Trial record 5 of 117 for:    small cell lung ca | Open Studies

Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer (CheckMate331)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Bristol-Myers Squibb
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02481830
First received: June 23, 2015
Last updated: July 26, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.

Condition Intervention Phase
Lung Cancer
Drug: Nivolumab
Drug: Topotecan
Drug: Amrubicin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall survival (OS) in subjects with relapsed SCLC [ Time Frame: approximately 12 months. Additional survival follow-up may continue for up to 5 years from the completion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: upto 12 months ] [ Designated as safety issue: No ]
  • Objective response rate (ORR) [ Time Frame: upto 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: August 2015
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Nivolumab
Nivolumab intravenous infusion as specified
Drug: Nivolumab
Active Comparator: Arm B Chemotherapy Topotecan
Topotecan as specified
Drug: Topotecan
Active Comparator: Arm B Chemotherapy Amrubicin
Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)
Drug: Amrubicin

  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:

  • Histologically or cytologically confirmed small cell lung cancer (SCLC)
  • Subjects with either limited or extensive disease stage at the initial diagnosis
  • Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

  • Untreated or symptomatic central nervous system (CNS) metastases
  • Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
  • Inadequate hematologic or hepatic function
  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: NCT02481830

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, Arkansas
Univ Of Ark For Med Sci Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Konstantinos Arnaoutakis, Site 0065    501-686-8274      
United States, Connecticut
Smilow Cancer Hospital. At Yale New Haven Recruiting
New Haven, Connecticut, United States, 06510
Contact: Scott Gettinger, Site 0024    203-785-6540      
United States, Florida
Local Institution Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Site 0101         
United States, Georgia
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Taofeek Owonikoko, Site 0018         
United States, Missouri
Washington University School Of Medicine Recruiting
St Louis, Missouri, United States, 63110
Contact: Saiama Waqar, Site 0056    314-362-4140      
United States, Nebraska
Nebraska Hematology Oncology Pc Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Eric Avery, Site 0088    402-484-4907      
United States, New York
Broome Oncology Recruiting
Johnson City, New York, United States, 13790
Contact: Ronald Harris, Site 0173         
United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Neal Ready, Site 0001    919-681-4768      
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Afshin Dowlati, Site 0090    216-844-5997      
United States, Pennsylvania
St. Luke'S University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Yacoub Faroun, Site 0002         
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17604
Contact: Samuel Kerr, Site 0057    717-544-9400      
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Hossein Borghaei, Site 0053    215-728-2895      
United States, Tennessee
Tennessee Oncology, Pllc Recruiting
Nashville, Tennessee, United States, 37203
Contact: David Spigel, Site 0089    615-329-7268      
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Leora Horn, Site 0009         
United States, Washington
Kadlec Clinic Hematology And Oncology Recruiting
Kennewick, Washington, United States, 99336
Contact: Eric Gamboa, Site 0070    509-783-4637      
Australia, New South Wales
Local Institution Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Site 0102         
Australia, Queensland
Local Institution Recruiting
Brisbane, Queensland, Australia, 4032
Contact: Site 0030         
Australia, South Australia
Local Institution Recruiting
Elizabeth Vale, South Australia, Australia, 5112
Contact: Site 0031         
Local Institution Recruiting
Kurralta Park, South Australia, Australia, 5037
Contact: Site 0103         
Australia, Western Australia
Local Institution Recruiting
Perth, Western Australia, Australia, 6150
Contact: Site 0028         
Australia
Local Institution Completed
Murdoch, Australia, 6150
Austria
Local Institution Recruiting
Graz, Austria, 8036
Contact: Site 0085         
Klinikum Wels-Grieskirchen Gmbh Recruiting
Wels, Austria, 4600
Contact: Rainer Kolb, Site 0084         
Akh Wien Recruiting
Wien, Austria, 1090
Contact: Thorsten Fuereder, Site 0086         
Belgium
Local Institution Recruiting
Bruxelles, Belgium, 1200
Contact: Site 0013         
Local Institution Recruiting
Edegem, Belgium, 2650
Contact: Site 0012         
Local Institution Recruiting
Leuven, Belgium, 3000
Contact: Site 0011         
Local Institution Recruiting
Yvoir, Belgium, 5530
Contact: Site 0010         
Brazil
Local Institution Recruiting
Ijui, Rio Grande do Sul, Brazil, 98700
Contact: Site 0095         
Local Institution Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90610
Contact: Site 0094         
Local Institution Recruiting
Barretos, Sao Paulo, Brazil, 14784
Contact: Site 0093         
Local Institution Recruiting
Sao Paulo, Brazil, 01321
Contact: Site 0099         
Chile
Local Institution Not yet recruiting
Santiago, Metropolitana, Chile
Contact: Site 0026         
Local Institution Recruiting
Recoleta, Santiago de Chile, Chile
Contact: Site 0025         
Czech Republic
Klinika Komplexni Onkologicke Pece Recruiting
Brno, Czech Republic, 656 53
Contact: Helena Coupkova, Site 0067    +420543136308      
Local Institution Recruiting
Brno, Czech Republic, 625 00
Contact: Site 0069         
Klinika Plicnich Nemoci A Tuberkulozy Recruiting
Olomouc, Czech Republic, 779 00
Contact: Vitezslav Kolek, Site 0068    +420588443560      
Pneumologicka Klinika 1. Lf A Tn Recruiting
Praha 4, Czech Republic, 140 59
Contact: Libor Havel, Site 0066    +420261083449      
Denmark
Local Institution Recruiting
Copenhagen, Denmark, 2100
Contact: Site 0106         
Local Institution Recruiting
Herlev, Denmark, 2730
Contact: Site 0098         
Local Institution Recruiting
Odense, Denmark, 5000
Contact: Site 0100         
France
Local Institution Recruiting
Brest, France, 29200
Contact: Site 0134         
Local Institution Recruiting
Lille Cedex, France, 59037
Contact: Site 0116         
Local Institution Recruiting
Paris Cedex 14, France, 75014
Contact: Site 0118         
Local Institution Recruiting
Pringy Cedex, France, 74374
Contact: Site 0131         
Local Institution Recruiting
Reims, France, 51100
Contact: Site 0132         
Local Institution Recruiting
Toulon Cedex, France, 83056
Contact: Site 0117         
Germany
Sozialstiftung Bamberg Recruiting
Bamberg, Germany, 96049
Contact: Rumo David Leistner, Site 0061    +4995150313713      
Evangelische Lungenklinik Berlin Recruiting
Berlin, Germany, 13125
Contact: Christian Grohe, Site 0055    +493094802299      
Universitaetsklinikum Essen Recruiting
Essen, Germany, 45122
Contact: Martin Schuler, Site 0047         
Klinikum Der Johann Wolfgang Goethe-Universitat Recruiting
Frankfurt am Main, Germany, 60590
Contact: Wolfgang Gleiber, Site 0071    +496963016337      
Srh Wald Klinikum Gera Ggmbh Recruiting
Gera, Germany, 07548
Contact: Susanne Lang, Site 0060    +493658287758      
Klinik Schillerhoehe Recruiting
Gerlingen, Germany, 70839
Contact: Martin Kohlhaeufl, Site 0019    +4971562037257      
Local Institution Recruiting
Grosshansdorf, Germany, 22927
Contact: Site 0021         
Krankenhaus Martha-Maria Halle-Doelau Ggmbh Recruiting
Halle (saale), Germany, 06120
Contact: Wolfgang Schuette, Site 0058    +493455591434      
Asklepios Klinik Harburg Recruiting
Hamburg, Germany, 21075
Contact: Claas Wesseler, Site 0059    +49401818863216      
Thoraxklinik-Heidelberg Ggmbh Recruiting
Heidelberg, Germany, 69126
Contact: Helge Bischoff, Site 0020    +4962213961359      
Local Institution Recruiting
Immenstadt, Germany, 87509
Contact: Site 0046         
Universitaetsklinik Koeln Recruiting
Koeln, Germany, 50937
Contact: Juergen Wolf, Site 0023    +4922147884555      
Local Institution Recruiting
Munich, Germany, 81925
Contact: Site 0022         
Onkologie Rhein Ruhr Recruiting
Oberhausen, Germany, 46145
Contact: Heike Steiniger, Site 0054    +492089704220      
University Hospital Of Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Christian Schulz, Site 0064    +499419444475      
Greece
Local Institution Recruiting
Athens, Greece, 11527
Contact: Site 0062         
Local Institution Recruiting
Heraklio, Greece, 71110
Contact: Site 0063         
Local Institution Recruiting
Thessaloniki, Greece, 57010
Contact: Site 0097         
Hungary
Orsz.Koranyi Tbc Es Pulm.Int. Recruiting
Budapest, Hungary, 1121
Contact: Gyula Ostoros, Site 0150    +3613913245      
Orsz.Koranyi Tbc Es Pulm.Int. Recruiting
Budapest, Hungary, 1121
Contact: Gabriella Temesi, Site 0110    +3613913280      
Pulmonologiai Klinika Recruiting
Budapest, Hungary, 1125
Contact: Gyorgy Losonczy, Site 0112    +3613559733      
Israel
Local Institution Recruiting
Beer Sheva, Israel, 84101
Contact: Site 0139         
Local Institution Recruiting
Kfar Saba, Israel
Contact: Site 0138         
Local Institution Recruiting
Ramat -Gan, Israel, 52621
Contact: Site 0136         
Local Institution Not yet recruiting
Safed, Israel, 13100
Contact: Site 0166         
Italy
Local Institution Recruiting
Bologna, Italy, 40139
Contact: Site 0081         
Local Institution Recruiting
Livorno, Italy, 57100
Contact: Site 0073         
Local Institution Recruiting
Lucca, Italy, 55100
Contact: Site 0108         
Local Institution Recruiting
Meldola, Italy, 47014
Contact: Site 0077         
Local Institution Recruiting
Milano, Italy, 20133
Contact: Site 0078         
Local Institution Recruiting
Monza, Italy, 20052
Contact: Site 0080         
Local Institution Recruiting
Rimini, Italy, 47923
Contact: Site 0107         
Local Institution Recruiting
Roma, Italy, 00189
Contact: Site 0079         
Japan
Local Institution Recruiting
Nagoya, Aichi, Japan, 4600001
Contact: Site 0169         
Local Institution Recruiting
Nagoya-shi, Aichi, Japan, 4648681
Contact: Site 0159         
Local Institution Recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact: Site 0196         
Local Institution Recruiting
Matsuyama, Ehime, Japan, 7910280
Contact: Site 0155         
Local Institution Recruiting
Fukuoka-shi, Fukuoka, Japan, 811-1395
Contact: Site 0153         
Local Institution Recruiting
Akashi-shi, Hyogo, Japan, 6738558
Contact: Site 0168         
Local Institution Recruiting
Kobe-shi, Hyogo, Japan, 6500047
Contact: Site 0163         
Local Institution Recruiting
Natori-shi, Miyagi, Japan, 9811293
Contact: Site 0164         
Local Institution Recruiting
Niigata-shi, Niigata, Japan, 9518566
Contact: Site 0161         
Local Institution Recruiting
Habikino-shi, Osaka, Japan, 563-8588
Contact: Site 0171         
Local Institution Recruiting
Hirakata-shi, Osaka, Japan, 5731191
Contact: Site 0175         
Local Institution Recruiting
Osaka-sayama, Osaka, Japan, 589-8511
Contact: Site 0151         
Local Institution Recruiting
Osaka-shi, Osaka, Japan, 5340021
Contact: Site 0165         
Local Institution Recruiting
Osaka-shi, Osaka, Japan, 537-8511
Contact: Site 0174         
Local Institution Recruiting
Sakai, Osaka, Japan, 591-8555
Contact: Site 0160         
Local Institution Recruiting
Kitaadachigun, Saitama, Japan, 362-0806
Contact: Site 0162         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1138431
Contact: Site 0176         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 1040045
Contact: Site 0170         
Local Institution Recruiting
Koto-ku, Tokyo, Japan, 1358550
Contact: Site 0154         
Local Institution Recruiting
Wakayama, Japan, 641-8510
Contact: Site 0152         
Korea, Republic of
Local Institution Recruiting
Cheongju-si, Chungcheonbuk-do, Korea, Republic of, 28644
Contact: Site 0146         
Local Institution Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 16247
Contact: Site 0145         
Local Institution Recruiting
Seoul, Korea, Republic of, 05505
Contact: Site 0148         
Local Institution Recruiting
Seoul, Korea, Republic of, 02841
Contact: Site 0147         
Norway
Local Institution Recruiting
Bergen, Norway, 5021
Contact: Site 0096         
Local Institution Recruiting
Oslo, Norway, 0424
Contact: Site 0072         
Poland
Wojewodzki Szpital Zespolony W Elblagu Recruiting
Elblag, Poland, 82-300
Contact: Iwona Ryniewicz- Zander, Site 0044    +48552395749      
Klinika Onkologii I Radioterapii Am Recruiting
Gdansk, Poland, 80211
Contact: Rafal Dziadziuszko, Site 0041    +48583492916      
Oddzial Onkologiczny Recruiting
Krakow, Poland, 31-202
Contact: Grzegorz Czyzewicz, Site 0032    +48126143454      
Regionalny Osrodek Onkologiczny Recruiting
Lodz, Poland, 93-513
Contact: Ewa Kalinka-Warzocha, Site 0033    +48792206646      
Oddzial Onkologii Klinicznej Recruiting
Poznan, Poland, 60-569
Contact: Maciej Bryl, Site 0042    +48616654242      
Klinika Nowotworow Pluca I Klatki Piersiowej Recruiting
Warszawa, Poland, 02-781
Contact: Dariusz Kowalski, Site 0035    +48225463066      
Romania
Local Institution Recruiting
Bucharest, Romania, 020122
Contact: Site 0135         
Local Institution Recruiting
Craiova, Romania, 200347
Contact: Site 0114         
Local Institution Recruiting
Romania, Romania, 400015
Contact: Site 0113         
Local Institution Recruiting
Timisoara, Timis, Romania, 300239
Contact: Site 0149         
Russian Federation
Local Institution Not yet recruiting
Istra, Russian Federation
Contact: Site 0120         
Local Institution Recruiting
Moscow, Russian Federation, 115478
Contact: Site 0122         
Local Institution Recruiting
Ryazan, Russian Federation, 390011
Contact: Site 0121         
Local Institution Recruiting
Saint-Petersburg, Russian Federation, 197758
Contact: Site 0126         
Local Institution Recruiting
St. Petersburg, Russian Federation, 194291
Contact: Site 0119         
Local Institution Not yet recruiting
St.petersburg, Russian Federation, 197758
Contact: Site 0127         
Spain
Local Institution Recruiting
Barcelona, Spain, 08025
Contact: Site 0006         
Local Institution Recruiting
Barcelona, Spain, 08035
Contact: Site 0005         
Local Institution Recruiting
Madrid, Spain, 28034
Contact: Site 0004         
Local Institution Recruiting
Madrid, Spain, 28050
Contact: Site 0003         
Local Institution Recruiting
Sevilla, Spain, 41009
Contact: Site 0008         
Local Institution Recruiting
Valencia, Spain, 46026
Contact: Site 0007         
Switzerland
Klinik Fur Onkologie Recruiting
Basel, Switzerland, 4031
Contact: Sacha Rothschild, Site 0104    +41612655445      
Local Institution Recruiting
Lausanne, Switzerland, 1011
Contact: Site 0133         
Local Institution Recruiting
Winterthur, Switzerland, 8401
Contact: Site 0109         
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Alessandra Curioni Fontecedro, Site 0156    +41442552214      
Taiwan
Local Institution Recruiting
Taichung, Taiwan, 404
Contact: Site 0143         
Local Institution Active, not recruiting
Taichung, Taiwan, 40705
Local Institution Recruiting
Taipei, Taiwan, 112
Contact: Site 0167         
United Kingdom
Local Institution Recruiting
London, Greater London, United Kingdom, SW3 6JJ
Contact: Site 0157         
Local Institution Recruiting
Manchester, Greater Manchester, United Kingdom, M20 4XB
Contact: Site 0082         
Local Institution Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Site 0123         
Local Institution Recruiting
Maidstone, Kent, United Kingdom, ME16 9QQ
Contact: Site 0083         
Local Institution Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Site 0124         
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: NCT02481830     History of Changes
Other Study ID Numbers: CA209-331  2015-001097-18 
Study First Received: June 23, 2015
Last Updated: July 26, 2016
Health Authority: Mexico: Federal Commission for Protection Against Health Risks
Canada: Health Canada
Italy: The Italian Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Switzerland: Swissmedic
Poland: Ministry of Health
Hungary: Ministry of Health, Social and Family Affairs
Romania: Ministry of Public Health
Czech Republic: Ministry of Health
Spain: Spanish Agency of Medicines
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ireland: Health Products Regulatory Authority
Korea: Ministry of Food and Drug Safety
Japan: Pharmaceuticals and Medical Devices Agency
Taiwan: Center for Drug Evaluation
United States: Food and Drug Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Paul-Ehrlich-Institut
Chile: Instituto de Salud Pública de Chile
Russia: Ministry of Health of the Russian Federation
Greece: National Organization of Medicines
Finland: Finnish Medicines Agency
Norway: Norwegian Medicines Agency
Denmark: Danish Health and Medicines Authority
Israel: Ministry of Health

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
Amrubicin
Topotecan
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2016