Tests sacituzumab tirumotecan to keep recurrent ovarian cancer controlled
Tests a drug, with or without bevacizumab, in adults with recurrent ovarian cancer.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Lisbon and Porto, PortugalSee the 2 sitesAlso in 28 other countries, 203 sites
- Trial code
- NCT06824467
- EU 2023-508015-23-00
- JRCT2031240722
- U1111-1297-4489
- Registry title
- 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
- Recruiting
- Phase
- Phase 3
- People taking part
- 770 people, planned
- Started
- 9 Apr 2025
- Expected to end
- 9 Nov 2032
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Sacituzumab tirumotecan
- Bevacizumab
- H1 receptor antagonist
- H2 receptor antagonist
- Acetaminophen (or equivalent)
- Dexamethasone (or equivalent)
- Steroid mouthwash (dexamethasone or equivalent)
- Record updated
- 10 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with ovarian, fallopian tube or primary peritoneal cancer that has come back after platinum chemotherapy and still responds to platinum drugs.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Locally advanced or metastatic epithelial ovarian, primary peritoneal or fallopian tube cancer that is platinum-sensitive and has come back
- Earlier treatment
- Must have had 4 or more cycles of platinum-based chemotherapy in first-line and a total of 6 to 8 cycles of carboplatin-based chemotherapy in second-line. Must not have had more than 2 earlier lines of systemic treatment.
- Biomarker or test result
- A tumor tissue sample that was not previously irradiated is needed.
Main reasons for not taking part
- Platinum-resistant or platinum-refractory ovarian cancer
- Certain rare tumor types, such as germ cell, low-grade serous, borderline or mucinous tumors
- Active brain or spinal fluid cancer spread (CNS metastases or carcinomatous meningitis)
- History of pneumonitis or interstitial lung disease that needed steroids, or current lung inflammation
- Active inflammatory bowel disease, severe eye disease or active infection needing systemic therapy
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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 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 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 history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- 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 an additional malignancy that is progressing or has required active treatment within the past 3 years
- Has an active infection requiring systemic therapy
- Has platinum-resistant OC or platinum-refractory OC
- Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has active or ongoing stomatitis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Have you ever been told you have ovarian, fallopian tube or peritoneal cancer?
- Have your doctors told you that your cancer is advanced (stage 3 or 4)? This means it has spread beyond the ovaries to other parts of the belly or the body, even if it was later removed by surgery.
- What type of ovarian cancer do you have?
Where in Portugal
Also in 28 other countries, 203 sites
- Hospital da Luz, S.ALisbon, PortugalTaking people
- Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.Porto, PortugalTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Part 1: Sacituzumab tirumotecan + BevacizumabTreatment being tested
Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks
Treatment: Sacituzumab tirumotecan, Bevacizumab, H1 receptor antagonist, H2 receptor antagonist, Acetaminophen (or equivalent), Dexamethasone (or equivalent), and Steroid mouthwash (dexamethasone or equivalent)
- Part 2: Sacituzumab tirumotecanTreatment being tested
Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion for up to approximately 2 years or until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.
Treatment: Sacituzumab tirumotecan, Bevacizumab, H1 receptor antagonist, H2 receptor antagonist, Acetaminophen (or equivalent), Dexamethasone (or equivalent), and Steroid mouthwash (dexamethasone or equivalent)
- Part 2: Standard of care (SOC)Existing treatment, for comparison
Participants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.
Treatment: Bevacizumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)
- Plain-language title
- Tests sacituzumab tirumotecan to keep recurrent ovarian cancer controlledGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06824467, who can take part
- Record updated
- 10 November 2026