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Trial record 1 of 1 for:    CA209-451
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02538666
Recruitment Status : Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: Nivolumab Biological: Ipilimumab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 30, 2015
Actual Primary Completion Date : October 1, 2018
Estimated Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Nivolumab monotherapy
Nivolumab intravenous fusion
Biological: Nivolumab
Other Name: Opdivo

Experimental: Nivolumab and ipilimumab combination therapy
Nivolumab and ipilimumab intravenous fusion
Biological: Nivolumab
Other Name: Opdivo

Biological: Ipilimumab
Other Name: Yervoy

Placebo Comparator: Placebo
Placebo
Other: Placebo



Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 37 months after the first subject is randomized ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Approximately 37 months ]
    Blinded Independent Central Review (BICR) assessed

  2. An OS descriptive analysis will be performed to evaluate nivolumab monotherapy versus nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 37 months ]
    Descriptive analyses of OS will be performed to evaluate differences between the two experimental arms

  3. A PFS descriptive analysis will be performed to evaluate nivolumab monotherapy versus nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 37 months ]
    Descriptive analyses of PFS will be performed to evaluate differences between the two experimental arms

  4. Tumor mutation burden (TMB) [ Time Frame: Approximately 37 months ]
    measured using FoundationOne CDx™ (F1CDx) assay



Information from the National Library of Medicine

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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 BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538666


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Locations
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United States, California
Sutter Cancer Center
Sacramento, California, United States, 95816
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
Florida Cancer Specialists S.
Fort Myers, Florida, United States, 33901
Cancer Specialists of North FL
Jacksonville, Florida, United States, 32256
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Winship Cancer Institute.
Atlanta, Georgia, United States, 30322
United States, Indiana
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
United States, Kansas
University of Kansas Cancer Center - Clinical Research Center
Fairway, Kansas, United States, 66205
Cancer Center Of Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Sanford Health
Fargo, North Dakota, United States, 58102
United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Donald Guthrie Foundation
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Medical University Of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Sanford Health
Sioux Falls, South Dakota, United States, 57104
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23226
Argentina
Local Institution
Berazategui, Buenos Aires, Argentina, 1880
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Capital Federal, Buenos Aires, Argentina, 1426
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Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181
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Cordoba, Argentina, 5004
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Tucuman, Argentina, 4000
Australia, New South Wales
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Kogarah, New South Wales, Australia
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Wollongong, New South Wales, Australia, 2500
Australia, Queensland
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Birtinya, Queensland, Australia, 4575
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Australia, South Australia
Local Institution
Adelaide, South Australia, Australia, 5000
Australia, Victoria
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East Melbourne, Victoria, Australia, 3165
Austria
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Innsbruck, Austria, 6020
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Salzburg, Austria, 5020
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Wien, Austria, 1130
Belgium
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Brussels, Belgium, 1090
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Charleroi, Belgium, 6000
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Roeselare, Belgium, 8800
Brazil
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Fortaleza, Ceara, Brazil, 60430-230
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Belo Horizonte, Minas Gerais, Brazil, 30110-022
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Ijui, RIO Grande DO SUL, Brazil, 98700-000
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Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
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Itajai, Santa Catarina, Brazil, 88301-220
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Barretos, SAO Paulo, Brazil, 14784-400
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Rio de Janeiro, Brazil, 22793-080
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Salvador, Brazil, 40170-110
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
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Oshawa, Ontario, Canada, L1G 2B9
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Sudbury, Ontario, Canada, P3E 5J1
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Windsor, Ontario, Canada, N8W 2X3
China, Anhui
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Hefei, Anhui, China, 230001
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Hefei, Anhui, China, 230022
China, Beijing
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Beijing, Beijing, China, 100001
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Beijing, Beijing, China, 100142
China, Heilongjiang
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Harbin, Heilongjiang, China, 155040
China, Hubei
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Wuhang, Hubei, China, 430030
China, Hunan
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Changsha, Hunan, China
China, Jiangsu
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Nantong, Jiangsu, China, 226361
China, Jiangxi
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Nanchang, Jiangxi, China, 330006
China, Jilin
Local Institution
Changchun, Jilin, China, 130021
China, Liaoning
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Shenyang, Liaoning, China, 110046
China, Shanghai
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Shanghai, Shanghai, China, 200030
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Shanghai, Shanghai, China, 200032
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Shanghai, Shanghai, China, 200433
China, Yunnan
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Kunming, Yunnan, China, 650118
China, Zhejiang
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Hangzhou, Zhejiang, China, 310003
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Hangzhou, Zhejiang, China, 310016
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Wenzhou, Zhejiang, China, 325000
China
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Guangzhou, China, 510515
Colombia
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Monteria, Cordoba, Colombia
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Bogota, Colombia
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Medellin, Colombia, MEDELLIN
Finland
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Oulu, Finland, 90029
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Tampere, Finland, 33521
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Turku, Finland, FIN-20521
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Vaasa, Finland, 65130
France
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Avignon Cedes 9, France, 84918
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Lyon Cedex 08, France, 69373
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Marseille Cedex 20, France, 13915
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Paris Cedex 20, France, 75970
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Pierre Benite, France, 69495
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Rennes Cedex 9, France, 35033
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Saint Herblain, France, 44805
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Strasbourg, France, 67090
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Toulouse, France, 31059
Germany
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Augsburg, Germany, 86156
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Bad Berka, Germany, 99437
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Berlin, Germany, 14165
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Bochum, Germany, 44791
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Gauting, Germany, 82131
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Grosshansdorf, Germany, 22927
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Immenhausen, Germany, 34376
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Tuebingen, Germany, 72076
Greece
Agioi Anargyroi Cancer Center
Nea Kifissia, Greece, 14564
Interbalkan European Medical Center
Thessaloniki, Greece, 57001
Hong Kong
Local Institution
Hong Kong, Hong Kong
Ireland
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Wilton, Cork, Ireland
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Dublin, Ireland, 24
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Dublin, Ireland, 4
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Galway, Ireland, ST4 6QG
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Limerick, Ireland
Israel
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Haifa, Israel, 31096
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Jerusalem, Israel, 91031
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Petach Tikva, Israel, 49100
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Tel Aviv, Israel, 64239
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Zerifin, Israel, 70300
Italy
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Avellino, Italy, 83100
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Bologna, Italy, 40138
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Messina, Italy, 98158
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Milan, Italy, 20141
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Perugia, Italy, 06132
Japan
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Kashiwa-shi, Chiba, Japan, 2778577
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Matsuyama-shi, Ehime, Japan, 7910280
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Fukuoka-shi, Fukuoka, Japan, 8128582
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Kurume-shi, Fukuoka, Japan, 8300011
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Gifu-shi, Gifu, Japan, 5008513
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Sapporo-shi, Hokkaido, Japan, 0608648
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Kobe-shi, Hyogo, Japan, 6500047
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Kanazawa-shi, Ishikawa, Japan, 9208641
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Yokohama-shi, Kanagawa, Japan, 2408555
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Sendai-shi, Miyagi, Japan, 9800873
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Sendai-shi, Miyagi, Japan, 9808574
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Kurashiki-shi, Okayama, Japan, 7108602
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Hirakata-shi, Osaka, Japan, 5731191
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Osaka-sayama-shi, Osaka, Japan, 5898511
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Osaka-shi, Osaka, Japan, 5340021
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Takatsuki-shi, Osaka, Japan, 5698686
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Hidaka-shi, Saitama, Japan, 3501298
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Bunkyo-ku, Tokyo, Japan, 1130022
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Chuo-ku, Tokyo, Japan, 1040045
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Koto-ku, Tokyo, Japan, 1358550
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Shinjuku-ku, Tokyo, Japan, 1600023
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Wakayama-shi, Wakayama, Japan, 6418510
Korea, Republic of
Local Institution
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Local Institution
Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
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Seoul, Korea, Republic of, 03722
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 06351
Mexico
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Mexico, Distrito Federal, Mexico, 14050
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Leon de los Aldama, Guanajuato, Mexico, 37000
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Monterrey, Nuevo LEON, Mexico, 64000
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Santiago de Queretaro, Queretaro, Mexico, 76090
Netherlands
Local Institution
's-Hertogenbosch, Netherlands, 5223 GZ
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Eindhoven, Netherlands, 5623 EJ
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Rotterdam, Netherlands, 3000 CA
Peru
Local Institution
Miraflores, Lima, Peru, 18
Local Institution
Lima, Peru, 27
Local Institution
Lima, Peru, 34
Poland
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Gdansk, Poland, 80-19
Local Institution
Gdynia, Poland, 81-519
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Olsztyn, Poland, 10-357
Local Institution
Warszawa, Poland, 02-781
Romania
Local Institution
Bucharest, Romania, 010991
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Bucharest, Romania, 020122
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Craiova, Romania, 200347
Local Institution
Lasi, Romania, 700106
Local Institution
Romania, Romania, 400015
Local Institution
Timisoara, Timis, Romania, 300239
Russian Federation
Local Institution
Moscow, Russian Federation, 105229
Local Institution
Moscow, Russian Federation, 115478
Local Institution
Moscow, Russian Federation, 121309
Local Institution
St Petersburg, Russian Federation, 197758
Local Institution
St Petersburg, Russian Federation, 198255
Local Institution
St. Petersburg, Russian Federation, 194291
Singapore
Local Institution
Singapore, Singapore, 169610
South Africa
Local Institution
Sandton, Gauteng, South Africa, 2199
Local Institution
Cape Town, Western CAPE, South Africa, 7570
Local Institution
Cape Town, Western CAPE, South Africa, 7700
Local Institution
George, Western CAPE, South Africa, 6530
Spain
Local Institution
Barcelona, Spain, 08035
Local Institution
Barcelona, Spain, 08036
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Madrid, Spain, 28040
Local Institution
Malaga, Spain, 29010
Local Institution
Sevilla, Spain, 41013
Sweden
Local Institution
Lund, Sweden, 221 85
Local Institution
Uppsala, Sweden, 751 85
Switzerland
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Aarau, Switzerland, 5000
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Geneve, Switzerland, 1205
Local Institution
St. Gallen, Switzerland, 9007
Taiwan
Local Institution
Tainan, Taiwan, 704
Local Institution
Taoyuan, Taiwan, 333
United Kingdom
Local Institution
Truro, Cornwall, United Kingdom, TR1 3LJ
Local Institution
London, Greater London, United Kingdom, NW1 2PG
Local Institution
London, Greater London, United Kingdom, SW3 6JJ
Local Institution
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Local Institution
Sutton, Surrey, United Kingdom, SM2 5PT
Local Institution
Sheffield, United Kingdom, S10 2SJ
Local Institution
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02538666     History of Changes
Other Study ID Numbers: CA209-451
2015-002441-61 ( EudraCT Number )
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

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

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents