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Набира участници Фаза 3 NCT06097728

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Фаза 3 – широко изпитване преди одобрение
Заболявания: Unresectable Pleural Mesothelioma

Спонсор: AstraZeneca

Налично на: БГ
Обобщение
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.
Описание
Adult patients with histologically proven diagnosis of pleural mesothelioma with advanced unresectable disease are eligible to be enrolled. Patients will be randomized 1:1 to receive Volrustomig (MEDI5752) + Carboplatin + Pemetrexed or the investigator's choice of platinum+Pemetrexed or Nivolumab+Ipilimumab, based on their histology.
Кой може да участва
Key Inclusion Criteria: * Participant must be ≥ 18 years at the time of screening * Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid) * Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy) * WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS\>1) over the previous 2 weeks prior to day of first dosing * Has measurable disease per modified RECIST1.1 * Has adequate bone marrow reserve and organ function at baseline Key Exclusion Criteria: * As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results. * Active or prior documented autoimmune or inflammatory disorders * History of another primary malignancy with exceptions. * Uncontrolled intercurrent illness * Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled * Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment * Untreated or progressive CNS metastatic disease
Места на провеждане 20
Австралия (1)
Research Site
Chermside
ACTIVE_NOT_RECRUITING
Белгия (1)
Research Site
Anderlecht
ACTIVE_NOT_RECRUITING
Бразилия (1)
Research Site
Barretos
ACTIVE_NOT_RECRUITING
Канада (1)
Research Site
Edmonton , Alberta
ACTIVE_NOT_RECRUITING
Китай (1)
Research Site
Beijing
ACTIVE_NOT_RECRUITING
Дания (1)
Research Site
Aarhus N
ACTIVE_NOT_RECRUITING
Франция (1)
Research Site
Brest
COMPLETED
Италия (1)
Research Site
Alessandria
ACTIVE_NOT_RECRUITING
Япония (1)
Research Site
Amagasaki-shi
ACTIVE_NOT_RECRUITING
Нидерландия (1)
Research Site
Amsterdam
ACTIVE_NOT_RECRUITING
Норвегия (1)
Research Site
Lørenskog
COMPLETED
Полша (1)
Research Site
Bydgoszcz
WITHDRAWN
South Africa (1)
Research Site
Cape Town
ACTIVE_NOT_RECRUITING
Южна Корея (1)
Research Site
Cheongju-si
WITHDRAWN
Испания (1)
Research Site
Barakaldo
Швейцария (1)
Research Site
Baden
ACTIVE_NOT_RECRUITING
Taiwan (1)
Research Site
Kaohsiung City
ACTIVE_NOT_RECRUITING
Турция (1)
Research Site
Adana
WITHDRAWN
Великобритания (1)
Research Site
Cambridge
ACTIVE_NOT_RECRUITING
САЩ (1)
Research Site
Phoenix , Arizona
WITHDRAWN
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
09.11.2023
Крайна дата
16.11.2028
Регистрационен номер
NCT06097728
Източник
anzctr
Запитване за медицински туризъм

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