Trial record 1 of 1 for:
NCT01285609
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01285609
First received: January 24, 2011
Last updated: June 22, 2016
Last verified: June 2016
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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 (Squamous) |
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:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint [ Time Frame: Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start) ] [ Designated as safety issue: No ]Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Secondary Outcome Measures:
- Overall Survival (OS) in All Randomized Participants at Primary Endpoint [ Time Frame: Randomization until 705 deaths, up to June 2015 (approximately 48 months post study start) ] [ Designated as safety issue: No ]Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
- Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint [ Time Frame: Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start) ] [ Designated as safety issue: No ]Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
| Enrollment: | 1289 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2016 |
| Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ipilimumab + Paclitaxel and Carboplatin
Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses |
Drug: Ipilimumab
Other Name: BMS-734016
Drug: Paclitaxel
Other Name: Taxol®
Drug: Carboplatin
Other Name: Paraplatin®
|
|
Placebo Comparator: Placebo + Paclitaxel and Carboplatin
Placebo + Active Chemo Backbone 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 until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses |
Drug: Placebo
Drug: Paclitaxel
Other Name: Taxol®
Drug: Carboplatin
Other Name: Paraplatin®
|
Detailed Description:
The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).
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:
- Non small cell lung cancer (NSCLC) - squamous cell
- Stage IV or recurrent NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Brain Metastases
- Autoimmune diseases
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: NCT01285609
Show 279 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285609
Show 279 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
| 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 |
| Results First Received: | May 16, 2016 |
| Last Updated: | June 22, 2016 |
| 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 Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel |
Albumin-Bound Paclitaxel Carboplatin Antibodies, Monoclonal Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 30, 2016