Back to resultsAn Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy (CheckMate 451)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects with histologically or cytologically confirmed extensive stage disease SCLC
- Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Subjects with symptomatic Central Nervous System (CNS) metastases
- Subjects receiving consolidative chest radiation
- Subjects with active, known, or suspected autoimmune disease are excluded
- All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Local Institution - 0003
- Local Institution - 0202
- Local Institution - 0127
- Local Institution - 0007
- Local Institution - 0128
- Local Institution - 0010
- Local Institution - 0013
- Local Institution - 0061
- Local Institution - 0012
- Local Institution - 0032
- Local Institution - 0051
- Local Institution - 0107
- Local Institution - 0207
- Local Institution - 0015
- Local Institution - 0008
- Local Institution - 0014
- Local Institution - 0016
- Local Institution - 0215
- Local Institution - 0129
- Local Institution - 0009
- Local Institution - 0001
- Local Institution - 0034
- Local Institution - 0004
- Local Institution - 0002
- Local Institution - 0005
- Local Institution - 0213
- Local Institution - 0011
- Local Institution - 0006
- Local Institution - 0110
- Local Institution - 0088
- Local Institution - 0109
- Local Institution - 0188
- Local Institution - 0029
- Local Institution
- Local Institution
- Local Institution
- Princess Alexandra Hospital
- Local Institution - 0137
- Local Institution - 0035
- Local Institution - 0174
- Local Institution - 0173
- Local Institution - 0172
- Local Institution - 0057
- Local Institution - 0059
- Local Institution - 0060
- Local Institution - 0067
- Local Institution - 0068
- Local Institution - 0063
- Local Institution - 0064
- Local Institution - 0017
- Local Institution - 0081
- Local Institution
- Local Institution
- Local Institution - 0094
- Local Institution - 0136
- Local Institution - 0123
- Local Institution - 0102
- Local Institution - 0111
- Local Institution - 0238
- Local Institution - 0243
- Local Institution
- Local Institution
- Local Institution - 0221
- Local Institution - 0244
- Local Institution - 0248
- Local Institution - 0230
- Local Institution
- Local Institution - 0237
- Local Institution - 0220
- Local Institution - 0228
- Local Institution - 0233
- Local Institution - 0245
- Local Institution - 0232
- Local Institution - 0239
- Local Institution - 0227
- Local Institution - 0246
- Local Institution - 0247
- Local Institution - 0240
- Local Institution
- Local Institution - 0078
- Local Institution
- Local Institution - 0044
- Local Institution - 0043
- Local Institution - 0045
- Local Institution - 0046
- Local Institution - 0149
- Local Institution - 0208
- Local Institution - 0099
- Local Institution - 0098
- Local Institution - 0097
- Local Institution - 0095
- Local Institution - 0100
- Local Institution - 0150
- Local Institution - 0096
- Local Institution - 0171
- Local Institution - 0170
- Local Institution - 0168
- Local Institution - 0164
- Local Institution - 0166
- Local Institution - 0165
- Local Institution - 0169
- Local Institution - 0167
- Local Institution - 0080
- Interbalkan European Medical Center
- Local Institution - 0052
- Local Institution - 0161
- Local Institution - 0175
- Local Institution
- Local Institution - 0162
- Local Institution - 0214
- Local Institution
- Local Institution - 0093
- Local Institution
- Local Institution - 0090
- Local Institution - 0089
- Local Institution - 0027
- Local Institution - 0026
- Local Institution - 0025
- Local Institution - 0112
- Local Institution - 0082
- Local Institution - 0139
- Local Institution - 0142
- Local Institution - 0146
- Local Institution - 0200
- Local Institution - 0198
- Local Institution - 0143
- Local Institution - 0076
- Local Institution - 0138
- Local Institution - 0072
- Local Institution - 0070
- Local Institution - 0069
- Local Institution - 0077
- Local Institution
- Local Institution - 0075
- Local Institution - 0145
- Local Institution - 0083
- Local Institution - 0193
- Local Institution - 0141
- Local Institution - 0071
- Local Institution - 0140
- Local Institution - 0144
- Local Institution - 0216
- Local Institution - 0047
- Local Institution - 0024
- Local Institution - 0021
- Local Institution - 0022
- Local Institution - 0154
- Local Institution - 0019
- Local Institution - 0020
- Local Institution - 0028
- Local Institution - 0135
- Local Institution - 0158
- Local Institution
- Local Institution - 0159
- Local Institution
- Local Institution
- Local Institution
- Local Institution - 0041
- Local Institution - 0054
- Local Institution - 0053
- Local Institution - 0187
- Local Institution - 0199
- Local Institution - 0186
- Local Institution - 0182
- Local Institution - 0178
- Local Institution - 0212
- Local Institution - 0181
- Local Institution - 0148
- Local Institution - 0217
- Local Institution - 0209
- Local Institution - 0157
- Local Institution - 0115
- Local Institution - 0116
- Local Institution - 0050
- Local Institution - 0087
- Local Institution - 0084
- Local Institution - 0085
- Local Institution - 0086
- Local Institution - 0132
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution - 0124
- Local Institution - 0185
- Local Institution - 0179
- Local Institution - 0180
- Local Institution - 0191
- Local Institution - 0049
- Local Institution - 0048
- Local Institution - 0153
- Local Institution - 0118
- Local Institution - 0201
- Local Institution - 0121
- Local Institution - 0152
- Local Institution - 0151
- Local Institution - 0192
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Nivolumab monotherapy
Nivolumab and ipilimumab combination therapy
Placebo
Arm Description
Nivolumab intravenous fusion
Nivolumab and ipilimumab intravenous fusion
Placebo
Outcomes
Primary Outcome Measures
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population
OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug
Secondary Outcome Measures
Overall Survival (OS) of Nivolumab Versus Placebo
Overall Survival (OS) comparing nivolumab monotherapy versus placebo. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab
Overall Survival (OS) comparing Nivolumab + Ipilimumab Versus Nivolumab. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.
Progression Free Survival (PFS) Per BICR
PFS was defined as the time between the date of randomization and the first date of documented progression as determined by Blind Independent Central Review (BICR) or death due to any cause, whichever occurred first. Participants who died with no reported progression were considered to have progressed on the date of death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on study tumor assessments and did not die (or died after initiation of the subsequent anti- cancer therapy) were censored on their date of randomization. Participants who started any subsequent anti- cancer therapy without a prior reported Progressive Disease (PD) per BICR were censored at the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population
Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.
OS in TMB by the following cutoff points: ≥10 mutations/mb, < 10 mutations/mb, ≥13 mutations/mb, <13 mutations/mb
Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population
Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.
PFS in TMB by the following cutoff points: ≥10 mutations/mb, < 10 mutations/mb, ≥13 mutations/mb, <13 mutations/mb.
Full Information
NCT ID
NCT02538666
First Posted
August 26, 2015
Last Updated
December 13, 2022
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02538666
Brief Title
An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy
Acronym
CheckMate 451
Official Title
A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 13, 2015 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
November 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
907 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nivolumab monotherapy
Arm Type
Experimental
Arm Description
Nivolumab intravenous fusion
Arm Title
Nivolumab and ipilimumab combination therapy
Arm Type
Experimental
Arm Description
Nivolumab and ipilimumab intravenous fusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population
Description
OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug
Time Frame
From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS) of Nivolumab Versus Placebo
Description
Overall Survival (OS) comparing nivolumab monotherapy versus placebo. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.
Time Frame
From randomization to the date of death or last known alive date (up to approximately 73 months)
Title
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab
Description
Overall Survival (OS) comparing Nivolumab + Ipilimumab Versus Nivolumab. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.
Time Frame
From randomization to the date of death or last known alive date (up to approximately 73 months)
Title
Progression Free Survival (PFS) Per BICR
Description
PFS was defined as the time between the date of randomization and the first date of documented progression as determined by Blind Independent Central Review (BICR) or death due to any cause, whichever occurred first. Participants who died with no reported progression were considered to have progressed on the date of death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on study tumor assessments and did not die (or died after initiation of the subsequent anti- cancer therapy) were censored on their date of randomization. Participants who started any subsequent anti- cancer therapy without a prior reported Progressive Disease (PD) per BICR were censored at the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
Time Frame
From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)
Title
Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population
Description
Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.
OS in TMB by the following cutoff points: ≥10 mutations/mb, < 10 mutations/mb, ≥13 mutations/mb, <13 mutations/mb
Time Frame
From randomization to the date of death or last known alive date (up to approximately 73 months)
Title
Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population
Description
Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined.
PFS in TMB by the following cutoff points: ≥10 mutations/mb, < 10 mutations/mb, ≥13 mutations/mb, <13 mutations/mb.
Time Frame
From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with histologically or cytologically confirmed extensive stage disease SCLC
Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
Subjects with symptomatic Central Nervous System (CNS) metastases
Subjects receiving consolidative chest radiation
Subjects with active, known, or suspected autoimmune disease are excluded
All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
Other protocol-defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0003
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Local Institution - 0202
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Local Institution - 0127
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Local Institution - 0007
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Local Institution - 0128
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Local Institution - 0010
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution - 0013
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Local Institution - 0061
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Local Institution - 0012
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Local Institution - 0032
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Local Institution - 0051
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Local Institution - 0107
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0207
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0015
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution - 0008
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 0014
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution - 0016
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Local Institution - 0215
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
Local Institution - 0129
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Local Institution - 0009
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Local Institution - 0001
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Local Institution - 0034
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Local Institution - 0004
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Local Institution - 0002
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Local Institution - 0005
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0213
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Local Institution - 0011
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Local Institution - 0006
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Local Institution - 0110
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
1880
Country
Argentina
Facility Name
Local Institution - 0088
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0109
City
Ciudad Autonoma De Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Local Institution - 0188
City
Cordoba
ZIP/Postal Code
5004
Country
Argentina
Facility Name
Local Institution - 0029
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
Local Institution
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Local Institution
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution - 0137
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution - 0035
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Local Institution - 0174
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Local Institution - 0173
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution - 0172
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Local Institution - 0057
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution - 0059
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Local Institution - 0060
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Local Institution - 0067
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
Local Institution - 0068
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-022
Country
Brazil
Facility Name
Local Institution - 0063
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution - 0064
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90610000
Country
Brazil
Facility Name
Local Institution - 0017
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Local Institution - 0081
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Local Institution
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Local Institution
City
Salvador
ZIP/Postal Code
40170-110
Country
Brazil
Facility Name
Local Institution - 0094
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution - 0136
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Local Institution - 0123
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Local Institution - 0102
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Local Institution - 0111
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1L9
Country
Canada
Facility Name
Local Institution - 0238
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Local Institution - 0243
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100001
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Local Institution - 0221
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
155040
Country
China
Facility Name
Local Institution - 0244
City
Wuhang
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Local Institution - 0248
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226361
Country
China
Facility Name
Local Institution - 0230
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution - 0237
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110046
Country
China
Facility Name
Local Institution - 0220
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Local Institution - 0228
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Local Institution - 0233
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Local Institution - 0245
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Local Institution - 0232
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Facility Name
Local Institution - 0239
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Local Institution - 0227
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Local Institution - 0246
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Local Institution - 0247
City
Changsha
ZIP/Postal Code
0
Country
China
Facility Name
Local Institution - 0240
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Local Institution
City
Monteria
State/Province
Cordoba
Country
Colombia
Facility Name
Local Institution - 0078
City
Bogota
ZIP/Postal Code
0
Country
Colombia
Facility Name
Local Institution
City
Medellin
ZIP/Postal Code
MEDELLIN
Country
Colombia
Facility Name
Local Institution - 0044
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
Local Institution - 0043
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Local Institution - 0045
City
Turku
ZIP/Postal Code
FIN-20521
Country
Finland
Facility Name
Local Institution - 0046
City
Vaasa
ZIP/Postal Code
65130
Country
Finland
Facility Name
Local Institution - 0149
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67091
Country
France
Facility Name
Local Institution - 0208
City
Avignon Cedes 9
ZIP/Postal Code
84918
Country
France
Facility Name
Local Institution - 0099
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Local Institution - 0098
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Local Institution - 0097
City
Paris Cedex 20
ZIP/Postal Code
75970
Country
France
Facility Name
Local Institution - 0095
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution - 0100
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution - 0150
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Local Institution - 0096
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution - 0171
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Local Institution - 0170
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Local Institution - 0168
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Local Institution - 0164
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Local Institution - 0166
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Local Institution - 0165
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Local Institution - 0169
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Local Institution - 0167
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution - 0080
City
N.Kifissia
ZIP/Postal Code
14564
Country
Greece
Facility Name
Interbalkan European Medical Center
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Local Institution - 0052
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Local Institution - 0161
City
Wilton
State/Province
Cork
ZIP/Postal Code
0
Country
Ireland
Facility Name
Local Institution - 0175
City
Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Local Institution - 0162
City
Galway
ZIP/Postal Code
ST4 6QG
Country
Ireland
Facility Name
Local Institution - 0214
City
Limerick
ZIP/Postal Code
0
Country
Ireland
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Local Institution - 0093
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Local Institution
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Local Institution - 0090
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution - 0089
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Local Institution - 0027
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution - 0026
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Local Institution - 0025
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution - 0112
City
Messina
ZIP/Postal Code
98158
Country
Italy
Facility Name
Local Institution - 0082
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Local Institution - 0139
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Local Institution - 0142
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
7910280
Country
Japan
Facility Name
Local Institution - 0146
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8128582
Country
Japan
Facility Name
Local Institution - 0200
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
8300011
Country
Japan
Facility Name
Local Institution - 0198
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
5008513
Country
Japan
Facility Name
Local Institution - 0143
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution - 0076
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
Facility Name
Local Institution - 0138
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
9208641
Country
Japan
Facility Name
Local Institution - 0072
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2408555
Country
Japan
Facility Name
Local Institution - 0070
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9800873
Country
Japan
Facility Name
Local Institution - 0069
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Local Institution - 0077
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
7108602
Country
Japan
Facility Name
Local Institution
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
5731191
Country
Japan
Facility Name
Local Institution - 0075
City
Osaka-sayama-shi
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution - 0145
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5340021
Country
Japan
Facility Name
Local Institution - 0083
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Facility Name
Local Institution - 0193
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Local Institution - 0141
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Local Institution - 0071
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
Local Institution - 0140
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
1358550
Country
Japan
Facility Name
Local Institution - 0144
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
1600023
Country
Japan
Facility Name
Local Institution - 0216
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Local Institution - 0047
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Local Institution - 0024
City
Suwon
State/Province
Kyǒnggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Local Institution - 0021
City
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 0022
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution - 0154
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution - 0019
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Local Institution - 0020
City
Leon de los Aldama
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Local Institution - 0028
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Local Institution - 0135
City
Queretaro
ZIP/Postal Code
76090
Country
Mexico
Facility Name
Local Institution - 0158
City
's-Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Local Institution
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Local Institution - 0159
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Local Institution
City
Miraflores
State/Province
Lima
ZIP/Postal Code
18
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
Local Institution - 0041
City
Gdansk
ZIP/Postal Code
80-19
Country
Poland
Facility Name
Local Institution - 0054
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Local Institution - 0053
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Local Institution - 0187
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0199
City
Bucharest
ZIP/Postal Code
010991
Country
Romania
Facility Name
Local Institution - 0186
City
Bucharest
ZIP/Postal Code
020122
Country
Romania
Facility Name
Local Institution - 0182
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Local Institution - 0178
City
Lasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Local Institution - 0212
City
Romania
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution - 0181
City
Timisoara, Timis
ZIP/Postal Code
300239
Country
Romania
Facility Name
Local Institution - 0148
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Local Institution - 0217
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution - 0209
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Local Institution - 0157
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution - 0115
City
St Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Local Institution - 0116
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Local Institution - 0050
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Local Institution - 0087
City
Sandton
State/Province
Gauteng
ZIP/Postal Code
2199
Country
South Africa
Facility Name
Local Institution - 0084
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Local Institution - 0085
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Local Institution - 0086
City
George
State/Province
Western CAPE
ZIP/Postal Code
6530
Country
South Africa
Facility Name
Local Institution - 0132
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Local Institution
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution - 0124
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Local Institution - 0185
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Local Institution - 0179
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Local Institution - 0180
City
Geneve
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Local Institution - 0191
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Local Institution - 0049
City
Tainan
State/Province
TNN
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution - 0048
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Local Institution - 0153
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Local Institution - 0118
City
London
State/Province
Greater London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Local Institution - 0201
City
London
State/Province
Greater London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Local Institution - 0121
City
Wirral
State/Province
Lancashire
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Local Institution - 0152
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Local Institution - 0151
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Local Institution - 0192
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35383114
Citation
Kang YK, Reck M, Nghiem P, Feng Y, Plautz G, Kim HR, Owonikoko TK, Boku N, Chen LT, Lei M, Chang H, Lin WH, Roy A, Bello A, Sheng J. Assessment of hyperprogression versus the natural course of disease development with nivolumab with or without ipilimumab versus placebo in phase III, randomized, controlled trials. J Immunother Cancer. 2022 Apr;10(4):e004273. doi: 10.1136/jitc-2021-004273.
Results Reference
derived
PubMed Identifier
33683919
Citation
Owonikoko TK, Park K, Govindan R, Ready N, Reck M, Peters S, Dakhil SR, Navarro A, Rodriguez-Cid J, Schenker M, Lee JS, Gutierrez V, Percent I, Morgensztern D, Barrios CH, Greillier L, Baka S, Patel M, Lin WH, Selvaggi G, Baudelet C, Baden J, Pandya D, Doshi P, Kim HR. Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451. J Clin Oncol. 2021 Apr 20;39(12):1349-1359. doi: 10.1200/JCO.20.02212. Epub 2021 Mar 8.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy
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