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Trial record 1 of 1 for:    02713867
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A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks (CheckMate 384)

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ClinicalTrials.gov Identifier: NCT02713867
Recruitment Status : Active, not recruiting
First Posted : March 21, 2016
Results First Posted : June 22, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Intervention Biological: Nivolumab
Enrollment 363
Recruitment Details  
Pre-assignment Details 363 Enrolled (Randomized), 358 Treated; reasons not treated: 3 Other Reasons, 2 withdrew consent.
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description Nivolumab 480mg Q4W Nivolumab 240mg Q2W
Period Title: Randomization
Started [1] 180 183
Completed [2] 178 180
Not Completed 2 3
Reason Not Completed
Other Reason             2             1
Participant Withdrew consent             0             2
[1]
= Participants Randomized
[2]
= Participants Treated
Period Title: Treatment Period
Started [1] 178 180
Completed [2] 31 30
Not Completed 147 150
Reason Not Completed
Not Reported             1             0
Other Reasons             12             18
Administrative reason by sponsor             9             4
No longer meets study criteria             2             1
Poor/Non Compliance             1             0
Maximum Clinical Benefit             3             4
Withdrew consent             1             6
Requested to Discontinue             8             7
AE unrelated to Study Drug             8             9
Death             7             3
Study Drug Toxicity             16             20
Disease Progression             79             78
[1]
= Started Treatment
[2]
= Continuing Treatment Period
Arm/Group Title Treatment A Treatment B Total
Hide Arm/Group Description Nivolumab 480mg Q4W Nivolumab 240mg Q2W Total of all reporting groups
Overall Number of Baseline Participants 180 183 363
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 183 participants 363 participants
66.4  (9.25) 66.5  (8.65) 66.5  (8.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 183 participants 363 participants
Female
49
  27.2%
54
  29.5%
103
  28.4%
Male
131
  72.8%
129
  70.5%
260
  71.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 183 participants 363 participants
Hispanic or Latino
3
   1.7%
4
   2.2%
7
   1.9%
Not Hispanic or Latino
118
  65.6%
115
  62.8%
233
  64.2%
Unknown or Not Reported
59
  32.8%
64
  35.0%
123
  33.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 183 participants 363 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.6%
3
   1.6%
4
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
   4.4%
8
   4.4%
16
   4.4%
White
169
  93.9%
167
  91.3%
336
  92.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.1%
5
   2.7%
7
   1.9%
1.Primary Outcome
Title Progression Free Survival Rate(PFSR) at 6 Months
Hide Description PFS is defined as the time from the date of randomization to the date of first documented tumor progression determined by the investigator or death, whichever is earlier. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment.
Time Frame at 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 180 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.76
(0.70 to 0.83)
0.79
(0.73 to 0.85)
2.Primary Outcome
Title Progression Free Survival Rate (PFSR) at 12 Months
Hide Description PFS is defined as the time from the date of randomization to the date of first documented tumor progression determined by the investigator or death, whichever is earlier. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment.is earlier. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment.
Time Frame at 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 180 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.53
(0.46 to 0.61)
0.55
(0.47 to 0.62)
3.Secondary Outcome
Title Progression Free Survival Rate (PFSR) by Tumor Histology
Hide Description PFS is defined as the time from the date of randomization to the date of first documented tumor progression determined by the investigator or death, whichever is earlier. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment.is earlier. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment.
Time Frame 12 Months after Randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 180 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
Squamous Number Analyzed 61 participants 64 participants
0.50
(0.37 to 0.64)
0.42
(0.29 to 0.55)
Non Squamous Number Analyzed 119 participants 119 participants
0.54
(0.45 to 0.63)
0.60
(0.51 to 0.70)
4.Secondary Outcome
Title Progression Free Survival Rate (PFSR) by Response Criteria
Hide Description PFS is defined as the time from the date of randomization to the date of first documented tumor progression determined by the investigator or death, whichever is earlier. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment.is earlier. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment.
Time Frame 12 Months after Randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 180 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
Complete Remission (CR)/Partial Remission (PR) Number Analyzed 61 participants 62 participants
0.63
(0.51 to 0.75)
0.66
(0.53 to 0.78)
Stable Disease (SD) Number Analyzed 119 participants 121 participants
0.47
(0.38 to 0.57)
0.48
(0.39 to 0.58)
5.Secondary Outcome
Title Overall Survival
Hide Description defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.
Time Frame Up to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 180 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
At 12 Months
0.851
(0.799 to 0.902)
0.908
(0.866 to 0.951)
At 6 Months
0.966
(0.938 to 0.993)
0.956
(0.922 to 0.991)
6.Secondary Outcome
Title Overall Survival by Histology
Hide Description defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.
Time Frame 12 Months after Randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 180 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
Squamous Number Analyzed 61 participants 64 participants
0.74
(0.63 to 0.85)
0.80
(0.70 to 0.90)
Non Squamous Number Analyzed 119 participants 119 participants
0.86
(0.80 to 0.92)
0.92
(0.87 to 0.97)
7.Secondary Outcome
Title Overall Survival by Response Criteria
Hide Description defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.
Time Frame 12 Months after Randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 180 183
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
CR/PR Number Analyzed 61 participants 62 participants
0.90
(0.82 to 0.98)
0.93
(0.87 to 1.00)
SD Number Analyzed 119 participants 121 participants
0.78
(0.70 to 0.86)
0.85
(0.78 to 0.92)
8.Secondary Outcome
Title Percentage of Participants With an Adverse Events (AEs)
Hide Description Percentage of Participants with an Adverse Event due to any cause
Time Frame between first dose and 100 days after last dose of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Unit of Measure: Percentage of Participants
90.4 97.8
9.Secondary Outcome
Title Percentage of Participants With an Serious Adverse Events (SAEs)
Hide Description Percentage of Participants with an Serious Adverse Event due to any cause
Time Frame between first dose and 100 days after last dose of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Unit of Measure: Percentage of Participants
32.0 38.3
10.Secondary Outcome
Title Percentage of Participants With an Adverse Events Leading to Discontinuation (AEsDC)
Hide Description Percentage of Participants with an Adverse Event leading to discontinuation (AEsDC) due to any cause
Time Frame between first dose and 100 days after last dose of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Unit of Measure: Percentage of Participants
16.9 17.2
11.Secondary Outcome
Title Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)
Hide Description Percentage of Participants with an Immune Mediated Adverse Events treated with Immune-Modulating Medication
Time Frame between first dose and 100 days after last dose of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Unit of Measure: Percentage of Participants
Diarrhea/Colitis 3.4 6.1
Hepatitis 0.0 1.1
Pneumonitis 1.7 3.3
Nephritis and Renal Dysfunction 0.6 0.0
Rash 7.3 6.7
Hypersensitivity/Infusion Reaction 0.0 0.0
12.Secondary Outcome
Title Percentage of Participants With an Select Adverse Events
Hide Description Percentage of Participants with an Select Adverse Event due to any cause
Time Frame between first dose and 100 days after last dose of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Unit of Measure: Percentage of Participants
Gastrointestinal 17.4 24.4
Hepatic 1.7 10.0
Pulmonary 6.2 5.0
Renal 10.1 5.6
Skin 28.7 32.2
Hypersensitivity/Infusion Reaction 0.0 1.1
Endocrine 16.3 18.9
13.Secondary Outcome
Title Percentage of Participants With an Event of Special Interest (ESI)
Hide Description Other ESI included the following categories: demyelination, encephalitis, Guillain-Barré syndrome (GBS), myasthenic syndrome, pancreatitis, uveitis, myositis, myocarditis, rhabdomyolysis, and Graft Versus Host Disease (GVHD).
Time Frame between first dose and 100 days after last dose of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Unit of Measure: Percentage of Participants
Pancreatitis 1.1 2.8
demyelination 0 0
encephalitis 0 0
GBS 0 0
myasthenic syndrome 0 0
uveitis 0 0
myositis 0 0
myocarditis 0 0
rhabdomyolysis 0 0
GVHD 0 0
14.Secondary Outcome
Title Percentage of Participants Who Experienced Death
Hide Description Percentage of Participants who experienced Death due to any cause
Time Frame between first dose and 100 days after last dose of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Unit of Measure: Percentage of Participants
36.0 28.3
15.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities
Hide Description number of participants with any laboratory test result that is clinically significant or meets the definition of an SAE (Grade 3+4 combined)
Time Frame between first dose and 100 days after last dose of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Unit of Measure: Number of Participants
Alanine Aminotransferase 1 1
Alkaline Phosphate 1 0
Aspartate Aminotransferase 1 2
Bilirubin, Total 1 1
Creatinine 1 2
Hemoglobin 0 4
Hypercalcemia 2 5
Hyperkalemia 4 3
Hypermagnesemia 4 5
Hypernatremia 0 0
Hypocalcemia 4 6
Hypokalemia 3 6
Hypomagnesemia 3 2
Hypnatremia 6 7
Leukocytes 1 3
Lymphocytes 22 21
Neutrophils 3 4
Platelet Count 3 1
16.Secondary Outcome
Title Percentage of Participants With an Adverse Event Leading to Dose Delays (AEsDD)
Hide Description Percentage of Participants with an Adverse Event leading to a Dose Delay due to any cause
Time Frame between first dose and 100 days after last dose of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description:
Nivolumab 480mg Q4W
Nivolumab 240mg Q2W
Overall Number of Participants Analyzed 178 180
Measure Type: Number
Unit of Measure: Percentage of Participants
NA [1]  NA [1] 
[1]
Data not measured
Time Frame between first dose and 100 days after last dose, (up to 4 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A Treatment B
Hide Arm/Group Description Nivolumab 480mg Q4W Nivolumab 240mg Q2W
All-Cause Mortality
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   64/178 (35.96%)   51/180 (28.33%) 
Hide Serious Adverse Events
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   57/178 (32.02%)   69/180 (38.33%) 
Cardiac disorders     
Acute myocardial infarction † 1  1/178 (0.56%)  0/180 (0.00%) 
Cardiac failure † 1  1/178 (0.56%)  0/180 (0.00%) 
Coronary artery occlusion † 1  1/178 (0.56%)  0/180 (0.00%) 
Myocardial infarction † 1  0/178 (0.00%)  1/180 (0.56%) 
Supraventricular tachycardia † 1  0/178 (0.00%)  1/180 (0.56%) 
Congenital, familial and genetic disorders     
Phimosis † 1  1/178 (0.56%)  0/180 (0.00%) 
Endocrine disorders     
Adrenal insufficiency † 1  1/178 (0.56%)  0/180 (0.00%) 
Hypophysitis † 1  1/178 (0.56%)  0/180 (0.00%) 
Inappropriate antidiuretic hormone secretion † 1  0/178 (0.00%)  1/180 (0.56%) 
Gastrointestinal disorders     
Abdominal pain upper † 1  0/178 (0.00%)  1/180 (0.56%) 
Autoimmune colitis † 1  0/178 (0.00%)  1/180 (0.56%) 
Colitis † 1  0/178 (0.00%)  1/180 (0.56%) 
Colitis ulcerative † 1  0/178 (0.00%)  1/180 (0.56%) 
Diarrhoea † 1  4/178 (2.25%)  1/180 (0.56%) 
Gastrointestinal haemorrhage † 1  1/178 (0.56%)  0/180 (0.00%) 
Gastrointestinal pain † 1  1/178 (0.56%)  0/180 (0.00%) 
Ileus † 1  0/178 (0.00%)  1/180 (0.56%) 
Nausea † 1  1/178 (0.56%)  0/180 (0.00%) 
Pancreatitis † 1  1/178 (0.56%)  0/180 (0.00%) 
Pancreatitis acute † 1  0/178 (0.00%)  1/180 (0.56%) 
Rectal haemorrhage † 1  1/178 (0.56%)  0/180 (0.00%) 
Small intestinal obstruction † 1  1/178 (0.56%)  0/180 (0.00%) 
Stomatitis † 1  0/178 (0.00%)  1/180 (0.56%) 
Upper gastrointestinal haemorrhage † 1  0/178 (0.00%)  1/180 (0.56%) 
Vomiting † 1  2/178 (1.12%)  0/180 (0.00%) 
General disorders     
Asthenia † 1  0/178 (0.00%)  1/180 (0.56%) 
Drowning † 1  1/178 (0.56%)  0/180 (0.00%) 
Fatigue † 1  1/178 (0.56%)  0/180 (0.00%) 
Multiple organ dysfunction syndrome † 1  0/178 (0.00%)  1/180 (0.56%) 
Sudden death † 1  1/178 (0.56%)  0/180 (0.00%) 
Systemic inflammatory response syndrome † 1  1/178 (0.56%)  0/180 (0.00%) 
Hepatobiliary disorders     
Cholecystitis † 1  1/178 (0.56%)  0/180 (0.00%) 
Hepatitis † 1  0/178 (0.00%)  1/180 (0.56%) 
Infections and infestations     
Bronchitis † 1  1/178 (0.56%)  0/180 (0.00%) 
Clostridium difficile colitis † 1  0/178 (0.00%)  1/180 (0.56%) 
Cystitis † 1  1/178 (0.56%)  0/180 (0.00%) 
Erysipelas † 1  1/178 (0.56%)  1/180 (0.56%) 
Herpes zoster † 1  0/178 (0.00%)  1/180 (0.56%) 
Infective exacerbation of chronic obstructive airways disease † 1  2/178 (1.12%)  0/180 (0.00%) 
Influenza † 1  1/178 (0.56%)  0/180 (0.00%) 
Lower respiratory tract infection † 1  0/178 (0.00%)  2/180 (1.11%) 
Lung abscess † 1  0/178 (0.00%)  1/180 (0.56%) 
Lung infection † 1  0/178 (0.00%)  1/180 (0.56%) 
Medical device site cellulitis † 1  1/178 (0.56%)  0/180 (0.00%) 
Neutropenic sepsis † 1  0/178 (0.00%)  1/180 (0.56%) 
Pneumonia † 1  5/178 (2.81%)  8/180 (4.44%) 
Pneumonia bacterial † 1  0/178 (0.00%)  1/180 (0.56%) 
Postoperative wound infection † 1  1/178 (0.56%)  0/180 (0.00%) 
Pulmonary sepsis † 1  1/178 (0.56%)  0/180 (0.00%) 
Respiratory tract infection † 1  0/178 (0.00%)  1/180 (0.56%) 
Sepsis † 1  3/178 (1.69%)  1/180 (0.56%) 
Upper respiratory tract infection † 1  1/178 (0.56%)  0/180 (0.00%) 
Upper respiratory tract infection bacterial † 1  1/178 (0.56%)  0/180 (0.00%) 
Urinary tract infection † 1  1/178 (0.56%)  1/180 (0.56%) 
Urosepsis † 1  1/178 (0.56%)  0/180 (0.00%) 
Injury, poisoning and procedural complications     
Animal bite † 1  0/178 (0.00%)  1/180 (0.56%) 
Fall † 1  1/178 (0.56%)  1/180 (0.56%) 
Femoral neck fracture † 1  1/178 (0.56%)  0/180 (0.00%) 
Femur fracture † 1  1/178 (0.56%)  1/180 (0.56%) 
Humerus fracture † 1  0/178 (0.00%)  1/180 (0.56%) 
Perirenal haematoma † 1  0/178 (0.00%)  1/180 (0.56%) 
Post procedural haematuria † 1  0/178 (0.00%)  1/180 (0.56%) 
Procedural pain † 1  1/178 (0.56%)  0/180 (0.00%) 
Road traffic accident † 1  1/178 (0.56%)  0/180 (0.00%) 
Spinal compression fracture † 1  0/178 (0.00%)  2/180 (1.11%) 
Wound evisceration † 1  0/178 (0.00%)  1/180 (0.56%) 
Investigations     
Alanine aminotransferase increased † 1  0/178 (0.00%)  1/180 (0.56%) 
Aspartate aminotransferase increased † 1  0/178 (0.00%)  1/180 (0.56%) 
Metabolism and nutrition disorders     
Dehydration † 1  2/178 (1.12%)  0/180 (0.00%) 
Diabetes mellitus † 1  1/178 (0.56%)  1/180 (0.56%) 
Failure to thrive † 1  1/178 (0.56%)  0/180 (0.00%) 
Hyperkalaemia † 1  1/178 (0.56%)  0/180 (0.00%) 
Hypokalaemia † 1  1/178 (0.56%)  0/180 (0.00%) 
Hyponatraemia † 1  0/178 (0.00%)  1/180 (0.56%) 
Musculoskeletal and connective tissue disorders     
Arthritis † 1  0/178 (0.00%)  1/180 (0.56%) 
Back pain † 1  1/178 (0.56%)  1/180 (0.56%) 
Lumbar spinal stenosis † 1  0/178 (0.00%)  1/180 (0.56%) 
Musculoskeletal chest pain † 1  1/178 (0.56%)  0/180 (0.00%) 
Musculoskeletal pain † 1  0/178 (0.00%)  1/180 (0.56%) 
Osteoarthritis † 1  1/178 (0.56%)  0/180 (0.00%) 
Osteoporosis † 1  0/178 (0.00%)  1/180 (0.56%) 
Polymyalgia rheumatica † 1  0/178 (0.00%)  1/180 (0.56%) 
Soft tissue disorder † 1  0/178 (0.00%)  1/180 (0.56%) 
Spinal pain † 1  0/178 (0.00%)  1/180 (0.56%) 
Spondylolisthesis † 1  0/178 (0.00%)  1/180 (0.56%) 
Thoracic spinal stenosis † 1  0/178 (0.00%)  1/180 (0.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Glottis carcinoma † 1  0/178 (0.00%)  1/180 (0.56%) 
Laryngeal cancer † 1  0/178 (0.00%)  1/180 (0.56%) 
Lung neoplasm malignant † 1  1/178 (0.56%)  0/180 (0.00%) 
Malignant melanoma † 1  1/178 (0.56%)  0/180 (0.00%) 
Malignant neoplasm progression † 1  2/178 (1.12%)  9/180 (5.00%) 
Metastases to central nervous system † 1  0/178 (0.00%)  1/180 (0.56%) 
Prostate cancer † 1  0/178 (0.00%)  1/180 (0.56%) 
Rectal adenocarcinoma † 1  1/178 (0.56%)  0/180 (0.00%) 
Squamous cell carcinoma of skin † 1  0/178 (0.00%)  1/180 (0.56%) 
Nervous system disorders     
Cerebral ischaemia † 1  0/178 (0.00%)  1/180 (0.56%) 
Cerebrovascular accident † 1  1/178 (0.56%)  0/180 (0.00%) 
Encephalopathy † 1  0/178 (0.00%)  1/180 (0.56%) 
Nystagmus † 1  0/178 (0.00%)  1/180 (0.56%) 
Seizure † 1  0/178 (0.00%)  2/180 (1.11%) 
Syncope † 1  1/178 (0.56%)  1/180 (0.56%) 
Psychiatric disorders     
Confusional state † 1  0/178 (0.00%)  1/180 (0.56%) 
Depression † 1  1/178 (0.56%)  0/180 (0.00%) 
Renal and urinary disorders     
Renal failure † 1  0/178 (0.00%)  1/180 (0.56%) 
Urinary retention † 1  1/178 (0.56%)  0/180 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia † 1  1/178 (0.56%)  0/180 (0.00%) 
Prostatitis † 1  1/178 (0.56%)  0/180 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure † 1  0/178 (0.00%)  2/180 (1.11%) 
Chronic obstructive pulmonary disease † 1  5/178 (2.81%)  3/180 (1.67%) 
Dyspnoea † 1  1/178 (0.56%)  1/180 (0.56%) 
Haemoptysis † 1  1/178 (0.56%)  0/180 (0.00%) 
Pneumonitis † 1  3/178 (1.69%)  5/180 (2.78%) 
Pneumothorax † 1  1/178 (0.56%)  1/180 (0.56%) 
Pulmonary embolism † 1  0/178 (0.00%)  4/180 (2.22%) 
Pulmonary hypertension † 1  1/178 (0.56%)  0/180 (0.00%) 
Respiratory failure † 1  1/178 (0.56%)  0/180 (0.00%) 
Vascular disorders     
Aortic aneurysm † 1  1/178 (0.56%)  0/180 (0.00%) 
Hypotension † 1  0/178 (0.00%)  1/180 (0.56%) 
Infarction † 1  1/178 (0.56%)  0/180 (0.00%) 
Peripheral artery occlusion † 1  0/178 (0.00%)  1/180 (0.56%) 
Peripheral ischaemia † 1  1/178 (0.56%)  0/180 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment A Treatment B
Affected / at Risk (%) Affected / at Risk (%)
Total   138/178 (77.53%)   167/180 (92.78%) 
Blood and lymphatic system disorders     
Anaemia † 1  10/178 (5.62%)  19/180 (10.56%) 
Endocrine disorders     
Hypothyroidism † 1  21/178 (11.80%)  16/180 (8.89%) 
Gastrointestinal disorders     
Abdominal pain † 1  10/178 (5.62%)  7/180 (3.89%) 
Abdominal pain upper † 1  5/178 (2.81%)  10/180 (5.56%) 
Constipation † 1  19/178 (10.67%)  22/180 (12.22%) 
Diarrhoea † 1  28/178 (15.73%)  40/180 (22.22%) 
Gastrooesophageal reflux disease † 1  7/178 (3.93%)  11/180 (6.11%) 
Nausea † 1  12/178 (6.74%)  28/180 (15.56%) 
Vomiting † 1  12/178 (6.74%)  18/180 (10.00%) 
General disorders     
Asthenia † 1  23/178 (12.92%)  22/180 (12.22%) 
Fatigue † 1  29/178 (16.29%)  40/180 (22.22%) 
Non-cardiac chest pain † 1  6/178 (3.37%)  10/180 (5.56%) 
Oedema peripheral † 1  11/178 (6.18%)  15/180 (8.33%) 
Pyrexia † 1  14/178 (7.87%)  14/180 (7.78%) 
Infections and infestations     
Bronchitis † 1  16/178 (8.99%)  22/180 (12.22%) 
Nasopharyngitis † 1  11/178 (6.18%)  16/180 (8.89%) 
Rhinitis † 1  1/178 (0.56%)  10/180 (5.56%) 
Sinusitis † 1  7/178 (3.93%)  10/180 (5.56%) 
Upper respiratory tract infection † 1  8/178 (4.49%)  14/180 (7.78%) 
Urinary tract infection † 1  4/178 (2.25%)  10/180 (5.56%) 
Injury, poisoning and procedural complications     
Fall † 1  8/178 (4.49%)  11/180 (6.11%) 
Investigations     
Blood creatinine increased † 1  14/178 (7.87%)  7/180 (3.89%) 
Lipase increased † 1  8/178 (4.49%)  14/180 (7.78%) 
Weight decreased † 1  8/178 (4.49%)  18/180 (10.00%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  14/178 (7.87%)  20/180 (11.11%) 
Hyperkalaemia † 1  4/178 (2.25%)  13/180 (7.22%) 
Hypomagnesaemia † 1  3/178 (1.69%)  10/180 (5.56%) 
Hypophosphataemia † 1  3/178 (1.69%)  11/180 (6.11%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  16/178 (8.99%)  27/180 (15.00%) 
Back pain † 1  24/178 (13.48%)  18/180 (10.00%) 
Muscle spasms † 1  3/178 (1.69%)  11/180 (6.11%) 
Musculoskeletal pain † 1  8/178 (4.49%)  16/180 (8.89%) 
Myalgia † 1  3/178 (1.69%)  11/180 (6.11%) 
Pain in extremity † 1  9/178 (5.06%)  15/180 (8.33%) 
Nervous system disorders     
Dizziness † 1  4/178 (2.25%)  17/180 (9.44%) 
Headache † 1  13/178 (7.30%)  14/180 (7.78%) 
Psychiatric disorders     
Insomnia † 1  5/178 (2.81%)  20/180 (11.11%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease † 1  8/178 (4.49%)  10/180 (5.56%) 
Cough † 1  24/178 (13.48%)  40/180 (22.22%) 
Dyspnoea † 1  22/178 (12.36%)  25/180 (13.89%) 
Skin and subcutaneous tissue disorders     
Dry skin † 1  6/178 (3.37%)  11/180 (6.11%) 
Pruritus † 1  20/178 (11.24%)  31/180 (17.22%) 
Pruritus generalised † 1  14/178 (7.87%)  12/180 (6.67%) 
Rash † 1  8/178 (4.49%)  10/180 (5.56%) 
Rash maculo-papular † 1  9/178 (5.06%)  6/180 (3.33%) 
Vascular disorders     
Hypertension † 1  10/178 (5.62%)  11/180 (6.11%) 
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
No formal statistical analyses were conducted. Median OS was not reached in either arm.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please Email
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02713867    
Other Study ID Numbers: CA209-384
First Submitted: March 11, 2016
First Posted: March 21, 2016
Results First Submitted: March 10, 2020
Results First Posted: June 22, 2020
Last Update Posted: June 22, 2020