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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)
NCT06824467 · Merck Sharp & Dohme LLC
In plain English
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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)
About this study
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 criteria
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 design
Enrollment target: 770 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-09
Estimated completion: 2032-11-09
Last updated: 2026-04-16
Interventions
Biological: Sacituzumab tirumotecanBiological: BevacizumabDrug: H1 receptor antagonistDrug: H2 receptor antagonistDrug: Acetaminophen (or equivalent)Drug: Dexamethasone (or equivalent)Drug: Steroid mouthwash (dexamethasone or equivalent)
Primary outcomes
- • Part 1: Number of participants with one or more adverse events (AEs) (Up to 6 weeks)
- • Part 1: Number of participants who discontinue study intervention due to an AE (Up to 6 weeks)
- • Part 2: Progression-free Survival (PFS) (Up to approximately 4 years)
Sponsor
Merck Sharp & Dohme LLC · industry
With: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (159)
University of Alabama at Birmingham ( Site 0006)Recruiting
Birmingham, Alabama, United States
Alaska Women's Cancer Care ( Site 0096)Recruiting
Anchorage, Alaska, United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)Recruiting
New Haven, Connecticut, United States
Mount Sinai Cancer Center ( Site 0078)Recruiting
Miami Beach, Florida, United States
Sarasota Memorial Hospital ( Site 0075)Recruiting
Sarasota, Florida, United States
Florida Cancer Specialists East ( Site 7000)Recruiting
West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University ( Site 0086)Recruiting
Atlanta, Georgia, United States
Augusta University - Georgia Cancer Center ( Site 0066)Recruiting
Augusta, Georgia, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0003)Recruiting
Fort Wayne, Indiana, United States
Women's Cancer Care ( Site 0067)Recruiting
Covington, Louisiana, United States
Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)Recruiting
Scarborough, Maine, United States
St. Dominic's Hospital ( Site 0064)Active Not Recruiting
Jackson, Mississippi, United States
Nebraska Methodist Hospital ( Site 0053)Recruiting
Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081)Recruiting
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 0071)Recruiting
New Brunswick, New Jersey, United States
University of New Mexico Comprehensive Cancer Center ( Site 0055)Recruiting
Albuquerque, New Mexico, United States
NYU Langone Hospital - Long Island ( Site 0015)Recruiting
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0076)Recruiting
New York, New York, United States
FirstHealth Cancer Center ( Site 0079)Recruiting
Pinehurst, North Carolina, United States
University of Cincinnati Medical Center ( Site 0090)Recruiting
Cincinnati, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)Recruiting
Tulsa, Oklahoma, United States
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010)Recruiting
Eugene, Oregon, United States
Women & Infants Hospital ( Site 0050)Recruiting
Providence, Rhode Island, United States
Henry-Joyce Cancer Clinic ( Site 0060)Recruiting
Nashville, Tennessee, United States
Texas Oncology - Central/South Texas ( Site 8009)Recruiting
Austin, Texas, United States
Texas Oncology - DFW ( Site 8001)Recruiting
Fort Worth, Texas, United States
Texas Oncology - San Antonio ( Site 8005)Recruiting
San Antonio, Texas, United States
Texas Oncology - Gulf Coast ( Site 8003)Recruiting
Webster, Texas, United States
Virginia Cancer Specialists (VCS) ( Site 8011)Recruiting
Fairfax, Virginia, United States
Instituto Alexander Fleming ( Site 2909)Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)Recruiting
Mar del Plata, Buenos Aires, Argentina
Fundación Respirar ( Site 2912)Recruiting
Buenos Aires, Buenos Aires F.D., Argentina
Instituto de Oncologia de Rosario ( Site 2910)Recruiting
Rosario, Santa Fe Province, Argentina
Hospital Aleman ( Site 2903)Recruiting
CABA, Argentina
Hospital Italiano de Cordoba ( Site 2908)Recruiting
Córdoba, Argentina
Blacktown Hospital ( Site 0211)Recruiting
Sydney, New South Wales, Australia
Gallipoli Medical Research Ltd ( Site 0214)Recruiting
Brisbane, Queensland, Australia
Epworth Freemasons ( Site 0217)Recruiting
East Melbourne, Victoria, Australia
Frankston Hospital ( Site 0216)Recruiting
Frankston, Victoria, Australia
Antwerp University Hospital ( Site 0304)Recruiting
Edegem, Antwerpen, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0306)Recruiting
Liège, Liege, Belgium
AZ Sint-Lucas ( Site 0305)Recruiting
Ghent, Oost-Vlaanderen, Belgium
CHU UCL Namur/Site Sainte Elisabeth ( Site 0302)Recruiting
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0301)Recruiting
Leuven, Vlaams-Brabant, Belgium
Liga Norte Riograndense Contra o Cancer ( Site 0423)Recruiting
Natal, Rio Grande do Norte, Brazil
ANIMI - Unidade de Tratamento Oncologico ( Site 0419)Recruiting
Lages, Santa Catarina, Brazil
Hospital Paulistano ( Site 0421)Recruiting
São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0424)Recruiting
São Paulo, Brazil
Princess Margaret Cancer Centre ( Site 0518)Recruiting
Toronto, Ontario, Canada
McGill University Health Centre ( Site 0502)Recruiting
Montreal, Quebec, Canada
Clinica Puerto Montt ( Site 0615)Recruiting
Port Montt, Los Lagos Region, Chile
ONCOCENTRO APYS-ACEREY ( Site 0612)Recruiting
Viña del Mar, Valparaiso, Chile
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0806)Recruiting
Bogotá, Bogota D.C., Colombia
Instituto Nacional De Cancerologia ( Site 0807)Recruiting
Bogotá, Bogota D.C., Colombia
Oncologos Del Occidente ( Site 0805)Recruiting
Pereira, Risaralda Department, Colombia
Fakultni nemocnice Ostrava ( Site 3323)Recruiting
Ostrava-Poruba, Ostrava Mesto, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 3325)Recruiting
Prague, Czechia
Fakultni nemocnice v Motole ( Site 3322)Recruiting
Prague, Czechia
Rigshospitalet ( Site 0904)Recruiting
Copenhagen, Capital Region, Denmark
Herlev Hospital ( Site 0903)Recruiting
Herlev, Capital Region, Denmark
Aalborg Universitetshospital ( Site 0901)Recruiting
Aalborg, North Denmark, Denmark
Vejle Sygehus ( Site 0902)Recruiting
Vejle, Region Syddanmark, Denmark
Oulun yliopistollinen sairaala ( Site 1003)Recruiting
Oulu, North Ostrobothnia, Finland
Kuopion Yliopistollinen Sairaala ( Site 1004)Recruiting
Kuopio, Northern Savonia, Finland
Tampereen yliopistollinen sairaala ( Site 1002)Recruiting
Tampere, Pirkanmaa, Finland
Centre Oscar Lambret ( Site 1104)Recruiting
Lille, Ain, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1101)Recruiting
Bordeaux, Aquitaine, France
Centre Hopitalier Lyon Sud ( Site 1110)Recruiting
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Centre Francois Baclesse ( Site 1108)Recruiting
Caen, Calvados, France
Hôpital Privé Des Côtes d'Armor ( Site 1106)Recruiting
Plérin, Cotes-d Armor, France
Oncopole Claudius Regaud ( Site 1109)Recruiting
Toulouse, Haute-Garonne, France
Pôle Santé Léonard de Vinci ( Site 1112)Recruiting
Chambray-lès-Tours, Indre-et-Loire, France
Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1111)Recruiting
Paris, Paris, France
Institut De Cancerologie De L Ouest ( Site 1107)Recruiting
Saint-Herblain, Pays de la Loire Region, France
Sainte Catherine Institut du Cancer Avignon Provence ( Site 1105)Recruiting
Avignon, Vaucluse, France
Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1102)Recruiting
Paris, France
Aretaieio Hospital ( Site 0701)Recruiting
Athens, Attica, Greece
Bacs-Kiskun Megyei Korhaz ( Site 3920)Recruiting
Kecskemét, Bács-Kiskun county, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 3924)Recruiting
Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 3922)Recruiting
Debrecen, Hajdú-Bihar, Hungary
Hillel Yaffe Medical Center ( Site 1404)Recruiting
Hadera, Israel
Rambam Health Care Campus ( Site 1402)Recruiting
Haifa, Israel
Shaare Zedek Medical Center ( Site 1405)Recruiting
Jerusalem, Israel
Meir Medical Center. ( Site 1403)Recruiting
Kfar Saba, Israel
Sheba Medical Center ( Site 1401)Recruiting
Ramat Gan, Israel
CRO-IRCCS ( Site 1510)Recruiting
Aviano, Friuli Venezia Giulia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1507)Recruiting
Milan, Milano, Italy
Azienda Ospedaliero Universitaria Pisana ( Site 1504)Recruiting
Pisa, Tuscany, Italy
Instituto Tumori Giovanni Paolo II ( Site 1505)Recruiting
Bari, Italy
Istituto Europeo di Oncologia ( Site 1506)Recruiting
Milan, Italy
Humanitas San Pio X Hospital ( Site 1503)Recruiting
Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1501)Recruiting
Naples, Italy
Istituto Oncologico Veneto IRCCS ( Site 1508)Recruiting
Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli ( Site 1502)Recruiting
Roma, Italy
Ospedale Mauriziano ( Site 1509)Recruiting
Torino, Italy
Aichi Cancer Center ( Site 1626)Recruiting
Nagoya, Aichi-ken, Japan
National Hospital Organization Shikoku Cancer Center ( Site 1631)Recruiting
Matsuyama, Ehime, Japan
Ehime University Hospital ( Site 1637)Recruiting
Tōon, Ehime, Japan
Kurume University Hospital ( Site 1640)Recruiting
Kurume, Fukuoka, Japan
Gunma Prefectural Cancer Center ( Site 1630)Recruiting
Ōta, Gunma, Japan
Hokkaido University Hospital ( Site 1634)Recruiting
Sapporo, Hokkaido, Japan
Iwate Medical University Hospital ( Site 1635)Recruiting
Shiwa-gun, Iwate, Japan
Saitama Medical University International Medical Center ( Site 1632)Recruiting
Hidaka, Saitama, Japan
Cancer Institute Hospital of JFCR ( Site 1639)Recruiting
Koto, Tokyo, Japan
Keio University Hospital ( Site 1636)Recruiting
Shinjyuku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 1628)Recruiting
Fukuoka, Japan
Kagoshima City Hospital ( Site 1638)Recruiting
Kagoshima, Japan
Niigata Cancer Center Hospital ( Site 1633)Recruiting
Niigata, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1629)Recruiting
Osaka, Japan
CIO - Centro de Inmuno-Oncología de Occidente ( Site 1719)Recruiting
Guadalajara, Jalisco, Mexico
Higiea Oncologia ( Site 1713)Recruiting
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 1711)Recruiting
Monterrey, Nuevo León, Mexico
I CAN ONCOLOGY CENTER S.A. DE C.V. ( Site 1716)Recruiting
Monterrey, Nuevo León, Mexico
Servicios de Oncología Médica Integral - Monterrey ( Site 1712)Recruiting
Monterrey, Nuevo León, Mexico
Centro de Investigación Oncológica Galerías SC ( Site 1720)Recruiting
Aguascalientes, Mexico
Cryptex Investigación Clínica S.A. de C.V. ( Site 1715)Recruiting
Cuauhtémoc, Mexico
COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 1717)Recruiting
Mexico City, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 1714)Recruiting
Oaxaca City, Mexico
Hospital Guillermo Almenara Irigoyen ( Site 3608)Recruiting
Lima, Peru
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)Recruiting
Lima, Peru
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 3601)Recruiting
Lima, Peru
Clínica San Felipe ( Site 3603)Recruiting
Lima, Peru
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2106)Recruiting
Poznan, Greater Poland Voivodeship, Poland
Bialostockie Centrum Onkologii ( Site 2104)Recruiting
Bialystok, Podlaskie Voivodeship, Poland
Swietokrzyskie Centrum Onkologii. ( Site 2105)Recruiting
Kielce, Świętokrzyskie Voivodeship, Poland
Hospital da Luz ( Site 3802)Recruiting
Lisbon, Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 3801)Recruiting
Porto, Portugal
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2215)Recruiting
Cluj-Napoca, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2211)Recruiting
Craiova, Dolj, Romania
Cabinet Medical Oncomed ( Site 2217)Recruiting
Timișoara, Timiș County, Romania
Spitalul Clinic Filantropia ( Site 2213)Recruiting
Bucharest, Romania
National Cancer Center ( Site 2305)Recruiting
Goyang-si, Kyonggi-do, South Korea
Severance Hospital ( Site 2302)Recruiting
Seodaemun-Gu, Seoul, South Korea
Asan Medical Center ( Site 2304)Recruiting
Songpa-gu, Seoul, South Korea
Seoul National University Hospital ( Site 2301)Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 2303)Recruiting
Seoul, South Korea
Institut Català d'Oncologia (ICO) - Girona ( Site 2402)Recruiting
Girona, Gerona, Spain
Hospital General Gregorio Maranon de Madrid ( Site 2412)Recruiting
Madrid, Madrid, Comunidad de, Spain
Clinica Universidad de Navarra ( Site 2407)Recruiting
Madrid, Madrid, Comunidad de, Spain
Hosp Clinico Universitario de Valencia ( Site 2401)Recruiting
Valencia, Valenciana, Comunitat, Spain
Hospital Vall D Hebron ( Site 2403)Recruiting
Barcelona, Spain
Hospital Clinic I Provincial de Barcelona ( Site 2409)Recruiting
Barcelona, Spain
ICO L Hospitalet ( Site 2408)Recruiting
Barcelona, Spain
Hospital Universitario Reina Sofia ( Site 2406)Recruiting
Córdoba, Spain
Hospital Ramon y Cajal ( Site 2405)Recruiting
Madrid, Spain
Hospital Clinico San Carlos... ( Site 2410)Recruiting
Madrid, Spain
Hospital Universitario 12 de Octubre ( Site 2411)Recruiting
Madrid, Spain
Hospital Universitario La Paz ( Site 2404)Recruiting
Madrid, Spain
Taichung Veterans General Hospital ( Site 2603)Recruiting
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 2602)Recruiting
Tainan, Taiwan
National Taiwan University Hospital ( Site 2601)Recruiting
Taipei, Taiwan
Mackay Memorial Hospital ( Site 2604)Recruiting
Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 2605)Recruiting
Taoyuan District, Taiwan
Ramathibodi Hospital ( Site 3402)Recruiting
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 3401)Recruiting
Bangkok, Bangkok, Thailand
Western General Hospital ( Site 2806)Recruiting
Edinburgh, Edinburgh, City of, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2801)Recruiting
London, London, City of, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 2802)Recruiting
Sutton, London, City of, United Kingdom
Leicester Royal Infirmary ( Site 2808)Recruiting
Leicester, United Kingdom