Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 5 of 111 for:    small cell lung ca | Open Studies

A 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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Bristol-Myers Squibb
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02538666
First received: August 26, 2015
Last updated: November 30, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to show that maintenance therapy with nivolumab, or nivolumab plus ipilimumab followed by nivolumab alone, will prolong Overall Survival and Progression Free Survival compared with placebo in subjects with extensive stage disease small cell lung cancer who have completed first line chemotherapy.

Condition Intervention Phase
Lung Cancer
Biological: Nivolumab
Biological: Ipilimumab
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Approximately 30 months after the first subject is randomized ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: Approximately 6 months after the last subject is randomized ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A PFS descriptive analysis will be performed to evaluate nivolumab monotherapy versus nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
    Descriptive analyses of PFS will be performed to evaluate differences between the two experimental arms

  • An OS descriptive analysis will be performed to evaluate nivolumab monotherapy versus nivolumab with Ipilimumab treatment regimen [ Time Frame: Approximately 30 months ] [ Designated as safety issue: No ]
    Descriptive analyses of OS will be performed to evaluate differences between the two experimental arms


Estimated Enrollment: 810
Study Start Date: September 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02538666

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, California
Sutter Medical Group Recruiting
Sacramento, California, United States, 95816
Contact: Deepti Behl, Site 0003    916-445-6931      
United States, Connecticut
Local Institution Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Site 0202         
United States, Florida
Florida Cancer Specialists S. Recruiting
Fort Myers, Florida, United States, 33916
Contact: Ivor Percent, Site 0127         
Cancer Specialists, Llc Recruiting
Jacksonville, Florida, United States, 32256
Contact: Augusto Villegas, Site 0007    904-825-4500      
Florida Cancer Specialists Recruiting
St. Petersburg, Florida, United States, 33705
Contact: Maen Hussein, Site 0128         
United States, Georgia
Winship Cancer Institute. Recruiting
Atlanta, Georgia, United States, 30322
Contact: Taofeek Owonikoko, Site 0010    404-778-4582      
United States, Indiana
Fpn Oncology And Hematology Specialists Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Nadeem Ikhlaque, Site 0013    317-782-7060      
United States, Kansas
University Of Kansas Clinical Research Center Recruiting
Fairway, Kansas, United States, 66205
Contact: Takefumi Komiya, Site 0061         
Cancer Center Of Kansas Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker Dakhil, Site 0012    316-268-8566      
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Firas Badin, Site 0032    859-260-6406      
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Christine Hann, Site 0051    443-287-9377      
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Site 0107         
United States, Michigan
St. Joseph Mercy Hospital Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Philip Stella, Site 0042    734-712-2704      
United States, Missouri
Washington University School Of Medicine Recruiting
St Louis, Missouri, United States, 63110
Contact: Daniel Morgensztern, Site 0015    314-362-4140      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jamie Chaft, Site 0008    646-888-4203      
United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Neal Ready, Site 0014    919-681-4768      
Novant Health Oncology Specialists Recruiting
Winston Salem, North Carolina, United States, 27103
Contact: Eugene Paschold, Site 0016         
United States, Ohio
Oncology Hematology Care, Inc. Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Patrick Ward, Site 0129         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Gregory Otterson, Site 0009    614-366-6387      
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Rachel Sanborn, Site 0001    503-215-2699      
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Jeremy Cetnar, Site 0034         
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Eliot Friedman, Site 0004    610-402-1642      
Guthrie Medical Group, Pc Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Bradley Lash, Site 0002    570-887-4882      
United States, South Carolina
Medical University Of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: John Wrangle, Site 0005    843-792-8795      
United States, Utah
University Of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Wallace Akerley, Site 0011    801-585-7844      
United States, Virginia
Virginia Cancer Institute Recruiting
Richmond, Virginia, United States, 23230
Contact: Maurice Schwarz, Site 0006    804-288-7159      
Argentina
Coiba Recruiting
Berazategui, Buenos Aires, Argentina, 1880
Contact: Mirta Susana Varela, Site 0110    +541142562451      
Instituto Alexander Fleming Recruiting
Capital Federal, Buenos Aires, Argentina, 1426
Contact: Carmen Sofia Pupareli, Site 0088    +541132218956      
Hospital Italiano De Buenos Aires Recruiting
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1181
Contact: Lorena Lupinacci, Site 0109    +541149590200      
Clinica Privada Universitaria Reina Fabiola Recruiting
Cordoba, Argentina, 5004
Contact: Ignacio Magri, Site 0188    +543514142121      
Centro Medico San Roque Recruiting
Tucuman, Argentina, 4000
Contact: Juan Jose Zarba, Site 0029    +543814221480      
Australia, New South Wales
Local Institution Recruiting
Kogarah, New South Wales, Australia
Contact: Site 0037         
Local Institution Recruiting
Wollongong, New South Wales, Australia, 2500
Contact: Site 0039         
Australia, Queensland
Local Institution Recruiting
Brisbane, Queensland, Australia, 4102
Contact: Site 0036         
Local Institution Recruiting
Nambour, Queensland, Australia, 4560
Contact: Site 0203         
Australia, South Australia
Local Institution Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Site 0137         
Australia, Victoria
Local Institution Recruiting
East Melbourne, Victoria, Australia, 3165
Contact: Site 0035         
Austria
Universitatsklinikum Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Heinz Zwierzina, Site 0174         
Salzburger Landeskliniken Lkh Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, Site 0173         
Krankenhaus Hietzing Recruiting
Wien, Austria, 1130
Contact: Alexander Kavina, Site 0172         
Belgium
Local Institution Recruiting
Brussels, Belgium, 1090
Contact: Site 0057         
Local Institution Recruiting
Charleroi, Belgium, 6000
Contact: Site 0059         
Local Institution Recruiting
Roeselare, Belgium, 8800
Contact: Site 0060         
Brazil
Local Institution Recruiting
Fortaleza, Ceara, Brazil, 60430
Contact: Site 0067         
Local Institution Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30150
Contact: Site 0068         
Local Institution Recruiting
Ijui, Rio Grande do Sul, Brazil, 98700
Contact: Site 0063         
Local Institution Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90610
Contact: Site 0064         
Local Institution Recruiting
Itajai, Santa Catarina, Brazil, 88301
Contact: Site 0017         
Local Institution Recruiting
Barretos, Sao Paulo, Brazil, 14784
Contact: Site 0081         
Local Institution Recruiting
Rio de Janeiro, Brazil, 22793
Contact: Site 0065         
Local Institution Recruiting
Salvador, Brazil, 40170
Contact: Site 0066         
Canada, Alberta
Cross Cancer Centre Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Randeep Sangha, Site 0094    780-577-8048      
Canada, Ontario
Lakeridge Health Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Gregory Lo, Site 0123    905-576-8711 ext 2812      
Health Sciences North Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Lacey Pitre, Site 0102    705-522-6237 ext 2409      
Windsor Regional Cancer Centre Recruiting
Windsor, Ontario, Canada, N8W 2X3
Contact: Tarek Elfiki, Site 0111    519-253-5253      
Colombia
Oncomedica S. A. Recruiting
Monteria, Cordoba, Colombia
Contact: Marco Torregroza, Site 0189         
Administradora Del Country S.A. - Clinica Del Country Recruiting
Bogota, Colombia
Contact: Andres Felipe Cardona, Site 0078         
Hospital Pablo Tobon Uribe Recruiting
Medellin, Colombia, MEDELLIN
Contact: Alicia Quiroga, Site 0190         
Finland
Local Institution Recruiting
Oulu, Finland, 90029
Contact: Site 0044         
Local Institution Recruiting
Tampere, Finland, 33521
Contact: Site 0043         
Local Institution Recruiting
Turku, Finland, FIN-20521
Contact: Site 0045         
Local Institution Recruiting
Vaasa, Finland, 65130
Contact: Site 0046         
France
Local Institution Recruiting
Avignon Cedes 9, France, 84918
Contact: Site 0208         
Local Institution Recruiting
Lyon Cedex 08, France, 69373
Contact: Site 0099         
Local Institution Recruiting
Marseille Cedex 20, France, 13915
Contact: Site 0098         
Local Institution Recruiting
Paris Cedex 20, France, 75970
Contact: Site 0097         
Local Institution Recruiting
Pierre Benite, France, 69495
Contact: Site 0095         
Local Institution Recruiting
Rennes Cedex 9, France, 35033
Contact: Site 0100         
Local Institution Recruiting
Saint Herblain, France, 44805
Contact: Site 0150         
Local Institution Recruiting
Strasbourg, France, 67090
Contact: Site 0149         
Local Institution Recruiting
Toulouse, France, 31059
Contact: Site 0096         
Germany
Klinikum Augsburg Recruiting
Augsburg, Germany, 86156
Contact: Bjoern Hackanson, Site 0171    +498214003716      
Zentralklinik Bad Berka Gmbh Recruiting
Bad Berka, Germany, 99437
Contact: Peter Fix, Site 0170    +493645853123      
Helios Klinikum Emil Von Behring Gmbh Recruiting
Berlin, Germany, 14165
Contact: Jens Kollmeier, Site 0168    +493081021680      
Klinik Fur Hamatologie Und Internistische Onkologie Recruiting
Bochum, Germany, 44791
Contact: Dirk Behringer, Site 0164    +492345172446      
Asklepius Fachkliniken Recruiting
Gauting, Germany, 82131
Contact: Joachim Von Pawel, Site 0166    +4989857912101      
Krankenhaus Grosshansdorf Recruiting
Grosshansdorf, Germany, 22927
Contact: Martin Reck, Site 0165    +4941026012425      
Fachklinik Fuer Lungenkrankheiten Recruiting
Immenhausen, Germany, 34376
Contact: Achim Rittmeyer, Site 0169    +495673501448      
Eberhard-Karls-Universitat Tubingen Recruiting
Tuebingen, Germany, 72076
Contact: Hans-Georg Kopp, Site 0167    +49070712982795      
Greece
Local Institution Recruiting
Nea Kifissia, Greece, 14564
Contact: Site 0080         
Local Institution Recruiting
Thessaloniki, Greece, 57001
Contact: Site 0101         
Ireland
Local Institution Recruiting
Cork, Ireland
Contact: Site 0161         
Local Institution Recruiting
Dublin, Ireland, 24
Contact: Site 0175         
Local Institution Not yet recruiting
Dublin, Ireland, 4
Contact: Site 0160         
Local Institution Recruiting
Galway, Ireland
Contact: Site 0162         
Israel
Local Institution Recruiting
Haifa, Israel, 31096
Contact: Site 0092         
Local Institution Recruiting
Jerusalem, Israel, 91031
Contact: Site 0093         
Local Institution Recruiting
Petach Tikva, Israel, 49100
Contact: Site 0091         
Local Institution Recruiting
Tel Aviv, Israel, 64239
Contact: Site 0090         
Local Institution Recruiting
Zerifin, Israel, 70300
Contact: Site 0089         
Italy
Local Institution Recruiting
Avellino, Italy, 83100
Contact: Site 0026         
Local Institution Recruiting
Bologna, Italy, 40138
Contact: Site 0025         
Local Institution Not yet recruiting
Messina, Italy, 98158
Contact: Site 0112         
Local Institution Recruiting
Milan, Italy, 20141
Contact: Site 0027         
Local Institution Recruiting
Perugia, Italy, 06132
Contact: Site 0082         
Japan
Local Institution Recruiting
Kashiwa-shi, Chiba, Japan, 2778577
Contact: Site 0139         
Local Institution Recruiting
Matsuyama-shi, Ehime, Japan, 7910280
Contact: Site 0142         
Local Institution Recruiting
Fukuoka-shi, Fukuoka, Japan, 8128582
Contact: Site 0146         
Local Institution Recruiting
Kurume-shi, Fukuoka, Japan, 8300011
Contact: Site 0200         
Local Institution Recruiting
Gifu-shi, Gifu, Japan, 5008513
Contact: Site 0198         
Local Institution Recruiting
Sapporo-shi, Hokkaido, Japan, 0608648
Contact: Site 0143         
Local Institution Recruiting
Kobe-shi, Hyogo, Japan, 6500047
Contact: Site 0076         
Local Institution Recruiting
Kanazawa-shi, Ishikawa, Japan, 9200934
Contact: Site 0138         
Local Institution Recruiting
Yokohama-shi, Kanagawa, Japan, 2408555
Contact: Site 0072         
Local Institution Recruiting
Sendai-shi, Miyagi, Japan, 9800873
Contact: Site 0070         
Local Institution Recruiting
Sendai-shi, Miyagi, Japan, 9808574
Contact: Site 0069         
Local Institution Recruiting
Kurashiki-shi, Okayama, Japan, 7108602
Contact: Site 0077         
Local Institution Recruiting
Hirakata-shi, Osaka, Japan, 5731191
Contact: Site 0074         
Local Institution Recruiting
Osaka-sayama-shi, Osaka, Japan, 5898511
Contact: Site 0075         
Local Institution Recruiting
Osaka-shi, Osaka, Japan, 5340021
Contact: Site 0145         
Local Institution Recruiting
Takatsuki-shi, Osaka, Japan, 5698686
Contact: Site 0083         
Local Institution Recruiting
Hidaka-shi, Saitama, Japan, 3501298
Contact: Site 0193         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1130022
Contact: Site 0141         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 1040045
Contact: Site 0071         
Local Institution Recruiting
Koto-ku, Tokyo, Japan, 1358550
Contact: Site 0140         
Local Institution Recruiting
Shinjuku-ku, Tokyo, Japan, 1600023
Contact: Site 0144         
Korea, Republic of
Local Institution Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Site 0047         
Local Institution Recruiting
Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
Contact: Site 0024         
Local Institution Recruiting
Seoul, Korea, Republic of, 03722
Contact: Site 0022         
Local Institution Recruiting
Seoul, Korea, Republic of, 05505
Contact: Site 0154         
Local Institution Recruiting
Seoul, Korea, Republic of, 06351
Contact: Site 0021         
Mexico
Local Institution Recruiting
Mexico, Distrito Federal, Mexico, 14050
Contact: Site 0019         
Local Institution Recruiting
Leon de los Aldama, Guanajuato, Mexico, 37000
Contact: Site 0020         
Local Institution Recruiting
Monterrey, Nuevo Leon, Mexico, 64000
Contact: Site 0028         
Local Institution Recruiting
Queretaro, Mexico, 76090
Contact: Site 0135         
Netherlands
Local Institution Not yet recruiting
's-Hertogenbosch, Netherlands, 5223 GZ
Contact: Site 0158         
Local Institution Not yet recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: Site 0163         
Local Institution Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Site 0159         
Peru
Inst. Oncologico Miraflores Recruiting
Miraflores, Lima, Peru, 18
Contact: Fernando Salas, Site 0031    5116512958      
Clinica Ricardo Palma Recruiting
Lima, Peru, 27
Contact: Manuel Leiva, Site 0108    51987255276      
Instituto Nacional De Enfermedades Neoplasicas Recruiting
Lima, Peru, 34
Contact: Luis Mas, Site 0030    +51966933686      
Poland
Local Institution Recruiting
Gdansk, Poland, 80-19
Contact: Site 0041         
Local Institution Recruiting
Gdynia, Poland, 81-519
Contact: Site 0054         
Local Institution Recruiting
Olsztyn, Poland, 10-357
Contact: Site 0053         
Local Institution Recruiting
Warszawa, Poland, 02-781
Contact: Site 0187         
Romania
Local Institution Recruiting
Bucharest, Romania, 010991
Contact: Site 0199         
Local Institution Recruiting
Bucharest, Romania, 020122
Contact: Site 0186         
Local Institution Recruiting
Craiova, Romania, 200347
Contact: Site 0182         
Local Institution Recruiting
Lasi, Romania, 700106
Contact: Site 0178         
Local Institution Recruiting
Timisoara, Timis, Romania, 300239
Contact: Site 0181         
Russian Federation
Local Institution Not yet recruiting
Moscow, Russian Federation, 105229
Contact: Site 0148         
Local Institution Not yet recruiting
Moscow, Russian Federation, 115478
Contact: Site 0119         
Local Institution Not yet recruiting
Moscow, Russian Federation, 121309
Contact: Site 0209         
Local Institution Not yet recruiting
St Petersburg, Russian Federation, 197758
Contact: Site 0157         
Local Institution Not yet recruiting
St Petersburg, Russian Federation, 198255
Contact: Site 0115         
Local Institution Recruiting
St. Petersburg, Russian Federation, 194291
Contact: Site 0116         
South Africa
Local Institution Recruiting
Johannesburg, Gauteng, South Africa, 2199
Contact: Site 0087         
Local Institution Recruiting
Cape Town, Western Cape, South Africa, 7570
Contact: Site 0084         
Local Institution Recruiting
George, Western Cape, South Africa, 6530
Contact: Site 0086         
Local Institution Recruiting
Rondebosch, South Africa, 7700
Contact: Site 0085         
Spain
Local Institution Recruiting
Barcelona, Spain, 08035
Contact: Site 0132         
Local Institution Recruiting
Barcelona, Spain, 08036
Contact: Site 0131         
Local Institution Recruiting
Madrid, Spain, 28040
Contact: Site 0130         
Local Institution Recruiting
Malaga, Spain, 29010
Contact: Site 0133         
Local Institution Recruiting
Sevilla, Spain, 41013
Contact: Site 0134         
Sweden
Local Institution Recruiting
Lund, Sweden, 221 85
Contact: Site 0124         
Local Institution Recruiting
Uppsala, Sweden, 751 85
Contact: Site 0185         
Switzerland
Kantonsspital Aarau Recruiting
Aarau, Switzerland, 5000
Contact: Christoph Mamot, Site 0179    +41628386050      
Hopitaux Universitaires De Geneva (Hug) Recruiting
Geneve, Switzerland, 1205
Contact: Nicolas Mach, Site 0180         
Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Martin Frueh, Site 0191         
United Kingdom
Local Institution Recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Contact: Site 0153         
Local Institution Recruiting
London, Greater London, United Kingdom, NW1 2PG
Contact: Site 0118         
Local Institution Recruiting
London, Greater London, United Kingdom, SW3 6JJ
Contact: Site 0201         
Local Institution Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Contact: Site 0152         
Local Institution Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Site 0151         
Local Institution Recruiting
Sheffield, United Kingdom, S10 2SJ
Contact: Site 0192         
Local Institution Recruiting
Wirral, United Kingdom, CH63 4JY
Contact: Site 0121         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02538666     History of Changes
Other Study ID Numbers: CA209-451 
Study First Received: August 26, 2015
Last Updated: November 30, 2016
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Korea: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ministry of Science and Higher Education
Spain: Spanish Agency of Medicines
Switzerland: Federal Office of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Institutional Review Board
Czech Republic: Ministry of Health
Korea: Institutional Review Board
Korea: Ministry for Health and Welfare
Korea: Ministry of Education, Science, and Technology
Korea: Ministry of Food and Drug Safety
Korea: National Cancer Center
Korea: National Strategic Coordinating Center for Clinical Research
Japan: Foundation for Biomedical Research and Innovation
Japan: Institutional Review Board
Japan: Ministry of Education, Culture, Sports, Science and Technology
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Brazil: Associação Fundo de Incentivo à Pesquisa
Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Israel: Ministry of Health
Israel: The Israel National Institute for Health Policy Research and Health Services Research
Canada: Canadian Cancer Society Research Institute
Canada: Canadian Institutes of Health Research
Canada: Consortium de recherche et innovations en bioprocédés industriels au Québec
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Institutional Review Board
Canada: Ministry of Health & Long Term Care, Ontario
Canada: Ministère santé et services sociaux du Québec
Canada: Public Health Agency of Canada
Taiwan : Food and Drug Administration
Taiwan: Center for Drug Evaluation
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: Ministry of Health and Welfare
Taiwan: National Bureau of Controlled Drugs
Taiwan: National Health Research Institutes
Taiwan: National Science Council
Taiwan: Research Ethics Committee
South Africa: Department of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Romania: Ethics Committee
Romania: Ministry of Public Health
Romania: National Agency for Medicines and Medical Devices
Romania: National Authority for Scientific Research
Romania: National Bioethics Committee of Medicines and Medical Devices
Romania: National Medicines Agency
Romania: State Institute for Drug Control
Finland: Data Protection Board
Finland: Ethics Committee
Finland: Finnish Medicines Agency
Finland: Finnish National Agency for Medicines
Finland: Ministry of Social Affairs and Health
Finland: National Advisory Board on Health Care Ethics
Finland: Valvira - National Supervisory Authority for Welfare and Health
Mexico: Coordinación de Investigación en Salud
Mexico: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Mexican Society of Cardiology
Mexico: Ministry of Health
Mexico: National Council of Science and Technology
Mexico: National Institute of Public Health, Health Secretariat
Mexico: Secretaria de Salud
Denmark: Centre for Public Health
Denmark: Danish Dataprotection Agency
Denmark: Danish Health and Medicines Authority
Denmark: Danish Medicines Agency
Denmark: Danish Ministry of the Environment
Denmark: Ethics Committee
Denmark: Mental Health Services in the Capital Region of Denmark
Denmark: Ministry of Food, Agriculture and Fisheries, Danish Veterinary and Food Administration
Denmark: National Board of Health
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Ministry of Health
Denmark: The National Committee on Health Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics
Sweden: Institutional Review Board
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Sweden: Swedish Data Inspection Board
Sweden: Swedish National Council on Medical Ethics
Sweden: Swedish Research Council
Sweden: The National Board of Health and Welfare
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Argentina: Institute for Clinical Effectiveness and Health Policy
Argentina: Ministry of Health
Peru: Ethics Committee
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Instituto Nacional de Salud
Peru: Ministry of Health
Greece: Ethics Committee
Greece: Ministry of Health and Welfare
Greece: National Organization of Medicines
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Singapore: Institutional Review Board
Singapore: Ministry of Health
Singapore: Singapore Clinical Research Institute
Colombia: Ethics Committee
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Colombia: Institutional Review Board
Colombia: Ministry of Health and Social Protection
Colombia: National Institutes of Health
Hong Kong: Department of Health
Hong Kong: Ethics Committee
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Ireland: Health Information and Quality Authority
Ireland: Health Service Executive
Ireland: Irish Medicines Board
Ireland: Medical Ethics Research Committee
Ireland: Ministry of Health
Ireland: Research Ethics Committee
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Russia: The Ministry of Education and Science of the Russian Federation
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Ireland: Health Products Regulatory Authority
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Main Pharmaceutical Inspectorate

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Lung Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016