A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMerck Sharp & Dohme LLC

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

770 Participants
are divided into 3 treatment groups

Locations

178
Argentina
Instituto Alexander Fleming ( Site 2909)C1426ANZ, Ciudad Autónoma de Buenos AiresBuenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)B7600FZO, Mar del PlataBuenos Aires, Argentina
Fundación Respirar ( Site 2912)C1426AAL, Buenos AiresBuenos Aires F.D., Argentina
Instituto de Oncologia de Rosario ( Site 2910)S2000KZE, RosarioSanta Fe Province, Argentina

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

GOG Foundation

Collaborator