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

A vizsgálat adatai

Ki végzi

Merck Sharp & Dohme LLC

Azonosító

NCT07318558EU 2023-508047-40-00

A regiszteradat frissítve

2026. november 10.

Eredeti leírás

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:A teljes eredeti leírásKevesebb

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)

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.

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.

ClinicalTrials.gov NCT07318558 · EU CTIS 2023-508047-40-00