NCT04008030
Recruiting
July 5, 2019
August 2, 2021
Brief summary:
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.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Arm B: Nivolumab + Ipilimumab Combination Specified dose on specified days |
Biological: Ipilimumab Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
Active Comparator: Arm C: Investigator's Choice Chemotherapy Specified dose on specified days. Participants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress |
Drug: Oxaliplatin Specified dose on specified days Drug: Leucovorin Specified dose on specified days Drug: Fluorouracil Specified dose on specified days Drug: Irinotecan Specified dose on specified days Drug: Bevacizumab Specified dose on specified days Drug: Cetuximab Specified dose on specified days |
Experimental: Arm A: Nivolumab Monotherapy Specified dose on specified days |
Biological: Nivolumab Specified dose on specified days |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 MSI-H or dMMR status per local standard of practice Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1 Exclusion Criteria: Participants with 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
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Arizona
Local Institution
Gilbert
United States, California
Local Institution
Los Angeles
United States, California
University of California Davis Medical Center
Sacramento
United States, Colorado
Rocky Mountain Cancer Centers
Denver
United States, Florida
Local Institution
Miami
United States, Georgia
Local Institution
Marietta
United States, Illinois
Illinois Cancer Specialists
Arlington Heights
United States, New York
Memorial Sloan Kettering Nassau
New York
United States, Oregon
Northwest Cancer Specialists (Broadway) - USOR
Portland
United States, Pennsylvania
Local Institution
Philadelphia
United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh
United States, Texas
Texas Oncology Sammons Cancer Center
Dallas
United States, Texas
Local Institution
Fort Worth
United States, Virginia
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Roanoke
Argentina, Buenos Aires
Local Institution
Ciudad Autonoma Beunos Aires
Argentina, RIO Negro
Centro de Investigaciones Clinicas. Clinica Viedma S. A
Viedma
Argentina
Fundacion Favaloro
Buenos Aires
Argentina
Hospital Italiano De Buenos Aires
Caba
Argentina
Instituto Medico Especialazado Alexander Fleming
Caba
Australia, New South Wales
Westmead Hospital
Westmead
Australia, Queensland
Local Institution
Woolloongabba
Australia, South Australia
Calvary Central Districts Hospital
Elizabeth Vale
Australia, Victoria
Local Institution
Clayton
Australia, Victoria
Warringal Private Hospital
Heidelberg
Austria
Lkh-Univ.Klinikum Graz
Graz
Austria
Ordensklinikum Standort Barmherzige Schwestern
Linz
Austria
Landeskrankenhaus-Universitaetsklinik fuer Innere Medizin III
Salzburg
Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt
Austria
Medizinische Universtaet Wien
Wien
Belgium
Local Institution
Bonheiden
Belgium
Local Institution
Brussel
Belgium
Local Institution
Bruxelles
Belgium
Local Institution
Leuven
Brazil, Minas Gerais
Local Institution
Ipatinga
Brazil, Sao Paulo
Local Institution
Barretos
Brazil, Sao Paulo
Local Institution
Sao Jose De Rio Preto
Brazil
Local Institution
Sao Paulo
Canada, Alberta
Local Institution
Edmonton
Canada, British Columbia
Local Institution
Vancouver
Canada, Nova Scotia
Local Institution
Halifax
Canada, Ontario
Mount Sinai Hospital
Toronto
Canada, Quebec
Centre Hospitalier De L'Universite De Montreal
Montreal
Canada, Quebec
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
Sherbrooke
Canada
Local Institution
Quebec
Chile, Metropolitana
Local Institution
Santiago
Chile, Metropolitana
Clinica San Carlos de Apoquindo
Santiago
Chile, Santiago
Hospital Clinico de la Universidad De Chile
Independencia
China, Anhui
Local Institution
Hefei
China, Fujian
Local Institution
Fuzhou
China, Fujian
Local Institution
Xiamen
China, Guangdong
Local Institution
Foshan
China, Guangdong
Local Institution
Guangzhou
China, Guangdong
Local Institution
Guangzhou
China, Guangdong
Local Institution
Guangzhou
China, Guangxi
Local Institution
Nanning
China, Heilongjiang
Local Institution
Harbin
China, Henan
Local Institution
Zhengzhou
China, Jiangsu
Local Institution
Changzhou
China, Jiangxi
Local Institution
Nanchang
China, Liaoning
Local Institution
Shenyang
China, Shan3xi
Local Institution
Xi'an
China, Shandong
Local Institution
Qingdao
China, Shandong
Local Institution
Yantai
China, Shanghai
Local Institution
Shanghai
China, Shanghai
Local Institution
Shanghai
China, Zhejiang
Local Institution
Hangzhou
Czechia
Klinika komplexni onkologicke pece
Brno
Czechia
Klinika onkologie a radioterapie
Hradec Kralove
Czechia
Komplexni onkologicke centrum
Novy Jicin
Czechia
Onkologicka klinika
Olomouc
Denmark
Local Institution
Herlev
Denmark
Local Institution
Odense
Denmark
Local Institution
Vejle
France
Local Institution
Bayonne
France
Chu Jean Minjoz
Besancon Cedex
France
Centre Oscar Lambret
Lille
France
CHU Limoges - Hopital Dupuytren
Limoges
France
Local Institution
Lyon
France
Centre Leon Berard
Lyon
France
Hopital De La Timone
Marseille
France
Institut du Cancer de Montpellier
Montpellier
France
CHU de Nantes - Hotel Dieu
Nantes
France
Hopital Saint Antoine
Paris
France
Hopital Du Haut-Leveque
Pessac Cedex
France
CHRU de Poitiers La Miletrie
Poitiers
France
Local Institution
Rouen
France
Local Institution
Strasbourg
France
Hopital De Rangueil C H U De Toulouse
Toulouse
Germany
Universitaetsklinikum Carl Gustav Carus
Dresden
Germany
University Hospital Essen
Essen
Germany
Facharztzentrum Eppendorf
Hamburg
Germany
Asklepios Klinik Altona
Hamburg
Germany
Medizinische Hochschule Hannover
Hannover
Germany
Uniklinik Heidelberg
Heidelberg
Germany
Universitaets-Klinikum Marburg
Marburg
Germany
Klinikum Grosshadern
Munich
Greece
Eugenidion Hospital
Athens
Greece
University General Hospital of Heraklion
Heraklion
Greece
Metropolitan General Hospital
Holargos
Greece
Ioannina University Hospital
Ioannina
Ireland, Dublin
Local Institution
Dublin 8
Ireland
Local Institution
Dublin
Ireland
Local Institution
Limerick
Italy
PO Garibaldi Nesima AORN Garibaldi
Catania
Italy
Local Institution
Genova
Italy
ASST Grande Ospedale Niguarda
Milan
Italy
AOU della Campania Luigi Vanvitelli
Napoli
Italy
I.O.V. Istituto Oncologico Veneto Ircss
Padova
Italy
Policlinico Gemelli
Roma
Japan, Aichi
Local Institution
Nagoya-shi
Japan, Chiba
Local Institution
Chiba-shi
Japan, Chiba
Local Institution
Kashiwa-shi
Japan, Ehime
Local Institution
Matsuyama
Japan, Fukuoka
Local Institution
Fukuoka-shi
Japan, Hokkaido
Local Institution
Sapporo-shi
Japan, Ishikawa
Local Institution
Kanazawa-city
Japan, Kanagawa
Local Institution
Kawasaki-shi
Japan, Kanagawa
Local Institution
Yokohama
Japan, Kumamoto
Local Institution
Kumamoto-shi
Japan, Miyagi
Local Institution
Osaki
Japan, Okayama
Local Institution
Kurashiki
Japan, Osaka
Local Institution
Suita-shi
Japan, Saitama
Local Institution
Hidaka
Japan, Saitama
Local Institution
Kitaadachigun
Japan, Shizuoka
Local Institution
Sunto-gun
Japan, Tokyo
Local Institution
Chuo-ku
Japan, Tokyo
Local Institution
Koto-ku
Japan, Tokyo
Local Institution
Minato-ku
Japan
Local Institution
Osaka
Netherlands
Local Institution
Amsterdam
Netherlands
Local Institution
Amsterdam
Netherlands
Local Institution
Utrecht
Norway
Local Institution
Bergen
Norway
Local Institution
Lorenskog
Norway
Local Institution
Oslo
Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras
Romania
Local Institution
Brasov
Romania
Local Institution
Bucharest
Romania
Local Institution
Cluj-Napoca
Romania
Local Institution
Constanta
Romania
Local Institution
Craiova
Romania
Local Institution
Suceava
Spain
Local Institution
A Coruna
Spain
Hospital Universitari Germans Trias I Pujol
Badalona-barcelona
Spain
H. Univ. Vall dHebron
Barcelona
Spain
Local Institution
Madrid
Spain
Hosp Univer 12 De Octubre
Madrid
Spain
Local Institution
Malaga
Spain
Hospital Universitario Virgen Del Rocio
Sevilla
Spain
Local Institution
Valencia
Turkey
Local Institution
Adana
Turkey
Local Institution
Istanbul
United Kingdom, Greater London
Local Institution
London
United Kingdom, Greater London
Local Institution
London
United Kingdom, Yorkshire
Local Institution
Leeds
United Kingdom
Local Institution
Oxford
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb