RecruitingPhase 3NCT07318558

A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

900 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Ovarian Neoplasms

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria15

Has histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies.
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.
If human immunodeficiency virus (HIV) infected, has well-controlled HIV on antiretroviral therapy.
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.
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.
Has active or ongoing stomatitis of any grade.

Exclusion Criteria6

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, or has current pneumonitis/ILD.

Interventions

DRUGSacituzumab tirumotecan

Administered via intravenous (IV) infusion at a dose of 4mg/kg

DRUGBevacizumab

Administered via IV infusion at a dose of 15mg/kg

DRUGRescue Medications

Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent.