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 (CheckMate 451)

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)

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Placebo; Biological: Nivolumab; Biological: Ipilimumab

• Study Type: Interventional
• Enrollment (Actual): 907
• Phase: Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, 5004
    • Local Institution - 0188
  • Tucuman, Argentina, 4000
    • Local Institution - 0029
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, 1880
      • Local Institution - 0110
    • Capital Federal, Buenos Aires, Argentina, 1426
      • Local Institution - 0088
    • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181
      • Local Institution - 0109
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia
      • Local Institution
    • Wollongong, New South Wales, Australia, 2500
      • Local Institution
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Local Institution
    • Brisbane, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution - 0137
  • Victoria
    • East Melbourne, Victoria, Australia, 3165
      • Local Institution - 0035
• Austria
  • Innsbruck, Austria, 6020
    • Local Institution - 0174
  • Salzburg, Austria, 5020
    • Local Institution - 0173
  • Wien, Austria, 1130
    • Local Institution - 0172
• Belgium
  • Brussels, Belgium, 1090
    • Local Institution - 0057
  • Charleroi, Belgium, 6000
    • Local Institution - 0059
  • Roeselare, Belgium, 8800
    • Local Institution - 0060
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Local Institution
  • Salvador, Brazil, 40170-110
    • Local Institution
  • Ceara
    • Fortaleza, Ceara, Brazil, 60430-230
      • Local Institution - 0067
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110-022
      • Local Institution - 0068
  • RIO Grande DO SUL
    • Ijui, RIO Grande DO SUL, Brazil, 98700-000
      • Local Institution - 0063
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90610000
      • Local Institution - 0064
  • Santa Catarina
    • Itajai, Santa Catarina, Brazil, 88301-220
      • Local Institution - 0017
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784-400
      • Local Institution - 0081
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Local Institution - 0094
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Local Institution - 0136
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • Local Institution - 0123
    • Sudbury, Ontario, Canada, P3E 5J1
      • Local Institution - 0102
    • Windsor, Ontario, Canada, N8W 1L9
      • Local Institution - 0111
• China
  • Changsha, China
    • Local Institution - 0247
  • Guangzhou, China, 510515
    • Local Institution - 0240
  • Anhui
    • Hefei, Anhui, China, 230001
      • Local Institution - 0238
    • Hefei, Anhui, China, 230022
      • Local Institution - 0243
  • Beijing
    • Beijing, Beijing, China, 100001
      • Local Institution
    • Beijing, Beijing, China, 100142
      • Local Institution
  • Heilongjiang
    • Harbin, Heilongjiang, China, 155040
      • Local Institution - 0221
  • Hubei
    • Wuhang, Hubei, China, 430030
      • Local Institution - 0244
  • Jiangsu
    • Nantong, Jiangsu, China, 226361
      • Local Institution - 0248
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Local Institution - 0230
  • Jilin
    • Changchun, Jilin, China, 130021
      • Local Institution
  • Liaoning
    • Shenyang, Liaoning, China, 110046
      • Local Institution - 0237
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Local Institution - 0220
    • Shanghai, Shanghai, China, 200030
      • Local Institution - 0228
    • Shanghai, Shanghai, China, 200032
      • Local Institution - 0233
    • Shanghai, Shanghai, China, 200433
      • Local Institution - 0245
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Local Institution - 0232
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Local Institution - 0239
    • Hangzhou, Zhejiang, China, 310016
      • Local Institution - 0227
    • Wenzhou, Zhejiang, China, 325000
      • Local Institution - 0246
• Colombia
  • Bogota, Colombia
    • Local Institution - 0078
  • Medellin, Colombia, MEDELLIN
    • Local Institution
  • Cordoba
    • Monteria, Cordoba, Colombia
      • Local Institution
• Finland
  • Oulu, Finland, 90029
    • Local Institution - 0044
  • Tampere, Finland, 33521
    • Local Institution - 0043
  • Turku, Finland, FIN-20521
    • Local Institution - 0045
  • Vaasa, Finland, 65130
    • Local Institution - 0046
• France
  • Avignon Cedes 9, France, 84918
    • Local Institution - 0208
  • Lyon Cedex 08, France, 69373
    • Local Institution - 0099
  • Marseille Cedex 20, France, 13915
    • Local Institution - 0098
  • Paris Cedex 20, France, 75970
    • Local Institution - 0097
  • Pierre Benite, France, 69495
    • Local Institution - 0095
  • Rennes Cedex 9, France, 35033
    • Local Institution - 0100
  • Saint Herblain, France, 44805
    • Local Institution - 0150
  • Toulouse, France, 31059
    • Local Institution - 0096
  • Alsace
    • Strasbourg, Alsace, France, 67091
      • Local Institution - 0149
• Germany
  • Augsburg, Germany, 86156
    • Local Institution - 0171
  • Bad Berka, Germany, 99437
    • Local Institution - 0170
  • Berlin, Germany, 14165
    • Local Institution - 0168
  • Bochum, Germany, 44791
    • Local Institution - 0164
  • Gauting, Germany, 82131
    • Local Institution - 0166
  • Grosshansdorf, Germany, 22927
    • Local Institution - 0165
  • Immenhausen, Germany, 34376
    • Local Institution - 0169
  • Tübingen, Germany, 72076
    • Local Institution - 0167
• Greece
  • N.Kifissia, Greece, 14564
    • Local Institution - 0080
  • Thessaloniki, Greece, 57001
    • Interbalkan European Medical Center
• Hong Kong
  • Hong Kong, Hong Kong
    • Local Institution - 0052
• Ireland
  • Dublin, Ireland, 4
    • Local Institution
  • Dublin, Ireland, 24
    • Local Institution - 0175
  • Galway, Ireland, ST4 6QG
    • Local Institution - 0162
  • Limerick, Ireland
    • Local Institution - 0214
  • Cork
    • Wilton, Cork, Ireland
      • Local Institution - 0161
• Israel
  • Haifa, Israel, 31096
    • Local Institution
  • Jerusalem, Israel, 91031
    • Local Institution - 0093
  • Petach Tikva, Israel, 49100
    • Local Institution
  • Tel Aviv, Israel, 64239
    • Local Institution - 0090
  • Zerifin, Israel, 70300
    • Local Institution - 0089
• Italy
  • Avellino, Italy, 83100
    • Local Institution - 0026
  • Bologna, Italy, 40138
    • Local Institution - 0025
  • Messina, Italy, 98158
    • Local Institution - 0112
  • Perugia, Italy, 06132
    • Local Institution - 0082
  • Lombardia
    • Milan, Lombardia, Italy, 20141
      • Local Institution - 0027
• Japan
  • Wakayama, Japan, 641-8510
    • Local Institution - 0216
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 2778577
      • Local Institution - 0139
  • Ehime
    • Matsuyama-shi, Ehime, Japan, 7910280
      • Local Institution - 0142
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 8128582
      • Local Institution - 0146
    • Kurume-shi, Fukuoka, Japan, 8300011
      • Local Institution - 0200
  • Gifu
    • Gifu-shi, Gifu, Japan, 5008513
      • Local Institution - 0198
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 0608648
      • Local Institution - 0143
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 6500047
      • Local Institution - 0076
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 9208641
      • Local Institution - 0138
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 2408555
      • Local Institution - 0072
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9800873
      • Local Institution - 0070
    • Sendai-shi, Miyagi, Japan, 9808574
      • Local Institution - 0069
  • Okayama
    • Kurashiki-shi, Okayama, Japan, 7108602
      • Local Institution - 0077
  • Osaka
    • Hirakata-shi, Osaka, Japan, 5731191
      • Local Institution
    • Osaka-sayama-shi, Osaka, Japan, 5898511
      • Local Institution - 0075
    • Osaka-shi, Osaka, Japan, 5340021
      • Local Institution - 0145
    • Takatsuki-shi, Osaka, Japan, 5698686
      • Local Institution - 0083
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Local Institution - 0193
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Local Institution - 0141
    • Chuo-ku, Tokyo, Japan, 1040045
      • Local Institution - 0071
    • Koto-ku, Tokyo, Japan, 1358550
      • Local Institution - 0140
    • Shinjuku-ku, Tokyo, Japan, 1600023
      • Local Institution - 0144
• Korea, Republic of
  • Gangnam-gu, Korea, Republic of, 06351
    • Local Institution - 0021
  • Seoul, Korea, Republic of, 03722
    • Local Institution - 0022
  • Seoul, Korea, Republic of, 05505
    • Local Institution - 0154
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Local Institution - 0047
  • Kyǒnggi-do
    • Suwon, Kyǒnggi-do, Korea, Republic of, 16499
      • Local Institution - 0024
• Mexico
  • Queretaro, Mexico, 76090
    • Local Institution - 0135
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 14050
      • Local Institution - 0019
  • Guanajuato
    • Leon de los Aldama, Guanajuato, Mexico, 37000
      • Local Institution - 0020
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64000
      • Local Institution - 0028
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5223 GZ
    • Local Institution - 0158
  • Eindhoven, Netherlands, 5623 EJ
    • Local Institution
  • Rotterdam, Netherlands, 3000 CA
    • Local Institution - 0159
• Peru
  • Lima, Peru, 34
    • Local Institution
  • Lima, Peru, 27
    • Local Institution
  • Lima
    • Miraflores, Lima, Peru, 18
      • Local Institution
• Poland
  • Gdansk, Poland, 80-19
    • Local Institution - 0041
  • Gdynia, Poland, 81-519
    • Local Institution - 0054
  • Olsztyn, Poland, 10-357
    • Local Institution - 0053
  • Warszawa, Poland, 02-781
    • Local Institution - 0187
• Romania
  • Bucharest, Romania, 010991
    • Local Institution - 0199
  • Bucharest, Romania, 020122
    • Local Institution - 0186
  • Craiova, Romania, 200347
    • Local Institution - 0182
  • Lasi, Romania, 700106
    • Local Institution - 0178
  • Romania, Romania, 400015
    • Local Institution - 0212
  • Timisoara, Timis, Romania, 300239
    • Local Institution - 0181
• Russian Federation
  • Moscow, Russian Federation, 105229
    • Local Institution - 0148
  • Moscow, Russian Federation, 115478
    • Local Institution - 0217
  • Moscow, Russian Federation, 121309
    • Local Institution - 0209
  • St Petersburg, Russian Federation, 197758
    • Local Institution - 0157
  • St Petersburg, Russian Federation, 198255
    • Local Institution - 0115
  • St. Petersburg, Russian Federation, 194291
    • Local Institution - 0116
• Singapore
  • Singapore, Singapore, 169610
    • Local Institution - 0050
• South Africa
  • Gauteng
    • Sandton, Gauteng, South Africa, 2199
      • Local Institution - 0087
  • Western CAPE
    • Cape Town, Western CAPE, South Africa, 7700
      • Local Institution - 0085
    • George, Western CAPE, South Africa, 6530
      • Local Institution - 0086
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7570
      • Local Institution - 0084
• Spain
  • Barcelona, Spain, 08036
    • Local Institution
  • Barcelona, Spain, 08035
    • Local Institution - 0132
  • Madrid, Spain, 28040
    • Local Institution
  • Malaga, Spain, 29011
    • Local Institution
  • Sevilla, Spain, 41013
    • Local Institution
• Sweden
  • Lund, Sweden, 221 85
    • Local Institution - 0124
  • Uppsala, Sweden, 751 85
    • Local Institution - 0185
• Switzerland
  • Aarau, Switzerland, 5001
    • Local Institution - 0179
  • Geneve, Switzerland, 1205
    • Local Institution - 0180
  • St. Gallen, Switzerland, 9007
    • Local Institution - 0191
• Taiwan
  • Taoyuan, Taiwan, 333
    • Local Institution - 0048
  • TNN
    • Tainan, TNN, Taiwan, 704
      • Local Institution - 0049
• United Kingdom
  • Sheffield, United Kingdom, S10 2SJ
    • Local Institution - 0192
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • Local Institution - 0153
  • Greater London
    • London, Greater London, United Kingdom, NW1 2PG
      • Local Institution - 0118
    • London, Greater London, United Kingdom, SW3 6JJ
      • Local Institution - 0201
  • Lancashire
    • Wirral, Lancashire, United Kingdom, CH63 4JY
      • Local Institution - 0121
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
      • Local Institution - 0152
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Local Institution - 0151
• United States
  • California
    • Sacramento, California, United States, 95816
      • Local Institution - 0003
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Local Institution - 0202
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Local Institution - 0127
    • Jacksonville, Florida, United States, 32256
      • Local Institution - 0007
    • Saint Petersburg, Florida, United States, 33705
      • Local Institution - 0128
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Local Institution - 0010
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Local Institution - 0013
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Local Institution - 0061
    • Wichita, Kansas, United States, 67214
      • Local Institution - 0012
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Local Institution - 0032
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Local Institution - 0051
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0107
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0207
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Local Institution - 0015
  • New York
    • New York, New York, United States, 10065
      • Local Institution - 0008
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Local Institution - 0014
    • Winston-Salem, North Carolina, United States, 27103
      • Local Institution - 0016
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Local Institution - 0215
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Local Institution - 0129
    • Columbus, Ohio, United States, 43210
      • Local Institution - 0009
  • Oregon
    • Portland, Oregon, United States, 97213
      • Local Institution - 0001
    • Portland, Oregon, United States, 97239
      • Local Institution - 0034
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Local Institution - 0004
    • Sayre, Pennsylvania, United States, 18840
      • Local Institution - 0002
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Local Institution - 0005
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Local Institution - 0213
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Local Institution - 0011
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Local Institution - 0006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo
Experimental: Nivolumab monotherapy; Nivolumab intravenous fusion	Biological: Nivolumab; Other Names: Opdivo
Experimental: Nivolumab and ipilimumab combination therapy; Nivolumab and ipilimumab intravenous fusion	Biological: Nivolumab; Other Names: Opdivo; Biological: Ipilimumab; Other Names: Yervoy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From randomization to the date of death or last known alive date (up to approximately 73 months)
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.	From randomization to the date of death or last known alive date (up to approximately 73 months)
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.	From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)
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	From randomization to the date of death or last known alive date (up to approximately 73 months)
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.	From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Ono Pharmaceutical Co. Ltd

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): November 11, 2021

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Ipilimumab
• Other Study ID Numbers: CA209-451; 2015-002441-61 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No