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Active (not recruiting) Phase 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)

Phase 3 – large-scale trial before approval
Conditions: Metastatic Colorectal Cancer

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 22
Argentina (1)
Local Institution - 0073
Ciudad Autonoma Beunos Aires , Buenos Aires
Australia (1)
Local Institution - 0019
Westmead , New South Wales
Belgium (1)
Local Institution - 0045
Bonheiden , Antwerpen
Brazil (1)
Local Institution - 0096
Ipatinga , Minas Gerais
Canada (1)
Local Institution - 0011
Edmonton , Alberta
Chile (1)
Local Institution - 0070
Independencia , Santiago Metropolitan
China (1)
Local Institution - 0146
Hefei , Anhui
Czech Republic (1)
Local Institution - 0087
Brno
Denmark (1)
Local Institution - 0038
Herlev
France (1)
Local Institution - 0176
Limoges , Haute-Vienne
Greece (1)
Local Institution - 0222
Athens
Ireland (1)
Local Institution - 0091
Dublin , Dublin
Italy (1)
Local Institution - 0055
Catania
Japan (1)
Local Institution - 0109
Nagoya , Aichi-ken
Netherlands (1)
Local Institution - 0052
Amsterdam , North Holland
Norway (1)
Local Institution - 0033
Bergen
Puerto Rico (1)
Local Institution - 0058
Rio Piedras
Romania (1)
Local Institution - 0076
Cluj-Napoca , Cluj
Spain (1)
Local Institution - 0056
Badalona , Barcelona [Barcelona]
Turkey (1)
Local Institution - 0092
Adana
United Kingdom (1)
Local Institution - 0127
London
United States (1)
Local Institution - 0059
Los Angeles , California
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
05.08.2019
Completion date
10.06.2026
Registry ID
NCT04008030
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.