美国腹部、大肠小肠 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)-出境医

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出境医 / 临床实验 / 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)

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 details |

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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	Intervention/treatment	Phase
Metastatic Colorectal Cancer	Biological: Ipilimumab Drug: Oxaliplatin Drug: Leucovorin Drug: Fluorouracil Drug: Irinotecan Drug: Bevacizumab Drug: Cetuximab Biological: Nivolumab	Phase 3

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
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 29, 2019
Estimated Primary Completion Date :	August 5, 2025
Estimated Study Completion Date :	August 5, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm A: Nivolumab Monotherapy Specified dose on specified days	Biological: Nivolumab Specified dose on specified days
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

Outcome Measures

Primary Outcome Measures :

Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
PFS by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :

Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
Overall Survival (OS) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing) [ Time Frame: Up to 5 years ]
PFS by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
ORR by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
ORR by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
OS (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
PFS by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
OS (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
ORR by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
OS (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
PFS by Investigator (arm A, B and C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
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 ]
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 ]
PFS by BICR (arm B vs C, 1L, by each central test) [ Time Frame: Up to 5 years ]
PFS by BICR (arm B vs A, all lines, by each central test) [ Time Frame: Up to 5 years ]
PFS by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]
ORR by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]

Eligibility Criteria

Layout table for eligibility information

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

Layout table for location 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

Show 147 study locations

Layout table for location information

United States, Arizona
Local Institution	Withdrawn
Gilbert, Arizona, United States, 85234
United States, California
Local Institution	Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Site 0059
University of California Davis Medical Center	Recruiting
Sacramento, California, United States, 95817
Contact: May Cho, Site 0130 916-734-3604
United States, Colorado
Rocky Mountain Cancer Centers	Recruiting
Denver, Colorado, United States, 80218
Contact: Allen Cohn, Site 0103 303-388-0136
United States, Florida
Local Institution	Withdrawn
Miami, Florida, United States, 33136
United States, Georgia
Local Institution	Withdrawn
Marietta, Georgia, United States, 30060
United States, Illinois
Illinois Cancer Specialists	Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Richard Siegel, Site 0119
United States, New York
Memorial Sloan Kettering Nassau	Recruiting
New York, New York, United States, 10065
Contact: Neil Segal, Site 0060 646-888-1396
United States, Oregon
Northwest Cancer Specialists (Broadway) - USOR	Recruiting
Portland, Oregon, United States, 97227
Contact: Spencer Shao, Site 0105 503-231-2612
United States, Pennsylvania
Local Institution	Withdrawn
Philadelphia, Pennsylvania, United States, 19104
UPMC Hillman Cancer Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Anuradha Krishnamurthy, Site 0121 412-623-8364
United States, Texas
Texas Oncology Sammons Cancer Center	Recruiting
Dallas, Texas, United States, 75246
Contact: Andrew Scott Paulson, Site 0106 214-370-1987
Local Institution	Not yet recruiting
Fort Worth, Texas, United States, 76104
Contact: Site 0170
United States, Virginia
Oncology & Hematology Associates Of Southwest Virginia, Inc.	Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mark Kochenderfer, Site 0104 540-982-0237
Argentina
Local Institution	Recruiting
Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina, 1431
Contact: Site 0073
Centro de Investigaciones Clinicas. Clinica Viedma S. A	Recruiting
Viedma, RIO Negro, Argentina, 8500
Contact: Ruben Kowalyszyn, Site 0074 542920428700
Fundacion Favaloro	Recruiting
Buenos Aires, Argentina, 1093
Contact: Guillermo Mendez, Site 0084 +541143781200
Hospital Italiano De Buenos Aires	Recruiting
Caba, Argentina, 1199
Contact: Lorena Lupinacci, Site 0100 +541149590200
Instituto Medico Especialazado Alexander Fleming	Recruiting
Caba, Argentina, 1426
Contact: Juan O'Connor, Site 0072 +541132218956
Australia, New South Wales
Local Institution	Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 0019
Australia, Queensland
Local Institution	Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Site 0053
Australia, South Australia
Local Institution	Recruiting
Elizabeth Vale, South Australia, Australia, 5112
Contact: Site 0018
Australia, Victoria
Local Institution	Recruiting
Clayton, Victoria, Australia, 3168
Contact: Site 0041
Local Institution	Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 0017
Austria
Lkh-Univ.Klinikum Graz	Recruiting
Graz, Austria, 8036
Contact: Armin Gerger, Site 0064 +4331638517070
Ordensklinikum Standort Barmherzige Schwestern	Recruiting
Linz, Austria, 4010
Contact: Holger Rumpold, Site 0068 +43073276774553
Landeskrankenhaus-Universitaetsklinik fuer Innere Medizin III	Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, Site 0120 +435725525800
Local Institution	Not yet recruiting
Wiener Neustadt, Austria, 2700
Contact: Site 0067
Medizinische Universtaet Wien	Recruiting
Wien, Austria, 1090
Contact: Gerald Prager, Site 0065 +4314040044570
Belgium
Local Institution	Recruiting
Bonheiden, Belgium, 2820
Contact: Site 0045
Local Institution	Withdrawn
Brussel, Belgium, 1090
Local Institution	Recruiting
Bruxelles, Belgium, 1000
Contact: Site 0025
Local Institution	Recruiting
Leuven, Belgium, 3000
Contact: Site 0024
Brazil
Local Institution	Recruiting
Ipatinga, Minas Gerais, Brazil, 35160-158
Contact: Site 0096
Local Institution	Recruiting
Barretos, SAO Paulo, Brazil, 14780-070
Contact: Site 0102
Local Institution	Recruiting
Sao Jose De Rio Preto, SAO Paulo, Brazil, 15091-000
Contact: Site 0094
Local Institution	Recruiting
Sao Paulo, Brazil, 01509-900
Contact: Site 0095
Canada, Alberta
Local Institution	Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site 0011
Canada, British Columbia
Local Institution	Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site 0039
Canada, Nova Scotia
Local Institution	Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Site 0012
Canada, Ontario
Mount Sinai Hospital	Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Ronald Burkes, Site 0013 4165865117
Canada, Quebec
Centre Hospitalier De L'Universite De Montreal	Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Francine Aubin, Site 0016 514890800035281
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS	Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Frederic Lemay, Site 0015 +8193461110
Canada
Local Institution	Withdrawn
Quebec, Canada, G1R 2J6
Chile
Local Institution	Recruiting
Santiago, Metropolitana, Chile, 7500921
Contact: Site 0071
Hospital Clinico de la Universidad De Chile	Recruiting
Independencia, Santiago, Chile
Contact: Olga Barajas, Site 0070 +229788974
Clinica San Carlos de Apoquindo	Recruiting
Santiago, Chile
Contact: Sebastian Mondaca, Site 0069 +56223545649
China, Anhui
Local Institution	Recruiting
Hefei, Anhui, China, 230061
Contact: Site 0146
China, Fujian
Local Institution	Not yet recruiting
Fuzhou, Fujian, China, 350001
Contact: Site 0136
Local Institution	Recruiting
Xiamen, Fujian, China, 361003
Contact: Site 0163
China, Guangdong
Local Institution	Recruiting
Foshan, Guangdong, China, 528000
Contact: Site 0158
Local Institution	Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Site 0167
Local Institution	Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Site 0149
China, Guangxi
Local Institution	Recruiting
Nanning, Guangxi, China, 530000
Contact: Site 0160
China, Jiangsu
Local Institution	Recruiting
Changzhou, Jiangsu, China, 213003
Contact: Site 0145
China, Jiangxi
Local Institution	Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Site 0151
China, Liaoning
Local Institution	Recruiting
Shenyang, Liaoning, China, 110042
Contact: Site 0162
China, Shandong
Local Institution	Recruiting
Qingdao, Shandong, China, 266061
Contact: Site 0154
Local Institution	Recruiting
Yantai, Shandong, China, 264000
Contact: Site 0165
China, Shanghai
Local Institution	Recruiting
Shanghai, Shanghai, China, 200080
Contact: Site 0143
Local Institution	Recruiting
Shanghai, Shanghai, China, 200120
Contact: Site 0131
China, Zhejiang
Local Institution	Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Site 0137
China
Local Institution	Not yet recruiting
Guangzhou, China, 510095
Contact: Site 0153
Czechia
Klinika komplexni onkologicke pece	Recruiting
Brno, Czechia, 656 53
Contact: Jiri Tomasek, Site 0087 +420543136309
Klinika onkologie a radioterapie	Recruiting
Hradec Kralove, Czechia, 500 05
Contact: Stanislav John, Site 0085 +420727854666
Komplexni onkologicke centrum	Recruiting
Novy Jicin, Czechia, 741 01
Contact: David Vrana, Site 0088 +420556916292
Onkologicka klinika	Recruiting
Olomouc, Czechia, 779 00
Contact: Bohuslav Melichar, Site 0086 +420588444295
Denmark
Local Institution	Recruiting
Herlev, Denmark, 2730
Contact: Site 0038
Local Institution	Withdrawn
Odense, Denmark, 5000
Local Institution	Recruiting
Vejle, Denmark, 7100
Contact: Site 0036
France
Chu Jean Minjoz	Recruiting
Besancon Cedex, France, 25030
Contact: Christophe Borg, Site 0028 +33381668166
Centre Oscar Lambret	Recruiting
Lille, France, 59000
Contact: Farid el Hajbi, Site 0138 +33320295942
CHU Limoges - Hopital Dupuytren	Recruiting
Limoges, France, 87042
Contact: Frederic Thuillier, Site 0176
Centre Leon Berard	Recruiting
Lyon Cedex 08, France, 69373
Contact: Christelle De La Fouchardiere, Site 0029 +33478782751
Hopital De La Timone	Recruiting
Marseille, France, 13005
Contact: Laetitia Dahan, Site 0066 +33491386023
Institut du Cancer de Montpellier	Recruiting
Montpellier, France, 34298
Contact: Emmanuelle Samalin, Site 0030 +33467613136
CHU de Nantes - Hotel Dieu	Recruiting
Nantes, France, 44093
Contact: Jaafar Bennouna, Site 0032 +33244768343
Hopital Saint Antoine	Recruiting
Paris, France, 75012
Contact: Thierry Andre, Site 0027 +33149280458
Hopital Du Haut-Leveque	Recruiting
Pessac Cedex, France, 33604
Contact: Denis Smith, Site 0061 +33557656439
CHRU de Poitiers La Miletrie	Recruiting
Poitiers, France, 86000
Contact: David Tougeron, Site 0031 +33549443751
Local Institution	Withdrawn
Rouen, France, 76000
Hopital De Rangueil C H U De Toulouse	Recruiting
Toulouse, France, 31059
Contact: Rosine Guimbaud, Site 0040 +33561323312
Germany
Universitaetsklinikum Carl Gustav Carus	Recruiting
Dresden, Germany, 01307
Contact: Gunnar Folprecht, Site 0042 +493514584190
University Hospital Essen	Recruiting
Essen, Germany, 45122
Contact: Stefan Kasper-Virchow, Site 0007 +492017231791
Facharztzentrum Eppendorf	Recruiting
Hamburg, Germany, 20249
Contact: Eray Goekkurt, Site 0043 +4940360352241
Asklepios Klinik Altona	Recruiting
Hamburg, Germany, 22763
Contact: Dirk Arnold, Site 0117 +49401818818626
Medizinische Hochschule Hannover	Recruiting
Hannover, Germany, 30625
Contact: Arndt Vogel, Site 0008
Uniklinik Heidelberg	Recruiting
Heidelberg, Germany, 69120
Contact: Georg Martin Haag, Site 0009 +4962215637630
Universitaets-Klinikum Marburg	Recruiting
Marburg, Germany, 35043
Contact: Jorge Riera-Knorrenschild, Site 0044 +4964215869034
Klinikum Grosshadern	Recruiting
Munich, Germany, 81377
Contact: Volker Heinemann, Site 0010 +4989440072333
Greece
Local Institution	Not yet recruiting
Athens, Greece, 11528
Contact: Site 0123
Local Institution

Tracking Information

First Submitted Date ^ICMJE

July 2, 2019

First Posted Date ^ICMJE

July 5, 2019

Last Update Posted Date

November 3, 2020

Actual Study Start Date ^ICMJE

July 29, 2019

Estimated Primary Completion Date

August 5, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
PFS by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]

Original Primary Outcome Measures ^ICMJE

Progression-Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to 5 years ]

Change History

Current Secondary Outcome Measures ^ICMJE

Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
Overall Survival (OS) (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed) [ Time Frame: Up to 5 years ]
PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing) [ Time Frame: Up to 5 years ]
PFS by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
ORR by BICR (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
ORR by BICR (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
OS (arm B vs A, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
PFS by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
OS (arm B vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
ORR by BICR (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
OS (arm A vs C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
PFS by Investigator (arm A, B and C, 1L, centrally confirmed) [ Time Frame: Up to 5 years ]
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 ]
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 ]
PFS by BICR (arm B vs C, 1L, by each central test) [ Time Frame: Up to 5 years ]
PFS by BICR (arm B vs A, all lines, by each central test) [ Time Frame: Up to 5 years ]
PFS by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]
ORR by BICR (crossover cohort, centrally confirmed) [ Time Frame: Up to 5 years ]

Original Secondary Outcome Measures ^ICMJE

Progression-Free Survival by Investigator Assessment [ Time Frame: Up to 5 years ]
Overall Response Rate (ORR) by Blinded Independent Central Review [ Time Frame: Up to 5 years ]
Overall Survival (OS) [ Time Frame: Up to 5 years ]
Disease Control Rate (DCR) by Blinded Independent Central Review [ Time Frame: Up to 5 years ]
Time to Response (TTR) [ Time Frame: Up to 5 years ]
Duration of Response (DOR) [ Time Frame: Up to 5 years ]
Overall Response Rate (ORR) by investigator assessment [ Time Frame: Up to 5 years ]
Disease Control Rate by Investigator Assessment [ Time Frame: Up to 5 years ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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

Brief Summary

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Colorectal Cancer

Intervention ^ICMJE

Biological: Ipilimumab
Specified dose on specified days
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
Biological: Nivolumab
Specified dose on specified days

Study Arms ^ICMJE

Experimental: Arm A: Nivolumab Monotherapy
Specified dose on specified days

Intervention: Biological: Nivolumab
Experimental: Arm B: Nivolumab + Ipilimumab Combination
Specified dose on specified days
Interventions:
- Biological: Ipilimumab
- Biological: Nivolumab
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
Interventions:
- Drug: Oxaliplatin
- Drug: Leucovorin
- Drug: Fluorouracil
- Drug: Irinotecan
- Drug: Bevacizumab
- Drug: Cetuximab

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

748

Original Estimated Enrollment ^ICMJE

494

Estimated Study Completion Date ^ICMJE

August 5, 2025

Estimated Primary Completion Date

August 5, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

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 #.

Listed Location Countries ^ICMJE

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Japan, Netherlands, Norway, Puerto Rico, Romania, Spain, Turkey, United Kingdom, United States

Removed Location Countries

Poland

Administrative Information

NCT Number ^ICMJE

NCT04008030

Other Study ID Numbers ^ICMJE

CA209-8HW
2018-000040-26 ( EudraCT Number )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Ono Pharmaceutical Co. Ltd

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

PRS Account

Bristol-Myers Squibb

Verification Date

November 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

梅奥诊所
美国最佳医院荣誉榜第1名
克利夫兰诊所
美国最佳医院荣誉榜第2名
约翰霍普金斯医院
美国最佳医院荣誉榜第3名
麻省总医院
美国最佳医院荣誉榜第4名
密歇根大学医院
美国最佳医院荣誉榜第5名
倉敷中央医院
日本综合排名第1名
順天堂医院
日本综合排名第2名
藤田医科大学医院（原藤田保健大学医院)
日本综合排名第3名
北里大学医院
日本综合排名第4名
東京医科大学医院
日本综合排名第5名

4006 776 356

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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)

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