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Trial record 1 of 1 for:    nivolumab + checkmate 274
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An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer (CheckMate 274)

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: NCT02632409
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Results First Posted : December 1, 2021
Last Update Posted : December 3, 2021
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Various Advanced Cancer
Interventions Biological: Nivolumab
Other: Placebo
Enrollment 709
Recruitment Details  
Pre-assignment Details 709 Participants Randomized, 699 Treated
Arm/Group Title Placebo Nivolumab
Hide Arm/Group Description Placebo Nivolumab 240mg IV Q2W
Period Title: Randomized
Started [1] 356 353
Completed [2] 348 351
Not Completed 8 2
Reason Not Completed
AE unrelated to study Drug             0             1
Participant withdrew consent             2             1
No Longer meets study criteria             5             0
other reasons             1             0
[1]
= Randomized
[2]
= Treated
Period Title: Treatment Period
Started [1] 348 351
Completed 132 143
Not Completed 216 208
Reason Not Completed
Ongoing Treatment             20             21
Disease Recurrence             147             90
Study Drug Toxicity             8             49
Death             1             0
AE unrelated to study drug             15             16
Request to discontinue treatment             4             19
Participant withdrew consent             7             5
Lost to Follow-up             0             1
Maximum clinical benefit             1             0
No longer meets study criteria             3             0
Administrative Reason by sponsor             0             1
Other Reasons             10             6
[1]
= Randomized and Treated
Arm/Group Title Placebo Nivolumab Total
Hide Arm/Group Description Placebo Nivolumab 240mg IV Q2W Total of all reporting groups
Overall Number of Baseline Participants 356 353 709
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 356 participants 353 participants 709 participants
65.9  (8.9) 65.3  (10.1) 65.6  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 356 participants 353 participants 709 participants
Female
81
  22.8%
88
  24.9%
169
  23.8%
Male
275
  77.2%
265
  75.1%
540
  76.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 356 participants 353 participants 709 participants
Hispanic or Latino
21
   5.9%
16
   4.5%
37
   5.2%
Not Hispanic or Latino
143
  40.2%
142
  40.2%
285
  40.2%
Unknown or Not Reported
192
  53.9%
195
  55.2%
387
  54.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 356 participants 353 participants 709 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.1%
Asian
75
  21.1%
80
  22.7%
155
  21.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   0.8%
2
   0.6%
5
   0.7%
White
272
  76.4%
264
  74.8%
536
  75.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
   1.7%
6
   1.7%
12
   1.7%
1.Primary Outcome
Title Disease Free Survival (DFS)
Hide Description The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time Frame approximately up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Placebo Nivolumab
Hide Arm/Group Description:
Placebo
Nivolumab 240mg IV Q2W
Overall Number of Participants Analyzed 356 353
Median (95% Confidence Interval)
Unit of Measure: Months
10.84
(8.25 to 13.86)
20.76
(16.49 to 27.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nivolumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Stratified Cox Proportional hazard model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.70
Confidence Interval (2-Sided) 98.22%
0.55 to 0.90
Estimation Comments [Not Specified]
2.Primary Outcome
Title Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
Hide Description The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time Frame approximately up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants with PD-L1 expression ≥ 1%
Arm/Group Title Placebo Nivolumab
Hide Arm/Group Description:
Placebo
Nivolumab 240mg IV Q2W
Overall Number of Participants Analyzed 142 140
Median (95% Confidence Interval)
Unit of Measure: Months
8.41
(5.59 to 21.19)
NA [1] 
(22.01 to NA)
[1]
Insufficient number of events to calculate median value. Upper limit number not reached
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Nivolumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Stratified Cox Proportional hazard model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.54
Confidence Interval (2-Sided) 98.72%
0.35 to 0.84
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Non-Urothelial Tract Recurrence Free Survival
Hide Description The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time Frame up to 53 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Placebo Nivolumab
Hide Arm/Group Description:
Placebo
Nivolumab 240mg IV Q2W
Overall Number of Participants Analyzed 356 353
Median (95% Confidence Interval)
Unit of Measure: Months
13.70
(8.41 to 20.34)
22.93
(19.15 to 33.41)
4.Secondary Outcome
Title Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population
Hide Description The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
Time Frame up to 53 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants with PD-L1 expression ≥ 1%
Arm/Group Title Placebo Nivolumab
Hide Arm/Group Description:
Placebo
Nivolumab 240mg IV Q2W
Overall Number of Participants Analyzed 142 140
Median (95% Confidence Interval)
Unit of Measure: Months
10.84
(5.65 to 22.14)
NA [1] 
(24.57 to NA)
[1]
Insufficient number of events to calculate median value. Upper limit number not reached
5.Secondary Outcome
Title Overall Survival
Hide Description the time from randomization to the date of death from any cause.
Time Frame on going
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Overall Survival in Participants With PD-L1 Expression ≥ 1%
Hide Description the time from randomization to the date of death from any cause.
Time Frame on going
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Disease Specific Survival
Hide Description the time from randomization to the date of death due to disease (urothelial cancer).
Time Frame on going
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%
Hide Description the time from randomization to the date of death due to disease (urothelial cancer).
Time Frame on going
Outcome Measure Data Not Reported
Time Frame appoximately up to 55 months
Adverse Event Reporting Description

All Treated Participants

All cause mortality is currently blinded at this time and will not be reported.

 
Arm/Group Title Placebo Nivolumab
Hide Arm/Group Description Placebo Nivolumab 240mg IV Q2W
All-Cause Mortality
Placebo Nivolumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Placebo Nivolumab
Affected / at Risk (%) Affected / at Risk (%)
Total   129/348 (37.07%)   122/351 (34.76%) 
Blood and lymphatic system disorders     
Anaemia  1  1/348 (0.29%)  0/351 (0.00%) 
Bone marrow failure  1  0/348 (0.00%)  1/351 (0.28%) 
Febrile neutropenia  1  1/348 (0.29%)  1/351 (0.28%) 
Neutropenia  1  1/348 (0.29%)  0/351 (0.00%) 
Cardiac disorders     
Arteriosclerosis coronary artery  1  1/348 (0.29%)  1/351 (0.28%) 
Atrial fibrillation  1  0/348 (0.00%)  3/351 (0.85%) 
Atrioventricular block  1  0/348 (0.00%)  1/351 (0.28%) 
Atrioventricular block complete  1  1/348 (0.29%)  1/351 (0.28%) 
Cardiac failure  1  2/348 (0.57%)  0/351 (0.00%) 
Cardiac failure congestive  1  0/348 (0.00%)  1/351 (0.28%) 
Coronary artery disease  1  0/348 (0.00%)  3/351 (0.85%) 
Coronary artery stenosis  1  0/348 (0.00%)  1/351 (0.28%) 
Immune-mediated myocarditis  1  0/348 (0.00%)  1/351 (0.28%) 
Myocardial infarction  1  1/348 (0.29%)  0/351 (0.00%) 
Myocarditis  1  0/348 (0.00%)  2/351 (0.57%) 
Ear and labyrinth disorders     
Vertigo  1  1/348 (0.29%)  0/351 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  0/348 (0.00%)  1/351 (0.28%) 
Hyperparathyroidism  1  0/348 (0.00%)  1/351 (0.28%) 
Secondary adrenocortical insufficiency  1  0/348 (0.00%)  1/351 (0.28%) 
Eye disorders     
Ocular hypertension  1  0/348 (0.00%)  1/351 (0.28%) 
Gastrointestinal disorders     
Colitis  1  2/348 (0.57%)  4/351 (1.14%) 
Colitis ischaemic  1  1/348 (0.29%)  0/351 (0.00%) 
Diarrhoea  1  1/348 (0.29%)  3/351 (0.85%) 
Duodenitis  1  0/348 (0.00%)  1/351 (0.28%) 
Enterocele  1  1/348 (0.29%)  0/351 (0.00%) 
Enterovesical fistula  1  0/348 (0.00%)  1/351 (0.28%) 
Gastrointestinal haemorrhage  1  1/348 (0.29%)  0/351 (0.00%) 
Ileus  1  0/348 (0.00%)  1/351 (0.28%) 
Immune-mediated enterocolitis  1  0/348 (0.00%)  1/351 (0.28%) 
Intestinal obstruction  1  6/348 (1.72%)  5/351 (1.42%) 
Nausea  1  0/348 (0.00%)  2/351 (0.57%) 
Necrotising oesophagitis  1  1/348 (0.29%)  0/351 (0.00%) 
Pancreatitis  1  2/348 (0.57%)  1/351 (0.28%) 
Pouchitis  1  1/348 (0.29%)  0/351 (0.00%) 
Small intestinal obstruction  1  5/348 (1.44%)  1/351 (0.28%) 
Subileus  1  0/348 (0.00%)  1/351 (0.28%) 
Umbilical hernia  1  1/348 (0.29%)  0/351 (0.00%) 
Vomiting  1  1/348 (0.29%)  0/351 (0.00%) 
General disorders     
Catheter site extravasation  1  0/348 (0.00%)  1/351 (0.28%) 
Complication associated with device  1  0/348 (0.00%)  1/351 (0.28%) 
Fatigue  1  0/348 (0.00%)  1/351 (0.28%) 
Generalised oedema  1  1/348 (0.29%)  0/351 (0.00%) 
Multiple organ dysfunction syndrome  1  0/348 (0.00%)  1/351 (0.28%) 
Non-cardiac chest pain  1  0/348 (0.00%)  1/351 (0.28%) 
Pain  1  1/348 (0.29%)  0/351 (0.00%) 
Pyrexia  1  1/348 (0.29%)  3/351 (0.85%) 
Sudden death  1  2/348 (0.57%)  1/351 (0.28%) 
Hepatobiliary disorders     
Bile duct stone  1  0/348 (0.00%)  1/351 (0.28%) 
Cholecystitis  1  1/348 (0.29%)  3/351 (0.85%) 
Drug-induced liver injury  1  0/348 (0.00%)  2/351 (0.57%) 
Hepatic function abnormal  1  0/348 (0.00%)  2/351 (0.57%) 
Hepatitis  1  1/348 (0.29%)  0/351 (0.00%) 
Infections and infestations     
Abscess limb  1  1/348 (0.29%)  0/351 (0.00%) 
Appendicitis  1  1/348 (0.29%)  0/351 (0.00%) 
Bacteraemia  1  1/348 (0.29%)  2/351 (0.57%) 
Bronchiolitis  1  1/348 (0.29%)  0/351 (0.00%) 
Cellulitis  1  0/348 (0.00%)  1/351 (0.28%) 
Chest wall abscess  1  0/348 (0.00%)  1/351 (0.28%) 
Citrobacter sepsis  1  0/348 (0.00%)  1/351 (0.28%) 
Device related infection  1  1/348 (0.29%)  1/351 (0.28%) 
Diverticulitis  1  1/348 (0.29%)  0/351 (0.00%) 
Erysipelas  1  0/348 (0.00%)  1/351 (0.28%) 
Escherichia sepsis  1  0/348 (0.00%)  1/351 (0.28%) 
Escherichia urinary tract infection  1  0/348 (0.00%)  1/351 (0.28%) 
Gastroenteritis  1  0/348 (0.00%)  1/351 (0.28%) 
Infected lymphocele  1  0/348 (0.00%)  2/351 (0.57%) 
Infection  1  2/348 (0.57%)  0/351 (0.00%) 
Influenza  1  1/348 (0.29%)  0/351 (0.00%) 
Klebsiella infection  1  1/348 (0.29%)  0/351 (0.00%) 
Lower respiratory tract infection  1  0/348 (0.00%)  1/351 (0.28%) 
Penile infection  1  1/348 (0.29%)  0/351 (0.00%) 
Peritonitis  1  2/348 (0.57%)  0/351 (0.00%) 
Pneumonia  1  5/348 (1.44%)  1/351 (0.28%) 
Pyelonephritis  1  2/348 (0.57%)  1/351 (0.28%) 
Pyelonephritis acute  1  2/348 (0.57%)  1/351 (0.28%) 
Respiratory tract infection viral  1  0/348 (0.00%)  1/351 (0.28%) 
Sepsis  1  4/348 (1.15%)  5/351 (1.42%) 
Septic encephalopathy  1  1/348 (0.29%)  0/351 (0.00%) 
Septic shock  1  2/348 (0.57%)  0/351 (0.00%) 
Skin infection  1  0/348 (0.00%)  1/351 (0.28%) 
Soft tissue infection  1  0/348 (0.00%)  1/351 (0.28%) 
Urinary tract infection  1  21/348 (6.03%)  12/351 (3.42%) 
Urinary tract infection bacterial  1  2/348 (0.57%)  0/351 (0.00%) 
Urosepsis  1  9/348 (2.59%)  3/351 (0.85%) 
Wound infection  1  0/348 (0.00%)  1/351 (0.28%) 
Injury, poisoning and procedural complications     
Craniocerebral injury  1  1/348 (0.29%)  0/351 (0.00%) 
Femoral neck fracture  1  0/348 (0.00%)  1/351 (0.28%) 
Hand fracture  1  0/348 (0.00%)  1/351 (0.28%) 
Hypobarism  1  0/348 (0.00%)  1/351 (0.28%) 
Incisional hernia  1  0/348 (0.00%)  3/351 (0.85%) 
Infusion related reaction  1  1/348 (0.29%)  2/351 (0.57%) 
Overdose  1  1/348 (0.29%)  0/351 (0.00%) 
Pelvic fracture  1  1/348 (0.29%)  0/351 (0.00%) 
Penetrating abdominal trauma  1  0/348 (0.00%)  1/351 (0.28%) 
Procedural pneumothorax  1  1/348 (0.29%)  0/351 (0.00%) 
Spinal compression fracture  1  0/348 (0.00%)  1/351 (0.28%) 
Stab wound  1  1/348 (0.29%)  0/351 (0.00%) 
Stoma site erythema  1  0/348 (0.00%)  1/351 (0.28%) 
Subdural haematoma  1  0/348 (0.00%)  1/351 (0.28%) 
Urinary tract stoma complication  1  1/348 (0.29%)  0/351 (0.00%) 
Urostomy complication  1  1/348 (0.29%)  2/351 (0.57%) 
Investigations     
Alanine aminotransferase increased  1  0/348 (0.00%)  1/351 (0.28%) 
Amylase increased  1  1/348 (0.29%)  0/351 (0.00%) 
Aspartate aminotransferase increased  1  0/348 (0.00%)  1/351 (0.28%) 
Blood alkaline phosphatase increased  1  0/348 (0.00%)  1/351 (0.28%) 
Blood bilirubin increased  1  1/348 (0.29%)  0/351 (0.00%) 
Blood magnesium decreased  1  1/348 (0.29%)  0/351 (0.00%) 
Clostridium test positive  1  1/348 (0.29%)  0/351 (0.00%) 
Lipase increased  1  1/348 (0.29%)  1/351 (0.28%) 
Platelet count decreased  1  0/348 (0.00%)  1/351 (0.28%) 
Transaminases increased  1  0/348 (0.00%)  1/351 (0.28%) 
Metabolism and nutrition disorders     
Dehydration  1  0/348 (0.00%)  1/351 (0.28%) 
Diabetic ketoacidosis  1  0/348 (0.00%)  1/351 (0.28%) 
Diabetic metabolic decompensation  1  1/348 (0.29%)  0/351 (0.00%) 
Hypercalcaemia  1  1/348 (0.29%)  0/351 (0.00%) 
Hyperglycaemia  1  1/348 (0.29%)  0/351 (0.00%) 
Hyperkalaemia  1  1/348 (0.29%)  2/351 (0.57%) 
Malnutrition  1  0/348 (0.00%)  1/351 (0.28%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/348 (0.00%)  1/351 (0.28%) 
Osteitis  1  0/348 (0.00%)  1/351 (0.28%) 
Osteonecrosis  1  0/348 (0.00%)  1/351 (0.28%) 
Pathological fracture  1  1/348 (0.29%)  0/351 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  1/348 (0.29%)  0/351 (0.00%) 
Bladder cancer recurrent  1  0/348 (0.00%)  1/351 (0.28%) 
Colon cancer  1  0/348 (0.00%)  1/351 (0.28%) 
Haemangioma of bone  1  0/348 (0.00%)  1/351 (0.28%) 
Leiomyosarcoma  1  1/348 (0.29%)  0/351 (0.00%) 
Lung adenocarcinoma  1  0/348 (0.00%)  1/351 (0.28%) 
Lung neoplasm malignant  1  0/348 (0.00%)  1/351 (0.28%) 
Malignant melanoma  1  1/348 (0.29%)  0/351 (0.00%) 
Malignant neoplasm progression  1  39/348 (11.21%)  15/351 (4.27%) 
Metastases to central nervous system  1  1/348 (0.29%)  0/351 (0.00%) 
Nodular melanoma  1  1/348 (0.29%)  0/351 (0.00%) 
Rectal cancer  1  1/348 (0.29%)  0/351 (0.00%) 
Recurrent cancer  1  2/348 (0.57%)  2/351 (0.57%) 
Squamous cell carcinoma of skin  1  1/348 (0.29%)  0/351 (0.00%) 
Transitional cell carcinoma metastatic  1  1/348 (0.29%)  0/351 (0.00%) 
Urinary tract carcinoma in situ  1  1/348 (0.29%)  0/351 (0.00%) 
Nervous system disorders     
Cerebral infarction  1  1/348 (0.29%)  0/351 (0.00%) 
Cerebrovascular accident  1  0/348 (0.00%)  1/351 (0.28%) 
Demyelination  1  0/348 (0.00%)  1/351 (0.28%) 
Dizziness  1  0/348 (0.00%)  1/351 (0.28%) 
Embolic stroke  1  0/348 (0.00%)  1/351 (0.28%) 
Haemorrhage intracranial  1  1/348 (0.29%)  0/351 (0.00%) 
Ischaemic cerebral infarction  1  1/348 (0.29%)  0/351 (0.00%) 
Myasthenia gravis  1  0/348 (0.00%)  2/351 (0.57%) 
Seizure  1  0/348 (0.00%)  1/351 (0.28%) 
Subarachnoid haemorrhage  1  0/348 (0.00%)  1/351 (0.28%) 
Syncope  1  1/348 (0.29%)  0/351 (0.00%) 
Transient ischaemic attack  1  1/348 (0.29%)  0/351 (0.00%) 
Product Issues     
Device malfunction  1  1/348 (0.29%)  0/351 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  3/348 (0.86%)  6/351 (1.71%) 
Autoimmune nephritis  1  0/348 (0.00%)  1/351 (0.28%) 
Haematuria  1  3/348 (0.86%)  0/351 (0.00%) 
Hydronephrosis  1  4/348 (1.15%)  3/351 (0.85%) 
Nephrolithiasis  1  1/348 (0.29%)  0/351 (0.00%) 
Pyelocaliectasis  1  1/348 (0.29%)  0/351 (0.00%) 
Renal failure  1  1/348 (0.29%)  1/351 (0.28%) 
Ureteric stenosis  1  1/348 (0.29%)  0/351 (0.00%) 
Urinary retention  1  0/348 (0.00%)  2/351 (0.57%) 
Urinary tract obstruction  1  5/348 (1.44%)  3/351 (0.85%) 
Reproductive system and breast disorders     
Pelvic fluid collection  1  1/348 (0.29%)  0/351 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/348 (0.29%)  0/351 (0.00%) 
Emphysema  1  0/348 (0.00%)  1/351 (0.28%) 
Haemothorax  1  0/348 (0.00%)  1/351 (0.28%) 
Immune-mediated pneumonitis  1  0/348 (0.00%)  1/351 (0.28%) 
Interstitial lung disease  1  0/348 (0.00%)  2/351 (0.57%) 
Pneumonitis  1  0/348 (0.00%)  6/351 (1.71%) 
Pneumothorax  1  0/348 (0.00%)  1/351 (0.28%) 
Pulmonary embolism  1  1/348 (0.29%)  3/351 (0.85%) 
Skin and subcutaneous tissue disorders     
Pemphigoid  1  0/348 (0.00%)  1/351 (0.28%) 
Rash  1  1/348 (0.29%)  1/351 (0.28%) 
Vascular disorders     
Aortic aneurysm  1  0/348 (0.00%)  1/351 (0.28%) 
Aortic rupture  1  0/348 (0.00%)  1/351 (0.28%) 
Deep vein thrombosis  1  2/348 (0.57%)  0/351 (0.00%) 
Hypotension  1  0/348 (0.00%)  1/351 (0.28%) 
Peripheral ischaemia  1  0/348 (0.00%)  1/351 (0.28%) 
Venous thrombosis limb  1  1/348 (0.29%)  0/351 (0.00%) 
1
Term from vocabulary, 23.0
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Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Nivolumab
Affected / at Risk (%) Affected / at Risk (%)
Total   307/348 (88.22%)   332/351 (94.59%) 
Blood and lymphatic system disorders     
Anaemia  1  41/348 (11.78%)  53/351 (15.10%) 
Endocrine disorders     
Hyperthyroidism  1  4/348 (1.15%)  37/351 (10.54%) 
Hypothyroidism  1  9/348 (2.59%)  41/351 (11.68%) 
Gastrointestinal disorders     
Abdominal pain  1  42/348 (12.07%)  37/351 (10.54%) 
Constipation  1  57/348 (16.38%)  50/351 (14.25%) 
Diarrhoea  1  92/348 (26.44%)  105/351 (29.91%) 
Dry mouth  1  2/348 (0.57%)  20/351 (5.70%) 
Nausea  1  52/348 (14.94%)  63/351 (17.95%) 
Vomiting  1  31/348 (8.91%)  31/351 (8.83%) 
General disorders     
Asthenia  1  31/348 (8.91%)  42/351 (11.97%) 
Fatigue  1  89/348 (25.57%)  99/351 (28.21%) 
Oedema peripheral  1  26/348 (7.47%)  32/351 (9.12%) 
Pyrexia  1  40/348 (11.49%)  37/351 (10.54%) 
Infections and infestations     
Nasopharyngitis  1  25/348 (7.18%)  23/351 (6.55%) 
Upper respiratory tract infection  1  26/348 (7.47%)  31/351 (8.83%) 
Urinary tract infection  1  55/348 (15.80%)  68/351 (19.37%) 
Investigations     
Alanine aminotransferase increased  1  17/348 (4.89%)  23/351 (6.55%) 
Amylase increased  1  29/348 (8.33%)  46/351 (13.11%) 
Aspartate aminotransferase increased  1  17/348 (4.89%)  19/351 (5.41%) 
Blood alkaline phosphatase increased  1  9/348 (2.59%)  18/351 (5.13%) 
Blood creatinine increased  1  49/348 (14.08%)  51/351 (14.53%) 
Lipase increased  1  30/348 (8.62%)  40/351 (11.40%) 
Metabolism and nutrition disorders     
Decreased appetite  1  30/348 (8.62%)  49/351 (13.96%) 
Hyperglycaemia  1  25/348 (7.18%)  19/351 (5.41%) 
Hyperkalaemia  1  26/348 (7.47%)  21/351 (5.98%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  45/348 (12.93%)  40/351 (11.40%) 
Back pain  1  44/348 (12.64%)  47/351 (13.39%) 
Myalgia  1  12/348 (3.45%)  22/351 (6.27%) 
Pain in extremity  1  21/348 (6.03%)  24/351 (6.84%) 
Nervous system disorders     
Dizziness  1  29/348 (8.33%)  32/351 (9.12%) 
Headache  1  30/348 (8.62%)  33/351 (9.40%) 
Psychiatric disorders     
Insomnia  1  17/348 (4.89%)  24/351 (6.84%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  39/348 (11.21%)  48/351 (13.68%) 
Dyspnoea  1  21/348 (6.03%)  42/351 (11.97%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  16/348 (4.60%)  25/351 (7.12%) 
Pruritus  1  56/348 (16.09%)  107/351 (30.48%) 
Rash  1  36/348 (10.34%)  67/351 (19.09%) 
Rash maculo-papular  1  9/348 (2.59%)  22/351 (6.27%) 
Vascular disorders     
Hypertension  1  19/348 (5.46%)  16/351 (4.56%) 
1
Term from vocabulary, 23.0
Indicates events were collected by systematic assessment
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
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Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please Email
EMail: Clinical.Trials@bms.com
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02632409    
Other Study ID Numbers: CA209-274
2014-003626-40 ( EudraCT Number )
First Submitted: December 14, 2015
First Posted: December 16, 2015
Results First Submitted: July 16, 2021
Results First Posted: December 1, 2021
Last Update Posted: December 3, 2021