Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01450761
First received: October 10, 2011
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.


Condition Intervention Phase
Small Cell Lung Carcinoma
Biological: Ipilimumab
Biological: Placebo matching Ipilimumab
Drug: Etoposide
Drug: Cisplatin
Drug: Carboplatin
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: Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall Survival among subjects who receive at least one dose of blinded study therapy [ Time Frame: Approximately 41 months after the 1st subject is randomized ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival in all Randomized Subjects [ Time Frame: Approximately 41 months after the 1st subject is randomized ] [ Designated as safety issue: No ]
  • Progression Free Survival per mWHO in subjects who have received at least one dose of blinded study therapy [ Time Frame: Approximately 41 months after the 1st subject is randomized ] [ Designated as safety issue: No ]

Estimated Enrollment: 1125
Study Start Date: December 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab+Etoposide+Cisplatin/Carboplatin

Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached

Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles

Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses

Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
Drug: Etoposide
Other Names:
  • Etopophos
  • Neoposid
  • Eposin
Drug: Cisplatin
Other Name: Platinol
Drug: Carboplatin
Other Name: Paraplatin
Placebo Comparator: Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin

Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached

Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles

Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses

Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses

Biological: Placebo matching Ipilimumab Drug: Etoposide
Other Names:
  • Etopophos
  • Neoposid
  • Eposin
Drug: Cisplatin
Other Name: Platinol
Drug: Carboplatin
Other Name: Paraplatin

  Eligibility

Ages Eligible for Study:   18 Years and older
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:

  • Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
  • Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria:

  • Prior systemic therapy for lung cancer
  • Symptomatic Central Nervous System (CNS) metastases
  • History of autoimmune disease
  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: NCT01450761

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
Genesis Cancer Center Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Roy Webb, Site 030    501-624-7700      
United States, California
Ucsd Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Lyudmila Bazhenova, Site 032    858-822-6189      
Sutter Cancer Center Recruiting
Sacramento, California, United States, 95816
Contact: Deepti Behl, Site 040         
United States, Florida
Cancer Specialists, Llc Recruiting
Jacksonville, Florida, United States, 32256
Contact: Jeffrey Bubis, Site 003    904-538-4488      
Cancer Care Of North Florida, Pa Recruiting
Lake City, Florida, United States, 32024
Contact: Wasseemullah Khan, Site 038    386-755-1655      
United States, Georgia
Medical Oncology Associates Of Augusta,Pc Recruiting
Augusta, Georgia, United States, 30901
Contact: Donald Townsend, Site 181    706-722-4245      
United States, Illinois
Quincy Medical Group Recruiting
Quincy, Illinois, United States, 62301
Contact: Christian El-Khoury, Site 0225    217-285-2113      
Presence Medical Group Hematology Oncology Recruiting
Skokie, Illinois, United States, 60077
Contact: Ira Anton Oliff, Site 020         
Siu School Of Medicine Recruiting
Springfield, Illinois, United States, 62794
Contact: Aziz Khan, Site 100    217-545-2219      
United States, Indiana
Franciscan Physician Network Oncology And Hematology Specialists Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Michael Slaughter, Site 025    317-782-7060      
Local Institution Not yet recruiting
New Albany, Indiana, United States, 47150
Contact: Site 005         
United States, Kansas
Cancer Center Of Kansas Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker Dakhil, Site 033    316-262-4467      
United States, Kentucky
Ashland Bellefonte Cancer Center Recruiting
Ashland, Kentucky, United States, 41101
Contact: Kirti Jain, Site 015    606-836-0202 ext x28      
University Of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Susanne Arnold, Site 216    859-323-0532      
Montgomery Cancer Center Recruiting
Mount Sterling, Kentucky, United States, 40353
Contact: Muhammad-Ali Zaydan, Site 078    859-499-1000      
United States, Louisiana
Local Institution Not yet recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Site 116         
United States, Michigan
St Joseph Mercy Hospital Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Philip Stella, Site 026    734-712-2704      
United States, Missouri
Local Institution Not yet recruiting
Kansas City, Missouri, United States, 64111
Contact: Site 037         
United States, Nebraska
Southeast Nebraska Hematology & Oncology Consultants, P.C. Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Steven G Dunder, Site 008    402-327-7363      
United States, New Jersey
Regional Cancer Care Associates, Llc/Cherry Hill Division Recruiting
Cherry Hill, New Jersey, United States, 08003
Contact: Richard Greenberg, Site 018         
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Contact: Nashat Gabrail, Site 017    330-492-3345      
Local Institution Not yet recruiting
Columbus, Ohio, United States, 43219
Contact: Site 043         
Signal Point Clinical Research Center, Llc Recruiting
Middletown, Ohio, United States, 45042
Contact: Nandagopal S Vrindavanam, Site 029    513-217-4809      
United States, Oklahoma
Local Institution Not yet recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Site 034         
Cancer Care Associates Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Steven C Buck, Site 004         
United States, Oregon
Kaiser Permanente Recruiting
Portland, Oregon, United States, 97227
Contact: Mark Urban Rarick, Site 024    503-249-3507      
United States, Tennessee
Associated In Oncology And Hematology Recruiting
Chattanooga, Tennessee, United States, 37421
Contact: Jitendra Gandhi, Site 0228         
The Jones Clinic, Pc Recruiting
Germantown, Tennessee, United States, 38138
Contact: C. Michael Jones, Site 011    901-685-5969 ext 322      
Tennessee Cancer Specialists Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Russell Devore Iii, Site 006    865-934-2672      
Tennessee Oncology, Pllc Recruiting
Nashville, Tennessee, United States, 37203
Contact: David Spigel, Site 012    615-329-7274      
Henry-Joyce Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Leora Horn, Site 023    615-936-2889      
United States, Utah
Huntsman Cancer Institute At The Univ. Of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Wallace Akerley, Site 129    801-585-7844      
United States, Virginia
Local Institution Not yet recruiting
Newport News, Virginia, United States, 23601
Contact: Site 028         
United States, West Virginia
Mary Babb Randolph Cancer Center Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Mohammed Almubarak, Site 0232    304-293-2633      
Argentina
Local Institution Completed
Rosario, Santa Fe, Argentina, S2000DSV
Local Institution Completed
Berazategui, Argentina, 1884
Local Institution Completed
Caba, Argentina, 1426
Local Institution Suspended
Ciudad Autonoma de Buenos, Argentina, C1280AEB
Australia, New South Wales
Local Institution Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Site 047         
Local Institution Recruiting
Wollongong, New South Wales, Australia, 2500
Contact: Site 050         
Australia, South Australia
Local Institution Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Site 051         
Australia, Victoria
Local Institution Not yet recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Site 045         
Australia, Western Australia
Local Institution Recruiting
Perth, Western Australia, Australia, 6009
Contact: Site 046         
Austria
Local Institution Not yet recruiting
Salzburg, Austria, 5020
Contact: Site 120         
Belgium
Local Institution Recruiting
Leuven, Belgium, 3000
Contact: Site 153         
Local Institution Recruiting
Yvoir, Belgium, 5530
Contact: Site 213         
Brazil
Local Institution Recruiting
Curitiba, Parana, Brazil, 81520
Contact: Site 204         
Local Institution Recruiting
Sao Paulo, Brazil, 01246
Contact: Site 209         
Canada, Quebec
Local Institution Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Site 002         
Local Institution Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Site 022         
Chile
Local Institution Recruiting
Santiago, Region Metropolitana, Chile, 8420383
Contact: Site 212         
Local Institution Recruiting
Vina Del Mar, Valparaiso, Chile, 2540364
Contact: Site 0239         
Local Institution Terminated
Valparaiso, Chile, 2363068
Colombia
Local Institution Not yet recruiting
Monteria, Cordoba, Colombia
Contact: Site 201         
Local Institution Not yet recruiting
Bogota, Cundinamarca, Colombia
Contact: Site 203         
Czech Republic
Local Institution Recruiting
Ostrava - Poruba, Czech Republic, 70852
Contact: Site 151         
Local Institution Recruiting
Prague, Czech Republic, 128 08
Contact: Site 149         
Local Institution Recruiting
Prague 8, Czech Republic, 180 81
Contact: Site 150         
France
Local Institution Not yet recruiting
Caen, France, 14076
Contact: Site 173         
Local Institution Recruiting
Rennes Cedex 9, France, 35033
Contact: Site 172         
Local Institution Not yet recruiting
Toulouse Cedex 9, France, 31059
Contact: Site 174         
Germany
Local Institution Recruiting
Bochum, Germany, 44791
Contact: Site 067         
Local Institution Recruiting
Gauting, Germany, 82131
Contact: Site 128         
Local Institution Recruiting
Grosshansdorf, Germany, 22927
Contact: Site 070         
Local Institution Recruiting
Heidelberg, Germany, 69126
Contact: Site 072         
Local Institution Recruiting
Mannheim, Germany, 68167
Contact: Site 071         
Local Institution Recruiting
Munchen, Germany, 81925
Contact: Site 068         
Hong Kong
Local Institution Recruiting
Hong Kong, Hong Kong
Contact: Site 079         
Local Institution Recruiting
Kowloon, Hong Kong
Contact: Site 157         
Hungary
Local Institution Recruiting
Budapest, Hungary, 1125
Contact: Site 096         
Local Institution Recruiting
Farkasgyepu, Hungary, 8582
Contact: Site 097         
Local Institution Recruiting
Matrahaza, Hungary, 3233
Contact: Site 093         
Local Institution Recruiting
Sopron, Hungary, 9400
Contact: Site 094         
Local Institution Not yet recruiting
Szekesfehervar, Hungary, 8000
Contact: Site 099         
Local Institution Recruiting
Szolnok, Hungary, H-5000
Contact: Site 189         
Ireland
Local Institution Recruiting
Dublin, Ireland, 8
Contact: Site 088         
Local Institution Recruiting
Dublin, Ireland, 4
Contact: Site 087         
Israel
Local Institution Recruiting
Kfar-saba, Israel, 44281
Contact: Site 108         
Local Institution Recruiting
Zerifin, Israel, 70300
Contact: Site 106         
Italy
Local Institution Recruiting
Lucca, Italy, 55100
Contact: Site 168         
Local Institution Recruiting
Siena, Italy, 53100
Contact: Site 170         
Japan
Local Institution Recruiting
Nagoya-shi, Aichi, Japan, 4600001
Contact: Site 0305         
Local Institution Recruiting
Yokohama-Shi, Kanagawa, Japan, 2360051
Contact: Site 0299         
Local Institution Recruiting
Yokohama-shi, Kanagawa, Japan, 2408555
Contact: Site 0298         
Local Institution Recruiting
Natori-shi, Miyagi, Japan, 9811293
Contact: Site 0304         
Local Institution Recruiting
Hirakata-shi, Osaka, Japan, 5731191
Contact: Site 0300         
Local Institution Recruiting
Ube-shi, Yamaguchi, Japan, 7550241
Contact: Site 0301         
Korea, Republic of
Local Institution Recruiting
Seoul, Gangnam-gu, Korea, Republic of, 135-710
Contact: Site 103         
Local Institution Recruiting
Goyang-si, Gyeonggji-do, Korea, Republic of, 410-769
Contact: Site 082         
Local Institution Recruiting
Hwasun-eup, Hwasun-gun, Jeonnam, Korea, Republic of, 519-763
Contact: Site 102         
Local Institution Recruiting
Busan, Korea, Republic of, 602-739
Contact: Site 152         
Local Institution Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Site 105         
Local Institution Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Site 104         
Local Institution Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Site 081         
Local Institution Recruiting
Suwon, Korea, Republic of, 443-721
Contact: Site 052         
Mexico
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Site 199         
Local Institution Not yet recruiting
San Luis Potosi, Mexico, 78419
Contact: Site 200         
Netherlands
Local Institution Recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: Site 138         
Peru
Local Institution Terminated
Lima, Peru, Lima 01
Poland
Local Institution Recruiting
Krakow, Poland, 31202
Contact: Site 159         
Local Institution Recruiting
Otwock, Poland, 05-400
Contact: Site 166         
Local Institution Recruiting
Torun, Poland, 87-100
Contact: Site 165         
Local Institution Recruiting
Warszawa, Poland, 02-781
Contact: Site 160         
Portugal
Local Institution Recruiting
Coimbra, Portugal, 3041853
Contact: Site 091         
Romania
Local Institution Recruiting
Cluj Napoca, Romania, 400058
Contact: Site 179         
Local Institution Recruiting
Craiova, Romania, 200385
Contact: Site 178         
Russian Federation
Local Institution Recruiting
Chelyabinsk, Russian Federation, 454087
Contact: Site 055         
Local Institution Recruiting
Krasnodar, Russian Federation, 350040
Contact: Site 053         
Local Institution Recruiting
Moscow, Russian Federation, 115478
Contact: Site 056         
Local Institution Recruiting
Moscow, Russian Federation, 115478
Contact: Site 059         
Local Institution Recruiting
Pyatigorsk, Russian Federation, 35702
Contact: Site 063         
Local Institution Recruiting
St. Petersburg, Russian Federation, 198255
Contact: Site 057         
Local Institution Recruiting
St. Petersburg, Russian Federation, 194291
Contact: Site 060         
South Africa
Local Institution Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6045
Contact: Site 111         
Spain
Local Institution Recruiting
Malaga, Andalucia, Spain, 29010
Contact: Site 148         
Local Institution Recruiting
A Coruna, Galicia, Spain, 15006
Contact: Site 143         
Local Institution Recruiting
Barcelona, Spain, 08035
Contact: Site 145         
Local Institution Recruiting
Benidorm-alicante, Spain, 03501
Contact: Site 144         
Local Institution Recruiting
Lleida, Spain, 25198
Contact: Site 146         
Local Institution Recruiting
Malaga, Spain, 29010
Contact: Site 0237         
Sweden
Local Institution Recruiting
Stockholm, Sweden, 17176
Contact: Site 115         
Local Institution Recruiting
Uppsala, Sweden, 75185
Contact: Site 114         
Switzerland
Local Institution Recruiting
Basel, Switzerland, 4031
Contact: Site 075         
Taiwan
Local Institution Not yet recruiting
Changhua, Taiwan, 500
Contact: Site 182         
Local Institution Recruiting
Taichung City, Taiwan, 40447
Contact: Site 183         
Thailand
Local Institution Recruiting
Chiang Mai, Thailand, 50200
Contact: Site 083         
United Kingdom
Local Institution Recruiting
Withington, Manchester, United Kingdom, M20 4BX
Contact: Site 132         
Local Institution Recruiting
London, United Kingdom, SW3 6JJ
Contact: Site 133         
Local Institution Recruiting
London, United Kingdom, N181QX
Contact: Site 131         
Local Institution Recruiting
Preston, United Kingdom, PR2 9HT
Contact: Site 130         
Local Institution Recruiting
Truro, United Kingdom, TR1 3LJ
Contact: Site 211         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01450761     History of Changes
Other Study ID Numbers: CA184-156, 2011-000850-48
Study First Received: October 10, 2011
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration
Hong Kong: Department of Health
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Thailand: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: National Institute of Medicines
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Federal Office of Public Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
South Africa: Medicines Control Council
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: CONEP
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Peru: Instituto Nacional de Salud
Mexico: Federal Commission for Sanitary Risks Protection
Denmark: Data inspectorate, Directorate for Health and Social Affairs
Finland: Finnish Medicines Agency
Norway: Directorate of Health
Sweden: Medical Products Agency
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Etoposide phosphate
Cisplatin
Carboplatin
Etoposide
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014