V. ( Site 1715)
        • Contact:
          • Study Coordinator
          • Phone Number: +525555743589
      • Mexico City, Mexico, 04700
        • Recruiting
        • COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 1717)
        • Contact:
          • Study Coordinator
          • Phone Number: +525554248970x4016
      • Oaxaca City, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca ( Site 1714)
        • Contact:
          • Study Coordinator
          • Phone Number: +529516035559
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44630
        • Recruiting
        • CIO - Centro de Inmuno-Oncología de Occidente ( Site 1719)
        • Contact:
          • Study Coordinator
          • Phone Number: +523313587270
    • Mexico City
      • Mexico City, Mexico City, Mexico, 11819
        • Recruiting
        • Higiea Oncologia ( Site 1713)
        • Contact:
          • Study Coordinator
          • Phone Number: +525579389376
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 1711)
        • Contact:
          • Study Coordinator
          • Phone Number: +528115443345
      • Monterrey, Nuevo León, Mexico, 64710
        • Recruiting
        • I CAN ONCOLOGY CENTER S.A. DE C.V. ( Site 1716)
        • Contact:
          • Study Coordinator
          • Phone Number: +528125558165
      • Monterrey, Nuevo León, Mexico, 66220
        • Recruiting
        • Servicios de Oncología Médica Integral - Monterrey ( Site 1712)
        • Contact:
          • Study Coordinator
          • Phone Number: +5218118213989
  • Peru
      • Lima, Peru, 15036
        • Recruiting
        • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 951 881 870
      • Lima, Peru, 15072
        • Recruiting
        • Clínica San Felipe ( Site 3603)
        • Contact:
          • Study Coordinator
          • Phone Number: +5112190000 Ext 8327
      • Lima, Peru, 15038
        • Recruiting
        • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 3601)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 940 238 282
      • Lima, Peru, 15001
        • Recruiting
        • Hospital Guillermo Almenara Irigoyen ( Site 3608)
        • Contact:
          • Study Coordinator
          • Phone Number: +51999903343
      • Lima, Peru, 15102
        • Recruiting
        • Hospital Cayetano Heredia ( Site 3607)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 922 371 048
    • Piura
      • Castilla, Piura, Peru, 20001
        • Recruiting
        • Unidad de Investigacion Oncologia Clínica Piura ( Site 3606)
        • Contact:
          • Study Coordinator
          • Phone Number: +51969618109
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-848
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2106)
        • Contact:
          • Study Coordinator
          • Phone Number: +48618549049
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-027
        • Recruiting
        • Bialostockie Centrum Onkologii ( Site 2104)
        • Contact:
          • Study Coordinator
          • Phone Number: 0048856646728
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Recruiting
        • Swietokrzyskie Centrum Onkologii. ( Site 2105)
        • Contact:
          • Study Coordinator
          • Phone Number: 0048413674128
  • Portugal
      • Lisbon, Portugal, 1500-650
        • Recruiting
        • Hospital da Luz ( Site 3802)
        • Contact:
          • Study Coordinator
          • Phone Number: +351217104400
      • Porto, Portugal, 4200-072
        • Recruiting
        • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 3801)
        • Contact:
          • Study Coordinator
          • Phone Number: +351225084000
  • Romania
      • Bucharest, Romania, 011132
        • Recruiting
        • Spitalul Clinic Filantropia ( Site 2213)
        • Contact:
          • Study Coordinator
          • Phone Number: +40213188930
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Recruiting
        • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2215)
        • Contact:
          • Study Coordinator
          • Phone Number: +40264598362
    • Dolj
      • Craiova, Dolj, Romania, 200746
        • Recruiting
        • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2211)
        • Contact:
          • Study Coordinator
          • Phone Number: +40731604432
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Recruiting
        • Cabinet Medical Oncomed ( Site 2217)
        • Contact:
          • Study Coordinator
          • Phone Number: +40256495403
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-2072-3511
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 2303)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-3410-0866
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center ( Site 2305)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-31-920-1760
    • Seoul
      • Seodaemun-Gu, Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-2227-7969
      • Songpa-gu, Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 2304)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-3010-3640
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Vall D Hebron ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932746085
      • Barcelona, Spain, 08907
        • Recruiting
        • ICO L Hospitalet ( Site 2408)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932607744
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic I Provincial de Barcelona ( Site 2409)
        • Contact:
          • Study Coordinator
          • Phone Number: 34932275402
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia ( Site 2406)
        • Contact:
          • Study Coordinator
          • Phone Number: +34957011464
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Ramon y Cajal ( Site 2405)
        • Contact:
          • Study Coordinator
          • Phone Number: +3491336 82 63
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre ( Site 2411)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913908626
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos... ( Site 2410)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 913303000 x484811
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz ( Site 2404)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 679927508
    • Gerona
      • Girona, Gerona, Spain, 17007
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Girona ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +34972225828
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra ( Site 2407)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913531920
      • Madrid, Madrid, Comunidad de, Spain, 28007
        • Recruiting
        • Hospital General Gregorio Maranon de Madrid ( Site 2412)
        • Contact:
          • Study Coordinator
          • Phone Number: +34915860860
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Recruiting
        • Hosp Clinico Universitario de Valencia ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 961973500
  • Taiwan
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: 886423592525x5822
      • Tainan, Taiwan, 704302
        • Recruiting
        • National Cheng Kung University Hospital ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662353535x5222
      • Taipei, Taiwan, 104
        • Recruiting
        • Mackay Memorial Hospital ( Site 2604)
        • Contact:
          • Study Coordinator
          • Phone Number: +886225433535x3941
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-223123456x271563
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital - Linkou Branch ( Site 2605)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-33281200x8258
  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10400
        • Recruiting
        • Ramathibodi Hospital ( Site 3402)
        • Contact:
          • Study Coordinator
          • Phone Number: +6622011451
      • Bangkok, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 3401)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624194685
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary ( Site 2808)
        • Contact:
          • Study Coordinator
          • Phone Number: 0300 303 1573
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Recruiting
        • Cambridge University Hospital ( Site 2803)
        • Contact:
          • Study Coordinator
          • Phone Number: 01223 216083
    • Edinburgh, City of
      • Edinburgh, Edinburgh, City of, United Kingdom, EH4 2XU
        • Recruiting
        • Western General Hospital ( Site 2806)
        • Contact:
          • Study Coordinator
          • Phone Number: +441315371000
    • London, City of
      • London, London, City of, United Kingdom, SW3 6JJ
        • Recruiting
        • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2801)
        • Contact:
          • Study Coordinator
          • Phone Number: 02089156899
      • Sutton, London, City of, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital (Sutton) ( Site 2802)
        • Contact:
          • Study Coordinator
          • Phone Number: 02089156899
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • University of Alabama at Birmingham ( Site 0006)
        • Contact:
          • Study Coordinator
          • Phone Number: (205) 934-7442
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Women's Cancer Care ( Site 0096)
        • Contact:
          • Study Coordinator
          • Phone Number: 907-562-4673
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-785-5702
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Cancer Center ( Site 0078)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-674-2625
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital ( Site 0075)
        • Contact:
          • Study Coordinator
          • Phone Number: 941-917-2225
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists East ( Site 7000)
        • Contact:
          • Study Coordinator
          • Phone Number: 561-366-4100
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute of Emory University ( Site 0086)
        • Contact:
          • Study Coordinator
          • Phone Number: 404-778-1900
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University - Georgia Cancer Center ( Site 0066)
        • Contact:
          • Study Coordinator
          • Phone Number: 706-721-6744
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Research Center at Parkview Regional Medical Center ( Site 0003)
        • Contact:
          • Study Coordinator
          • Phone Number: 260-425-6981
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Women's Cancer Care ( Site 0067)
        • Contact:
          • Study Coordinator
          • Phone Number: 985-892-2252
    • Maine
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)
        • Contact:
          • Study Coordinator
          • Phone Number: 207-883-0069
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Active, not recruiting
        • St. Dominic's Hospital ( Site 0064)
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital ( Site 0053)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-354-8534
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081)
        • Contact:
          • Study Coordinator
          • Phone Number: 551-996-5855
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey ( Site 0071)
        • Contact:
          • Study Coordinator
          • Phone Number: 732-235-7258
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico Comprehensive Cancer Center ( Site 0055)
        • Contact:
          • Study Coordinator
          • Phone Number: 505-272-4946
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Langone Hospital - Long Island ( Site 0015)
        • Contact:
          • Study Coordinator
          • Phone Number: 516-663-0333
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center ( Site 0076)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-731-6000
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • FirstHealth Cancer Center ( Site 0079)
        • Contact:
          • Study Coordinator
          • Phone Number: 910-715-8684
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center ( Site 0090)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-584-1958
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0054)
        • Contact:
          • Study Coordinator
          • Phone Number: 614-293-3300
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)
        • Contact:
          • Study Coordinator
          • Phone Number: 918-505-3200
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010)
        • Contact:
          • Study Coordinator
          • Phone Number: 541-683-5001
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women & Infants Hospital ( Site 0050)
        • Contact:
          • Study Coordinator
          • Phone Number: 401-274-1100
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Henry-Joyce Cancer Clinic ( Site 0060)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-936-8422
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • Texas Oncology - Central/South Texas ( Site 8009)
        • Contact:
          • Study Coordinator
          • Phone Number: 512-873-8900
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Oncology - DFW ( Site 8001)
        • Contact:
          • Study Coordinator
          • Phone Number: 817-413-1500
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio ( Site 8005)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-595-5300
      • Webster, Texas, United States, 77598
        • Recruiting
        • Texas Oncology - Gulf Coast ( Site 8003)
        • Contact:
          • Study Coordinator
          • Phone Number: 281-332-7505
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists (VCS) ( Site 8011)
        • Contact:
          • Study Coordinator
          • Phone Number: (571) 350-8400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV 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 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)

Exclusion Criteria:

  • 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 or has current pneumonitis/ILD
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Sacituzumab tirumotecan + Bevacizumab
Participants 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
Biological: Sacituzumab tirumotecan
IV Infusion
Other Names:
  • SKB264
  • MK-2870
  • sac-TMT
Biological: Bevacizumab
IV Infusion
Other Names:
  • Avastin
  • MVASI
  • Altusan
Drug: H1 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
Drug: H2 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
Drug: Acetaminophen (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
Drug: Dexamethasone (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
Drug: Steroid mouthwash (dexamethasone or equivalent)
Rescue medication taken orally 2-4 times daily
Experimental: Part 2: Sacituzumab tirumotecan
Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion 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.
Biological: Sacituzumab tirumotecan
IV Infusion
Other Names:
  • SKB264
  • MK-2870
  • sac-TMT
Biological: Bevacizumab
IV Infusion
Other Names:
  • Avastin
  • MVASI
  • Altusan
Drug: H1 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
Drug: H2 receptor antagonist
Rescue medication taken per approved product label before sacituzumab tirumotecan
Drug: Acetaminophen (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
Drug: Dexamethasone (or equivalent)
Rescue medication taken per approved product label before sacituzumab tirumotecan
Drug: Steroid mouthwash (dexamethasone or equivalent)
Rescue medication taken orally 2-4 times daily
Active Comparator: Part 2: Standard of care (SOC)
Participants 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.
Biological: Bevacizumab
IV Infusion
Other Names:
  • Avastin
  • MVASI
  • Altusan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Number of participants with one or more adverse events (AEs)
Time Frame: Up to 6 weeks
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.
Up to 6 weeks
Part 1: Number of participants who discontinue study intervention due to an AE
Time Frame: Up to 6 weeks
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.
Up to 6 weeks
Part 2: Progression-free Survival (PFS)
Time Frame: Up to approximately 4 years
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.
Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 2: Overall Survival (OS)
Time Frame: Up to approximately 4 years
OS is defined as the time from randomization to death due to any cause
Up to approximately 4 years
Part 2: Number of participants with one or more AEs
Time Frame: Up to approximately 4 years
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.
Up to approximately 4 years
Part 2: Number of participants who discontinue study intervention due to an AE
Time Frame: Up to approximately 4 years
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.
Up to approximately 4 years
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
Time Frame: Baseline and up to approximately 4 years
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.
Baseline and up to approximately 4 years
Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score
Time Frame: Baseline and up to approximately 4 years
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.
Baseline and up to approximately 4 years
Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score
Time Frame: Baseline and up to approximately 4 years
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.
Baseline and up to approximately 4 years
Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 (QLQ-OV28) abdominal/gastrointestinal (GI) symptom scale
Time Frame: Baseline and up to approximately 4 years
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).
Baseline and up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2025

Primary Completion (Estimated)

April 27, 2029

Study Completion (Estimated)

November 9, 2032

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

February 13, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2870-022
  • MK-2870-022 (Other Identifier: MSD)
  • TroFuse-022 (Other Identifier: MSD)
  • U1111-1297-4489 (Registry Identifier: UTN)
  • GOG-3103 (Other Identifier: Gynecologic Oncology Group)
  • ENGOT-ov84 (Other Identifier: European Network of Gynaecological Oncological Trial Groups (ENGOT))
  • jRCT2031240722 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
  • 2023-508015-23-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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