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

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Carboplatin Etoposide phosphate Ipilimumab

U.S. FDA Resources

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

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

Show 149 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

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:	February 19, 2015
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:


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

ClinicalTrials.gov processed this record on February 25, 2015