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An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma

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: NCT02253992
Recruitment Status : Terminated
First Posted : October 1, 2014
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Solid Tumors
Advanced B-cell NHL
Interventions Biological: Urelumab
Biological: Nivolumab
Enrollment 232
Recruitment Details  
Pre-assignment Details 160 enrolled and treated
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description URE3 Q4WK+NIV3 Q2WK URE8 Q4WK+NIV3 Q2WK URE8 Q4WK+NIV240mg Q2WK
Period Title: Overall Study
Started 6 4 150
Completed [1] 0 0 6
Not Completed 6 4 144
Reason Not Completed
Study drug toxicity             1             0             10
Disease progression             4             3             98
Withdrawal by Subject             0             0             3
Adverse Event             0             0             8
Death             0             0             1
Subject discontinued study drug             1             0             1
Completed treatment as per protocol             0             1             22
Other             0             0             1
[1]
Completed= Continuing in the treatment period.
Arm/Group Title TRT A TRT B TRT D Total
Hide Arm/Group Description URE3 Q4WK+NIV3 Q2WK URE8 Q4WK+NIV3 Q2WK URE8 Q4WK+NIV240mg Q2WK Total of all reporting groups
Overall Number of Baseline Participants 6 4 150 160
Hide Baseline Analysis Population Description
All treated participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 150 participants 160 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  16.7%
2
  50.0%
67
  44.7%
70
  43.8%
>=65 years
5
  83.3%
2
  50.0%
83
  55.3%
90
  56.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 4 participants 150 participants 160 participants
64.7  (9.40) 64.0  (8.52) 63.8  (11.71) 63.9  (11.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 150 participants 160 participants
Female
2
  33.3%
2
  50.0%
47
  31.3%
51
  31.9%
Male
4
  66.7%
2
  50.0%
103
  68.7%
109
  68.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 150 participants 160 participants
Hispanic or Latino
0
   0.0%
1
  25.0%
1
   0.7%
2
   1.3%
Not Hispanic or Latino
5
  83.3%
2
  50.0%
107
  71.3%
114
  71.3%
Unknown or Not Reported
1
  16.7%
1
  25.0%
42
  28.0%
44
  27.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 150 participants 160 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   0.7%
1
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
9
   6.0%
9
   5.6%
White
6
 100.0%
4
 100.0%
136
  90.7%
146
  91.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
4
   2.7%
4
   2.5%
1.Primary Outcome
Title The Incidence of Adverse Events.
Hide Description [Not Specified]
Time Frame From day 1 until 100 days after participant last dose of study drug.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description:
URE3 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV240mg Q2WK
Overall Number of Participants Analyzed 6 4 150
Measure Type: Number
Unit of Measure: Number of participants
6 4 150
2.Primary Outcome
Title The Incidence of Seriuos Adverse Events.
Hide Description [Not Specified]
Time Frame From day 1 until 100 days after participant last dose of the study drug.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description:
URE3 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV240mg Q2WK
Overall Number of Participants Analyzed 6 4 150
Measure Type: Number
Unit of Measure: Number of participants
3 3 86
3.Primary Outcome
Title The Incidence of Death.
Hide Description [Not Specified]
Time Frame From day 1 until 100 days after participant last dose of study drug.
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated participants
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description:
URE3 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV240mg Q2WK
Overall Number of Participants Analyzed 6 4 150
Measure Type: Number
Unit of Measure: Number of participants
6 2 93
4.Secondary Outcome
Title Best Overall Response (BOR)
Hide Description The total number of subjects whose best overall response (BOR) is either a complete response or partial response for solid tumors and complete remission or partial remission for B-cell NHL, divided by the total number of subjects in the population of interest.
Time Frame Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated Participants
Arm/Group Title TRT D - NSCLC pd1/Pd-l1 Experienced TRT D - NSCLC pd1/Pd-l1 Naive TRT D - Melanoma pd1/Pd-l1 Experienced TRT A - Melanoma pd1/Pd-l1 Naive TRT B - TRT D - Melanoma pd1/Pd-l1 Naive TRT A - SCCHN TRT D - SCCHN TRT A - Other Solid Tumors TRT B - Other Solid Tumors TRT D - DLBCL TRT D - FL
Hide Arm/Group Description:
URE8 Q4WK+NIV240mg Q2WK- Non small cell lung cancer pd1/pd-l1 experienced
URE8 Q4WK+NIV240mg Q2WK - Non samll cell lung cancer pd1/pd-l1 naive.
URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 experienced
URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
URE8 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 naive
URE3 Q4WK+NIV3 Q2WK - Squamous cell carcinoma of head and neck.
URE8 Q4WK+NIV240mg Q2WK - Squamous cell carcinoma of head and neck.
URE3 Q4WK+NIV3 Q2WK - Other solid tumors
URE8 Q4WK+NIV3 Q2WK - Other Solid tumors.
URE8 Q4WK+NIV240mg Q2WK - Diffuse Large B-cell lymphoma.
URE8 Q4WK+NIV240mg Q2WK - Follicular Lymphoma.
Overall Number of Participants Analyzed 20 20 20 4 1 43 1 21 1 3 22 4
Measure Type: Number
Unit of Measure: Number of participants
Complete response 0 0 0 0 1 6 0 1 0 0 0 0
Partial response 1 1 2 1 0 15 0 0 0 0 0 0
5.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description Objective response rate (ORR) is defined as the total number of subjects whose BOR is either CR or PR divided by the total number of subjects in the population of interest.
Time Frame Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated Participants
Arm/Group Title TRT D - NSCLC pd1/Pd-l1 Experienced TRT D - NSCLC pd1/Pd-l1 Naive TRT D - Melanoma pd1/Pd-l1 Experienced TRT A - Melanoma pd1/Pd-l1 Naive TRT B - TRT D - Melanoma pd1/Pd-l1 Naive TRT A - SCCHN TRT D - SCCHN TRT A - Other Solid Tumors TRT B - Other Solid Tumors TRT D - DLBCL TRT D - FL
Hide Arm/Group Description:
URE8 Q4WK+NIV240mg Q2WK- Non small cell lung cancer pd1/pd-l1 experienced
URE8 Q4WK+NIV240mg Q2WK - Non samll cell lung cancer pd1/pd-l1 naive.
URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 experienced
URE3 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
URE8 Q4WK+NIV3 Q2WK - Melanoma pd1/pd-l1 naive
URE8 Q4WK+NIV240mg Q2WK - Melanoma pd1/pd-l1 naive
URE3 Q4WK+NIV3 Q2WK - Squamous cell carcinoma of head and neck.
URE8 Q4WK+NIV240mg Q2WK - Squamous cell carcinoma of head and neck.
URE3 Q4WK+NIV3 Q2WK - Other solid tumors
URE8 Q4WK+NIV3 Q2WK - Other Solid tumors.
URE8 Q4WK+NIV240mg Q2WK - Diffuse Large B-cell lymphoma.
URE8 Q4WK+NIV240mg Q2WK - Follicular Lymphoma.
Overall Number of Participants Analyzed 20 20 20 4 1 43 1 21 1 3 22 4
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
5.0
(0.1 to 24.9)
5.0
(0.1 to 24.9)
10.0
(1.2 to 31.7)
25.0
(0.6 to 80.6)
100.0
(2.5 to 100.0)
48.8
(33.3 to 64.5)
0
(0.0 to 97.5)
4.8
(0.1 to 23.8)
0
(0.0 to 97.5)
0
(0.0 to 70.8)
0
(0.0 to 16.1)
0
(0.0 to 60.2)
6.Secondary Outcome
Title Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab
Hide Description [Not Specified]
Time Frame Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Urelumab ADA Nivolumab ADA
Hide Arm/Group Description:
Urelumab Anti drug antibody
Nivolumab anti drug antibody
Overall Number of Participants Analyzed 133 128
Measure Type: Number
Unit of Measure: Number of participants
Baseline ADA positive 5 2
ADA positive 55 9
ADA negative 78 119
7.Secondary Outcome
Title Duration of Response (DOR)
Hide Description

DOR is defined as the number of days between the date of first response and the subsequent date of objectively documented disease progression based on the criteria (RECIST v1.1) or relapse based on IWG, or death due to any cause, if death occurred within 100 days after last dose, whichever occurs first.

Data was not collected due to discontinuation of the study/Due to study termination.

Time Frame Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected due to discontinuation of the study/Due to study termination.
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description:
URE3 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV240mg Q2WK
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Progression-free Survival Rate (PFSR)
Hide Description

PFSR is defined as the probability of a subject remaining progression-free and surviving a specific length of time.

Data was not collected due to discontinuation of the study/Due to study termination.

Time Frame Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected due to discontinuation of the study/Due to study termination.
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description:
URE3 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV240mg Q2WK
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax)
Hide Description Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected due to discontinuation of the study/Due to study termination.
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description:
URE3 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV240mg Q2WK
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Time of Maximum Observed Serum Concentration (Tmax)
Hide Description Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected due to discontinuation of the study/Due to study termination.
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description:
URE3 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV240mg Q2WK
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)
Hide Description Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected due to discontinuation of the study/Due to study termination.
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description:
URE3 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV240mg Q2WK
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Trough Observed Plasma Concentration(Ctrough)
Hide Description Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected due to discontinuation of the study/Due to study termination.
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description:
URE3 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV240mg Q2WK
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title End of Infusion Concentration (Ceoinf)
Hide Description Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected due to discontinuation of the study/Due to study termination.
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description:
URE3 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV240mg Q2WK
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)
Hide Description Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected due to discontinuation of the study/Due to study termination.
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description:
URE3 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV3 Q2WK
URE8 Q4WK+NIV240mg Q2WK
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From the start dosing day and up to 100 days after participant's last dose ( up to 3 years).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TRT A TRT B TRT D
Hide Arm/Group Description URE3 Q4WK+NIV3 Q2WK URE8 Q4WK+NIV3 Q2WK URE8 Q4WK+NIV240mg Q2WK
All-Cause Mortality
TRT A TRT B TRT D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   2/4 (50.00%)   93/150 (62.00%) 
Hide Serious Adverse Events
TRT A TRT B TRT D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   3/4 (75.00%)   86/150 (57.33%) 
Blood and lymphatic system disorders       
Anaemia  1  0/6 (0.00%)  0/4 (0.00%)  2/150 (1.33%) 
Febrile neutropenia  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Cardiac disorders       
Atrial fibrillation  1  0/6 (0.00%)  0/4 (0.00%)  2/150 (1.33%) 
Atrial flutter  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Atrioventricular block  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Stress cardiomyopathy  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Endocrine disorders       
Diabetes insipidus  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Hypogonadism  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Hypophysitis  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Hypothyroidism  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Gastrointestinal disorders       
Abdominal pain  1  0/6 (0.00%)  0/4 (0.00%)  3/150 (2.00%) 
Abdominal pain upper  1  0/6 (0.00%)  0/4 (0.00%)  2/150 (1.33%) 
Colitis  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Constipation  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Diarrhoea  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Diverticulum intestinal haemorrhagic  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Enteritis  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Faecaloma  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Ileus  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Vomiting  1  0/6 (0.00%)  0/4 (0.00%)  3/150 (2.00%) 
General disorders       
Asthenia  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Fatigue  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
General physical health deterioration  1  1/6 (16.67%)  0/4 (0.00%)  4/150 (2.67%) 
Hyperthermia  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Hypothermia  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Pain  1  0/6 (0.00%)  0/4 (0.00%)  4/150 (2.67%) 
Pelvic mass  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Pyrexia  1  0/6 (0.00%)  0/4 (0.00%)  5/150 (3.33%) 
Sudden death  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Hepatobiliary disorders       
Autoimmune hepatitis  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Bile duct stenosis  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Immune system disorders       
Contrast media reaction  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Drug hypersensitivity  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Haemophagocytic lymphohistiocytosis  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Infections and infestations       
Bacteraemia  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Bronchitis  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Cellulitis  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Device related infection  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Erysipelas  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Lung infection  1  0/6 (0.00%)  0/4 (0.00%)  3/150 (2.00%) 
Pneumonia  1  0/6 (0.00%)  0/4 (0.00%)  4/150 (2.67%) 
Pneumonia haemophilus  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Urinary tract infection  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Injury, poisoning and procedural complications       
Lumbar vertebral fracture  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Tracheal obstruction  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Investigations       
Alanine aminotransferase increased  1  0/6 (0.00%)  0/4 (0.00%)  2/150 (1.33%) 
Aspartate aminotransferase increased  1  0/6 (0.00%)  0/4 (0.00%)  2/150 (1.33%) 
Blood alkaline phosphatase increased  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Blood bilirubin increased  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Gamma-glutamyltransferase increased  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Metabolism and nutrition disorders       
Dehydration  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Diabetes mellitus  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Diabetic ketoacidosis  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Failure to thrive  1  0/6 (0.00%)  0/4 (0.00%)  3/150 (2.00%) 
Gout  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Hypercalcaemia  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Hypoglycaemia  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal chest pain  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Pain in extremity  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Abdominal neoplasm  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Basal cell carcinoma  1  0/6 (0.00%)  0/4 (0.00%)  2/150 (1.33%) 
Cancer pain  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Malignant neoplasm progression  1  1/6 (16.67%)  1/4 (25.00%)  37/150 (24.67%) 
Metastases to central nervous system  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Metastases to lymph nodes  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Squamous cell carcinoma  1  0/6 (0.00%)  1/4 (25.00%)  3/150 (2.00%) 
Tumour haemorrhage  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Tumour pain  1  0/6 (0.00%)  0/4 (0.00%)  3/150 (2.00%) 
Nervous system disorders       
Ataxia  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Central nervous system lesion  1  0/6 (0.00%)  1/4 (25.00%)  0/150 (0.00%) 
Cerebral haematoma  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Cerebrovascular accident  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Dizziness  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Monoplegia  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Paraparesis  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Seizure  1  0/6 (0.00%)  0/4 (0.00%)  3/150 (2.00%) 
Syncope  1  0/6 (0.00%)  0/4 (0.00%)  3/150 (2.00%) 
Psychiatric disorders       
Confusional state  1  0/6 (0.00%)  1/4 (25.00%)  1/150 (0.67%) 
Mental status changes  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Persistent depressive disorder  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Renal and urinary disorders       
Acute kidney injury  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Haematuria  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Hydronephrosis  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Urinary tract obstruction  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Respiratory, thoracic and mediastinal disorders       
Aspiration  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Dyspnoea  1  0/6 (0.00%)  0/4 (0.00%)  2/150 (1.33%) 
Haemoptysis  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Hydrothorax  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Hypoxia  1  0/6 (0.00%)  0/4 (0.00%)  2/150 (1.33%) 
Obstructive airways disorder  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Pharyngeal haemorrhage  1  0/6 (0.00%)  0/4 (0.00%)  2/150 (1.33%) 
Pleural effusion  1  0/6 (0.00%)  0/4 (0.00%)  4/150 (2.67%) 
Pneumonia aspiration  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Pneumonitis  1  0/6 (0.00%)  0/4 (0.00%)  3/150 (2.00%) 
Pulmonary embolism  1  0/6 (0.00%)  0/4 (0.00%)  3/150 (2.00%) 
Pulmonary haemorrhage  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Respiratory failure  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Skin and subcutaneous tissue disorders       
Rash maculo-papular  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Vascular disorders       
Embolism  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Extremity necrosis  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
Peripheral ischaemia  1  0/6 (0.00%)  0/4 (0.00%)  1/150 (0.67%) 
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%
TRT A TRT B TRT D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   4/4 (100.00%)   147/150 (98.00%) 
Blood and lymphatic system disorders       
Anaemia  1  3/6 (50.00%)  1/4 (25.00%)  47/150 (31.33%) 
Neutropenia  1  0/6 (0.00%)  0/4 (0.00%)  8/150 (5.33%) 
Endocrine disorders       
Adrenal insufficiency  1  1/6 (16.67%)  0/4 (0.00%)  2/150 (1.33%) 
Hypothyroidism  1  0/6 (0.00%)  1/4 (25.00%)  16/150 (10.67%) 
Eye disorders       
Dry eye  1  0/6 (0.00%)  1/4 (25.00%)  5/150 (3.33%) 
Lacrimation increased  1  0/6 (0.00%)  1/4 (25.00%)  2/150 (1.33%) 
Vision blurred  1  2/6 (33.33%)  0/4 (0.00%)  2/150 (1.33%) 
Gastrointestinal disorders       
Abdominal discomfort  1  0/6 (0.00%)  1/4 (25.00%)  0/150 (0.00%) 
Abdominal distension  1  1/6 (16.67%)  0/4 (0.00%)  6/150 (4.00%) 
Abdominal pain  1  2/6 (33.33%)  1/4 (25.00%)  19/150 (12.67%) 
Abdominal pain upper  1  1/6 (16.67%)  0/4 (0.00%)  6/150 (4.00%) 
Anal incontinence  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Ascites  1  0/6 (0.00%)  1/4 (25.00%)  0/150 (0.00%) 
Constipation  1  1/6 (16.67%)  0/4 (0.00%)  31/150 (20.67%) 
Dental caries  1  0/6 (0.00%)  1/4 (25.00%)  0/150 (0.00%) 
Diarrhoea  1  5/6 (83.33%)  0/4 (0.00%)  32/150 (21.33%) 
Dry mouth  1  1/6 (16.67%)  0/4 (0.00%)  8/150 (5.33%) 
Dysphagia  1  2/6 (33.33%)  1/4 (25.00%)  6/150 (4.00%) 
Gastritis  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Gastrooesophageal reflux disease  1  0/6 (0.00%)  1/4 (25.00%)  3/150 (2.00%) 
Lip swelling  1  0/6 (0.00%)  1/4 (25.00%)  0/150 (0.00%) 
Melaena  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Nausea  1  3/6 (50.00%)  0/4 (0.00%)  37/150 (24.67%) 
Vomiting  1  3/6 (50.00%)  0/4 (0.00%)  26/150 (17.33%) 
General disorders       
Asthenia  1  1/6 (16.67%)  1/4 (25.00%)  16/150 (10.67%) 
Chills  1  0/6 (0.00%)  0/4 (0.00%)  14/150 (9.33%) 
Fatigue  1  4/6 (66.67%)  2/4 (50.00%)  61/150 (40.67%) 
Gait disturbance  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Oedema peripheral  1  1/6 (16.67%)  0/4 (0.00%)  25/150 (16.67%) 
Performance status decreased  1  0/6 (0.00%)  1/4 (25.00%)  1/150 (0.67%) 
Pyrexia  1  4/6 (66.67%)  1/4 (25.00%)  29/150 (19.33%) 
Hepatobiliary disorders       
Hepatic haemorrhage  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Infections and infestations       
Gastroenteritis  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Gingivitis  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Localised infection  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Nasopharyngitis  1  0/6 (0.00%)  1/4 (25.00%)  6/150 (4.00%) 
Pneumonia  1  1/6 (16.67%)  0/4 (0.00%)  4/150 (2.67%) 
Upper respiratory tract infection  1  1/6 (16.67%)  0/4 (0.00%)  12/150 (8.00%) 
Urinary tract infection  1  1/6 (16.67%)  0/4 (0.00%)  12/150 (8.00%) 
Injury, poisoning and procedural complications       
Fall  1  1/6 (16.67%)  1/4 (25.00%)  8/150 (5.33%) 
Infusion related reaction  1  0/6 (0.00%)  1/4 (25.00%)  2/150 (1.33%) 
Skin abrasion  1  0/6 (0.00%)  1/4 (25.00%)  1/150 (0.67%) 
Sunburn  1  0/6 (0.00%)  1/4 (25.00%)  1/150 (0.67%) 
Investigations       
Alanine aminotransferase increased  1  2/6 (33.33%)  0/4 (0.00%)  26/150 (17.33%) 
Amylase increased  1  0/6 (0.00%)  0/4 (0.00%)  13/150 (8.67%) 
Aspartate aminotransferase increased  1  0/6 (0.00%)  0/4 (0.00%)  26/150 (17.33%) 
Blood alkaline phosphatase increased  1  2/6 (33.33%)  0/4 (0.00%)  20/150 (13.33%) 
Blood creatinine increased  1  1/6 (16.67%)  0/4 (0.00%)  8/150 (5.33%) 
Blood thyroid stimulating hormone increased  1  0/6 (0.00%)  1/4 (25.00%)  4/150 (2.67%) 
Blood uric acid decreased  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Gamma-glutamyltransferase increased  1  2/6 (33.33%)  0/4 (0.00%)  18/150 (12.00%) 
Lipase increased  1  1/6 (16.67%)  0/4 (0.00%)  17/150 (11.33%) 
Lymphocyte count decreased  1  2/6 (33.33%)  0/4 (0.00%)  7/150 (4.67%) 
Neutrophil count decreased  1  1/6 (16.67%)  0/4 (0.00%)  3/150 (2.00%) 
Platelet count decreased  1  1/6 (16.67%)  0/4 (0.00%)  8/150 (5.33%) 
Weight decreased  1  1/6 (16.67%)  0/4 (0.00%)  18/150 (12.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  2/6 (33.33%)  1/4 (25.00%)  24/150 (16.00%) 
Dehydration  1  1/6 (16.67%)  0/4 (0.00%)  4/150 (2.67%) 
Hypercalcaemia  1  0/6 (0.00%)  0/4 (0.00%)  8/150 (5.33%) 
Hyperglycaemia  1  0/6 (0.00%)  0/4 (0.00%)  14/150 (9.33%) 
Hyperkalaemia  1  1/6 (16.67%)  0/4 (0.00%)  11/150 (7.33%) 
Hypermagnesaemia  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Hyperuricaemia  1  1/6 (16.67%)  0/4 (0.00%)  2/150 (1.33%) 
Hypoalbuminaemia  1  0/6 (0.00%)  0/4 (0.00%)  12/150 (8.00%) 
Hypokalaemia  1  0/6 (0.00%)  1/4 (25.00%)  9/150 (6.00%) 
Hypomagnesaemia  1  1/6 (16.67%)  0/4 (0.00%)  4/150 (2.67%) 
Hyponatraemia  1  0/6 (0.00%)  0/4 (0.00%)  14/150 (9.33%) 
Hypophosphataemia  1  2/6 (33.33%)  0/4 (0.00%)  16/150 (10.67%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/6 (0.00%)  2/4 (50.00%)  17/150 (11.33%) 
Back pain  1  0/6 (0.00%)  0/4 (0.00%)  23/150 (15.33%) 
Flank pain  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Joint range of motion decreased  1  0/6 (0.00%)  1/4 (25.00%)  1/150 (0.67%) 
Muscular weakness  1  2/6 (33.33%)  1/4 (25.00%)  5/150 (3.33%) 
Musculoskeletal pain  1  0/6 (0.00%)  0/4 (0.00%)  11/150 (7.33%) 
Myalgia  1  0/6 (0.00%)  1/4 (25.00%)  15/150 (10.00%) 
Neck pain  1  0/6 (0.00%)  1/4 (25.00%)  6/150 (4.00%) 
Pain in extremity  1  0/6 (0.00%)  0/4 (0.00%)  15/150 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Squamous cell carcinoma  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Nervous system disorders       
Balance disorder  1  0/6 (0.00%)  1/4 (25.00%)  1/150 (0.67%) 
Carotid artery occlusion  1  0/6 (0.00%)  1/4 (25.00%)  0/150 (0.00%) 
Cognitive disorder  1  0/6 (0.00%)  1/4 (25.00%)  1/150 (0.67%) 
Dizziness  1  1/6 (16.67%)  0/4 (0.00%)  13/150 (8.67%) 
Headache  1  4/6 (66.67%)  0/4 (0.00%)  23/150 (15.33%) 
Peripheral motor neuropathy  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Peripheral sensory neuropathy  1  1/6 (16.67%)  0/4 (0.00%)  3/150 (2.00%) 
Restless legs syndrome  1  0/6 (0.00%)  1/4 (25.00%)  1/150 (0.67%) 
Sciatica  1  0/6 (0.00%)  1/4 (25.00%)  0/150 (0.00%) 
Sinus headache  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Psychiatric disorders       
Anxiety  1  0/6 (0.00%)  0/4 (0.00%)  11/150 (7.33%) 
Depression  1  1/6 (16.67%)  0/4 (0.00%)  3/150 (2.00%) 
Insomnia  1  0/6 (0.00%)  0/4 (0.00%)  11/150 (7.33%) 
Renal and urinary disorders       
Dysuria  1  1/6 (16.67%)  0/4 (0.00%)  3/150 (2.00%) 
Pollakiuria  1  1/6 (16.67%)  0/4 (0.00%)  6/150 (4.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/6 (33.33%)  0/4 (0.00%)  33/150 (22.00%) 
Dyspnoea  1  2/6 (33.33%)  0/4 (0.00%)  26/150 (17.33%) 
Nasal congestion  1  1/6 (16.67%)  0/4 (0.00%)  6/150 (4.00%) 
Rhinitis allergic  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Skin and subcutaneous tissue disorders       
Actinic keratosis  1  1/6 (16.67%)  1/4 (25.00%)  5/150 (3.33%) 
Drug eruption  1  1/6 (16.67%)  0/4 (0.00%)  2/150 (1.33%) 
Dry skin  1  0/6 (0.00%)  0/4 (0.00%)  13/150 (8.67%) 
Hyperkeratosis  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Lichen planus  1  1/6 (16.67%)  0/4 (0.00%)  0/150 (0.00%) 
Pruritus  1  0/6 (0.00%)  2/4 (50.00%)  22/150 (14.67%) 
Rash  1  0/6 (0.00%)  1/4 (25.00%)  16/150 (10.67%) 
Rash macular  1  1/6 (16.67%)  0/4 (0.00%)  2/150 (1.33%) 
Rash maculo-papular  1  0/6 (0.00%)  2/4 (50.00%)  9/150 (6.00%) 
Rash papular  1  0/6 (0.00%)  1/4 (25.00%)  0/150 (0.00%) 
Rash pruritic  1  1/6 (16.67%)  0/4 (0.00%)  2/150 (1.33%) 
Skin ulcer  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Vascular disorders       
Hot flush  1  1/6 (16.67%)  0/4 (0.00%)  1/150 (0.67%) 
Hypertension  1  2/6 (33.33%)  0/4 (0.00%)  3/150 (2.00%) 
Hypotension  1  1/6 (16.67%)  0/4 (0.00%)  6/150 (4.00%) 
1
Term from vocabulary, MedDRA 22.0
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: Please email
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02253992    
Other Study ID Numbers: CA186-107
2014-002241-22 ( EudraCT Number )
First Submitted: September 29, 2014
First Posted: October 1, 2014
Results First Submitted: May 19, 2020
Results First Posted: October 5, 2020
Last Update Posted: October 5, 2020