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