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 April 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: July 9, 2014
Last verified: April 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 [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
    After 816 Death Events have been observed (Interim analysis after 612 death events)


Secondary Outcome Measures:
  • Overall Survival (OS) of subjects who received blinded study therapy [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
    After 816 death events have been observed (analyses will be performed at the same time as the Primary Analysis)

  • Immune-related Progression Free Survival (irPFS) [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
    After 816 death events have been observed (analyses will be performed at the same time as the Primary Analysis)

  • Progression Free Survival [using Modified World Health Organization (mWHO) criteria] [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
    After 816 death events have been observed (analyses will be performed at the same time as the Primary Analysis)

  • Best Overall Response Rate by mWHO (BORR) [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
    After 816 death events have been observed (analyses will be performed at the same time as the Primary Analysis)

  • Duration of Response by mWHO (DoR) [ Time Frame: Approximately 40.8 months after the first subject is randomized ] [ Designated as safety issue: No ]
    After 816 death events have been observed (analyses will be performed at the same time as the Primary Analysis)


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 Biological: 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
Other Names:
  • Yervoy
  • BMS-734016
Drug: Etoposide
IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Other Names:
  • Etopophos
  • Neoposid
  • Eposin
Drug: Cisplatin
IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Other Name: Platinol
Drug: Carboplatin
IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Other Name: Paraplatin
Placebo Comparator: Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin Biological: 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
Drug: Etoposide
IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles
Other Names:
  • Etopophos
  • Neoposid
  • Eposin
Drug: Cisplatin
IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses
Other Name: Platinol
Drug: Carboplatin
IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
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 #.

  Show 129 Study Locations
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: July 9, 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:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Cisplatin
Etoposide
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 22, 2014