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)
Status: Recruiting
Location: See all (156) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Alaska
Alaska Women's Cancer Care ( Site 0096)
RECRUITING
Anchorage
Alabama
University of Alabama at Birmingham ( Site 0006)
RECRUITING
Birmingham
Connecticut
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)
RECRUITING
New Haven
Florida
Mount Sinai Cancer Center ( Site 0078)
RECRUITING
Miami Beach
Sarasota Memorial Hospital ( Site 0075)
RECRUITING
Sarasota
Florida Cancer Specialists East ( Site 7000)
RECRUITING
West Palm Beach
Georgia
Winship Cancer Institute of Emory University ( Site 0086)
RECRUITING
Atlanta
Augusta University - Georgia Cancer Center ( Site 0066)
RECRUITING
Augusta
Indiana
Parkview Research Center at Parkview Regional Medical Center ( Site 0003)
RECRUITING
Fort Wayne
Louisiana
Women's Cancer Care ( Site 0067)
RECRUITING
Covington
Maine
Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)
RECRUITING
Scarborough
Mississippi
St. Dominic's Hospital ( Site 0064)
ACTIVE_NOT_RECRUITING
Jackson
North Carolina
FirstHealth Cancer Center ( Site 0079)
RECRUITING
Pinehurst
Nebraska
Nebraska Methodist Hospital ( Site 0053)
RECRUITING
Omaha
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081)
RECRUITING
Hackensack
Rutgers Cancer Institute of New Jersey ( Site 0071)
RECRUITING
New Brunswick
New Mexico
University of New Mexico Comprehensive Cancer Center ( Site 0055)
RECRUITING
Albuquerque
New York
NYU Langone Hospital - Long Island ( Site 0015)
RECRUITING
Mineola
Laura and Isaac Perlmutter Cancer Center ( Site 0076)
RECRUITING
New York
Ohio
University of Cincinnati Medical Center ( Site 0090)
RECRUITING
Cincinnati
Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)
RECRUITING
Tulsa
Oregon
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010)
RECRUITING
Eugene
Rhode Island
Women & Infants Hospital ( Site 0050)
RECRUITING
Providence
Tennessee
Henry-Joyce Cancer Clinic ( Site 0060)
RECRUITING
Nashville
Texas
Texas Oncology - Central/South Texas ( Site 8009)
RECRUITING
Austin
Texas Oncology - DFW ( Site 8001)
RECRUITING
Fort Worth
Texas Oncology - San Antonio ( Site 8005)
RECRUITING
San Antonio
Texas Oncology - Gulf Coast ( Site 8003)
RECRUITING
Webster
Virginia
Virginia Cancer Specialists (VCS) ( Site 8011)
RECRUITING
Fairfax
Other Locations
Argentina
Fundación Respirar ( Site 2912)
RECRUITING
Buenos Aires
Hospital Aleman ( Site 2903)
RECRUITING
Caba
Instituto Alexander Fleming ( Site 2909)
RECRUITING
Ciudad Autónoma De Buenos Aires
Hospital Italiano de Cordoba ( Site 2908)
RECRUITING
Córdoba
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)
RECRUITING
Mar Del Plata
Instituto de Oncologia de Rosario ( Site 2910)
RECRUITING
Rosario
Australia
Gallipoli Medical Research Ltd ( Site 0214)
RECRUITING
Brisbane
Epworth Freemasons ( Site 0217)
RECRUITING
East Melbourne
Frankston Hospital ( Site 0216)
RECRUITING
Frankston
Blacktown Hospital ( Site 0211)
RECRUITING
Sydney
Belgium
Antwerp University Hospital ( Site 0304)
RECRUITING
Edegem
AZ Sint-Lucas ( Site 0305)
RECRUITING
Ghent
CHU UCL Namur/Site Sainte Elisabeth ( Site 0302)
RECRUITING
Ghent
UZ Leuven ( Site 0301)
RECRUITING
Leuven
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0306)
RECRUITING
Liège
Brazil
ANIMI - Unidade de Tratamento Oncologico ( Site 0419)
RECRUITING
Lages
Liga Norte Riograndense Contra o Cancer ( Site 0423)
RECRUITING
Natal
Hospital Paulistano ( Site 0421)
RECRUITING
São Paulo
IBCC - Núcleo de Pesquisa e Ensino ( Site 0424)
RECRUITING
São Paulo
Canada
McGill University Health Centre ( Site 0502)
RECRUITING
Montreal
Princess Margaret Cancer Centre ( Site 0518)
RECRUITING
Toronto
Chile
Clinica Puerto Montt ( Site 0615)
RECRUITING
Port Montt
ONCOCENTRO APYS-ACEREY ( Site 0612)
RECRUITING
Viña Del Mar
Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0806)
RECRUITING
Bogotá
Instituto Nacional De Cancerologia ( Site 0807)
RECRUITING
Bogotá
Oncologos Del Occidente ( Site 0805)
RECRUITING
Pereira
Denmark
Aalborg Universitetshospital ( Site 0901)
RECRUITING
Aalborg
Rigshospitalet ( Site 0904)
RECRUITING
Copenhagen
Herlev Hospital ( Site 0903)
RECRUITING
Herlev
Vejle Sygehus ( Site 0902)
RECRUITING
Vejle
Finland
Kuopion Yliopistollinen Sairaala ( Site 1004)
RECRUITING
Kuopio
Oulun yliopistollinen sairaala ( Site 1003)
RECRUITING
Oulu
Tampereen yliopistollinen sairaala ( Site 1002)
RECRUITING
Tampere
France
Sainte Catherine Institut du Cancer Avignon Provence ( Site 1105)
RECRUITING
Avignon
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1101)
RECRUITING
Bordeaux
Centre Francois Baclesse ( Site 1108)
RECRUITING
Caen
Pôle Santé Léonard de Vinci ( Site 1112)
RECRUITING
Chambray-lès-tours
Centre Oscar Lambret ( Site 1104)
RECRUITING
Lille
Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1111)
RECRUITING
Paris
Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1102)
RECRUITING
Paris
Centre Hopitalier Lyon Sud ( Site 1110)
RECRUITING
Pierre-bénite
Hôpital Privé Des Côtes d'Armor ( Site 1106)
RECRUITING
Plérin
Institut De Cancerologie De L Ouest ( Site 1107)
RECRUITING
Saint-herblain
Oncopole Claudius Regaud ( Site 1109)
RECRUITING
Toulouse
Greece
Aretaieio Hospital ( Site 0701)
RECRUITING
Athens
Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 3922)
RECRUITING
Debrecen
Bacs-Kiskun Megyei Korhaz ( Site 3920)
RECRUITING
Kecskemét
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 3924)
RECRUITING
Szeged
Israel
Hillel Yaffe Medical Center ( Site 1404)
RECRUITING
Hadera
Rambam Health Care Campus ( Site 1402)
RECRUITING
Haifa
Shaare Zedek Medical Center ( Site 1405)
RECRUITING
Jerusalem
Meir Medical Center. ( Site 1403)
RECRUITING
Kfar Saba
Sheba Medical Center ( Site 1401)
RECRUITING
Ramat Gan
Italy
CRO-IRCCS ( Site 1510)
RECRUITING
Aviano
Instituto Tumori Giovanni Paolo II ( Site 1505)
RECRUITING
Bari
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1507)
RECRUITING
Milan
Humanitas San Pio X Hospital ( Site 1503)
RECRUITING
Milan
Istituto Europeo di Oncologia ( Site 1506)
RECRUITING
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1501)
RECRUITING
Naples
Istituto Oncologico Veneto IRCCS ( Site 1508)
RECRUITING
Padova
Azienda Ospedaliero Universitaria Pisana ( Site 1504)
RECRUITING
Pisa
Fondazione Policlinico Universitario Agostino Gemelli ( Site 1502)
RECRUITING
Roma
Ospedale Mauriziano ( Site 1509)
RECRUITING
Torino
Japan
National Hospital Organization Kyushu Cancer Center ( Site 1628)
RECRUITING
Fukuoka
Saitama Medical University International Medical Center ( Site 1632)
RECRUITING
Hidaka
Kagoshima City Hospital ( Site 1638)
RECRUITING
Kagoshima
Cancer Institute Hospital of JFCR ( Site 1639)
RECRUITING
Koto
Kurume University Hospital ( Site 1640)
RECRUITING
Kurume
National Hospital Organization Shikoku Cancer Center ( Site 1631)
RECRUITING
Matsuyama
Aichi Cancer Center ( Site 1626)
RECRUITING
Nagoya
Niigata Cancer Center Hospital ( Site 1633)
RECRUITING
Niigata
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1629)
RECRUITING
Osaka
Gunma Prefectural Cancer Center ( Site 1630)
RECRUITING
Ōta
Hokkaido University Hospital ( Site 1634)
RECRUITING
Sapporo
Keio University Hospital ( Site 1636)
RECRUITING
Shinjyuku
Iwate Medical University Hospital ( Site 1635)
RECRUITING
Shiwa-gun
Ehime University Hospital ( Site 1637)
RECRUITING
Tōon
Mexico
Centro de Investigación Oncológica Galerías SC ( Site 1720)
RECRUITING
Aguascalientes
Cryptex Investigación Clínica S.A. de C.V. ( Site 1715)
RECRUITING
Cuauhtémoc
CIO - Centro de Inmuno-Oncología de Occidente ( Site 1719)
RECRUITING
Guadalajara
COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 1717)
RECRUITING
Mexico City
Higiea Oncologia ( Site 1713)
RECRUITING
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 1711)
RECRUITING
Monterrey
I CAN ONCOLOGY CENTER S.A. DE C.V. ( Site 1716)
RECRUITING
Monterrey
Servicios de Oncología Médica Integral - Monterrey ( Site 1712)
RECRUITING
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 1714)
RECRUITING
Oaxaca City
Peru
Clínica San Felipe ( Site 3603)
RECRUITING
Lima
Hospital Guillermo Almenara Irigoyen ( Site 3608)
RECRUITING
Lima
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 3601)
RECRUITING
Lima
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)
RECRUITING
Lima
Poland
Bialostockie Centrum Onkologii ( Site 2104)
RECRUITING
Bialystok
Swietokrzyskie Centrum Onkologii. ( Site 2105)
RECRUITING
Kielce
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2106)
RECRUITING
Poznan
Portugal
Hospital da Luz ( Site 3802)
RECRUITING
Lisbon
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 3801)
RECRUITING
Porto
Republic of Korea
National Cancer Center ( Site 2305)
RECRUITING
Goyang-si
Severance Hospital ( Site 2302)
RECRUITING
Seodaemun-gu
Samsung Medical Center ( Site 2303)
RECRUITING
Seoul
Seoul National University Hospital ( Site 2301)
RECRUITING
Seoul
Asan Medical Center ( Site 2304)
RECRUITING
Songpa-gu
Romania
Spitalul Clinic Filantropia ( Site 2213)
RECRUITING
Bucharest
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2215)
RECRUITING
Cluj-napoca
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2211)
RECRUITING
Craiova
Cabinet Medical Oncomed ( Site 2217)
RECRUITING
Timișoara
Spain
Hospital Clinic I Provincial de Barcelona ( Site 2409)
RECRUITING
Barcelona
Hospital Vall D Hebron ( Site 2403)
RECRUITING
Barcelona
ICO L Hospitalet ( Site 2408)
RECRUITING
Barcelona
Hospital Universitario Reina Sofia ( Site 2406)
RECRUITING
Córdoba
Institut Català d'Oncologia (ICO) - Girona ( Site 2402)
RECRUITING
Girona
Clinica Universidad de Navarra ( Site 2407)
RECRUITING
Madrid
Hospital Clinico San Carlos... ( Site 2410)
RECRUITING
Madrid
Hospital General Gregorio Maranon de Madrid ( Site 2412)
RECRUITING
Madrid
Hospital Ramon y Cajal ( Site 2405)
RECRUITING
Madrid
Hospital Universitario 12 de Octubre ( Site 2411)
RECRUITING
Madrid
Hospital Universitario La Paz ( Site 2404)
RECRUITING
Madrid
Hosp Clinico Universitario de Valencia ( Site 2401)
RECRUITING
Valencia
Taiwan
Taichung Veterans General Hospital ( Site 2603)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 2602)
RECRUITING
Tainan
Mackay Memorial Hospital ( Site 2604)
RECRUITING
Taipei
National Taiwan University Hospital ( Site 2601)
RECRUITING
Taipei
Chang Gung Memorial Hospital - Linkou Branch ( Site 2605)
RECRUITING
Taoyuan District
Thailand
Faculty of Medicine Siriraj Hospital ( Site 3401)
RECRUITING
Bangkok
Ramathibodi Hospital ( Site 3402)
RECRUITING
Bangkok
United Kingdom
Western General Hospital ( Site 2806)
RECRUITING
Edinburgh
Leicester Royal Infirmary ( Site 2808)
RECRUITING
Leicester
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2801)
RECRUITING
London
Royal Marsden Hospital (Sutton) ( Site 2802)
RECRUITING
Sutton
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-04-09
Estimated Completion Date: 2032-11-09
Participants
Target number of participants: 770
Treatments
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
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation