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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)
770 patients around the world
Available in Brazil, Colombia, Peru, United States, Argentina
Merck Sharp & Dohme LLC
31Research sites
770Patients around the world
This study is for people with
Ovarian cancer
Requirements for the patient
From 18 Years
Female
Medical requirements
- Has locally advanced or metastatic, histologically confirmed 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 to 8 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer.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 or randomization.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 to 1 assessed within 7 days before allocation or randomization.
- Has nonepithelial cancers (germ cell tumors and sex cord-stromal 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 or delays corneal healing.Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening.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 or randomization.Has received prior radiotherapy within 2 weeks of allocation or randomization, 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.
Sites
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Sociedad de Beneficencia Hospital Italiano - Córdoba
Recruiting
Fundación Respirar
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Hospital Alemán
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital Paulistano
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
StudyTroFuse-022
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Ovarian cancer
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT06824467
