A clinical study of sacituzumab tirumotecan in people with ovarian cancer (MK-2870-021)

Prior treatment

• Has concurrent and active HBV and HCV infections.
• Has not recovered from major surgery or has ongoing surgical complications.
• Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.
• Had prior systemic anticancer therapy.
• Had a live or live-attenuated vaccine within 30 days of randomization.

Other illness

• Has nonepithelial cancers, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.
• Has active infection requiring systemic therapy.
• Has HIV infection and a history of Kaposi’s sarcoma and/or multicentric Castleman’s disease.
• Has a history of severe eye 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.
• Has a known additional malignancy that is progressing or required active treatment within the past 3 years.

Other

• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Has histologically confirmed FIGO Stage III or Stage IV epithelial ovarian, primary peritoneal, or fallopian tube cancer.
• 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, or complete response per protocol.
• Has provided tumor tissue that is not previously irradiated.
• Has well-controlled human immunodeficiency virus (HIV) with antiretroviral therapy if HIV-infected.
• 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.