NCT04008030 - Bristol Myers Squibb™

Study Description

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.

Condition or Disease:Metastatic Colorectal Cancer
Intervention/Treatment: Biological: Ipilimumab
Drug: Oxaliplatin
Drug: Leucovorin
Drug: Fluorouracil
Drug: Irinotecan
Drug: Bevacizumab
Drug: Cetuximab
Biological: Nivolumab
Phase: Phase 3

Detailed Description

N/A

Study Design

Study Type: Interventional
Estimated Enrollment: 748 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Clinical Trial of Nivolumab Alone, Nivolumab in Combination With Ipilimumab, or an Investigator's Choice Chemotherapy in Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer

Actual Study Start Date: July 2019
Estimated Primary Completion Date: August 2025
Estimated Study Completion Date: August 2025

Arms and interventions

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

Outcome Measures

Primary Outcome Measures: 1. Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
Primary Outcome Measures: 2. PFS by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 1. Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 2. Overall Survival (OS) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 3. PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 4. PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 5. PFS by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 6. ORR by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 7. ORR by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 8. OS (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 9. PFS by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 10. OS (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 11. ORR by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 12. OS (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 13. PFS by Investigator (arm A, B and C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 14. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 15. PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 16. PFS by BICR (arm B vs C, 1L, by each central test) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 17. PFS by BICR (arm B vs A, all lines, by each central test) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 18. PFS by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures: 19. ORR by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]

Eligibility Criteria

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

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 #.

Locations

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, 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, 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
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, Yorkshire
Local Institution
Leeds

United Kingdom
Local Institution
Oxford

Sponsors and Collaborators

Bristol-Myers Squibb

Ono Pharmaceutical Co. Ltd

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04008030 History of Changes
Other Study ID Numbers: CA209-8HW, 2018-000040-26
First Posted: July 5, 2019 Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms: Microsatellite Instability Colorectal Neoplasms

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Condition Categories

Clinical Trials of Interest

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) (CheckMate 8HW)

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

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Condition Categories

Clinical Trials of Interest

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) (CheckMate 8HW)

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

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