Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin - Full Text View

Purpose

The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

Condition	Intervention	Phase
Lung Cancer - Non Small Cell	Drug: Ipilimumab Drug: Placebo Drug: Paclitaxel 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 in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Ipilimumab

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Overall Survival (defined as the time from the date of randomization until the date of death or the last known date the subject was alive) [ Time Frame: Approximately 48 months post study start ] [ Designated as safety issue: No ]
Until 705 Death Events have occurred, Interim analysis at 528 events

Secondary Outcome Measures:

Overall Survival (OS) in subjects who receive one dose of blinded therapy [ Time Frame: Approximately 42 months post study start ] [ Designated as safety issue: No ]
Progression Free Survival [determined as the time between the date of randomization and the date of progression per modified World Health Organization (mWHO) criteria] [ Time Frame: Approximately 42 months post study start ] [ Designated as safety issue: No ]
Best Overall Response Rate (determined by the number of subjects who are complete or partial responders divided by the total number of subjects in the data set) [ Time Frame: Approximately 42 months post study start ] [ Designated as safety issue: No ]

Estimated Enrollment:	1100
Study Start Date:	August 2011
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ipilimumab + Paclitaxel and Carboplatin Ipilimumab + Active Chemo Backbone	Drug: Ipilimumab IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks beginning at week 24 Other Name: BMS-734016 Drug: Paclitaxel IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Other Name: Taxol® Drug: Carboplatin IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses Other Name: Paraplatin®
Placebo Comparator: Placebo + Paclitaxel and Carboplatin Placebo + Active Chemo Backbone	Drug: Placebo IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks beginning at week 24 Drug: Paclitaxel IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Other Name: Taxol® Drug: Carboplatin IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses Other Name: Paraplatin®

Arms

Assigned Interventions

Experimental: Ipilimumab + Paclitaxel and Carboplatin

Ipilimumab + Active Chemo Backbone

Drug: Ipilimumab

IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks beginning at week 24

Other Name: BMS-734016

Drug: Paclitaxel

IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses

Other Name: Taxol®

Drug: Carboplatin

IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

Other Name: Paraplatin®

Placebo Comparator: Placebo + Paclitaxel and Carboplatin

Placebo + Active Chemo Backbone

Drug: Placebo

IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks beginning at week 24

Drug: Paclitaxel

IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses

Other Name: Taxol®

Drug: Carboplatin

IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

Other Name: Paraplatin®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

Non small cell lung cancer (NSCLC) - squamous cell
Stage IV or recurrent NSCLC
Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria:

Brain Metastases
Autoimmune diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285609

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 197 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01285609 History of Changes
Other Study ID Numbers:	CA184-104, 2009-017396-19
Study First Received:	January 24, 2011
Last Updated:	May 10, 2013
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, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013