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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01450761
First received: October 10, 2011
Last updated: June 7, 2016
Last verified: June 2016
Results First Received: March 7, 2016  
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
Condition: Small Cell Lung Carcinoma
Interventions: Biological: Ipilimumab
Biological: Placebo matching Ipilimumab
Drug: Etoposide
Drug: Cisplatin
Drug: Carboplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 1414 enrolled participants, 566 participants each were randomized to Ipilimumab and placebo arms. The remaining 282 participants were not randomized, the most frequently reported reason being that the participants no longer met study criteria.

Reporting Groups
  Description
Ipilimumab and Platinum/Etoposide During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with ipilimumab (10 mg/kg IV) every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
Placebo and Platinum/Etoposide During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with placebo every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of placebo.

Participant Flow for 3 periods

Period 1:   Randomization
    Ipilimumab and Platinum/Etoposide     Placebo and Platinum/Etoposide  
STARTED     566     566  
COMPLETED     562     561  
NOT COMPLETED     4     5  
Subject no longer meets study criteria                 1                 2  
Withdrawal by Subject                 2                 0  
Disease progression                 0                 2  
Adverse Event unrelated to study drug                 1                 0  
Unspecified                 0                 1  

Period 2:   Lead-in Chemotherapy
    Ipilimumab and Platinum/Etoposide     Placebo and Platinum/Etoposide  
STARTED     562     561  
COMPLETED     478     476  
NOT COMPLETED     84     85  
Disease progression                 33                 32  
Adverse event unrelated to study drug                 21                 19  
Withdrawal by Subject                 14                 12  
Study drug toxicity                 6                 10  
No longer meets study criteria                 3                 7  
Death                 3                 3  
Unspecified                 2                 2  
Lost to Follow-up                 2                 0  

Period 3:   Treatment With Blinded Study Therapy
    Ipilimumab and Platinum/Etoposide     Placebo and Platinum/Etoposide  
STARTED     478     476  
COMPLETED     14     10  
NOT COMPLETED     464     466  
Disease progression                 314                 409  
Study drug toxicity                 85                 9  
Adverse event unrelated to study drug                 25                 19  
Subject request to discontinue treatment                 14                 8  
Withdrawal by Subject                 11                 5  
Death                 5                 6  
Other/Unspecified                 5                 4  
Lost to Follow-up                 2                 1  
Maximum clinical benefit                 1                 2  
No longer meets study criteria                 1                 2  
Not reported                 0                 1  
Poor/non-compliance                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of blinded study therapy

Reporting Groups
  Description
Ipilimumab and Platinum/Etoposide Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
Placebo and Platinum/Etoposide Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
Total Total of all reporting groups

Baseline Measures
    Ipilimumab and Platinum/Etoposide     Placebo and Platinum/Etoposide     Total  
Number of Participants  
[units: participants]
  478     476     954  
Age  
[units: years]
Mean (Standard Deviation)
  61.3  (8.90)     62.6  (8.61)     61.9  (8.78)  
Gender  
[units: participants]
     
Female     161     150     311  
Male     317     326     643  



  Outcome Measures
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1.  Primary:   Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy   [ Time Frame: Randomization until date of death, up to March 2015, approximately 38 months ]

2.  Secondary:   Overall Survival in All Randomized Participants   [ Time Frame: From randomization until date of death, up to March 2015, approximately 38 months ]

3.  Secondary:   Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy   [ Time Frame: From randomization until disease progression, up to March 2015, approximately 38 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01450761     History of Changes
Other Study ID Numbers: CA184-156
2011-000850-48 ( EudraCT Number )
Study First Received: October 10, 2011
Results First Received: March 7, 2016
Last Updated: June 7, 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