Trials / Recruiting
RecruitingNCT06824467
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 770 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Sacituzumab tirumotecan | IV Infusion |
| BIOLOGICAL | Bevacizumab | IV Infusion |
| DRUG | H1 receptor antagonist | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| DRUG | H2 receptor antagonist | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| DRUG | Acetaminophen (or equivalent) | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| DRUG | Dexamethasone (or equivalent) | Rescue medication taken per approved product label before sacituzumab tirumotecan |
| DRUG | Steroid mouthwash (dexamethasone or equivalent) | Rescue medication taken orally 2-4 times daily |
Timeline
- Start date
- 2025-04-09
- Primary completion
- 2029-04-27
- Completion
- 2032-11-09
- First posted
- 2025-02-13
- Last updated
- 2026-04-16
Locations
159 sites across 27 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, Finland, France, Greece, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, Portugal, Romania, South Korea, Spain, Taiwan, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06824467. Inclusion in this directory is not an endorsement.