Език: EN EN
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Активно (без набиране) Фаза 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)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Ovarian cancer recurrent

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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)
Описание
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
Кой може да участва
Age group: 65+ years, 18-64 years Gender: Female Target enrollment: 251 participants
Интервенции
BEVACIZUMAB
Drug
PARACETAMOL
Drug
MK-2870
Drug
DEXAMETHASONE
Drug
BEVACIZUMAB
Drug
-
Drug
-
Drug
MK-2870
Drug
-
Drug
Места на провеждане 14
Австрия (1)
Белгия (1)
Чехия (1)
Дания (1)
Финландия (1)
Франция (1)
Гърция (1)
Унгария (1)
Ireland (1)
Италия (1)
Полша (1)
Португалия (1)
Румъния (1)
Испания (1)
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
22.08.2025
Регистрационен номер
2023-508015-23-00
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

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