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Active (not recruiting) Phase 3 2023-508015-23-00

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)

Phase 3 – large-scale trial before approval
Conditions: Ovarian cancer recurrent

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
Trial status: Authorised 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 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)
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
Who can participate
Age group: 65+ years, 18-64 years Gender: Female Target enrollment: 251 participants
Interventions
BEVACIZUMAB
Drug
PARACETAMOL
Drug
MK-2870
Drug
DEXAMETHASONE
Drug
BEVACIZUMAB
Drug
-
Drug
-
Drug
MK-2870
Drug
-
Drug
Locations 14
Austria (1)
Belgium (1)
Czech Republic (1)
Denmark (1)
Finland (1)
France (1)
Greece (1)
Hungary (1)
Ireland (1)
Italy (1)
Poland (1)
Portugal (1)
Romania (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
22.08.2025
Registry ID
2023-508015-23-00
Source
euclinicaltrials.eu
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