NCT07318558Recruiting
A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
Summary
Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include: * Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread. * Observation, which is watching to see if cancer grows or worsens The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.
Eligibility criteria
The main inclusion criteria include but are not limited to the following: • Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (\>50%) Grade 3 features are present. • Has completed primary debulking surgery or interval debulking surgery. • Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol. • Has provided tumor tissue that is not previously irradiated. • Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV • Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive. • Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection. The main exclusion criteria include but are not limited to the following: • Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma. • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. • Has a history of severe eye disease. • Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease. • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. • Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening. • Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria. • Had a live or live-attenuated vaccine within 30 days of randomization. • Has a known additional malignancy that is progressing or required active treatment within the past 3 years. • Has active infection requiring systemic therapy. • Has concurrent and active HBV and HCV infections. • Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease. • Has not recovered from major surgery or has ongoing surgical complications. • Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory. • Active or ongoing stomatitis of any grade.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, Finland, Greece, Hungary, Ireland, Israel, Japan, Norway, Peru, Poland, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom
- Sponsor
- Merck Sharp & Dohme LLC(Industry)
- Protocol no.
- 2870-021
- Conditions
- Ovarian Neoplasms, Ovarian Cancer
- Interventions
- Drug
Treatments studied
- Sacituzumab tirumotecan
- Bevacizumab
- Rescue Medications
Locations · 167
- Bern, SwitzerlandInselspital Bern ( Site 3504)Recruiting at this site
- Bellinzona, SwitzerlandOspedale Regionale Bellinzona e Valli ( Site 3501)Recruiting at this site
- Chur, SwitzerlandKantonsspital Graubünden ( Site 3503)Recruiting at this site
- Geneva, SwitzerlandHôpitaux Universitaires de Genève (HUG) ( Site 3502)Recruiting at this site
- Lyon, FranceCENTRE LEON BERARD ( Site 1101)Recruiting at this site
- Strasbourg, FranceHopitaux Universitaires de Strasbourg ( Site 1109)Recruiting at this site
- Marseille, FranceInstitut Paoli Calmettes ( Site 1111)Recruiting at this site
- Plérin, FranceHôpital Privé Des Côtes d'Armor ( Site 1102)Recruiting at this site
- Brest, FranceCHRU de Brest - Hopital de la Cavale Blanche ( Site 1104)Recruiting at this site
- Toulouse, FranceLBM ONCOPOLE CLAUDIUS REGAUD ( Site 1114)Recruiting at this site
- Limoges, FranceCentre Hospitalier Universitaire Dupuytren ( Site 1112)Recruiting at this site
- Tours, FranceCentre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1105)Recruiting at this site
- Lille, FranceCentre Oscar Lambret ( Site 1106)Recruiting at this site
- Clermont-Ferrand, FranceCentre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)Recruiting at this site
- Jena, GermanyUniversitätsklinikum Jena ( Site 1211)Recruiting at this site
- Brescia, ItalyAzienda Ospedaliera Spedali Civili di Brescia ( Site 1501)Recruiting at this site
- Lecco, ItalyASST DI LECCO ( Site 1509)Recruiting at this site
- Milan, ItalyIstituto Nazionale dei Tumori ( Site 1504)Recruiting at this site
- Milan, ItalyIstituto Europeo di Oncologia ( Site 1503)Recruiting at this site
- Padova, ItalyIstituto Oncologico Veneto ( Site 1506)Recruiting at this site
- Roma, ItalyFondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510)Recruiting at this site
- Torino, ItalyOspedale Mauriziano ( Site 1507)Recruiting at this site
- Vienna, AustriaMedizinische Universitat Wien ( Site 0102)Recruiting at this site
- Innsbruck, AustriaMedizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)Recruiting at this site
- Birmingham, United StatesUniversity of Alabama - Birmingham ( Site 0058)Recruiting at this site
- Walnut Creek, United StatesJohn Muir Health Cancer Center ( Site 0069)Recruiting at this site
- Miami Beach, United StatesMount Sinai Cancer Center ( Site 0029)Recruiting at this site
- Orlando, United StatesOrlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)Recruiting at this site
- Atlanta, United StatesWinship Cancer Institute of Emory University ( Site 0037)Recruiting at this site
- Arlington Heights, United StatesIllinois Cancer Specialists (ICS) ( Site 8009)Recruiting at this site
In total, worldwide, all 167 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 13, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 137 more locations
Other identifiers
- MK-2870-021 · other identifier
- GOG-3102 · other identifier
- ENGOT-ov85 · other identifier
- U1111-1297-5158 · other registry
- 2023-508047-40-00 · other registry
- jRCT2031250647 · other registry
- 2023 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.