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A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) 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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508015-23-00
Acronym
MK-2870-022
Enrollment
235
Registered
2025-03-26
Start date
2025-04-11
Completion date
Unknown
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer recurrent

Brief summary

Part 1: Number of Participants with One or More Adverse Events (AE), Part 1: Number of Participants who Discontinue Study Intervention Due to an AE, Part 2: Progression-free Survival (PFS)

Detailed description

Part 2: Overall Survival (OS), Part 2: Number of Participants with One or More AEs, Part 2: Number of Participants who Discontinue Study Intervention Due to an AE, Part 2: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score, Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score, Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score, Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 Abdominal/Gastrointestinal Symptom Scale

Interventions

DRUGBEVACIZUMAB
DRUGPARACETAMOL
DRUGDEXAMETHASONE
DRUG-

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1: Number of Participants with One or More Adverse Events (AE), Part 1: Number of Participants who Discontinue Study Intervention Due to an AE, Part 2: Progression-free Survival (PFS)

Secondary

MeasureTime frame
Part 2: Overall Survival (OS), Part 2: Number of Participants with One or More AEs, Part 2: Number of Participants who Discontinue Study Intervention Due to an AE, Part 2: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score, Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score, Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score, Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 Abdominal/Gastrointestinal Symptom Scale

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026