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Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer (CheckMate331)

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ClinicalTrials.gov Identifier: NCT02481830
Recruitment Status : Active, not recruiting
First Posted : June 25, 2015
Results First Posted : January 9, 2020
Last Update Posted : August 6, 2020
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: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: Nivolumab
Drug: Topotecan
Drug: Amrubicin
Enrollment 803
Recruitment Details  
Pre-assignment Details 803 Participants were enrolled into the study,569 Randomized ,212 not randomized, reasons not randomized:2 adverse events(AEs),20 consent withdraw, 12 death, 2 loss of follow up,176 not meet study criteria.
Arm/Group Title Group A Group B
Hide Arm/Group Description Nivolumab 240mg Chemotherapy (Topotecan/Amrubicin)
Period Title: Overall Study
Started [1] 284 285
Completed [2] 282 265
Not Completed 2 20
Reason Not Completed
No longer meets Study Criteria             1             4
Withdrawal by Subject             0             14
Disease Progression             1             1
Participant not eligible for trial             0             1
[1]
Randomized Participants
[2]
Treated Participants Not completed= Never treated
Arm/Group Title Group A Group B Total
Hide Arm/Group Description Nivolumab 240mg Chemotherapy (Topotecan/Amrubicin) Total of all reporting groups
Overall Number of Baseline Participants 284 285 569
Hide Baseline Analysis Population Description
All Randomized Participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 284 participants 285 participants 569 participants
61.5  (9.2) 61.6  (8.4) 61.6  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants 285 participants 569 participants
Female
110
  38.7%
108
  37.9%
218
  38.3%
Male
174
  61.3%
177
  62.1%
351
  61.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants 285 participants 569 participants
Hispanic or Latino
4
   1.4%
6
   2.1%
10
   1.8%
Not Hispanic or Latino
125
  44.0%
142
  49.8%
267
  46.9%
Unknown or Not Reported
155
  54.6%
137
  48.1%
292
  51.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants 285 participants 569 participants
American Indian or Alaska Native
0
   0.0%
1
   0.4%
1
   0.2%
Asian
70
  24.6%
71
  24.9%
141
  24.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.4%
2
   0.7%
3
   0.5%
White
211
  74.3%
211
  74.0%
422
  74.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   0.7%
0
   0.0%
2
   0.4%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description The time from randomization to the date of death, data was based on Kaplan-Meier Estimates.
Time Frame OS was followed continuously while participants were on the study drug and every 3 months ,minimum follow up for overall survival was 15.8 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Group A Group B
Hide Arm/Group Description:
Nivolumab 240mg
Chemotherapy (Topotecan/Amrubicin)
Overall Number of Participants Analyzed 284 285
Median (95% Confidence Interval)
Unit of Measure: Months
7.46
(5.65 to 9.20)
8.38
(7.03 to 10.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A, Group B
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1144
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.72 to 1.04
Estimation Comments Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin
2.Secondary Outcome
Title Progression Free Survival (PFS )
Hide Description

the time from randomization to the date of the first documented tumor progression (based on investigator assesment,using Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria) or death the data was based on Kaplan-Meier Estimates.

PFS was censored when subsequent anti cancer therapy was started before progression.

Time Frame assessed every 6 weeks from the first dose to week 30, and every 12 weeks up to 34 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Group A Group B
Hide Arm/Group Description:
Nivolumab 240mg
Chemotherapy (Topotecan/Amrubicin)
Overall Number of Participants Analyzed 284 285
Median (95% Confidence Interval)
Unit of Measure: Months
1.45
(1.41 to 1.51)
3.78
(2.96 to 4.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A, Group B
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.18 to 1.69
Estimation Comments Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin
3.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description The proportion of all randomized Participants who achieved BOR(Best Overall response) from baseline is either a CR(complete response) or PR(Partial response),using the RECIST v1.1 criteria based on investigator assessment,CR+PR, confidence interval based on the Clopper and Pearson method
Time Frame Between the date of randomization and the date of progression or the date of subsequent anti-cancer therapy,whichever occurs first up to 34 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Participants
Arm/Group Title Group A Group B
Hide Arm/Group Description:
Nivolumab 240mg
Chemotherapy (Topotecan/Amrubicin)
Overall Number of Participants Analyzed 284 285
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
13.7
(10.0 to 18.3)
16.5
(12.4 to 21.3)
Time Frame Reporting Adverse Events (AEs) include events reported between first dose and 30 days after last dose of study therapy.
Adverse Event Reporting Description If a participant experienced more than 1 of a given AE, the participant is counted only once for that AE.
 
Arm/Group Title Group A Group B
Hide Arm/Group Description Nivolumab 240mg Chemotherapy (Topotecan/Amrubicin)
All-Cause Mortality
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   223/282 (79.08%)   235/265 (88.68%) 
Hide Serious Adverse Events
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   143/282 (50.71%)   138/265 (52.08%) 
Blood and lymphatic system disorders     
Anaemia  1  1/282 (0.35%)  15/265 (5.66%) 
Bone marrow failure  1  0/282 (0.00%)  11/265 (4.15%) 
Febrile neutropenia  1  1/282 (0.35%)  23/265 (8.68%) 
Leukopenia  1  0/282 (0.00%)  2/265 (0.75%) 
Lymphadenopathy  1  0/282 (0.00%)  1/265 (0.38%) 
Neutropenia  1  0/282 (0.00%)  11/265 (4.15%) 
Pancytopenia  1  0/282 (0.00%)  7/265 (2.64%) 
Thrombocytopenia  1  1/282 (0.35%)  15/265 (5.66%) 
Cardiac disorders     
Acute myocardial infarction  1  0/282 (0.00%)  1/265 (0.38%) 
Atrial fibrillation  1  1/282 (0.35%)  0/265 (0.00%) 
Atrial flutter  1  0/282 (0.00%)  1/265 (0.38%) 
Cardiac failure  1  2/282 (0.71%)  1/265 (0.38%) 
Cardiac failure acute  1  1/282 (0.35%)  0/265 (0.00%) 
Cardiac tamponade  1  1/282 (0.35%)  0/265 (0.00%) 
Cardio-respiratory arrest  1  0/282 (0.00%)  1/265 (0.38%) 
Pericardial effusion  1  1/282 (0.35%)  0/265 (0.00%) 
Endocrine disorders     
Adrenocorticotropic hormone deficiency  1  1/282 (0.35%)  0/265 (0.00%) 
Cushing's syndrome  1  1/282 (0.35%)  0/265 (0.00%) 
Hyperthyroidism  1  2/282 (0.71%)  0/265 (0.00%) 
Inappropriate antidiuretic hormone secretion  1  0/282 (0.00%)  1/265 (0.38%) 
Secondary adrenocortical insufficiency  1  0/282 (0.00%)  1/265 (0.38%) 
Gastrointestinal disorders     
Abdominal hernia obstructive  1  1/282 (0.35%)  0/265 (0.00%) 
Abdominal pain  1  3/282 (1.06%)  2/265 (0.75%) 
Abdominal pain upper  1  0/282 (0.00%)  1/265 (0.38%) 
Ascites  1  1/282 (0.35%)  0/265 (0.00%) 
Autoimmune colitis  1  1/282 (0.35%)  0/265 (0.00%) 
Colitis  1  2/282 (0.71%)  0/265 (0.00%) 
Diarrhoea  1  2/282 (0.71%)  1/265 (0.38%) 
Dysphagia  1  1/282 (0.35%)  0/265 (0.00%) 
Gastric haemorrhage  1  1/282 (0.35%)  0/265 (0.00%) 
Gastrooesophageal reflux disease  1  1/282 (0.35%)  0/265 (0.00%) 
Intestinal haemorrhage  1  0/282 (0.00%)  1/265 (0.38%) 
Intestinal obstruction  1  1/282 (0.35%)  0/265 (0.00%) 
Nausea  1  1/282 (0.35%)  1/265 (0.38%) 
Oral disorder  1  1/282 (0.35%)  0/265 (0.00%) 
Vomiting  1  2/282 (0.71%)  1/265 (0.38%) 
General disorders     
Asthenia  1  0/282 (0.00%)  3/265 (1.13%) 
Chest pain  1  1/282 (0.35%)  0/265 (0.00%) 
Disease progression  1  1/282 (0.35%)  1/265 (0.38%) 
Fatigue  1  0/282 (0.00%)  1/265 (0.38%) 
General physical health deterioration  1  8/282 (2.84%)  3/265 (1.13%) 
Non-cardiac chest pain  1  1/282 (0.35%)  1/265 (0.38%) 
Oedema  1  1/282 (0.35%)  0/265 (0.00%) 
Pain  1  1/282 (0.35%)  2/265 (0.75%) 
Pyrexia  1  3/282 (1.06%)  3/265 (1.13%) 
Sudden death  1  0/282 (0.00%)  1/265 (0.38%) 
Hepatobiliary disorders     
Hepatic failure  1  1/282 (0.35%)  0/265 (0.00%) 
Hepatitis  1  1/282 (0.35%)  0/265 (0.00%) 
Jaundice cholestatic  1  1/282 (0.35%)  0/265 (0.00%) 
Infections and infestations     
Appendicitis  1  1/282 (0.35%)  0/265 (0.00%) 
Bacteraemia  1  0/282 (0.00%)  1/265 (0.38%) 
Bronchitis  1  1/282 (0.35%)  0/265 (0.00%) 
Cellulitis  1  0/282 (0.00%)  1/265 (0.38%) 
Device related infection  1  0/282 (0.00%)  2/265 (0.75%) 
Encephalitis  1  1/282 (0.35%)  0/265 (0.00%) 
Enterocolitis infectious  1  0/282 (0.00%)  1/265 (0.38%) 
Erysipelas  1  0/282 (0.00%)  1/265 (0.38%) 
Herpes simplex  1  1/282 (0.35%)  0/265 (0.00%) 
Infectious pleural effusion  1  1/282 (0.35%)  0/265 (0.00%) 
Localised infection  1  0/282 (0.00%)  1/265 (0.38%) 
Lower respiratory tract infection  1  0/282 (0.00%)  1/265 (0.38%) 
Lung infection  1  1/282 (0.35%)  2/265 (0.75%) 
Neutropenic sepsis  1  0/282 (0.00%)  3/265 (1.13%) 
Ophthalmic herpes zoster  1  0/282 (0.00%)  1/265 (0.38%) 
Peritonsillar abscess  1  1/282 (0.35%)  0/265 (0.00%) 
Pneumocystis jirovecii pneumonia  1  0/282 (0.00%)  1/265 (0.38%) 
Pneumonia  1  11/282 (3.90%)  4/265 (1.51%) 
Post procedural infection  1  0/282 (0.00%)  1/265 (0.38%) 
Pulmonary sepsis  1  0/282 (0.00%)  1/265 (0.38%) 
Respiratory tract infection  1  3/282 (1.06%)  2/265 (0.75%) 
Sepsis  1  1/282 (0.35%)  2/265 (0.75%) 
Upper respiratory tract infection  1  1/282 (0.35%)  0/265 (0.00%) 
Urinary tract infection  1  2/282 (0.71%)  0/265 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  1/282 (0.35%)  0/265 (0.00%) 
Femoral neck fracture  1  1/282 (0.35%)  0/265 (0.00%) 
Infusion related reaction  1  1/282 (0.35%)  1/265 (0.38%) 
Injection related reaction  1  1/282 (0.35%)  0/265 (0.00%) 
Subdural haematoma  1  1/282 (0.35%)  0/265 (0.00%) 
Synovial rupture  1  0/282 (0.00%)  1/265 (0.38%) 
Toxicity to various agents  1  1/282 (0.35%)  0/265 (0.00%) 
Investigations     
Amylase increased  1  1/282 (0.35%)  0/265 (0.00%) 
Aspartate aminotransferase increased  1  1/282 (0.35%)  0/265 (0.00%) 
Blood creatinine increased  1  1/282 (0.35%)  0/265 (0.00%) 
C-reactive protein increased  1  0/282 (0.00%)  2/265 (0.75%) 
Gamma-glutamyltransferase increased  1  1/282 (0.35%)  0/265 (0.00%) 
Lipase increased  1  2/282 (0.71%)  0/265 (0.00%) 
Neutrophil count decreased  1  0/282 (0.00%)  4/265 (1.51%) 
Platelet count decreased  1  2/282 (0.71%)  10/265 (3.77%) 
White blood cell count decreased  1  0/282 (0.00%)  2/265 (0.75%) 
Metabolism and nutrition disorders     
Dehydration  1  1/282 (0.35%)  0/265 (0.00%) 
Electrolyte imbalance  1  0/282 (0.00%)  1/265 (0.38%) 
Glucose tolerance impaired  1  1/282 (0.35%)  0/265 (0.00%) 
Hyperglycaemia  1  1/282 (0.35%)  0/265 (0.00%) 
Hypokalaemia  1  0/282 (0.00%)  1/265 (0.38%) 
Hyponatraemia  1  5/282 (1.77%)  2/265 (0.75%) 
Type 1 diabetes mellitus  1  1/282 (0.35%)  0/265 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/282 (0.35%)  0/265 (0.00%) 
Arthritis  1  1/282 (0.35%)  0/265 (0.00%) 
Back pain  1  1/282 (0.35%)  1/265 (0.38%) 
Bone pain  1  1/282 (0.35%)  0/265 (0.00%) 
Osteonecrosis of jaw  1  1/282 (0.35%)  0/265 (0.00%) 
Pain in extremity  1  1/282 (0.35%)  0/265 (0.00%) 
Pathological fracture  1  0/282 (0.00%)  1/265 (0.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/282 (0.35%)  0/265 (0.00%) 
Epiglottic carcinoma  1  1/282 (0.35%)  0/265 (0.00%) 
Malignant neoplasm progression  1  66/282 (23.40%)  28/265 (10.57%) 
Second primary malignancy  1  0/282 (0.00%)  1/265 (0.38%) 
Squamous cell carcinoma of the tongue  1  1/282 (0.35%)  0/265 (0.00%) 
Tongue neoplasm  1  1/282 (0.35%)  0/265 (0.00%) 
Tumour invasion  1  1/282 (0.35%)  0/265 (0.00%) 
Tumour pain  1  0/282 (0.00%)  1/265 (0.38%) 
Nervous system disorders     
Brain oedema  1  1/282 (0.35%)  0/265 (0.00%) 
Cerebellar ataxia  1  1/282 (0.35%)  0/265 (0.00%) 
Cerebrovascular accident  1  0/282 (0.00%)  2/265 (0.75%) 
Dizziness  1  1/282 (0.35%)  0/265 (0.00%) 
Epilepsy  1  1/282 (0.35%)  0/265 (0.00%) 
Haemorrhage intracranial  1  1/282 (0.35%)  0/265 (0.00%) 
Headache  1  1/282 (0.35%)  0/265 (0.00%) 
Hemiparesis  1  0/282 (0.00%)  1/265 (0.38%) 
Lacunar infarction  1  1/282 (0.35%)  0/265 (0.00%) 
Neurological symptom  1  0/282 (0.00%)  1/265 (0.38%) 
Paraneoplastic neurological syndrome  1  1/282 (0.35%)  0/265 (0.00%) 
Spinal cord compression  1  1/282 (0.35%)  1/265 (0.38%) 
Syncope  1  1/282 (0.35%)  0/265 (0.00%) 
Psychiatric disorders     
Confusional state  1  1/282 (0.35%)  2/265 (0.75%) 
Delirium  1  0/282 (0.00%)  1/265 (0.38%) 
Disorientation  1  0/282 (0.00%)  1/265 (0.38%) 
Renal and urinary disorders     
Bladder dilatation  1  0/282 (0.00%)  1/265 (0.38%) 
Haematuria  1  1/282 (0.35%)  0/265 (0.00%) 
Renal failure  1  0/282 (0.00%)  1/265 (0.38%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/282 (0.35%)  0/265 (0.00%) 
Atelectasis  1  0/282 (0.00%)  1/265 (0.38%) 
Chronic obstructive pulmonary disease  1  1/282 (0.35%)  2/265 (0.75%) 
Dyspnoea  1  6/282 (2.13%)  5/265 (1.89%) 
Epistaxis  1  0/282 (0.00%)  1/265 (0.38%) 
Haemoptysis  1  1/282 (0.35%)  3/265 (1.13%) 
Hypoxia  1  1/282 (0.35%)  0/265 (0.00%) 
Interstitial lung disease  1  2/282 (0.71%)  0/265 (0.00%) 
Lung infiltration  1  0/282 (0.00%)  1/265 (0.38%) 
Mediastinal disorder  1  1/282 (0.35%)  0/265 (0.00%) 
Pleural effusion  1  2/282 (0.71%)  2/265 (0.75%) 
Pleurisy  1  1/282 (0.35%)  0/265 (0.00%) 
Pneumonia aspiration  1  1/282 (0.35%)  0/265 (0.00%) 
Pneumonitis  1  9/282 (3.19%)  0/265 (0.00%) 
Pneumothorax  1  1/282 (0.35%)  1/265 (0.38%) 
Pulmonary embolism  1  1/282 (0.35%)  4/265 (1.51%) 
Pulmonary haemorrhage  1  0/282 (0.00%)  1/265 (0.38%) 
Respiratory distress  1  0/282 (0.00%)  1/265 (0.38%) 
Respiratory failure  1  2/282 (0.71%)  2/265 (0.75%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  1/282 (0.35%)  0/265 (0.00%) 
Paraneoplastic pemphigus  1  1/282 (0.35%)  0/265 (0.00%) 
Pruritus  1  1/282 (0.35%)  0/265 (0.00%) 
Stevens-Johnson syndrome  1  1/282 (0.35%)  0/265 (0.00%) 
Vascular disorders     
Shock  1  0/282 (0.00%)  1/265 (0.38%) 
Superior vena cava syndrome  1  0/282 (0.00%)  2/265 (0.75%) 
1
Term from vocabulary, 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   242/282 (85.82%)   248/265 (93.58%) 
Blood and lymphatic system disorders     
Anaemia  1  46/282 (16.31%)  159/265 (60.00%) 
Leukopenia  1  9/282 (3.19%)  41/265 (15.47%) 
Neutropenia  1  11/282 (3.90%)  88/265 (33.21%) 
Thrombocytopenia  1  13/282 (4.61%)  77/265 (29.06%) 
Endocrine disorders     
Hypothyroidism  1  16/282 (5.67%)  0/265 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  16/282 (5.67%)  11/265 (4.15%) 
Constipation  1  37/282 (13.12%)  47/265 (17.74%) 
Diarrhoea  1  28/282 (9.93%)  39/265 (14.72%) 
Nausea  1  41/282 (14.54%)  55/265 (20.75%) 
Stomatitis  1  9/282 (3.19%)  17/265 (6.42%) 
Vomiting  1  26/282 (9.22%)  38/265 (14.34%) 
General disorders     
Asthenia  1  60/282 (21.28%)  59/265 (22.26%) 
Fatigue  1  60/282 (21.28%)  73/265 (27.55%) 
Pyrexia  1  22/282 (7.80%)  35/265 (13.21%) 
Infections and infestations     
Pneumonia  1  8/282 (2.84%)  15/265 (5.66%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  8/282 (2.84%)  16/265 (6.04%) 
Investigations     
Alanine aminotransferase increased  1  18/282 (6.38%)  9/265 (3.40%) 
Aspartate aminotransferase increased  1  18/282 (6.38%)  14/265 (5.28%) 
Haemoglobin decreased  1  4/282 (1.42%)  14/265 (5.28%) 
Lipase increased  1  23/282 (8.16%)  3/265 (1.13%) 
Neutrophil count decreased  1  6/282 (2.13%)  59/265 (22.26%) 
Platelet count decreased  1  15/282 (5.32%)  61/265 (23.02%) 
Weight decreased  1  21/282 (7.45%)  15/265 (5.66%) 
White blood cell count decreased  1  11/282 (3.90%)  46/265 (17.36%) 
Metabolism and nutrition disorders     
Decreased appetite  1  71/282 (25.18%)  65/265 (24.53%) 
Hypokalaemia  1  13/282 (4.61%)  15/265 (5.66%) 
Hyponatraemia  1  22/282 (7.80%)  22/265 (8.30%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  19/282 (6.74%)  11/265 (4.15%) 
Back pain  1  26/282 (9.22%)  23/265 (8.68%) 
Pain in extremity  1  15/282 (5.32%)  8/265 (3.02%) 
Nervous system disorders     
Dizziness  1  15/282 (5.32%)  15/265 (5.66%) 
Headache  1  26/282 (9.22%)  17/265 (6.42%) 
Psychiatric disorders     
Insomnia  1  19/282 (6.74%)  15/265 (5.66%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  59/282 (20.92%)  47/265 (17.74%) 
Dyspnoea  1  57/282 (20.21%)  40/265 (15.09%) 
Productive cough  1  16/282 (5.67%)  8/265 (3.02%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  0/282 (0.00%)  23/265 (8.68%) 
Pruritus  1  23/282 (8.16%)  4/265 (1.51%) 
Rash  1  19/282 (6.74%)  10/265 (3.77%) 
1
Term from vocabulary, 21.0
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
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: 1(800) 332-2056
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02481830    
Other Study ID Numbers: CA209-331
2015-001097-18 ( EudraCT Number )
First Submitted: June 23, 2015
First Posted: June 25, 2015
Results First Submitted: August 13, 2019
Results First Posted: January 9, 2020
Last Update Posted: August 6, 2020