Clinical trial · Interventional
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)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen (or equivalent) | Drug | — | UNRESOLVED |
| Bevacizumab | Biological | Bevacizumab | ALIAS |
| Dexamethasone (or equivalent) | Drug | Dexamethasone | ALIAS |
| H1 receptor antagonist | Drug | — | UNRESOLVED |
| H2 receptor antagonist | Drug | — | UNRESOLVED |
| Sacituzumab tirumotecan | Biological | — | UNRESOLVED |
| Steroid mouthwash (dexamethasone or equivalent) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1: Sacituzumab tirumotecan + Bevacizumab
- description
- 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
- interventionNames
- Biological: Sacituzumab tirumotecan
- Biological: Bevacizumab
- Drug: H1 receptor antagonist
- Drug: H2 receptor antagonist
- Drug: Acetaminophen (or equivalent)
- Drug: Dexamethasone (or equivalent)
- Drug: Steroid mouthwash (dexamethasone or equivalent)
- type
- EXPERIMENTAL
- label
- Part 2: Sacituzumab tirumotecan
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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
References
Publications (0)
Data not yet available