NCT07318558Recrutement en cours
A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
Résumé
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.
Critères d'éligibilité
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
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 3
- Type d'étude
- Interventionnelle
- Pays
- Suisse, France, Allemagne, Italie, Autriche, États-Unis, Argentine, Australie, Belgique, Brésil, Canada, Chili, Colombie, Tchéquie, Danemark, Finlande, Grèce, Hongrie, Irlande, Israël, Japon, Norvège, Pérou, Pologne, Corée du Sud, Espagne, Suède, Taïwan, Thaïlande, Royaume-Uni
- Promoteur
- Merck Sharp & Dohme LLC(Industrie)
- N° de protocole
- 2870-021
- Pathologies
- Ovarian Neoplasms, Ovarian Cancer
- Interventions
- Médicament
Traitements évalués
- Sacituzumab tirumotecan
- Bevacizumab
- Rescue Medications
Lieux · 167
- Bern, SuisseInselspital Bern ( Site 3504)Recrute dans ce centre
- Bellinzona, SuisseOspedale Regionale Bellinzona e Valli ( Site 3501)Recrute dans ce centre
- Chur, SuisseKantonsspital Graubünden ( Site 3503)Recrute dans ce centre
- Geneva, SuisseHôpitaux Universitaires de Genève (HUG) ( Site 3502)Recrute dans ce centre
- Lyon, FranceCENTRE LEON BERARD ( Site 1101)Recrute dans ce centre
- Strasbourg, FranceHopitaux Universitaires de Strasbourg ( Site 1109)Recrute dans ce centre
- Marseille, FranceInstitut Paoli Calmettes ( Site 1111)Recrute dans ce centre
- Plérin, FranceHôpital Privé Des Côtes d'Armor ( Site 1102)Recrute dans ce centre
- Brest, FranceCHRU de Brest - Hopital de la Cavale Blanche ( Site 1104)Recrute dans ce centre
- Toulouse, FranceLBM ONCOPOLE CLAUDIUS REGAUD ( Site 1114)Recrute dans ce centre
- Limoges, FranceCentre Hospitalier Universitaire Dupuytren ( Site 1112)Recrute dans ce centre
- Tours, FranceCentre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1105)Recrute dans ce centre
- Lille, FranceCentre Oscar Lambret ( Site 1106)Recrute dans ce centre
- Clermont-Ferrand, FranceCentre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)Recrute dans ce centre
- Jena, AllemagneUniversitätsklinikum Jena ( Site 1211)Recrute dans ce centre
- Brescia, ItalieAzienda Ospedaliera Spedali Civili di Brescia ( Site 1501)Recrute dans ce centre
- Lecco, ItalieASST DI LECCO ( Site 1509)Recrute dans ce centre
- Milan, ItalieIstituto Nazionale dei Tumori ( Site 1504)Recrute dans ce centre
- Milan, ItalieIstituto Europeo di Oncologia ( Site 1503)Recrute dans ce centre
- Padova, ItalieIstituto Oncologico Veneto ( Site 1506)Recrute dans ce centre
- Roma, ItalieFondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510)Recrute dans ce centre
- Torino, ItalieOspedale Mauriziano ( Site 1507)Recrute dans ce centre
- Vienna, AutricheMedizinische Universitat Wien ( Site 0102)Recrute dans ce centre
- Innsbruck, AutricheMedizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)Recrute dans ce centre
- Birmingham, États-UnisUniversity of Alabama - Birmingham ( Site 0058)Recrute dans ce centre
- Walnut Creek, États-UnisJohn Muir Health Cancer Center ( Site 0069)Recrute dans ce centre
- Miami Beach, États-UnisMount Sinai Cancer Center ( Site 0029)Recrute dans ce centre
- Orlando, États-UnisOrlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)Recrute dans ce centre
- Atlanta, États-UnisWinship Cancer Institute of Emory University ( Site 0037)Recrute dans ce centre
- Arlington Heights, États-UnisIllinois Cancer Specialists (ICS) ( Site 8009)Recrute dans ce centre
Au total, dans le monde, les 167 centres listés au registre recrutent.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 13 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 137 autres lieux
Autres identifiants
- MK-2870-021 · autre identifiant
- GOG-3102 · autre identifiant
- ENGOT-ov85 · autre identifiant
- U1111-1297-5158 · autre registre
- 2023-508047-40-00 · autre registre
- jRCT2031250647 · autre registre
- 2023 · financement NIH
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.