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)

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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)

Status
Active
Cancer Type
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06824467
Protocol IDs
2870-022 (primary)
NCI-2025-03436
2023-508015-23
2023-508015-23-00
ENGOT-ov84
GOG-3103
jRCT2031240722
MK-2870-022
TroFuse-022
U1111-1297-4489
Study Sponsor
Merck Sharp and Dohme LLC

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

  1. Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies
  2. 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)
  3. Has platinum-sensitive epithelial OC
  4. Has provided tissue of a tumor lesion that was not previously irradiated
  5. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
  6. 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)
  7. Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  8. Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)

Treatment Sites in Georgia

Augusta University Medical Center


1120 15th Street
Augusta, GA 30912
706-721-4430
www.augustahealth.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.