About this trial
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
Qualifiers
Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies
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
Disqualifiers
Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid 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)
Trial design
Treatments tested in this trial
- Sacituzumab tirumotecan
- Bevacizumab
- H1 receptor antagonist
- H2 receptor antagonist
- Acetaminophen (or equivalent)
- Dexamethasone (or equivalent)
- Steroid mouthwash (dexamethasone or equivalent)
Treatment groups
Locations
178Sponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
GOG Foundation
Collaborator