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

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ClinicalTrials.gov Identifier: NCT01450761
Recruitment Status : Completed
First Posted : October 12, 2011
Results First Posted : July 18, 2016
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Small Cell Lung Carcinoma
Interventions Biological: Ipilimumab
Biological: Placebo matching Ipilimumab
Drug: Etoposide
Drug: Cisplatin
Drug: Carboplatin
Enrollment 1351
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Ipilimumab and Platinum/Etoposide Placebo and Platinum/Etoposide
Hide Arm/Group Description 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. 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.
Period Title: Randomization
Started 566 566
Completed 562 561
Not Completed 4 5
Reason Not Completed
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
Other             0             1
Period Title: Lead-in Chemotherapy
Started 562 561
Completed 478 476
Not Completed 84 85
Reason Not Completed
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
Other             2             2
Lost to Follow-up             2             0
Period Title: Treatment With Blinded Study Therapy
Started 478 476
Completed [1] 0 0
Not Completed 478 476
Reason Not Completed
Disease progression             318             415
Study drug toxicity             87             9
Adverse event unrelated to study drug             27             19
Subject request to discontinue treatment             15             8
Withdrawal by Subject             12             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             2             2
Poor/non-compliance             1             0
Administrative reason by sponsor             2             3
[1]
Completed = remaining on study therapy
Arm/Group Title Ipilimumab and Platinum/Etoposide Placebo and Platinum/Etoposide Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 478 476 954
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of blinded study therapy
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 478 participants 476 participants 954 participants
61.3  (8.90) 62.6  (8.61) 61.9  (8.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 478 participants 476 participants 954 participants
Female
161
  33.7%
150
  31.5%
311
  32.6%
Male
317
  66.3%
326
  68.5%
643
  67.4%
1.Primary Outcome
Title Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy
Hide Description Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Time Frame Randomization until date of death, up to March 2015, approximately 38 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of blinded study therapy
Arm/Group Title Ipilimumab and Platinum/Etoposide Placebo and Platinum/Etoposide
Hide Arm/Group Description:
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) 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.
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) 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.
Overall Number of Participants Analyzed 478 476
Median (95% Confidence Interval)
Unit of Measure: months
10.97
(10.45 to 11.33)
10.94
(10.02 to 11.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab and Platinum/Etoposide, Placebo and Platinum/Etoposide
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3775
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.936
Confidence Interval (2-Sided) 95%
0.807 to 1.085
Estimation Comments HR = ipilimumab over placebo
2.Secondary Outcome
Title Overall Survival in All Randomized Participants
Hide Description Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Time Frame From randomization until date of death, up to March 2015, approximately 38 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Ipilimumab and Platinum/Etoposide Placebo and Platinum/Etoposide
Hide Arm/Group Description:
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) 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.
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) 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.
Overall Number of Participants Analyzed 566 566
Median (95% Confidence Interval)
Unit of Measure: months
10.22
(9.59 to 10.81)
9.95
(9.33 to 10.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab and Platinum/Etoposide, Placebo and Platinum/Etoposide
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5678
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.961
Confidence Interval (2-Sided) 95%
0.838 to 1.102
Estimation Comments HR = ipilimumab over placebo
3.Secondary Outcome
Title Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy
Hide Description Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Time Frame From randomization until disease progression, up to March 2015, approximately 38 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of blinded study therapy
Arm/Group Title Ipilimumab and Platinum/Etoposide Placebo and Platinum/Etoposide
Hide Arm/Group Description:
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) 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.
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) 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.
Overall Number of Participants Analyzed 478 476
Median (95% Confidence Interval)
Unit of Measure: months
4.63
(4.50 to 4.99)
4.44
(4.37 to 4.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab and Platinum/Etoposide, Placebo and Platinum/Etoposide
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0161
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.851
Confidence Interval (2-Sided) 95%
0.747 to 0.971
Estimation Comments HR = ipilimumab over placebo
Time Frame From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE PLACEBO + PLATINUM/ETOPOSIDE
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE PLACEBO + PLATINUM/ETOPOSIDE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE PLACEBO + PLATINUM/ETOPOSIDE
Affected / at Risk (%) Affected / at Risk (%)
Total   316/562 (56.23%)   278/561 (49.55%) 
Blood and lymphatic system disorders     
Febrile bone marrow aplasia  1  0/562 (0.00%)  1/561 (0.18%) 
Granulocytopenia  1  1/562 (0.18%)  1/561 (0.18%) 
Haematotoxicity  1  1/562 (0.18%)  0/561 (0.00%) 
Leukopenia  1  0/562 (0.00%)  1/561 (0.18%) 
Eosinophilia  1  1/562 (0.18%)  0/561 (0.00%) 
Febrile neutropenia  1  25/562 (4.45%)  15/561 (2.67%) 
Pancytopenia  1  6/562 (1.07%)  7/561 (1.25%) 
Anaemia  1  13/562 (2.31%)  23/561 (4.10%) 
Bone marrow failure  1  3/562 (0.53%)  5/561 (0.89%) 
Neutropenia  1  15/562 (2.67%)  20/561 (3.57%) 
Thrombocytopenia  1  4/562 (0.71%)  8/561 (1.43%) 
Cardiac disorders     
Acute coronary syndrome  1  2/562 (0.36%)  0/561 (0.00%) 
Cardiac arrest  1  1/562 (0.18%)  0/561 (0.00%) 
Cardio-respiratory distress  1  1/562 (0.18%)  0/561 (0.00%) 
Cardiopulmonary failure  1  1/562 (0.18%)  3/561 (0.53%) 
Atrial fibrillation  1  4/562 (0.71%)  2/561 (0.36%) 
Cardiac tamponade  1  0/562 (0.00%)  2/561 (0.36%) 
Supraventricular tachycardia  1  1/562 (0.18%)  0/561 (0.00%) 
Cardiac failure  1  3/562 (0.53%)  3/561 (0.53%) 
Cardiogenic shock  1  0/562 (0.00%)  1/561 (0.18%) 
Myocardial infarction  1  3/562 (0.53%)  3/561 (0.53%) 
Arrhythmia supraventricular  1  0/562 (0.00%)  1/561 (0.18%) 
Myocardial ischaemia  1  0/562 (0.00%)  1/561 (0.18%) 
Angina pectoris  1  0/562 (0.00%)  1/561 (0.18%) 
Right ventricular failure  1  1/562 (0.18%)  0/561 (0.00%) 
Cardiac failure acute  1  0/562 (0.00%)  1/561 (0.18%) 
Cardiovascular insufficiency  1  0/562 (0.00%)  1/561 (0.18%) 
Pericardial effusion  1  2/562 (0.36%)  1/561 (0.18%) 
Cardiac failure congestive  1  0/562 (0.00%)  1/561 (0.18%) 
Ear and labyrinth disorders     
Vertigo  1  2/562 (0.36%)  0/561 (0.00%) 
Endocrine disorders     
Inappropriate antidiuretic hormone secretion  1  1/562 (0.18%)  0/561 (0.00%) 
Adrenal insufficiency  1  1/562 (0.18%)  0/561 (0.00%) 
Hypophysitis  1  4/562 (0.71%)  1/561 (0.18%) 
Autoimmune thyroiditis  1  1/562 (0.18%)  0/561 (0.00%) 
Hyperthyroidism  1  2/562 (0.36%)  0/561 (0.00%) 
Hypothyroidism  1  3/562 (0.53%)  0/561 (0.00%) 
Myxoedema  1  1/562 (0.18%)  0/561 (0.00%) 
Hypopituitarism  1  2/562 (0.36%)  0/561 (0.00%) 
Eye disorders     
Glaucoma  1  1/562 (0.18%)  0/561 (0.00%) 
Gastrointestinal disorders     
Autoimmune colitis  1  1/562 (0.18%)  0/561 (0.00%) 
Proctalgia  1  0/562 (0.00%)  1/561 (0.18%) 
Stomatitis  1  0/562 (0.00%)  1/561 (0.18%) 
Diarrhoea  1  42/562 (7.47%)  13/561 (2.32%) 
Diverticular perforation  1  0/562 (0.00%)  1/561 (0.18%) 
Gastrointestinal hypomotility  1  1/562 (0.18%)  0/561 (0.00%) 
Haematemesis  1  1/562 (0.18%)  1/561 (0.18%) 
Ileus  1  2/562 (0.36%)  0/561 (0.00%) 
Intestinal obstruction  1  1/562 (0.18%)  1/561 (0.18%) 
Oesophagitis  1  0/562 (0.00%)  2/561 (0.36%) 
Abdominal pain upper  1  0/562 (0.00%)  2/561 (0.36%) 
Enteritis  1  2/562 (0.36%)  0/561 (0.00%) 
Enterocolitis  1  2/562 (0.36%)  0/561 (0.00%) 
Gastric ulcer perforation  1  1/562 (0.18%)  0/561 (0.00%) 
Vomiting  1  10/562 (1.78%)  9/561 (1.60%) 
Nausea  1  12/562 (2.14%)  5/561 (0.89%) 
Odynophagia  1  0/562 (0.00%)  1/561 (0.18%) 
Pancreatitis acute  1  1/562 (0.18%)  0/561 (0.00%) 
Colitis  1  24/562 (4.27%)  1/561 (0.18%) 
Dysphagia  1  0/562 (0.00%)  2/561 (0.36%) 
Gastritis  1  1/562 (0.18%)  0/561 (0.00%) 
Colitis ulcerative  1  1/562 (0.18%)  0/561 (0.00%) 
Duodenal perforation  1  1/562 (0.18%)  0/561 (0.00%) 
Intestinal perforation  1  1/562 (0.18%)  0/561 (0.00%) 
Constipation  1  0/562 (0.00%)  2/561 (0.36%) 
Abdominal pain  1  4/562 (0.71%)  2/561 (0.36%) 
Faecaloma  1  0/562 (0.00%)  1/561 (0.18%) 
Gastrointestinal haemorrhage  1  1/562 (0.18%)  0/561 (0.00%) 
Pancreatitis  1  0/562 (0.00%)  1/561 (0.18%) 
Subileus  1  0/562 (0.00%)  1/561 (0.18%) 
General disorders     
Chest pain  1  5/562 (0.89%)  5/561 (0.89%) 
Condition aggravated  1  1/562 (0.18%)  0/561 (0.00%) 
Death  1  4/562 (0.71%)  3/561 (0.53%) 
Fatigue  1  4/562 (0.71%)  1/561 (0.18%) 
Sudden cardiac death  1  1/562 (0.18%)  0/561 (0.00%) 
Multi-organ failure  1  0/562 (0.00%)  6/561 (1.07%) 
Sudden death  1  1/562 (0.18%)  0/561 (0.00%) 
Euthanasia  1  1/562 (0.18%)  0/561 (0.00%) 
Disease progression  1  6/562 (1.07%)  9/561 (1.60%) 
Pain  1  1/562 (0.18%)  4/561 (0.71%) 
Asthenia  1  4/562 (0.71%)  5/561 (0.89%) 
Influenza like illness  1  0/562 (0.00%)  1/561 (0.18%) 
General physical health deterioration  1  13/562 (2.31%)  5/561 (0.89%) 
Oedema peripheral  1  1/562 (0.18%)  0/561 (0.00%) 
Pyrexia  1  7/562 (1.25%)  5/561 (0.89%) 
Malaise  1  1/562 (0.18%)  2/561 (0.36%) 
Non-cardiac chest pain  1  2/562 (0.36%)  0/561 (0.00%) 
Hepatobiliary disorders     
Hepatocellular injury  1  1/562 (0.18%)  0/561 (0.00%) 
Hepatic failure  1  0/562 (0.00%)  1/561 (0.18%) 
Hepatitis acute  1  1/562 (0.18%)  0/561 (0.00%) 
Hepatic function abnormal  1  1/562 (0.18%)  0/561 (0.00%) 
Drug-induced liver injury  1  4/562 (0.71%)  0/561 (0.00%) 
Hepatotoxicity  1  1/562 (0.18%)  0/561 (0.00%) 
Cholangitis sclerosing  1  1/562 (0.18%)  0/561 (0.00%) 
Hyperbilirubinaemia  1  1/562 (0.18%)  0/561 (0.00%) 
Cholangitis  1  1/562 (0.18%)  0/561 (0.00%) 
Cholecystitis  1  1/562 (0.18%)  0/561 (0.00%) 
Immune system disorders     
Food allergy  1  1/562 (0.18%)  0/561 (0.00%) 
Drug hypersensitivity  1  1/562 (0.18%)  0/561 (0.00%) 
Hypersensitivity  1  2/562 (0.36%)  1/561 (0.18%) 
Infections and infestations     
Clostridium difficile colitis  1  0/562 (0.00%)  1/561 (0.18%) 
Pyomyositis  1  0/562 (0.00%)  1/561 (0.18%) 
Encephalitis  1  1/562 (0.18%)  0/561 (0.00%) 
Gastroenteritis viral  1  0/562 (0.00%)  1/561 (0.18%) 
Rectal abscess  1  0/562 (0.00%)  1/561 (0.18%) 
Septic shock  1  3/562 (0.53%)  3/561 (0.53%) 
Adrenalitis  1  1/562 (0.18%)  0/561 (0.00%) 
Epididymitis  1  0/562 (0.00%)  1/561 (0.18%) 
Infection  1  3/562 (0.53%)  3/561 (0.53%) 
Influenza  1  2/562 (0.36%)  0/561 (0.00%) 
Appendicitis  1  0/562 (0.00%)  1/561 (0.18%) 
Infectious pleural effusion  1  1/562 (0.18%)  2/561 (0.36%) 
Neutropenic sepsis  1  0/562 (0.00%)  2/561 (0.36%) 
Pulmonary sepsis  1  0/562 (0.00%)  1/561 (0.18%) 
Respiratory tract infection  1  3/562 (0.53%)  6/561 (1.07%) 
Upper respiratory tract infection  1  0/562 (0.00%)  1/561 (0.18%) 
Bronchopneumonia  1  1/562 (0.18%)  1/561 (0.18%) 
Lung infection  1  1/562 (0.18%)  3/561 (0.53%) 
Oral candidiasis  1  1/562 (0.18%)  0/561 (0.00%) 
Pneumonia  1  33/562 (5.87%)  16/561 (2.85%) 
Staphylococcal infection  1  1/562 (0.18%)  0/561 (0.00%) 
Tooth abscess  1  0/562 (0.00%)  1/561 (0.18%) 
Cellulitis  1  0/562 (0.00%)  2/561 (0.36%) 
Pneumonia bacterial  1  1/562 (0.18%)  0/561 (0.00%) 
Sepsis  1  7/562 (1.25%)  3/561 (0.53%) 
Subcutaneous abscess  1  0/562 (0.00%)  1/561 (0.18%) 
Viral infection  1  1/562 (0.18%)  0/561 (0.00%) 
Clostridium difficile infection  1  1/562 (0.18%)  0/561 (0.00%) 
Respiratory tract infection bacterial  1  0/562 (0.00%)  1/561 (0.18%) 
Urinary tract infection  1  2/562 (0.36%)  5/561 (0.89%) 
Atypical pneumonia  1  0/562 (0.00%)  1/561 (0.18%) 
Bronchitis  1  1/562 (0.18%)  0/561 (0.00%) 
Device related infection  1  0/562 (0.00%)  1/561 (0.18%) 
Gastroenteritis  1  1/562 (0.18%)  0/561 (0.00%) 
Lobar pneumonia  1  1/562 (0.18%)  0/561 (0.00%) 
Lower respiratory tract infection  1  3/562 (0.53%)  1/561 (0.18%) 
H1n1 influenza  1  1/562 (0.18%)  0/561 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  0/562 (0.00%)  1/561 (0.18%) 
Fracture  1  0/562 (0.00%)  1/561 (0.18%) 
Rib fracture  1  1/562 (0.18%)  0/561 (0.00%) 
Vascular graft occlusion  1  1/562 (0.18%)  0/561 (0.00%) 
Hip fracture  1  1/562 (0.18%)  0/561 (0.00%) 
Overdose  1  2/562 (0.36%)  1/561 (0.18%) 
Subdural haematoma  1  1/562 (0.18%)  0/561 (0.00%) 
Contrast media reaction  1  1/562 (0.18%)  0/561 (0.00%) 
Femoral neck fracture  1  1/562 (0.18%)  1/561 (0.18%) 
Spinal compression fracture  1  0/562 (0.00%)  1/561 (0.18%) 
Toxicity to various agents  1  1/562 (0.18%)  0/561 (0.00%) 
Femur fracture  1  0/562 (0.00%)  1/561 (0.18%) 
Investigations     
General physical condition abnormal  1  1/562 (0.18%)  0/561 (0.00%) 
Neutrophil count decreased  1  0/562 (0.00%)  1/561 (0.18%) 
Weight decreased  1  1/562 (0.18%)  0/561 (0.00%) 
Blood creatinine increased  1  3/562 (0.53%)  1/561 (0.18%) 
Full blood count decreased  1  0/562 (0.00%)  1/561 (0.18%) 
Haemoglobin decreased  1  0/562 (0.00%)  1/561 (0.18%) 
Lipase increased  1  1/562 (0.18%)  0/561 (0.00%) 
Blood sodium decreased  1  0/562 (0.00%)  1/561 (0.18%) 
Platelet count decreased  1  0/562 (0.00%)  1/561 (0.18%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/562 (0.00%)  1/561 (0.18%) 
Decreased appetite  1  3/562 (0.53%)  0/561 (0.00%) 
Diabetic ketoacidosis  1  0/562 (0.00%)  1/561 (0.18%) 
Hyperglycaemia  1  3/562 (0.53%)  3/561 (0.53%) 
Hyponatraemia  1  12/562 (2.14%)  13/561 (2.32%) 
Hypoglycaemia  1  1/562 (0.18%)  1/561 (0.18%) 
Hypokalaemia  1  2/562 (0.36%)  2/561 (0.36%) 
Electrolyte imbalance  1  2/562 (0.36%)  1/561 (0.18%) 
Dehydration  1  4/562 (0.71%)  5/561 (0.89%) 
Hypocalcaemia  1  1/562 (0.18%)  0/561 (0.00%) 
Vitamin d deficiency  1  1/562 (0.18%)  0/561 (0.00%) 
Musculoskeletal and connective tissue disorders     
Flank pain  1  0/562 (0.00%)  3/561 (0.53%) 
Back pain  1  2/562 (0.36%)  5/561 (0.89%) 
Muscular weakness  1  3/562 (0.53%)  0/561 (0.00%) 
Rheumatoid arthritis  1  1/562 (0.18%)  0/561 (0.00%) 
Bone pain  1  1/562 (0.18%)  0/561 (0.00%) 
Spinal pain  1  0/562 (0.00%)  1/561 (0.18%) 
Joint range of motion decreased  1  0/562 (0.00%)  1/561 (0.18%) 
Musculoskeletal pain  1  1/562 (0.18%)  0/561 (0.00%) 
Groin pain  1  0/562 (0.00%)  1/561 (0.18%) 
Myositis  1  2/562 (0.36%)  0/561 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  36/562 (6.41%)  43/561 (7.66%) 
Neoplasm progression  1  0/562 (0.00%)  2/561 (0.36%) 
Metastatic pain  1  1/562 (0.18%)  0/561 (0.00%) 
Metastases to central nervous system  1  3/562 (0.53%)  8/561 (1.43%) 
Small cell lung cancer  1  9/562 (1.60%)  13/561 (2.32%) 
Lung cancer metastatic  1  1/562 (0.18%)  0/561 (0.00%) 
Colon cancer  1  0/562 (0.00%)  1/561 (0.18%) 
Metastatic neoplasm  1  1/562 (0.18%)  0/561 (0.00%) 
Tumour embolism  1  1/562 (0.18%)  0/561 (0.00%) 
Tumour pain  1  0/562 (0.00%)  3/561 (0.53%) 
Bone neoplasm  1  0/562 (0.00%)  1/561 (0.18%) 
Lung neoplasm malignant  1  1/562 (0.18%)  1/561 (0.18%) 
Metastases to meninges  1  3/562 (0.53%)  1/561 (0.18%) 
Tumour haemorrhage  1  0/562 (0.00%)  1/561 (0.18%) 
Nervous system disorders     
Seizure  1  5/562 (0.89%)  3/561 (0.53%) 
Cauda equina syndrome  1  0/562 (0.00%)  1/561 (0.18%) 
Embolic stroke  1  1/562 (0.18%)  0/561 (0.00%) 
Epilepsy  1  0/562 (0.00%)  1/561 (0.18%) 
Ischaemic stroke  1  0/562 (0.00%)  1/561 (0.18%) 
Neuralgia  1  0/562 (0.00%)  1/561 (0.18%) 
Spinal cord disorder  1  0/562 (0.00%)  1/561 (0.18%) 
Brain oedema  1  0/562 (0.00%)  1/561 (0.18%) 
Cerebral ischaemia  1  3/562 (0.53%)  0/561 (0.00%) 
Cerebral haemorrhage  1  0/562 (0.00%)  1/561 (0.18%) 
Cerebrovascular accident  1  1/562 (0.18%)  3/561 (0.53%) 
Depressed level of consciousness  1  1/562 (0.18%)  0/561 (0.00%) 
Monoplegia  1  1/562 (0.18%)  0/561 (0.00%) 
Spinal cord compression  1  2/562 (0.36%)  1/561 (0.18%) 
Toxic encephalopathy  1  1/562 (0.18%)  0/561 (0.00%) 
Vertebral artery occlusion  1  1/562 (0.18%)  0/561 (0.00%) 
Central nervous system haemorrhage  1  1/562 (0.18%)  0/561 (0.00%) 
Headache  1  4/562 (0.71%)  0/561 (0.00%) 
Ischaemic neuropathy  1  1/562 (0.18%)  0/561 (0.00%) 
Memory impairment  1  0/562 (0.00%)  1/561 (0.18%) 
Myasthenic syndrome  1  1/562 (0.18%)  0/561 (0.00%) 
Paraparesis  1  0/562 (0.00%)  1/561 (0.18%) 
Pyramidal tract syndrome  1  1/562 (0.18%)  0/561 (0.00%) 
Cerebral infarction  1  1/562 (0.18%)  1/561 (0.18%) 
Hepatic encephalopathy  1  0/562 (0.00%)  1/561 (0.18%) 
Presyncope  1  1/562 (0.18%)  0/561 (0.00%) 
Cognitive disorder  1  0/562 (0.00%)  1/561 (0.18%) 
Partial seizures  1  1/562 (0.18%)  0/561 (0.00%) 
Transient ischaemic attack  1  1/562 (0.18%)  0/561 (0.00%) 
Ataxia  1  0/562 (0.00%)  1/561 (0.18%) 
Dizziness  1  2/562 (0.36%)  2/561 (0.36%) 
Dysarthria  1  0/562 (0.00%)  1/561 (0.18%) 
Paraplegia  1  0/562 (0.00%)  1/561 (0.18%) 
Syncope  1  4/562 (0.71%)  1/561 (0.18%) 
Guillain-barre syndrome  1  1/562 (0.18%)  0/561 (0.00%) 
Iiird nerve disorder  1  1/562 (0.18%)  0/561 (0.00%) 
Viith nerve paralysis  1  1/562 (0.18%)  0/561 (0.00%) 
Psychiatric disorders     
Mental disorder  1  0/562 (0.00%)  1/561 (0.18%) 
Depression  1  0/562 (0.00%)  1/561 (0.18%) 
Anxiety  1  0/562 (0.00%)  1/561 (0.18%) 
Acute psychosis  1  1/562 (0.18%)  0/561 (0.00%) 
Confusional state  1  1/562 (0.18%)  4/561 (0.71%) 
Mental status changes  1  2/562 (0.36%)  2/561 (0.36%) 
Renal and urinary disorders     
Haematuria  1  1/562 (0.18%)  0/561 (0.00%) 
Tubulointerstitial nephritis  1  1/562 (0.18%)  0/561 (0.00%) 
Acute kidney injury  1  4/562 (0.71%)  1/561 (0.18%) 
Proteinuria  1  0/562 (0.00%)  1/561 (0.18%) 
Renal failure  1  1/562 (0.18%)  1/561 (0.18%) 
Reproductive system and breast disorders     
Prostatitis  1  0/562 (0.00%)  1/561 (0.18%) 
Respiratory, thoracic and mediastinal disorders     
Apnoea  1  1/562 (0.18%)  0/561 (0.00%) 
Pneumonitis  1  2/562 (0.36%)  4/561 (0.71%) 
Cough  1  1/562 (0.18%)  0/561 (0.00%) 
Pulmonary embolism  1  9/562 (1.60%)  4/561 (0.71%) 
Obstructive airways disorder  1  0/562 (0.00%)  1/561 (0.18%) 
Respiratory distress  1  0/562 (0.00%)  1/561 (0.18%) 
Acute respiratory distress syndrome  1  1/562 (0.18%)  0/561 (0.00%) 
Acute respiratory failure  1  1/562 (0.18%)  2/561 (0.36%) 
Dyspnoea  1  13/562 (2.31%)  16/561 (2.85%) 
Haemoptysis  1  4/562 (0.71%)  5/561 (0.89%) 
Pulmonary artery thrombosis  1  1/562 (0.18%)  0/561 (0.00%) 
Respiratory failure  1  9/562 (1.60%)  14/561 (2.50%) 
Chronic obstructive pulmonary disease  1  4/562 (0.71%)  1/561 (0.18%) 
Epistaxis  1  0/562 (0.00%)  1/561 (0.18%) 
Bronchospasm  1  1/562 (0.18%)  0/561 (0.00%) 
Hypoxia  1  1/562 (0.18%)  1/561 (0.18%) 
Interstitial lung disease  1  1/562 (0.18%)  1/561 (0.18%) 
Pneumothorax  1  0/562 (0.00%)  1/561 (0.18%) 
Hiccups  1  1/562 (0.18%)  0/561 (0.00%) 
Pleural effusion  1  6/562 (1.07%)  3/561 (0.53%) 
Pulmonary haemorrhage  1  1/562 (0.18%)  3/561 (0.53%) 
Skin and subcutaneous tissue disorders     
Rash macular  1  1/562 (0.18%)  0/561 (0.00%) 
Rash  1  3/562 (0.53%)  0/561 (0.00%) 
Pruritus  1  1/562 (0.18%)  0/561 (0.00%) 
Vascular disorders     
Hypotension  1  1/562 (0.18%)  1/561 (0.18%) 
Superior vena cava syndrome  1  0/562 (0.00%)  7/561 (1.25%) 
Thrombophlebitis  1  1/562 (0.18%)  1/561 (0.18%) 
Thrombosis  1  2/562 (0.36%)  1/561 (0.18%) 
Circulatory collapse  1  1/562 (0.18%)  2/561 (0.36%) 
Deep vein thrombosis  1  1/562 (0.18%)  0/561 (0.00%) 
Embolism  1  0/562 (0.00%)  1/561 (0.18%) 
Peripheral arterial occlusive disease  1  0/562 (0.00%)  2/561 (0.36%) 
Peripheral ischaemia  1  1/562 (0.18%)  0/561 (0.00%) 
Vascular occlusion  1  1/562 (0.18%)  0/561 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE PLACEBO + PLATINUM/ETOPOSIDE
Affected / at Risk (%) Affected / at Risk (%)
Total   519/562 (92.35%)   520/561 (92.69%) 
Blood and lymphatic system disorders     
Leukopenia  1  73/562 (12.99%)  87/561 (15.51%) 
Anaemia  1  171/562 (30.43%)  189/561 (33.69%) 
Neutropenia  1  234/562 (41.64%)  261/561 (46.52%) 
Thrombocytopenia  1  64/562 (11.39%)  84/561 (14.97%) 
Gastrointestinal disorders     
Diarrhoea  1  159/562 (28.29%)  116/561 (20.68%) 
Abdominal pain upper  1  30/562 (5.34%)  24/561 (4.28%) 
Vomiting  1  115/562 (20.46%)  97/561 (17.29%) 
Nausea  1  232/562 (41.28%)  209/561 (37.25%) 
Constipation  1  121/562 (21.53%)  99/561 (17.65%) 
Abdominal pain  1  34/562 (6.05%)  33/561 (5.88%) 
General disorders     
Chest pain  1  38/562 (6.76%)  45/561 (8.02%) 
Fatigue  1  180/562 (32.03%)  170/561 (30.30%) 
Asthenia  1  55/562 (9.79%)  61/561 (10.87%) 
Oedema peripheral  1  38/562 (6.76%)  27/561 (4.81%) 
Pyrexia  1  79/562 (14.06%)  60/561 (10.70%) 
Investigations     
Neutrophil count decreased  1  87/562 (15.48%)  67/561 (11.94%) 
Weight decreased  1  46/562 (8.19%)  41/561 (7.31%) 
Haemoglobin decreased  1  38/562 (6.76%)  32/561 (5.70%) 
Alanine aminotransferase increased  1  47/562 (8.36%)  26/561 (4.63%) 
Aspartate aminotransferase increased  1  44/562 (7.83%)  23/561 (4.10%) 
Platelet count decreased  1  39/562 (6.94%)  48/561 (8.56%) 
White blood cell count decreased  1  51/562 (9.07%)  51/561 (9.09%) 
Metabolism and nutrition disorders     
Decreased appetite  1  169/562 (30.07%)  138/561 (24.60%) 
Hyponatraemia  1  53/562 (9.43%)  50/561 (8.91%) 
Hypokalaemia  1  47/562 (8.36%)  31/561 (5.53%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  43/562 (7.65%)  47/561 (8.38%) 
Arthralgia  1  37/562 (6.58%)  26/561 (4.63%) 
Pain in extremity  1  24/562 (4.27%)  36/561 (6.42%) 
Nervous system disorders     
Headache  1  67/562 (11.92%)  56/561 (9.98%) 
Dizziness  1  52/562 (9.25%)  59/561 (10.52%) 
Psychiatric disorders     
Insomnia  1  53/562 (9.43%)  62/561 (11.05%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  94/562 (16.73%)  81/561 (14.44%) 
Dyspnoea  1  75/562 (13.35%)  83/561 (14.80%) 
Hiccups  1  26/562 (4.63%)  32/561 (5.70%) 
Skin and subcutaneous tissue disorders     
Rash  1  121/562 (21.53%)  28/561 (4.99%) 
Alopecia  1  199/562 (35.41%)  208/561 (37.08%) 
Pruritus  1  82/562 (14.59%)  15/561 (2.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01450761    
Other Study ID Numbers: CA184-156
2011-000850-48 ( EudraCT Number )
First Submitted: October 10, 2011
First Posted: October 12, 2011
Results First Submitted: March 7, 2016
Results First Posted: July 18, 2016
Last Update Posted: July 8, 2020