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/ENGOT-ov85/GOG-3102)

未提供0 个研究点目标入组 45 人开始时间: 待定

适应症

试验速览

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•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.

•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.
•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.
•Has active or ongoing stomatitis of any grade.

发起方

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