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
- Conditions
- Lung Cancer
- Interventions
- Biological: NivolumabOther: PlaceboBiological: Ipilimumab
- Registration Number
- NCT02538666
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 907
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nivolumab monotherapy Nivolumab Nivolumab intravenous fusion Nivolumab and ipilimumab combination therapy Ipilimumab Nivolumab and ipilimumab intravenous fusion Placebo Placebo Placebo Nivolumab and ipilimumab combination therapy Nivolumab Nivolumab and ipilimumab intravenous fusion
- Primary Outcome Measures
Name Time Method Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months) 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
Name Time Method Overall Survival (OS) of Nivolumab Versus Placebo From randomization to the date of death or last known alive date (up to approximately 73 months) 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 From randomization to the date of death or last known alive date (up to approximately 73 months) 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 From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months) 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 From randomization to the date of death or last known alive date (up to approximately 73 months) 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/mbProgression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months) 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.
Trial Locations
- Locations (176)
Local Institution - 0020
🇲🇽Leon de los Aldama, Guanajuato, Mexico
Local Institution - 0063
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0244
🇨🇳Wuhang, Hubei, China
Local Institution - 0230
🇨🇳Nanchang, Jiangxi, China
Local Institution - 0237
🇨🇳Shenyang, Liaoning, China
Local Institution - 0228
🇨🇳Shanghai, Shanghai, China
Local Institution - 0239
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0014
🇺🇸Durham, North Carolina, United States
Local Institution - 0129
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0001
🇺🇸Portland, Oregon, United States
Local Institution - 0034
🇺🇸Portland, Oregon, United States
Local Institution - 0142
🇯🇵Matsuyama-shi, Ehime, Japan
Local Institution - 0143
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution - 0083
🇯🇵Takatsuki-shi, Osaka, Japan
Local Institution - 0127
🇺🇸Fort Myers, Florida, United States
Local Institution - 0004
🇺🇸Allentown, Pennsylvania, United States
Local Institution - 0013
🇺🇸Indianapolis, Indiana, United States
Local Institution - 0008
🇺🇸New York, New York, United States
Local Institution - 0003
🇺🇸Sacramento, California, United States
Local Institution - 0015
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0107
🇺🇸Boston, Massachusetts, United States
Local Institution - 0032
🇺🇸Lexington, Kentucky, United States
Local Institution - 0213
🇺🇸Sioux Falls, South Dakota, United States
Local Institution - 0035
🇦🇺East Melbourne, Victoria, Australia
Local Institution
🇪🇸Sevilla, Spain
Local Institution - 0188
🇦🇷Cordoba, Argentina
Local Institution - 0173
🇦🇹Salzburg, Austria
Local Institution - 0137
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0233
🇨🇳Shanghai, Shanghai, China
Local Institution - 0245
🇨🇳Shanghai, Shanghai, China
Local Institution - 0080
🇬🇷N.Kifissia, Greece
Local Institution - 0240
🇨🇳Guangzhou, China
Local Institution - 0128
🇺🇸Saint Petersburg, Florida, United States
Local Institution - 0094
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0002
🇺🇸Sayre, Pennsylvania, United States
Local Institution - 0238
🇨🇳Hefei, Anhui, China
Local Institution - 0243
🇨🇳Hefei, Anhui, China
Local Institution - 0221
🇨🇳Harbin, Heilongjiang, China
Local Institution - 0248
🇨🇳Nantong, Jiangsu, China
Local Institution - 0111
🇨🇦Windsor, Ontario, Canada
Local Institution - 0029
🇦🇷Tucuman, Argentina
Local Institution - 0123
🇨🇦Oshawa, Ontario, Canada
Local Institution - 0232
🇨🇳Kunming, Yunnan, China
Local Institution - 0068
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0166
🇩🇪Gauting, Germany
Local Institution - 0102
🇨🇦Sudbury, Ontario, Canada
Local Institution - 0220
🇨🇳Shanghai, Shanghai, China
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0081
🇧🇷Barretos, Sao Paulo, Brazil
Local Institution - 0097
🇫🇷Paris Cedex 20, France
Local Institution - 0247
🇨🇳Changsha, China
Local Institution - 0150
🇫🇷Saint Herblain, France
Local Institution - 0096
🇫🇷Toulouse, France
Local Institution - 0078
🇨🇴Bogota, Colombia
Local Institution - 0045
🇫🇮Turku, Finland
Local Institution - 0046
🇫🇮Vaasa, Finland
Local Institution - 0208
🇫🇷Avignon Cedes 9, France
Local Institution - 0098
🇫🇷Marseille Cedex 20, France
Local Institution - 0246
🇨🇳Wenzhou, Zhejiang, China
Local Institution - 0112
🇮🇹Messina, Italy
Local Institution - 0171
🇩🇪Augsburg, Germany
Local Institution - 0099
🇫🇷Lyon Cedex 08, France
Local Institution - 0139
🇯🇵Kashiwa-shi, Chiba, Japan
Local Institution - 0072
🇯🇵Yokohama-shi, Kanagawa, Japan
Local Institution - 0090
🇮🇱Tel Aviv, Israel
Local Institution - 0100
🇫🇷Rennes Cedex 9, France
Local Institution - 0095
🇫🇷Pierre Benite, France
Interbalkan European Medical Center
🇬🇷Thessaloniki, Greece
Local Institution - 0164
🇩🇪Bochum, Germany
Local Institution - 0025
🇮🇹Bologna, Italy
Local Institution - 0146
🇯🇵Fukuoka-shi, Fukuoka, Japan
Local Institution - 0027
🇮🇹Milan, Lombardia, Italy
Local Institution - 0026
🇮🇹Avellino, Italy
Local Institution - 0076
🇯🇵Kobe-shi, Hyogo, Japan
Local Institution - 0145
🇯🇵Osaka-shi, Osaka, Japan
Local Institution - 0082
🇮🇹Perugia, Italy
Local Institution - 0200
🇯🇵Kurume-shi, Fukuoka, Japan
Local Institution - 0198
🇯🇵Gifu-shi, Gifu, Japan
Local Institution - 0069
🇯🇵Sendai-shi, Miyagi, Japan
Local Institution - 0138
🇯🇵Kanazawa-shi, Ishikawa, Japan
Local Institution - 0077
🇯🇵Kurashiki-shi, Okayama, Japan
Local Institution - 0159
🇳🇱Rotterdam, Netherlands
Local Institution - 0070
🇯🇵Sendai-shi, Miyagi, Japan
Local Institution - 0135
🇲🇽Queretaro, Mexico
Local Institution - 0157
🇷🇺St Petersburg, Russian Federation
Local Institution - 0115
🇷🇺St Petersburg, Russian Federation
Local Institution - 0087
🇿🇦Sandton, Gauteng, South Africa
Local Institution - 0067
🇧🇷Fortaleza, Ceara, Brazil
Local Institution - 0168
🇩🇪Berlin, Germany
Local Institution - 0169
🇩🇪Immenhausen, Germany
Local Institution - 0093
🇮🇱Jerusalem, Israel
Local Institution - 0207
🇺🇸Boston, Massachusetts, United States
Local Institution - 0005
🇺🇸Charleston, South Carolina, United States
Local Institution - 0009
🇺🇸Columbus, Ohio, United States
Local Institution - 0006
🇺🇸Richmond, Virginia, United States
Local Institution - 0010
🇺🇸Atlanta, Georgia, United States
Local Institution - 0061
🇺🇸Fairway, Kansas, United States
Local Institution - 0051
🇺🇸Baltimore, Maryland, United States
Local Institution - 0007
🇺🇸Jacksonville, Florida, United States
Local Institution - 0215
🇺🇸Fargo, North Dakota, United States
Local Institution - 0011
🇺🇸Salt Lake City, Utah, United States
Local Institution - 0110
🇦🇷Berazategui, Buenos Aires, Argentina
Local Institution - 0017
🇧🇷Itajai, Santa Catarina, Brazil
Local Institution - 0167
🇩🇪Tübingen, Germany
Local Institution - 0149
🇫🇷Strasbourg, Alsace, France
Local Institution - 0227
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0170
🇩🇪Bad Berka, Germany
Local Institution - 0165
🇩🇪Grosshansdorf, Germany
Local Institution - 0089
🇮🇱Zerifin, Israel
Local Institution - 0075
🇯🇵Osaka-sayama-shi, Osaka, Japan
Local Institution - 0193
🇯🇵Hidaka, Saitama, Japan
Local Institution - 0140
🇯🇵Koto-ku, Tokyo, Japan
Local Institution - 0071
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0144
🇯🇵Shinjuku-ku, Tokyo, Japan
Local Institution - 0216
🇯🇵Wakayama, Japan
Local Institution - 0047
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Local Institution - 0022
🇰🇷Seoul, Korea, Republic of
Local Institution - 0154
🇰🇷Seoul, Korea, Republic of
Local Institution - 0024
🇰🇷Suwon, Kyǒnggi-do, Korea, Republic of
Local Institution - 0021
🇰🇷Gangnam-gu, Korea, Republic of
Local Institution - 0028
🇲🇽Monterrey, Nuevo Leon, Mexico
Local Institution - 0019
🇲🇽Mexico, Distrito Federal, Mexico
Local Institution - 0158
🇳🇱's-Hertogenbosch, Netherlands
Local Institution - 0054
🇵🇱Gdynia, Poland
Local Institution - 0041
🇵🇱Gdansk, Poland
Local Institution - 0186
🇷🇴Bucharest, Romania
Local Institution - 0053
🇵🇱Olsztyn, Poland
Local Institution - 0187
🇵🇱Warszawa, Poland
Local Institution - 0209
🇷🇺Moscow, Russian Federation
Local Institution - 0182
🇷🇴Craiova, Romania
Local Institution - 0178
🇷🇴Lasi, Romania
Local Institution - 0212
🇷🇴Romania, Romania
Local Institution - 0148
🇷🇺Moscow, Russian Federation
Local Institution - 0181
🇷🇴Timisoara, Timis, Romania
Local Institution - 0217
🇷🇺Moscow, Russian Federation
Local Institution - 0116
🇷🇺St. Petersburg, Russian Federation
Local Institution - 0086
🇿🇦George, Western CAPE, South Africa
Local Institution - 0084
🇿🇦Cape Town, Western Cape, South Africa
Local Institution - 0085
🇿🇦Cape Town, Western CAPE, South Africa
Local Institution - 0050
🇸🇬Singapore, Singapore
Local Institution - 0124
🇸🇪Lund, Sweden
Local Institution - 0185
🇸🇪Uppsala, Sweden
Local Institution - 0132
🇪🇸Barcelona, Spain
Local Institution - 0179
🇨🇭Aarau, Switzerland
Local Institution - 0191
🇨🇭St. Gallen, Switzerland
Local Institution - 0153
🇬🇧Truro, Cornwall, United Kingdom
Local Institution - 0049
🇨🇳Tainan, TNN, Taiwan
Local Institution - 0201
🇬🇧London, Greater London, United Kingdom
Local Institution - 0118
🇬🇧London, Greater London, United Kingdom
Local Institution - 0048
🇨🇳Taoyuan, Taiwan
Local Institution - 0152
🇬🇧Oxford, Oxfordshire, United Kingdom
Local Institution - 0151
🇬🇧Sutton, Surrey, United Kingdom
Local Institution - 0192
🇬🇧Sheffield, United Kingdom
Local Institution - 0121
🇬🇧Wirral, Lancashire, United Kingdom
Local Institution - 0109
🇦🇷Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Local Institution - 0059
🇧🇪Charleroi, Belgium
Local Institution - 0175
🇮🇪Dublin, Ireland
Local Institution - 0214
🇮🇪Limerick, Ireland
Local Institution - 0199
🇷🇴Bucharest, Romania
Local Institution - 0136
🇨🇦Moncton, New Brunswick, Canada
Local Institution - 0172
🇦🇹Wien, Austria
Local Institution - 0060
🇧🇪Roeselare, Belgium
Local Institution - 0043
🇫🇮Tampere, Finland
Local Institution - 0141
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0057
🇧🇪Brussels, Belgium
Local Institution - 0180
🇨🇭Geneve, Switzerland
Local Institution - 0044
🇫🇮Oulu, Finland
Local Institution - 0174
🇦🇹Innsbruck, Austria
Local Institution - 0161
🇮🇪Wilton, Cork, Ireland
Local Institution - 0162
🇮🇪Galway, Ireland
Local Institution - 0202
🇺🇸New Haven, Connecticut, United States
Local Institution - 0012
🇺🇸Wichita, Kansas, United States
Local Institution - 0016
🇺🇸Winston-Salem, North Carolina, United States
Local Institution - 0064
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0088
🇦🇷Capital Federal, Buenos Aires, Argentina
Local Institution - 0052
🇭🇰Hong Kong, Hong Kong