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Активно (без набиране) Фаза 3 NCT04008030

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Metastatic Colorectal Cancer

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.
Кой може да участва
Inclusion Criteria: * Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study) * Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study) * Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice * Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1 Exclusion Criteria: * An active, known or suspected autoimmune disease * History of interstitial lung disease or pneumonitis * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Other protocol-defined inclusion/exclusion criteria apply
Места на провеждане 22
Argentina (1)
Local Institution - 0073
Ciudad Autonoma Beunos Aires , Buenos Aires
Австралия (1)
Local Institution - 0019
Westmead , New South Wales
Белгия (1)
Local Institution - 0045
Bonheiden , Antwerpen
Бразилия (1)
Local Institution - 0096
Ipatinga , Minas Gerais
Канада (1)
Local Institution - 0011
Edmonton , Alberta
Chile (1)
Local Institution - 0070
Independencia , Santiago Metropolitan
Китай (1)
Local Institution - 0146
Hefei , Anhui
Чехия (1)
Local Institution - 0087
Brno
Дания (1)
Local Institution - 0038
Herlev
Франция (1)
Local Institution - 0176
Limoges , Haute-Vienne
Гърция (1)
Local Institution - 0222
Athens
Ireland (1)
Local Institution - 0091
Dublin , Dublin
Италия (1)
Local Institution - 0055
Catania
Япония (1)
Local Institution - 0109
Nagoya , Aichi-ken
Нидерландия (1)
Local Institution - 0052
Amsterdam , North Holland
Норвегия (1)
Local Institution - 0033
Bergen
Puerto Rico (1)
Local Institution - 0058
Rio Piedras
Румъния (1)
Local Institution - 0076
Cluj-Napoca , Cluj
Испания (1)
Local Institution - 0056
Badalona , Barcelona [Barcelona]
Турция (1)
Local Institution - 0092
Adana
Великобритания (1)
Local Institution - 0127
London
САЩ (1)
Local Institution - 0059
Los Angeles , California
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
05.08.2019
Крайна дата
10.06.2026
Регистрационен номер
NCT04008030
Източник
anzctr
Запитване за медицински туризъм

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