Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577)

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: NCT02743494
Recruitment Status : Active, not recruiting
First Posted : April 19, 2016
Results First Posted : June 22, 2021
Last Update Posted : June 22, 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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Advanced Cancer
Interventions Drug: Nivolumab
Other: Placebo
Enrollment 794
Recruitment Details  
Pre-assignment Details 794 participants were randomized and 792 were treated. The reasons for the 2 participants not being treated were: Participant request to discontinue study treatment (1) and Participant no longer meeting study criteria (1).
Arm/Group Title Nivolumab Placebo
Hide Arm/Group Description Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
Period Title: Pre-treatment Period
Started [1] 532 262
Completed [2] 532 260
Not Completed 0 2
Reason Not Completed
Participant request to discontinue treatment             0             1
Participant no longer meeting study criteria             0             1
[1]
Started = randomized
[2]
Completed = Entering the treatment period
Period Title: Treatment Period
Started 532 260
Completed [1] 31 19
Not Completed 501 241
Reason Not Completed
Completed treatment             229             99
Disease recurrence             149             113
Study drug toxicity             57             8
Death             1             0
Adverse event unrelated to study drug             15             9
Participant request to discontinue treatment             30             5
Participant withdrew consent             12             4
Lost to Follow-up             0             1
Poor/Non-compliance             1             0
Other reasons             7             2
[1]
Completed = continuing in the treatment
Arm/Group Title Nivolumab Placebo Total
Hide Arm/Group Description Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles Total of all reporting groups
Overall Number of Baseline Participants 532 262 794
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 532 participants 262 participants 794 participants
60.8  (9.2) 59.9  (10.1) 60.5  (9.5)
[1]
Measure Description: All randomized participants
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 532 participants 262 participants 794 participants
Female
83
  15.6%
40
  15.3%
123
  15.5%
Male
449
  84.4%
222
  84.7%
671
  84.5%
[1]
Measure Description: All randomized participants
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 532 participants 262 participants 794 participants
Hispanic or Latino
33
   6.2%
11
   4.2%
44
   5.5%
Not Hispanic or Latino
268
  50.4%
144
  55.0%
412
  51.9%
Unknown or Not Reported
231
  43.4%
107
  40.8%
338
  42.6%
[1]
Measure Description: All randomized participants
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 532 participants 262 participants 794 participants
White
432
  81.2%
216
  82.4%
648
  81.6%
Black or African American
7
   1.3%
2
   0.8%
9
   1.1%
Asian
83
  15.6%
34
  13.0%
117
  14.7%
American Indian or Alaska Native
0
   0.0%
2
   0.8%
2
   0.3%
Other
10
   1.9%
7
   2.7%
17
   2.1%
Not Reported
0
   0.0%
1
   0.4%
1
   0.1%
1.Primary Outcome
Title Disease-free Survival (DFS)
Hide Description

Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first.

Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment

Time Frame From randomization to the date of recurrence or death (up to approximately 46 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Nivolumab Placebo
Hide Arm/Group Description:
Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles
Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
Overall Number of Participants Analyzed 532 262
Median (95% Confidence Interval)
Unit of Measure: Months
22.41
(16.62 to 34.00)
11.04
(8.34 to 14.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nivolumab, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Stratified log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.69
Confidence Interval (2-Sided) 96.4%
0.56 to 0.86
Estimation Comments Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Placebo.
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.
Time Frame From randomization to the date of death (up to approximately 46 months)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Survival Rate
Hide Description Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization
Time Frame From randomization to 1, 2 and 3 years later
Outcome Measure Data Not Reported
Time Frame From first dose to 30 days following last dose
Adverse Event Reporting Description Number of All cause mortality events is set to 0 because of the Data Monitoring Committee (DMC) suggestion to maintain the blinding of the death data by arm in the study while the investigators and patients are blinded until study completion.
 
Arm/Group Title Nivolumab Placebo
Hide Arm/Group Description Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
All-Cause Mortality
Nivolumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Nivolumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   193/532 (36.28%)   95/260 (36.54%) 
Blood and lymphatic system disorders     
Bone marrow failure  1  1/532 (0.19%)  0/260 (0.00%) 
Disseminated intravascular coagulation  1  1/532 (0.19%)  0/260 (0.00%) 
Febrile neutropenia  1  1/532 (0.19%)  0/260 (0.00%) 
Lymphadenopathy  1  2/532 (0.38%)  1/260 (0.38%) 
Lymphadenopathy mediastinal  1  0/532 (0.00%)  1/260 (0.38%) 
Cardiac disorders     
Acute myocardial infarction  1  1/532 (0.19%)  0/260 (0.00%) 
Atrial fibrillation  1  4/532 (0.75%)  1/260 (0.38%) 
Atrial flutter  1  1/532 (0.19%)  0/260 (0.00%) 
Bradycardia  1  1/532 (0.19%)  0/260 (0.00%) 
Cardiac arrest  1  1/532 (0.19%)  1/260 (0.38%) 
Cardiac failure  1  1/532 (0.19%)  0/260 (0.00%) 
Myocardial infarction  1  2/532 (0.38%)  2/260 (0.77%) 
Myocarditis  1  3/532 (0.56%)  0/260 (0.00%) 
Tachycardia  1  1/532 (0.19%)  0/260 (0.00%) 
Ventricular extrasystoles  1  1/532 (0.19%)  0/260 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  2/532 (0.38%)  0/260 (0.00%) 
Goitre  1  0/532 (0.00%)  1/260 (0.38%) 
Hyperthyroidism  1  1/532 (0.19%)  0/260 (0.00%) 
Hypophysitis  1  1/532 (0.19%)  0/260 (0.00%) 
Hypothyroidism  1  1/532 (0.19%)  0/260 (0.00%) 
Thyroiditis  1  1/532 (0.19%)  0/260 (0.00%) 
Eye disorders     
Vision blurred  1  0/532 (0.00%)  1/260 (0.38%) 
Gastrointestinal disorders     
Abdominal adhesions  1  0/532 (0.00%)  1/260 (0.38%) 
Abdominal hernia  1  0/532 (0.00%)  1/260 (0.38%) 
Abdominal pain  1  1/532 (0.19%)  0/260 (0.00%) 
Abdominal pain upper  1  1/532 (0.19%)  0/260 (0.00%) 
Anal fistula  1  1/532 (0.19%)  0/260 (0.00%) 
Ascites  1  1/532 (0.19%)  0/260 (0.00%) 
Colitis  1  3/532 (0.56%)  0/260 (0.00%) 
Diaphragmatic hernia  1  5/532 (0.94%)  3/260 (1.15%) 
Diarrhoea  1  4/532 (0.75%)  0/260 (0.00%) 
Dysphagia  1  6/532 (1.13%)  6/260 (2.31%) 
Enterocutaneous fistula  1  1/532 (0.19%)  0/260 (0.00%) 
Fibrosing colonopathy  1  1/532 (0.19%)  0/260 (0.00%) 
Gastric fistula  1  1/532 (0.19%)  0/260 (0.00%) 
Gastritis  1  0/532 (0.00%)  1/260 (0.38%) 
Gastrointestinal disorder  1  1/532 (0.19%)  0/260 (0.00%) 
Gastrointestinal haemorrhage  1  1/532 (0.19%)  1/260 (0.38%) 
Gastrointestinal obstruction  1  1/532 (0.19%)  0/260 (0.00%) 
Gastrointestinal pain  1  1/532 (0.19%)  0/260 (0.00%) 
Gastrooesophageal reflux disease  1  1/532 (0.19%)  0/260 (0.00%) 
Hiatus hernia  1  5/532 (0.94%)  2/260 (0.77%) 
Ileus  1  2/532 (0.38%)  1/260 (0.38%) 
Impaired gastric emptying  1  0/532 (0.00%)  1/260 (0.38%) 
Inguinal hernia  1  2/532 (0.38%)  0/260 (0.00%) 
Intestinal dilatation  1  1/532 (0.19%)  0/260 (0.00%) 
Intestinal obstruction  1  1/532 (0.19%)  1/260 (0.38%) 
Intra-abdominal fluid collection  1  1/532 (0.19%)  0/260 (0.00%) 
Intussusception  1  0/532 (0.00%)  1/260 (0.38%) 
Nausea  1  4/532 (0.75%)  1/260 (0.38%) 
Obstruction gastric  1  1/532 (0.19%)  1/260 (0.38%) 
Oesophageal perforation  1  0/532 (0.00%)  1/260 (0.38%) 
Oesophageal rupture  1  0/532 (0.00%)  1/260 (0.38%) 
Oesophageal stenosis  1  4/532 (0.75%)  3/260 (1.15%) 
Pancreatitis  1  1/532 (0.19%)  0/260 (0.00%) 
Pylorospasm  1  0/532 (0.00%)  1/260 (0.38%) 
Small intestinal obstruction  1  5/532 (0.94%)  1/260 (0.38%) 
Volvulus of small bowel  1  0/532 (0.00%)  2/260 (0.77%) 
Vomiting  1  1/532 (0.19%)  1/260 (0.38%) 
General disorders     
Adverse event  1  3/532 (0.56%)  0/260 (0.00%) 
Asthenia  1  0/532 (0.00%)  1/260 (0.38%) 
Catheter site haemorrhage  1  0/532 (0.00%)  1/260 (0.38%) 
Chest pain  1  1/532 (0.19%)  0/260 (0.00%) 
Complication associated with device  1  0/532 (0.00%)  1/260 (0.38%) 
Euthanasia  1  0/532 (0.00%)  1/260 (0.38%) 
Fatigue  1  1/532 (0.19%)  0/260 (0.00%) 
General physical health deterioration  1  0/532 (0.00%)  1/260 (0.38%) 
Hernia  1  1/532 (0.19%)  0/260 (0.00%) 
Impaired healing  1  1/532 (0.19%)  0/260 (0.00%) 
Malaise  1  1/532 (0.19%)  0/260 (0.00%) 
Pain  1  1/532 (0.19%)  1/260 (0.38%) 
Polyserositis  1  1/532 (0.19%)  0/260 (0.00%) 
Pyrexia  1  3/532 (0.56%)  0/260 (0.00%) 
Sudden death  1  2/532 (0.38%)  0/260 (0.00%) 
Hepatobiliary disorders     
Autoimmune hepatitis  1  1/532 (0.19%)  0/260 (0.00%) 
Bile duct obstruction  1  0/532 (0.00%)  1/260 (0.38%) 
Bile duct stenosis  1  1/532 (0.19%)  0/260 (0.00%) 
Cholangitis  1  1/532 (0.19%)  2/260 (0.77%) 
Cholecystitis  1  2/532 (0.38%)  0/260 (0.00%) 
Cholecystitis acute  1  2/532 (0.38%)  1/260 (0.38%) 
Hepatitis  1  0/532 (0.00%)  1/260 (0.38%) 
Immune-mediated hepatitis  1  1/532 (0.19%)  0/260 (0.00%) 
Jaundice cholestatic  1  1/532 (0.19%)  0/260 (0.00%) 
Infections and infestations     
Acute sinusitis  1  1/532 (0.19%)  0/260 (0.00%) 
Anal abscess  1  1/532 (0.19%)  0/260 (0.00%) 
Appendicitis  1  2/532 (0.38%)  0/260 (0.00%) 
Bacterial sepsis  1  1/532 (0.19%)  0/260 (0.00%) 
Diverticulitis  1  2/532 (0.38%)  0/260 (0.00%) 
Hepatitis viral  1  1/532 (0.19%)  0/260 (0.00%) 
Herpes zoster  1  1/532 (0.19%)  1/260 (0.38%) 
Osteomyelitis  1  1/532 (0.19%)  0/260 (0.00%) 
Periumbilical abscess  1  1/532 (0.19%)  0/260 (0.00%) 
Pharyngeal abscess  1  0/532 (0.00%)  1/260 (0.38%) 
Pleural infection  1  1/532 (0.19%)  0/260 (0.00%) 
Pneumonia  1  21/532 (3.95%)  6/260 (2.31%) 
Postoperative wound infection  1  1/532 (0.19%)  1/260 (0.38%) 
Pulmonary sepsis  1  1/532 (0.19%)  0/260 (0.00%) 
Sepsis  1  3/532 (0.56%)  0/260 (0.00%) 
Septic shock  1  1/532 (0.19%)  0/260 (0.00%) 
Skin infection  1  1/532 (0.19%)  0/260 (0.00%) 
Soft tissue infection  1  1/532 (0.19%)  0/260 (0.00%) 
Stoma site infection  1  0/532 (0.00%)  1/260 (0.38%) 
Subacute endocarditis  1  0/532 (0.00%)  1/260 (0.38%) 
Upper respiratory tract infection  1  1/532 (0.19%)  2/260 (0.77%) 
Urinary tract infection  1  3/532 (0.56%)  0/260 (0.00%) 
Wound infection  1  1/532 (0.19%)  0/260 (0.00%) 
Injury, poisoning and procedural complications     
Anastomotic complication  1  1/532 (0.19%)  0/260 (0.00%) 
Anastomotic stenosis  1  1/532 (0.19%)  1/260 (0.38%) 
Anastomotic ulcer  1  1/532 (0.19%)  0/260 (0.00%) 
Fall  1  1/532 (0.19%)  0/260 (0.00%) 
Foreign body  1  1/532 (0.19%)  0/260 (0.00%) 
Gastroparesis postoperative  1  1/532 (0.19%)  0/260 (0.00%) 
Hip fracture  1  1/532 (0.19%)  0/260 (0.00%) 
Incisional hernia  1  1/532 (0.19%)  0/260 (0.00%) 
Procedural complication  1  0/532 (0.00%)  1/260 (0.38%) 
Procedural haemorrhage  1  1/532 (0.19%)  0/260 (0.00%) 
Procedural pneumothorax  1  1/532 (0.19%)  0/260 (0.00%) 
Product dispensing error  1  0/532 (0.00%)  1/260 (0.38%) 
Skin laceration  1  1/532 (0.19%)  0/260 (0.00%) 
Wound complication  1  1/532 (0.19%)  0/260 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  0/532 (0.00%)  1/260 (0.38%) 
Amylase increased  1  1/532 (0.19%)  0/260 (0.00%) 
Blood creatinine increased  1  0/532 (0.00%)  1/260 (0.38%) 
Influenza A virus test positive  1  1/532 (0.19%)  1/260 (0.38%) 
Lipase increased  1  1/532 (0.19%)  0/260 (0.00%) 
Platelet count decreased  1  1/532 (0.19%)  0/260 (0.00%) 
Weight decreased  1  2/532 (0.38%)  1/260 (0.38%) 
White blood cell count decreased  1  1/532 (0.19%)  0/260 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  3/532 (0.56%)  0/260 (0.00%) 
Dehydration  1  3/532 (0.56%)  1/260 (0.38%) 
Diabetes mellitus  1  1/532 (0.19%)  0/260 (0.00%) 
Hyperglycaemia  1  1/532 (0.19%)  0/260 (0.00%) 
Hypoglycaemia  1  1/532 (0.19%)  2/260 (0.77%) 
Hypokalaemia  1  1/532 (0.19%)  0/260 (0.00%) 
Hypovitaminosis  1  1/532 (0.19%)  0/260 (0.00%) 
Type 1 diabetes mellitus  1  1/532 (0.19%)  0/260 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/532 (0.19%)  0/260 (0.00%) 
Fistula  1  1/532 (0.19%)  0/260 (0.00%) 
Joint range of motion decreased  1  1/532 (0.19%)  0/260 (0.00%) 
Muscle necrosis  1  1/532 (0.19%)  0/260 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute monocytic leukaemia  1  1/532 (0.19%)  0/260 (0.00%) 
Adenocarcinoma pancreas  1  1/532 (0.19%)  0/260 (0.00%) 
Basal cell carcinoma  1  0/532 (0.00%)  1/260 (0.38%) 
Benign neoplasm  1  1/532 (0.19%)  0/260 (0.00%) 
Brain neoplasm  1  0/532 (0.00%)  1/260 (0.38%) 
Laryngeal cancer  1  1/532 (0.19%)  0/260 (0.00%) 
Laryngeal cancer recurrent  1  1/532 (0.19%)  0/260 (0.00%) 
Malignant melanoma  1  1/532 (0.19%)  0/260 (0.00%) 
Malignant neoplasm progression  1  27/532 (5.08%)  21/260 (8.08%) 
Mediastinum neoplasm  1  0/532 (0.00%)  1/260 (0.38%) 
Metastases to adrenals  1  1/532 (0.19%)  0/260 (0.00%) 
Metastases to bone  1  1/532 (0.19%)  0/260 (0.00%) 
Metastases to breast  1  0/532 (0.00%)  1/260 (0.38%) 
Metastases to central nervous system  1  2/532 (0.38%)  2/260 (0.77%) 
Metastases to lung  1  1/532 (0.19%)  1/260 (0.38%) 
Metastases to meninges  1  0/532 (0.00%)  1/260 (0.38%) 
Metastases to pancreas  1  1/532 (0.19%)  0/260 (0.00%) 
Metastatic neoplasm  1  1/532 (0.19%)  1/260 (0.38%) 
Myxofibrosarcoma  1  0/532 (0.00%)  1/260 (0.38%) 
Neoplasm malignant  1  1/532 (0.19%)  1/260 (0.38%) 
Neoplasm recurrence  1  1/532 (0.19%)  2/260 (0.77%) 
Oesophageal adenocarcinoma  1  1/532 (0.19%)  0/260 (0.00%) 
Oesophageal neoplasm  1  1/532 (0.19%)  0/260 (0.00%) 
Pleomorphic adenoma  1  0/532 (0.00%)  1/260 (0.38%) 
Prostate cancer recurrent  1  0/532 (0.00%)  1/260 (0.38%) 
Recurrent cancer  1  0/532 (0.00%)  1/260 (0.38%) 
Squamous cell carcinoma  1  1/532 (0.19%)  0/260 (0.00%) 
Transitional cell carcinoma  1  0/532 (0.00%)  1/260 (0.38%) 
Nervous system disorders     
Cerebellar haemorrhage  1  0/532 (0.00%)  1/260 (0.38%) 
Cerebrovascular disorder  1  1/532 (0.19%)  0/260 (0.00%) 
Encephalopathy  1  1/532 (0.19%)  0/260 (0.00%) 
Epilepsy  1  0/532 (0.00%)  2/260 (0.77%) 
Facial nerve disorder  1  1/532 (0.19%)  0/260 (0.00%) 
Guillain-Barre syndrome  1  1/532 (0.19%)  0/260 (0.00%) 
Haemorrhage intracranial  1  1/532 (0.19%)  0/260 (0.00%) 
Headache  1  1/532 (0.19%)  0/260 (0.00%) 
Ischaemic stroke  1  1/532 (0.19%)  0/260 (0.00%) 
Lhermitte's sign  1  1/532 (0.19%)  0/260 (0.00%) 
Seizure  1  2/532 (0.38%)  0/260 (0.00%) 
Subarachnoid haemorrhage  1  1/532 (0.19%)  0/260 (0.00%) 
Syncope  1  1/532 (0.19%)  0/260 (0.00%) 
Transient ischaemic attack  1  0/532 (0.00%)  2/260 (0.77%) 
Vocal cord paralysis  1  0/532 (0.00%)  1/260 (0.38%) 
Product Issues     
Device occlusion  1  0/532 (0.00%)  2/260 (0.77%) 
Psychiatric disorders     
Completed suicide  1  1/532 (0.19%)  0/260 (0.00%) 
Confusional state  1  1/532 (0.19%)  0/260 (0.00%) 
Depression  1  1/532 (0.19%)  1/260 (0.38%) 
Psychotic disorder  1  1/532 (0.19%)  0/260 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/532 (0.19%)  1/260 (0.38%) 
Nephrolithiasis  1  0/532 (0.00%)  1/260 (0.38%) 
Renal colic  1  0/532 (0.00%)  1/260 (0.38%) 
Urinary retention  1  2/532 (0.38%)  0/260 (0.00%) 
Urinary tract obstruction  1  1/532 (0.19%)  0/260 (0.00%) 
Reproductive system and breast disorders     
Uterine polyp  1  1/532 (0.19%)  0/260 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchial fistula  1  1/532 (0.19%)  0/260 (0.00%) 
Bronchospasm  1  2/532 (0.38%)  0/260 (0.00%) 
Chylothorax  1  0/532 (0.00%)  1/260 (0.38%) 
Cough  1  0/532 (0.00%)  1/260 (0.38%) 
Dyspnoea  1  2/532 (0.38%)  3/260 (1.15%) 
Immune-mediated pneumonitis  1  1/532 (0.19%)  0/260 (0.00%) 
Interstitial lung disease  1  4/532 (0.75%)  0/260 (0.00%) 
Lung disorder  1  1/532 (0.19%)  0/260 (0.00%) 
Oesophagobronchial fistula  1  0/532 (0.00%)  1/260 (0.38%) 
Pleural effusion  1  5/532 (0.94%)  6/260 (2.31%) 
Pneumonia aspiration  1  8/532 (1.50%)  0/260 (0.00%) 
Pneumonitis  1  10/532 (1.88%)  2/260 (0.77%) 
Pneumothorax  1  3/532 (0.56%)  4/260 (1.54%) 
Pulmonary embolism  1  1/532 (0.19%)  1/260 (0.38%) 
Pulmonary thrombosis  1  1/532 (0.19%)  0/260 (0.00%) 
Pulmonary toxicity  1  1/532 (0.19%)  0/260 (0.00%) 
Respiratory failure  1  1/532 (0.19%)  0/260 (0.00%) 
Respiratory tract haemorrhage  1  0/532 (0.00%)  1/260 (0.38%) 
Tracheal fistula  1  2/532 (0.38%)  0/260 (0.00%) 
Tracheal stenosis  1  1/532 (0.19%)  0/260 (0.00%) 
Skin and subcutaneous tissue disorders     
Psoriasis  1  1/532 (0.19%)  0/260 (0.00%) 
Vascular disorders     
Circulatory collapse  1  1/532 (0.19%)  0/260 (0.00%) 
Hypotension  1  1/532 (0.19%)  1/260 (0.38%) 
Thrombophlebitis superficial  1  1/532 (0.19%)  0/260 (0.00%) 
1
Term from vocabulary, 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nivolumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   461/532 (86.65%)   210/260 (80.77%) 
Blood and lymphatic system disorders     
Anaemia  1  49/532 (9.21%)  22/260 (8.46%) 
Endocrine disorders     
Hyperthyroidism  1  41/532 (7.71%)  1/260 (0.38%) 
Hypothyroidism  1  64/532 (12.03%)  5/260 (1.92%) 
Gastrointestinal disorders     
Abdominal pain  1  68/532 (12.78%)  39/260 (15.00%) 
Abdominal pain upper  1  23/532 (4.32%)  19/260 (7.31%) 
Constipation  1  64/532 (12.03%)  36/260 (13.85%) 
Diarrhoea  1  164/532 (30.83%)  82/260 (31.54%) 
Dysphagia  1  68/532 (12.78%)  41/260 (15.77%) 
Gastrooesophageal reflux disease  1  45/532 (8.46%)  34/260 (13.08%) 
Nausea  1  126/532 (23.68%)  61/260 (23.46%) 
Vomiting  1  83/532 (15.60%)  42/260 (16.15%) 
General disorders     
Asthenia  1  44/532 (8.27%)  17/260 (6.54%) 
Fatigue  1  150/532 (28.20%)  66/260 (25.38%) 
Pyrexia  1  32/532 (6.02%)  11/260 (4.23%) 
Infections and infestations     
Nasopharyngitis  1  15/532 (2.82%)  14/260 (5.38%) 
Pneumonia  1  31/532 (5.83%)  10/260 (3.85%) 
Upper respiratory tract infection  1  18/532 (3.38%)  15/260 (5.77%) 
Investigations     
Alanine aminotransferase increased  1  43/532 (8.08%)  8/260 (3.08%) 
Amylase increased  1  28/532 (5.26%)  4/260 (1.54%) 
Aspartate aminotransferase increased  1  51/532 (9.59%)  14/260 (5.38%) 
Blood alkaline phosphatase increased  1  32/532 (6.02%)  6/260 (2.31%) 
Weight decreased  1  73/532 (13.72%)  24/260 (9.23%) 
Metabolism and nutrition disorders     
Decreased appetite  1  86/532 (16.17%)  30/260 (11.54%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  54/532 (10.15%)  22/260 (8.46%) 
Back pain  1  41/532 (7.71%)  25/260 (9.62%) 
Myalgia  1  38/532 (7.14%)  13/260 (5.00%) 
Nervous system disorders     
Dizziness  1  50/532 (9.40%)  24/260 (9.23%) 
Headache  1  41/532 (7.71%)  31/260 (11.92%) 
Psychiatric disorders     
Insomnia  1  27/532 (5.08%)  11/260 (4.23%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  100/532 (18.80%)  50/260 (19.23%) 
Dyspnoea  1  55/532 (10.34%)  25/260 (9.62%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  72/532 (13.53%)  16/260 (6.15%) 
Rash  1  67/532 (12.59%)  17/260 (6.54%) 
Vascular disorders     
Hypertension  1  37/532 (6.95%)  11/260 (4.23%) 
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.
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
Phone: Please email
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02743494    
Other Study ID Numbers: CA209-577
2015-005556-10 ( EudraCT Number )
First Submitted: April 15, 2016
First Posted: April 19, 2016
Results First Submitted: May 6, 2021
Results First Posted: June 22, 2021
Last Update Posted: June 22, 2021