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Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01057810
Recruitment Status : Completed
First Posted : January 27, 2010
Results First Posted : August 18, 2016
Last Update Posted : August 18, 2016
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 Prostate Cancer
Interventions Drug: Ipilimumab
Drug: Placebo
Enrollment 837
Recruitment Details  
Pre-assignment Details 837 participants enrolled; 602 randomized; 598 treated. Of the 235 not randomized, 189 no longer met criteria, 28 withdrew consent, 2 suffered Adverse Events, 2 were non-compliant, 1 was lost to follow-up, and 13 were removed for other/unspecified reasons. Post-randomization, 4 no longer met criteria and were not treated (3 placebo, 1 ipilimumab)
Arm/Group Title Placebo Ipilimumab
Hide Arm/Group Description Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure. Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Period Title: Overall Study
Started 199 399
Completed 1 1
Not Completed 198 398
Reason Not Completed
Disease progression             156             197
Study drug toxicity             5             114
Adverse event unrelated to study drug             13             29
Withdrawal by Subject             10             25
Death             2             12
Maximum clinical benefit             5             5
Poor/non-compliance             0             1
No longer met study criteria             0             1
Other             7             14
Arm/Group Title Placebo Ipilimumab Total
Hide Arm/Group Description Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure. Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure. Total of all reporting groups
Overall Number of Baseline Participants 202 400 602
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 202 participants 400 participants 602 participants
68.6
(42 to 92)
69.3
(44 to 91)
69.0
(42 to 92)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 202 participants 400 participants 602 participants
< 65 years 65 104 169
>= 65 years 137 296 433
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 400 participants 602 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
202
 100.0%
400
 100.0%
602
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 202 participants 400 participants 602 participants
North America 79 154 233
South America 25 52 77
Europe 74 161 235
Australia 24 33 57
1.Primary Outcome
Title Overall Survival (OS) Time
Hide Description OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.
Time Frame Randomization until death from any cause, up to April 2015, approximately 57 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Placebo Ipilimumab
Hide Arm/Group Description:
Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Overall Number of Participants Analyzed 202 400
Median (95% Confidence Interval)
Unit of Measure: months
29.73
(26.12 to 34.17)
28.65
(24.48 to 32.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ipilimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3667
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95.87%
0.88 to 1.39
Estimation Comments Hazard ratio = ipilimumab over placebo
2.Secondary Outcome
Title Progression-Free Survival (PFS) Time
Hide Description Progression-free survival, as determined by the investigator, was defined as the time from randomization to the earliest date of confirmed Prostate-Specific Antigen (PSA) progression, confirmed radiological progression, clinical deterioration, or death.
Time Frame Randomization until disease progression, up to April 2015, approximately 57 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Placebo Ipilimumab
Hide Arm/Group Description:
Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Overall Number of Participants Analyzed 202 400
Median (95% Confidence Interval)
Unit of Measure: months
3.81
(2.76 to 4.11)
5.59
(5.32 to 6.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ipilimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.55 to 0.80
Estimation Comments HR = ipilimumab over placebo
3.Secondary Outcome
Title Time to Subsequent Non-hormonal Cytotoxic Therapy
Hide Description For participants who discontinued treatment or experienced disease progression while on study therapy and then received subsequent non-hormonal cytotoxic therapy, time to subsequent non-hormonal cytotoxic therapy was defined as the time from randomization to the time of initiation of subsequent non-hormonal cytotoxic therapy. Participants who did not receive subsequent non-hormonal cytotoxic therapy were censored on the last known alive date (for participants who have not died) or the date of last follow-up contact at which the participants was known alive (for participants who died).
Time Frame Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received subsequent non-hormonal cytotoxic therapy
Arm/Group Title Placebo Ipilimumab
Hide Arm/Group Description:
Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Overall Number of Participants Analyzed 128 199
Median (95% Confidence Interval)
Unit of Measure: months
10.91
(8.44 to 14.59)
18.04
(15.18 to 24.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ipilimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95.87%
0.52 to 0.83
Estimation Comments HR = Ipilimumab over placebo
4.Secondary Outcome
Title Time to Pain Progression
Hide Description

Time to pain progression was defined as the time from randomization to the time of the earliest date of any of the following 4 events: 1) an increase in average daily worst pain intensity of >= 2 points from baseline according to the Brief Pain Inventory - Short Form (BPI-SF), maintained over 2 consecutive time periods. 2) initiation of opioid analgesic (excluding codeine or dextropropoxyphene). 3) initiation of palliative radiotherapy for prostate cancer. 4) increase in mean Analgesic Score (AS) of >= 25% from baseline (for participants with baseline AS > 10) or increase in mean AS >= 10 points from baseline (for participants with baseline AS <= 10).

Participants who did not experience any of these events were censored on the earliest date among the latest BPI-SF completion date with non-missing worst pain assessment and last evaluable disease assessment date as defined in the PFS censoring mechanism.

Time Frame Randomization until pain progression, up to April 2015, approximately 57 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Placebo Ipilimumab
Hide Arm/Group Description:
Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Overall Number of Participants Analyzed 202 400
Median (95% Confidence Interval)
Unit of Measure: months
16.62 [1] 
(11.53 to NA)
21.68 [1] 
(19.22 to NA)
[1]
Upper bounds were not estimable due to censoring
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ipilimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95.87%
0.71 to 1.35
Estimation Comments HR = Ipilimumab over placebo
5.Secondary Outcome
Title Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. irAE=AEs consistent with an immune mediated mechanism. imAR=AEs of special interest that were adjudicated as imAR by investigator. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame Day 1 of study therapy to last dose plus 70 days
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Placebo Ipilimumab
Hide Arm/Group Description:
Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Overall Number of Participants Analyzed 199 399
Measure Type: Number
Unit of Measure: participants
AE (grade 3-4) 59 223
Drug-related AE (any grade) 98 325
Drug-related AE (grade 3-4) 11 158
SAE (any grade) 53 213
SAE (grade 3-4) 39 153
AE leading to DC (any grade) 20 139
AE leading to DC (grade 3-4) 14 103
irAE (any grade) 57 309
irAE (grade 3-4) 3 125
imAR (grade >= 2) 14 273
Deaths 130 259
6.Secondary Outcome
Title Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities
Hide Description

NCI CTC, Version 3 used to assess parameters. LLN=lower limit of normal. ULN=upper limit of normal. CTC criteria:

White blood cells (WBC): Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L.

Platelet count: Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin: Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute Lymphocyte Count (ALC): Gr 3: 0.2 - <0.5*10^9/L, Gr 4: <0.2*10^9/L.

Lipase: Gr 3:> 2.0 - 5.0 * ULN; Gr 4: > 5.0 X ULN. Amylase: Gr 3: > 2.0 - 5.0 * ULN; Gr 4: > 5.0 * ULN. Alanine Aminotransferase (ALT) Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST): Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Bilirubin: Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase: Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Creatinine: Gr 3: > 3.0-6.0 * ULN, Gr 4: >6.0 * ULN.

Time Frame Randomization up to April 2015, approximately 57 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with on-study laboratory results
Arm/Group Title Placebo Ipilimumab
Hide Arm/Group Description:
Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
Overall Number of Participants Analyzed 198 386
Measure Type: Number
Unit of Measure: participants
WBC (n=195;383) 0 3
ANC (n=195;383) 0 2
Platelet count (n=194;381) 0 2
Hemoglobin (n=195;383) 2 5
ALC (n=195;383) 4 12
Lipase (n=196;382) 4 27
Amylase (n=198;385) 2 9
ALT (n=198;386) 1 16
AST (n=196;383) 1 18
Total Bilirubin (n=198;386) 0 4
Alkaline phosphatase (n=196;383) 11 18
Creatinine (n=9;23) 0 0
Time Frame Day 1 of study therapy to last dose plus 70 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PLACEBO 10 MG/KG IPILIMUMAB
Hide Arm/Group Description Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure. Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
All-Cause Mortality
PLACEBO 10 MG/KG IPILIMUMAB
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
PLACEBO 10 MG/KG IPILIMUMAB
Affected / at Risk (%) Affected / at Risk (%)
Total   53/199 (26.63%)   213/399 (53.38%) 
Blood and lymphatic system disorders     
Agranulocytosis  1  1/199 (0.50%)  1/399 (0.25%) 
Anaemia  1  0/199 (0.00%)  2/399 (0.50%) 
White blood cell disorder  1  0/199 (0.00%)  1/399 (0.25%) 
Bandaemia  1  0/199 (0.00%)  2/399 (0.50%) 
Bone marrow disorder  1  1/199 (0.50%)  0/399 (0.00%) 
Febrile neutropenia  1  0/199 (0.00%)  1/399 (0.25%) 
Neutropenia  1  0/199 (0.00%)  1/399 (0.25%) 
Pancytopenia  1  1/199 (0.50%)  0/399 (0.00%) 
Thrombocytopenia  1  2/199 (1.01%)  0/399 (0.00%) 
Cardiac disorders     
Cardiac failure  1  0/199 (0.00%)  3/399 (0.75%) 
Cardio-respiratory arrest  1  0/199 (0.00%)  1/399 (0.25%) 
Atrial fibrillation  1  1/199 (0.50%)  8/399 (2.01%) 
Bradycardia  1  0/199 (0.00%)  1/399 (0.25%) 
Myocardial ischaemia  1  1/199 (0.50%)  1/399 (0.25%) 
Atrial flutter  1  0/199 (0.00%)  1/399 (0.25%) 
Cardiac failure congestive  1  0/199 (0.00%)  1/399 (0.25%) 
Cardiopulmonary failure  1  0/199 (0.00%)  1/399 (0.25%) 
Coronary artery insufficiency  1  0/199 (0.00%)  1/399 (0.25%) 
Myocardial infarction  1  0/199 (0.00%)  3/399 (0.75%) 
Acute myocardial infarction  1  0/199 (0.00%)  1/399 (0.25%) 
Atrial tachycardia  1  1/199 (0.50%)  0/399 (0.00%) 
Cardiac arrest  1  0/199 (0.00%)  3/399 (0.75%) 
Tachycardia  1  0/199 (0.00%)  1/399 (0.25%) 
Ventricular tachycardia  1  0/199 (0.00%)  1/399 (0.25%) 
Ear and labyrinth disorders     
Deafness  1  1/199 (0.50%)  0/399 (0.00%) 
Endocrine disorders     
Hyperthyroidism  1  0/199 (0.00%)  1/399 (0.25%) 
Adrenocortical insufficiency acute  1  0/199 (0.00%)  1/399 (0.25%) 
Adrenal insufficiency  1  0/199 (0.00%)  6/399 (1.50%) 
Hypophysitis  1  0/199 (0.00%)  12/399 (3.01%) 
Hypopituitarism  1  0/199 (0.00%)  4/399 (1.00%) 
Hypothyroidism  1  0/199 (0.00%)  2/399 (0.50%) 
Endocrine disorder  1  0/199 (0.00%)  1/399 (0.25%) 
Secondary adrenocortical insufficiency  1  0/199 (0.00%)  1/399 (0.25%) 
Secondary hypothyroidism  1  0/199 (0.00%)  2/399 (0.50%) 
Eye disorders     
Diplopia  1  0/199 (0.00%)  1/399 (0.25%) 
Eye disorder  1  0/199 (0.00%)  1/399 (0.25%) 
Gastrointestinal disorders     
Abdominal distension  1  0/199 (0.00%)  2/399 (0.50%) 
Anal fistula  1  0/199 (0.00%)  1/399 (0.25%) 
Diarrhoea  1  0/199 (0.00%)  47/399 (11.78%) 
Gastrointestinal necrosis  1  0/199 (0.00%)  1/399 (0.25%) 
Hernial eventration  1  0/199 (0.00%)  1/399 (0.25%) 
Vomiting  1  1/199 (0.50%)  6/399 (1.50%) 
Colitis  1  2/199 (1.01%)  29/399 (7.27%) 
Odynophagia  1  0/199 (0.00%)  1/399 (0.25%) 
Abdominal pain  1  2/199 (1.01%)  5/399 (1.25%) 
Colitis ulcerative  1  0/199 (0.00%)  1/399 (0.25%) 
Enterocolitis  1  0/199 (0.00%)  1/399 (0.25%) 
Gastrooesophageal reflux disease  1  0/199 (0.00%)  1/399 (0.25%) 
Large intestine perforation  1  0/199 (0.00%)  1/399 (0.25%) 
Diarrhoea haemorrhagic  1  0/199 (0.00%)  1/399 (0.25%) 
Ileus paralytic  1  0/199 (0.00%)  2/399 (0.50%) 
Melaena  1  1/199 (0.50%)  0/399 (0.00%) 
Gastrointestinal haemorrhage  1  0/199 (0.00%)  3/399 (0.75%) 
Constipation  1  1/199 (0.50%)  1/399 (0.25%) 
Megacolon  1  0/199 (0.00%)  1/399 (0.25%) 
Abdominal pain upper  1  1/199 (0.50%)  0/399 (0.00%) 
Coeliac disease  1  0/199 (0.00%)  1/399 (0.25%) 
Enteritis  1  0/199 (0.00%)  1/399 (0.25%) 
Gastric ulcer haemorrhage  1  0/199 (0.00%)  1/399 (0.25%) 
Nausea  1  0/199 (0.00%)  10/399 (2.51%) 
Rectal haemorrhage  1  0/199 (0.00%)  2/399 (0.50%) 
Subileus  1  0/199 (0.00%)  1/399 (0.25%) 
Diverticulum intestinal  1  0/199 (0.00%)  1/399 (0.25%) 
Haemorrhoids  1  0/199 (0.00%)  1/399 (0.25%) 
Ileus  1  0/199 (0.00%)  3/399 (0.75%) 
Intestinal obstruction  1  0/199 (0.00%)  2/399 (0.50%) 
Intestinal perforation  1  0/199 (0.00%)  1/399 (0.25%) 
Small intestinal obstruction  1  0/199 (0.00%)  1/399 (0.25%) 
General disorders     
Death  1  1/199 (0.50%)  2/399 (0.50%) 
Fibrosis  1  1/199 (0.50%)  0/399 (0.00%) 
Peripheral swelling  1  0/199 (0.00%)  2/399 (0.50%) 
Malaise  1  0/199 (0.00%)  3/399 (0.75%) 
Impaired healing  1  0/199 (0.00%)  1/399 (0.25%) 
Oedema  1  0/199 (0.00%)  1/399 (0.25%) 
Pyrexia  1  1/199 (0.50%)  14/399 (3.51%) 
Asthenia  1  0/199 (0.00%)  4/399 (1.00%) 
Fatigue  1  2/199 (1.01%)  11/399 (2.76%) 
Chills  1  0/199 (0.00%)  1/399 (0.25%) 
Generalised oedema  1  0/199 (0.00%)  1/399 (0.25%) 
Multi-organ failure  1  0/199 (0.00%)  1/399 (0.25%) 
Oedema peripheral  1  0/199 (0.00%)  3/399 (0.75%) 
Sudden death  1  0/199 (0.00%)  1/399 (0.25%) 
Chest pain  1  2/199 (1.01%)  2/399 (0.50%) 
Pain  1  2/199 (1.01%)  0/399 (0.00%) 
General physical health deterioration  1  1/199 (0.50%)  1/399 (0.25%) 
Mucosal inflammation  1  0/199 (0.00%)  1/399 (0.25%) 
Hepatobiliary disorders     
Autoimmune hepatitis  1  0/199 (0.00%)  3/399 (0.75%) 
Hepatitis  1  0/199 (0.00%)  3/399 (0.75%) 
Hepatotoxicity  1  0/199 (0.00%)  2/399 (0.50%) 
Hypertransaminasaemia  1  0/199 (0.00%)  1/399 (0.25%) 
Hepatocellular injury  1  0/199 (0.00%)  1/399 (0.25%) 
Immune system disorders     
Hypersensitivity  1  0/199 (0.00%)  2/399 (0.50%) 
Infections and infestations     
Abscess  1  0/199 (0.00%)  1/399 (0.25%) 
Pneumonia  1  0/199 (0.00%)  13/399 (3.26%) 
Urinary tract infection  1  6/199 (3.02%)  2/399 (0.50%) 
Cytomegalovirus colitis  1  0/199 (0.00%)  1/399 (0.25%) 
Enterocolitis infectious  1  0/199 (0.00%)  1/399 (0.25%) 
Febrile infection  1  0/199 (0.00%)  1/399 (0.25%) 
Neutropenic sepsis  1  0/199 (0.00%)  1/399 (0.25%) 
Bronchitis  1  0/199 (0.00%)  1/399 (0.25%) 
Campylobacter gastroenteritis  1  0/199 (0.00%)  1/399 (0.25%) 
Infected skin ulcer  1  0/199 (0.00%)  1/399 (0.25%) 
Lobar pneumonia  1  1/199 (0.50%)  0/399 (0.00%) 
Pneumonia klebsiella  1  0/199 (0.00%)  1/399 (0.25%) 
Pyelonephritis acute  1  1/199 (0.50%)  0/399 (0.00%) 
Respiratory tract infection  1  0/199 (0.00%)  1/399 (0.25%) 
Urosepsis  1  1/199 (0.50%)  1/399 (0.25%) 
Bacteraemia  1  2/199 (1.01%)  0/399 (0.00%) 
Cytomegalovirus infection  1  0/199 (0.00%)  1/399 (0.25%) 
Gastroenteritis  1  0/199 (0.00%)  3/399 (0.75%) 
Gastroenteritis viral  1  0/199 (0.00%)  1/399 (0.25%) 
Cystitis  1  1/199 (0.50%)  0/399 (0.00%) 
Device related infection  1  0/199 (0.00%)  1/399 (0.25%) 
Meningitis aseptic  1  0/199 (0.00%)  1/399 (0.25%) 
Osteomyelitis  1  1/199 (0.50%)  0/399 (0.00%) 
Clostridium difficile colitis  1  1/199 (0.50%)  2/399 (0.50%) 
Herpes virus infection  1  0/199 (0.00%)  1/399 (0.25%) 
Septic shock  1  0/199 (0.00%)  1/399 (0.25%) 
Spinal cord infection  1  0/199 (0.00%)  1/399 (0.25%) 
Urinary tract infection fungal  1  1/199 (0.50%)  0/399 (0.00%) 
Diverticulitis  1  0/199 (0.00%)  4/399 (1.00%) 
Sepsis  1  1/199 (0.50%)  2/399 (0.50%) 
Sinusitis  1  0/199 (0.00%)  1/399 (0.25%) 
Viral infection  1  0/199 (0.00%)  1/399 (0.25%) 
Abscess limb  1  0/199 (0.00%)  1/399 (0.25%) 
Cellulitis  1  0/199 (0.00%)  2/399 (0.50%) 
Enterocolitis bacterial  1  0/199 (0.00%)  1/399 (0.25%) 
Infection  1  0/199 (0.00%)  3/399 (0.75%) 
Pyelonephritis  1  1/199 (0.50%)  1/399 (0.25%) 
Injury, poisoning and procedural complications     
Fall  1  0/199 (0.00%)  2/399 (0.50%) 
Fracture  1  0/199 (0.00%)  2/399 (0.50%) 
Spinal cord injury  1  1/199 (0.50%)  0/399 (0.00%) 
Overdose  1  0/199 (0.00%)  1/399 (0.25%) 
Clavicle fracture  1  0/199 (0.00%)  1/399 (0.25%) 
Femoral neck fracture  1  1/199 (0.50%)  0/399 (0.00%) 
Lumbar vertebral fracture  1  1/199 (0.50%)  0/399 (0.00%) 
Post procedural haemorrhage  1  0/199 (0.00%)  1/399 (0.25%) 
Ankle fracture  1  1/199 (0.50%)  0/399 (0.00%) 
Femur fracture  1  1/199 (0.50%)  0/399 (0.00%) 
Investigations     
International normalised ratio increased  1  0/199 (0.00%)  1/399 (0.25%) 
Alanine aminotransferase increased  1  0/199 (0.00%)  5/399 (1.25%) 
Blood creatine phosphokinase increased  1  0/199 (0.00%)  1/399 (0.25%) 
Lipase increased  1  0/199 (0.00%)  1/399 (0.25%) 
Aspartate aminotransferase increased  1  0/199 (0.00%)  6/399 (1.50%) 
Weight decreased  1  1/199 (0.50%)  1/399 (0.25%) 
Liver function test abnormal  1  1/199 (0.50%)  2/399 (0.50%) 
Transaminases increased  1  0/199 (0.00%)  1/399 (0.25%) 
Metabolism and nutrition disorders     
Type 2 diabetes mellitus  1  0/199 (0.00%)  1/399 (0.25%) 
Hypercalcaemia  1  0/199 (0.00%)  1/399 (0.25%) 
Hyperkalaemia  1  1/199 (0.50%)  1/399 (0.25%) 
Dehydration  1  1/199 (0.50%)  14/399 (3.51%) 
Hyperglycaemia  1  0/199 (0.00%)  1/399 (0.25%) 
Decreased appetite  1  2/199 (1.01%)  4/399 (1.00%) 
Hypocalcaemia  1  0/199 (0.00%)  1/399 (0.25%) 
Hypokalaemia  1  0/199 (0.00%)  3/399 (0.75%) 
Hyponatraemia  1  1/199 (0.50%)  3/399 (0.75%) 
Hypovolaemia  1  0/199 (0.00%)  1/399 (0.25%) 
Hypoglycaemia  1  0/199 (0.00%)  2/399 (0.50%) 
Diabetes mellitus  1  0/199 (0.00%)  1/399 (0.25%) 
Fluid overload  1  0/199 (0.00%)  1/399 (0.25%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  1/199 (0.50%)  1/399 (0.25%) 
Arthralgia  1  1/199 (0.50%)  0/399 (0.00%) 
Pathological fracture  1  0/199 (0.00%)  1/399 (0.25%) 
Back pain  1  2/199 (1.01%)  4/399 (1.00%) 
Flank pain  1  0/199 (0.00%)  1/399 (0.25%) 
Soft tissue mass  1  0/199 (0.00%)  1/399 (0.25%) 
Pain in jaw  1  0/199 (0.00%)  1/399 (0.25%) 
Muscular weakness  1  0/199 (0.00%)  2/399 (0.50%) 
Pain in extremity  1  1/199 (0.50%)  2/399 (0.50%) 
Chondrocalcinosis pyrophosphate  1  0/199 (0.00%)  1/399 (0.25%) 
Musculoskeletal pain  1  0/199 (0.00%)  2/399 (0.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Glioblastoma  1  0/199 (0.00%)  1/399 (0.25%) 
Metastatic pain  1  1/199 (0.50%)  1/399 (0.25%) 
Tumour pain  1  0/199 (0.00%)  2/399 (0.50%) 
Malignant neoplasm progression  1  8/199 (4.02%)  12/399 (3.01%) 
Bladder transitional cell carcinoma  1  0/199 (0.00%)  1/399 (0.25%) 
Prostate cancer metastatic  1  0/199 (0.00%)  1/399 (0.25%) 
Metastases to central nervous system  1  2/199 (1.01%)  1/399 (0.25%) 
Squamous cell carcinoma  1  1/199 (0.50%)  0/399 (0.00%) 
Rectal cancer  1  1/199 (0.50%)  1/399 (0.25%) 
Renal cell carcinoma  1  0/199 (0.00%)  1/399 (0.25%) 
Colorectal adenocarcinoma  1  1/199 (0.50%)  0/399 (0.00%) 
Nervous system disorders     
Cauda equina syndrome  1  0/199 (0.00%)  1/399 (0.25%) 
Peripheral motor neuropathy  1  0/199 (0.00%)  2/399 (0.50%) 
Cranial nerve disorder  1  0/199 (0.00%)  1/399 (0.25%) 
Depressed level of consciousness  1  0/199 (0.00%)  1/399 (0.25%) 
Motor dysfunction  1  0/199 (0.00%)  1/399 (0.25%) 
Brain oedema  1  0/199 (0.00%)  1/399 (0.25%) 
Haemorrhage intracranial  1  0/199 (0.00%)  2/399 (0.50%) 
Hypoaesthesia  1  0/199 (0.00%)  1/399 (0.25%) 
Neurological symptom  1  1/199 (0.50%)  0/399 (0.00%) 
Peripheral sensory neuropathy  1  0/199 (0.00%)  1/399 (0.25%) 
Spinal cord compression  1  2/199 (1.01%)  1/399 (0.25%) 
Syncope  1  1/199 (0.50%)  5/399 (1.25%) 
Guillain-Barre syndrome  1  0/199 (0.00%)  1/399 (0.25%) 
Headache  1  0/199 (0.00%)  2/399 (0.50%) 
IVth nerve paresis  1  0/199 (0.00%)  1/399 (0.25%) 
VIIth nerve paralysis  1  0/199 (0.00%)  2/399 (0.50%) 
Cerebral thrombosis  1  1/199 (0.50%)  0/399 (0.00%) 
Cluster headache  1  0/199 (0.00%)  1/399 (0.25%) 
Dizziness  1  0/199 (0.00%)  2/399 (0.50%) 
Mononeuropathy  1  1/199 (0.50%)  0/399 (0.00%) 
Myasthenia gravis crisis  1  0/199 (0.00%)  1/399 (0.25%) 
Cerebrovascular accident  1  1/199 (0.50%)  0/399 (0.00%) 
Psychiatric disorders     
Depressed mood  1  0/199 (0.00%)  1/399 (0.25%) 
Delirium  1  0/199 (0.00%)  1/399 (0.25%) 
Substance-induced psychotic disorder  1  0/199 (0.00%)  1/399 (0.25%) 
Confusional state  1  1/199 (0.50%)  2/399 (0.50%) 
Drug dependence  1  0/199 (0.00%)  1/399 (0.25%) 
Renal and urinary disorders     
Nephritis  1  0/199 (0.00%)  2/399 (0.50%) 
Obstructive uropathy  1  1/199 (0.50%)  1/399 (0.25%) 
Ureteric obstruction  1  2/199 (1.01%)  0/399 (0.00%) 
Renal failure  1  1/199 (0.50%)  4/399 (1.00%) 
Urinary tract obstruction  1  1/199 (0.50%)  0/399 (0.00%) 
Haemorrhage urinary tract  1  1/199 (0.50%)  0/399 (0.00%) 
Haematuria  1  4/199 (2.01%)  4/399 (1.00%) 
Renal failure acute  1  1/199 (0.50%)  8/399 (2.01%) 
Hydronephrosis  1  0/199 (0.00%)  1/399 (0.25%) 
Renal tubular acidosis  1  0/199 (0.00%)  1/399 (0.25%) 
Anuria  1  0/199 (0.00%)  1/399 (0.25%) 
Dysuria  1  2/199 (1.01%)  1/399 (0.25%) 
Renal cyst haemorrhage  1  1/199 (0.50%)  0/399 (0.00%) 
Urinary retention  1  2/199 (1.01%)  0/399 (0.00%) 
Bladder obstruction  1  0/199 (0.00%)  2/399 (0.50%) 
Nephrolithiasis  1  0/199 (0.00%)  1/399 (0.25%) 
Urogenital disorder  1  1/199 (0.50%)  1/399 (0.25%) 
Reproductive system and breast disorders     
Pelvic pain  1  0/199 (0.00%)  1/399 (0.25%) 
Respiratory, thoracic and mediastinal disorders     
Haemoptysis  1  0/199 (0.00%)  1/399 (0.25%) 
Pulmonary embolism  1  4/199 (2.01%)  1/399 (0.25%) 
Respiratory failure  1  0/199 (0.00%)  1/399 (0.25%) 
Bronchial obstruction  1  0/199 (0.00%)  1/399 (0.25%) 
Chronic obstructive pulmonary disease  1  0/199 (0.00%)  1/399 (0.25%) 
Lung infiltration  1  1/199 (0.50%)  2/399 (0.50%) 
Pleural effusion  1  0/199 (0.00%)  2/399 (0.50%) 
Respiratory distress  1  0/199 (0.00%)  1/399 (0.25%) 
Asthma  1  1/199 (0.50%)  1/399 (0.25%) 
Cough  1  0/199 (0.00%)  1/399 (0.25%) 
Aspiration  1  0/199 (0.00%)  1/399 (0.25%) 
Dyspnoea  1  0/199 (0.00%)  7/399 (1.75%) 
Pneumonitis  1  0/199 (0.00%)  6/399 (1.50%) 
Skin and subcutaneous tissue disorders     
Skin disorder  1  0/199 (0.00%)  1/399 (0.25%) 
Skin ulcer  1  0/199 (0.00%)  1/399 (0.25%) 
Rash morbilliform  1  0/199 (0.00%)  1/399 (0.25%) 
Angioedema  1  0/199 (0.00%)  1/399 (0.25%) 
Dermatitis exfoliative  1  0/199 (0.00%)  1/399 (0.25%) 
Rash  1  0/199 (0.00%)  4/399 (1.00%) 
Vascular disorders     
Deep vein thrombosis  1  2/199 (1.01%)  3/399 (0.75%) 
Hypertension  1  0/199 (0.00%)  1/399 (0.25%) 
Hypotension  1  0/199 (0.00%)  4/399 (1.00%) 
Orthostatic hypotension  1  0/199 (0.00%)  2/399 (0.50%) 
Haemorrhagic infarction  1  0/199 (0.00%)  1/399 (0.25%) 
Thrombosis  1  1/199 (0.50%)  1/399 (0.25%) 
Arterial thrombosis  1  0/199 (0.00%)  1/399 (0.25%) 
Embolism  1  0/199 (0.00%)  1/399 (0.25%) 
Circulatory collapse  1  0/199 (0.00%)  1/399 (0.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PLACEBO 10 MG/KG IPILIMUMAB
Affected / at Risk (%) Affected / at Risk (%)
Total   166/199 (83.42%)   361/399 (90.48%) 
Blood and lymphatic system disorders     
Anaemia  1  12/199 (6.03%)  31/399 (7.77%) 
Endocrine disorders     
Hypothyroidism  1  0/199 (0.00%)  25/399 (6.27%) 
Eye disorders     
Vision blurred  1  1/199 (0.50%)  21/399 (5.26%) 
Gastrointestinal disorders     
Diarrhoea  1  48/199 (24.12%)  190/399 (47.62%) 
Vomiting  1  18/199 (9.05%)  75/399 (18.80%) 
Abdominal pain  1  13/199 (6.53%)  50/399 (12.53%) 
Constipation  1  37/199 (18.59%)  84/399 (21.05%) 
Nausea  1  36/199 (18.09%)  115/399 (28.82%) 
General disorders     
Pyrexia  1  18/199 (9.05%)  63/399 (15.79%) 
Asthenia  1  20/199 (10.05%)  61/399 (15.29%) 
Fatigue  1  55/199 (27.64%)  144/399 (36.09%) 
Oedema peripheral  1  9/199 (4.52%)  44/399 (11.03%) 
Pain  1  17/199 (8.54%)  25/399 (6.27%) 
Infections and infestations     
Urinary tract infection  1  15/199 (7.54%)  31/399 (7.77%) 
Investigations     
Alanine aminotransferase increased  1  1/199 (0.50%)  31/399 (7.77%) 
Aspartate aminotransferase increased  1  2/199 (1.01%)  27/399 (6.77%) 
Weight decreased  1  17/199 (8.54%)  61/399 (15.29%) 
Metabolism and nutrition disorders     
Dehydration  1  6/199 (3.02%)  31/399 (7.77%) 
Decreased appetite  1  30/199 (15.08%)  114/399 (28.57%) 
Hypokalaemia  1  5/199 (2.51%)  25/399 (6.27%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  14/199 (7.04%)  21/399 (5.26%) 
Arthralgia  1  33/199 (16.58%)  51/399 (12.78%) 
Back pain  1  42/199 (21.11%)  69/399 (17.29%) 
Neck pain  1  11/199 (5.53%)  8/399 (2.01%) 
Pain in extremity  1  27/199 (13.57%)  45/399 (11.28%) 
Musculoskeletal pain  1  27/199 (13.57%)  41/399 (10.28%) 
Musculoskeletal chest pain  1  10/199 (5.03%)  8/399 (2.01%) 
Myalgia  1  9/199 (4.52%)  24/399 (6.02%) 
Nervous system disorders     
Headache  1  24/199 (12.06%)  73/399 (18.30%) 
Dizziness  1  17/199 (8.54%)  39/399 (9.77%) 
Dysgeusia  1  6/199 (3.02%)  21/399 (5.26%) 
Psychiatric disorders     
Insomnia  1  9/199 (4.52%)  38/399 (9.52%) 
Renal and urinary disorders     
Pollakiuria  1  10/199 (5.03%)  16/399 (4.01%) 
Haematuria  1  11/199 (5.53%)  13/399 (3.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/199 (8.54%)  45/399 (11.28%) 
Dyspnoea  1  9/199 (4.52%)  33/399 (8.27%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  21/199 (10.55%)  123/399 (30.83%) 
Rash  1  22/199 (11.06%)  145/399 (36.34%) 
Vascular disorders     
Hot flush  1  11/199 (5.53%)  15/399 (3.76%) 
Hypertension  1  7/199 (3.52%)  24/399 (6.02%) 
Hypotension  1  6/199 (3.02%)  21/399 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01057810    
Other Study ID Numbers: CA184-095
2009-016217-23 ( EudraCT Number )
First Submitted: January 26, 2010
First Posted: January 27, 2010
Results First Submitted: March 7, 2016
Results First Posted: August 18, 2016
Last Update Posted: August 18, 2016