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
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-Free Survival (PFS)
Time frame: Up to approximately 49 months
Secondary Endpoints
Overall Survival (OS)
Progression-Free Survival 2 (PFS2)
Number of Participants Who Experience an Adverse Event (AE)
Eligibility Criteria
The main inclusion criteria include but are not limited to the following: * 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. The main exclusion criteria include but are not limited to the following: * Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borde…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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