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)

Recruiting now · Phase 3

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT06824467

Run by

Merck Sharp & Dohme LLC

People needed

770

Starts

2025-04-09

Expected to finish

2032-11-09

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Has locally advanced or metastatic, histologically confirmed 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 to 8 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 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)

You may not qualify if…

• 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)
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening
• 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
• Has active or ongoing stomatitis

Where it is running

• Alaska Women's Cancer Care ( Site 0096) — Anchorage, Alaska, United States (enrolling)
• University of Alabama at Birmingham ( Site 0006) — Birmingham, Alabama, United States (enrolling)
• John Muir Health Cancer Center ( Site 0016) — Walnut Creek, California, United States (enrolling)
• Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001) — New Haven, Connecticut, United States (enrolling)
• Mount Sinai Braman Comprehensive Cancer Center ( Site 0078) — Miami Beach, Florida, United States (enrolling)
• UCSF Medical Center at Mission Bay ( Site 0013) — San Francisco, California, United States (enrolling)
• Florida Cancer Specialists East ( Site 7000) — West Palm Beach, Florida, United States (enrolling)
• Winship Cancer Institute of Emory University ( Site 0086) — Atlanta, Georgia, United States (enrolling)
• Augusta University - Georgia Cancer Center ( Site 0066) — Augusta, Georgia, United States (enrolling)
• Parkview Research Center at Parkview Regional Medical Center ( Site 0003) — Fort Wayne, Indiana, United States (enrolling)
• Women's Cancer Care ( Site 0067) — Covington, Louisiana, United States (enrolling)
• Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008) — Scarborough, Maine, United States (enrolling)
• Sarasota Memorial Hospital ( Site 0075) — Sarasota, Florida, United States (enrolling)
• Washington University School of Medicine ( Site 0052) — St Louis, Missouri, United States (enrolling)
• Nebraska Methodist Hospital ( Site 0053) — Omaha, Nebraska, United States (enrolling)
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081) — Hackensack, New Jersey, United States (enrolling)
• Rutgers Cancer Institute of New Jersey ( Site 0071) — New Brunswick, New Jersey, United States (enrolling)
• University of New Mexico Comprehensive Cancer Center ( Site 0055) — Albuquerque, New Mexico, United States (enrolling)
• NYU Langone Hospital - Long Island ( Site 0015) — Mineola, New York, United States (enrolling)
• Laura and Isaac Perlmutter Cancer Center ( Site 0076) — New York, New York, United States (enrolling)
• FirstHealth Cancer Center ( Site 0079) — Pinehurst, North Carolina, United States (enrolling)
• University of Cincinnati Medical Center ( Site 0090) — Cincinnati, Ohio, United States (enrolling)
• The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0054) — Columbus, Ohio, United States (enrolling)
• Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056) — Tulsa, Oklahoma, United States (enrolling)
• Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010) — Eugene, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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