a study to evaluate the efficacy and safety of sacituzumab tirumotecan (mk-2870) treatment versus standard of care in participants with platinum-sensitive recurrent ovarian cancer (mk-2870-022/trofuse-022/engot-ov84/gog-3103)

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Summary: the main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.


Eligibility criteria:
inclusion criteria: * has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. * has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (oc). * has platinum-sensitive epithelial oc, * has provided tissue of a tumor lesion that was not previously irradiated * human immunodeficiency virus (hiv)-infected participants must have well controlled hiv on antiretroviral therapy * participants who are hepatitis b surface antigen positive are eligible if they have received hepatitis b virus (hbv) antiviral therapy for at least 4 weeks, and have undetectable hbv viral load prior to allocation (part 1) or randomization (part 2) * participants with a history of hepatitis c virus (hcv) infection are eligible if hcv viral load is undetectable at screening * has an ecog performance status of 0 to 1 assessed within 7 days before allocation (part 1) or randomization (part 2) exclusion criteria: * has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant brenner's tumor and undifferentiated carcinoma * has platinum-resistant oc or platinum-refractory oc * has history of documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing. * has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. crohn's disease, ulcerative colitis, or chronic diarrhea) * has uncontrolled, significant cardiovascular disease or cerebrovascular disease. * has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * hiv-infected participants with a history of kaposi's sarcoma and/or multicentric castleman's disease * has received more than 2 prior lines of systemic therapy for oc. * has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (part 1) or randomization (part 2) * has received prior radiotherapy within 2 weeks of allocation (part 1) or randomization (part 2), or has radiation related toxicities, requiring corticosteroids * has an additional malignancy that is progressing or has required active treatment within the past 3 years * has active central nervous system (cns) metastases and/or carcinomatous meningitis * has an active infection requiring systemic therapy