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Trial record 3 of 6 for:    "Peritoneal Mesothelioma" | "Antibodies"

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab)

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: NCT01843374
Recruitment Status : Active, not recruiting
First Posted : April 30, 2013
Results First Posted : August 17, 2017
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Unresectable Pleural or Peritoneal Malignant Mesothelioma
Interventions Drug: Tremelimumab
Drug: Placebo
Enrollment 571
Recruitment Details  
Pre-assignment Details

A total of 658 patients were screened, 87 patients were excluded from randomisation and 571 patients were randomised:

Of the 78 excluded, 66 did not meet inclusion/exclusion criteria; 19 withdrew consent and 2 were excluded for other reasons.

Arm/Group Title PLACEBO TREMELIMUMAB
Hide Arm/Group Description Placebo. TREMELIMUMAB 10 mg/kg
Period Title: Overall Study
Started 189 382
RANDOMIZED 189 382
Completed 0 3
Not Completed 189 379
Reason Not Completed
Death             155             313
Withdrawal by Subject             14             20
Withdrawing due to Other reason             20             46
Arm/Group Title TREMELIMUMAB PLACEBO Total
Hide Arm/Group Description TREMELIMUMAB 10 mg/kg Placebo. Total of all reporting groups
Overall Number of Baseline Participants 382 189 571
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 382 participants 189 participants 571 participants
65.2  (9.24) 66.3  (8.8) 65.6  (9.10)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 382 participants 189 participants 571 participants
< 65 years
162
  42.4%
75
  39.7%
237
  41.5%
>= 65 years
220
  57.6%
114
  60.3%
334
  58.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 382 participants 189 participants 571 participants
Female
99
  25.9%
38
  20.1%
137
  24.0%
Male
283
  74.1%
151
  79.9%
434
  76.0%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) by treatment arm
Time Frame 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title PLACEBO TREMELIMUMAB
Hide Arm/Group Description:
Placebo.
TREMELIMUMAB 10 mg/kg
Overall Number of Participants Analyzed 189 282
Measure Type: Number
Unit of Measure: Number of Participants
Number of patients with Events (Death) 154 307
Number patients censored <= 2 weeks before DCO 25 58
Number of patients censored > 2 weeks before DCO 10 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, TREMELIMUMAB
Comments H0: No difference between tremelimumab and placebo H1: Difference between tremelimumab and placebo
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4081
Comments P-value was estimated using the method of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and Line of therapy.
Method Log Rank
Comments The stratification factors included EORTC status and line of therapy as recorded in IVRS/IWRS.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.76 to 1.12
Estimation Comments Tremelimumab represents the numerator and Placebo the denominator
2.Secondary Outcome
Title OS Rate at 18 Months by Treatment Arm
Hide Description The percentage of patients still alive at 18 months
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title TREMELIMUMAB PLACEBO
Hide Arm/Group Description:
Tremelimumab 10mg/kg
Placebo.
Overall Number of Participants Analyzed 382 189
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
17.4
(13.4 to 21.8)
18.2
(12.7 to 24.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TREMELIMUMAB, PLACEBO
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.926
Comments Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.011
Confidence Interval (2-Sided) 95%
0.793 to 1.289
Estimation Comments Tremelimumab is the numerator and Placebo the denominator
3.Secondary Outcome
Title Progression-free Survival by Treatment Arm
Hide Description Progression-free survival will be measured from randomization to the first documentation of disease progression or death due to any cause, whichever occurs first. Progression is defined using the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title TREMELIMUMAB PLACEBO
Hide Arm/Group Description:
Tremelimumab 10mg/kg
Placebo.
Overall Number of Participants Analyzed 382 189
Median (95% Confidence Interval)
Unit of Measure: Months
2.69
(2.66 to 2.76)
2.76
(2.76 to 2.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TREMELIMUMAB, PLACEBO
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0325
Comments Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.
Method Log Rank
Comments Stratification factors were EORTC status and Line of therapy
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.68 to 0.98
Estimation Comments Tremelimumab is the numerator and placebo, the denominator
4.Secondary Outcome
Title Overall Response Rate by Treatment Arm
Hide Description Overall response rate is defined as the proportion of participants with confirmed CR or PR per the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR) corresponds to disappearance of all target lesions, and Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.
Time Frame Time from randomization to best response to treatment, assessed up to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title TREMELIMUMAB PLACEBO
Hide Arm/Group Description:
Tremelimumab 10mg/kg
Placebo.
Overall Number of Participants Analyzed 382 189
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
4.5
(2.6 to 7.0)
1.1
(0.1 to 3.8)
5.Secondary Outcome
Title Duration of Response by Treatment Arm
Hide Description Duration of response will be defined as the duration from the first documentation of complete response (CR), partial response (PR) to the first documented disease progression.
Time Frame Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 14 weeks after the initial response.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title TREMELIMUMAB PLACEBO
Hide Arm/Group Description:
Tremelimumab 10mg/kg
Placebo.
Overall Number of Participants Analyzed 382 189
Median (Full Range)
Unit of Measure: Months
4.8
(0 to 13.4)
5.57
(2.8 to 8.3)
6.Secondary Outcome
Title Disease Control Rate by Treatment Arm
Hide Description Disease control rate (DCR) is defined as the proportion of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 12 weeks duration
Time Frame Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title TREMELIMUMAB PLACEBO
Hide Arm/Group Description:
Tremelimumab 10mg/kg
Placebo.
Overall Number of Participants Analyzed 382 189
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
21.7
(16.0 to 28.3)
27.7
(23.3 to 32.5)
7.Secondary Outcome
Title Durable Disease Control Rate by Treatment Arm
Hide Description Durable disease control rate (DDCR) is defined as the percentage of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 6 months duration
Time Frame Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title TREMELIMUMAB PLACEBO
Hide Arm/Group Description:
Tremelimumab 10mg/kg
Placebo.
Overall Number of Participants Analyzed 382 189
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
16.8
(13.1 to 20.9)
11.6
(7.4 to 17.1)
8.Secondary Outcome
Title Number of Participants Reporting Any Adverse Event
Hide Description Any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame Day 1- 90 days post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title TREMELIMUMAB PLACEBO
Hide Arm/Group Description:
Tremelimumab 10mg/kg
Placebo.
Overall Number of Participants Analyzed 380 189
Measure Type: Number
Unit of Measure: Participants
364 179
9.Secondary Outcome
Title Number of Participants Reporting Any Serious Adverse Events
Hide Description [Not Specified]
Time Frame Day 1 to 90 days post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title PLACEBO TREMELIMUMAB
Hide Arm/Group Description:
Placebo.
Tremelimumab 10mg/kg
Overall Number of Participants Analyzed 189 380
Measure Type: Number
Unit of Measure: Participants
85 218
10.Secondary Outcome
Title Number of Participants With Positive Anti-drug Antibodies
Hide Description The immunogenicity titer is reported for samples confirmed positive for the presence of anti tremelimumab antibodies.
Time Frame Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title PLACEBO TREMELIMUMAB
Hide Arm/Group Description:
Placebo.
Tremelimumab 10mg/kg
Overall Number of Participants Analyzed 188 377
Measure Type: Number
Unit of Measure: Participants
0 15
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PLACEBO TREMELIMUMAB
Hide Arm/Group Description Placebo. Tremelimumab 10mg/kg
All-Cause Mortality
PLACEBO TREMELIMUMAB
Affected / at Risk (%) Affected / at Risk (%)
Total   160/189 (84.66%)      318/382 (83.25%)    
Show Serious Adverse Events Hide Serious Adverse Events
PLACEBO TREMELIMUMAB
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   85/189 (44.97%)      218/380 (57.37%)    
Blood and lymphatic system disorders     
Anaemia  1  1/189 (0.53%)  1 5/380 (1.32%)  6
Leukocytosis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Neutropenia  1  0/189 (0.00%)  0 3/380 (0.79%)  3
Pancytopenia  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Thrombocytopenia  1  0/189 (0.00%)  0 2/380 (0.53%)  3
Cardiac disorders     
Acute myocardial infarction  1  1/189 (0.53%)  2 1/380 (0.26%)  1
Atrial fibrillation  1  3/189 (1.59%)  3 4/380 (1.05%)  7
Atrial flutter  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Atrioventricular block second degree  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Cardiac arrest  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Cardiac failure  1  1/189 (0.53%)  1 2/380 (0.53%)  4
Cardiac tamponade  1  2/189 (1.06%)  2 0/380 (0.00%)  0
Cardio-respiratory arrest  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Left ventricular failure  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Myocardial infarction  1  0/189 (0.00%)  0 3/380 (0.79%)  4
Myocardial ischaemia  1  0/189 (0.00%)  0 1/380 (0.26%)  2
Pericardial effusion  1  6/189 (3.17%)  6 9/380 (2.37%)  10
Ear and labyrinth disorders     
Vertigo  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Endocrine disorders     
Adrenal insufficiency  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Hypophysitis  1  0/189 (0.00%)  0 3/380 (0.79%)  3
Hypopituitarism  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Hypothyroidism  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Lymphocytic hypophysitis  1  0/189 (0.00%)  0 3/380 (0.79%)  3
Thyroiditis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Eye disorders     
Diplopia  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  2/189 (1.06%)  2 3/380 (0.79%)  3
Abdominal pain  1  4/189 (2.12%)  4 7/380 (1.84%)  7
Abdominal pain upper  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Ascites  1  6/189 (3.17%)  10 3/380 (0.79%)  3
Colitis  1  0/189 (0.00%)  0 24/380 (6.32%)  27
Colitis ischaemic  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Constipation  1  1/189 (0.53%)  1 3/380 (0.79%)  3
Diarrhoea  1  1/189 (0.53%)  1 69/380 (18.16%)  106
Diarrhoea haemorrhagic  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Diverticular perforation  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Dysphagia  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Faecaloma  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Gastric perforation  1  0/189 (0.00%)  0 1/380 (0.26%)  2
Gastrointestinal haemorrhage  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Gastrointestinal toxicity  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Intestinal obstruction  1  0/189 (0.00%)  0 2/380 (0.53%)  3
Intestinal perforation  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Nausea  1  1/189 (0.53%)  1 9/380 (2.37%)  11
Oesophageal compression  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Pancreatitis  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Post-tussive vomiting  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Small intestinal obstruction  1  0/189 (0.00%)  0 5/380 (1.32%)  5
Upper gastrointestinal haemorrhage  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Vomiting  1  7/189 (3.70%)  9 12/380 (3.16%)  13
General disorders     
Asthenia  1  3/189 (1.59%)  3 4/380 (1.05%)  5
Device breakage  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Device dislocation  1  0/189 (0.00%)  0 1/380 (0.26%)  2
Early satiety  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Fatigue  1  2/189 (1.06%)  2 3/380 (0.79%)  4
General physical health deterioration  1  4/189 (2.12%)  4 9/380 (2.37%)  10
Malaise  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Multi-organ failure  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Non-cardiac chest pain  1  4/189 (2.12%)  4 2/380 (0.53%)  2
Oedema  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Oedema peripheral  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Pain  1  3/189 (1.59%)  4 0/380 (0.00%)  0
Pyrexia  1  0/189 (0.00%)  0 11/380 (2.89%)  12
Hepatobiliary disorders     
Hepatitis acute  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Jaundice cholestatic  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Infections and infestations     
Abdominal infection  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Anal abscess  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Appendicitis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Bronchitis  1  0/189 (0.00%)  0 1/380 (0.26%)  3
Bronchopneumonia  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Cellulitis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Clostridium colitis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Clostridium difficile colitis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Encephalitis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Gastroenteritis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Herpes zoster  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Infection  1  0/189 (0.00%)  0 1/380 (0.26%)  3
Lower respiratory tract infection  1  1/189 (0.53%)  1 3/380 (0.79%)  3
Lung infection  1  2/189 (1.06%)  2 5/380 (1.32%)  8
Lymphangitis  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Meningitis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Pneumococcal sepsis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Pneumonia  1  6/189 (3.17%)  8 11/380 (2.89%)  13
Respiratory syncytial virus infection  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Respiratory tract infection  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Sepsis  1  1/189 (0.53%)  1 6/380 (1.58%)  7
Septic shock  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Systemic mycosis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Upper respiratory tract infection  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Urinary tract infection  1  0/189 (0.00%)  0 3/380 (0.79%)  3
Injury, poisoning and procedural complications     
Infusion related reaction  1  1/189 (0.53%)  1 4/380 (1.05%)  4
Joint dislocation  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Overdose  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Pelvic fracture  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Post procedural discharge  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Spinal compression fracture  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Spinal fracture  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Investigations     
Amylase increased  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Blood creatinine increased  1  0/189 (0.00%)  0 2/380 (0.53%)  2
C-reactive protein increased  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Haemoglobin decreased  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Liver function test abnormal  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Platelet count decreased  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Troponin T increased  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Weight decreased  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Metabolism and nutrition disorders     
Acidosis  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Decreased appetite  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Dehydration  1  1/189 (0.53%)  1 10/380 (2.63%)  12
Failure to thrive  1  0/189 (0.00%)  0 1/380 (0.26%)  2
Fluid overload  1  0/189 (0.00%)  0 1/380 (0.26%)  2
Hypercalcaemia  1  1/189 (0.53%)  1 2/380 (0.53%)  2
Hyperglycaemia  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Hyperkalaemia  1  0/189 (0.00%)  0 3/380 (0.79%)  3
Hypocalcaemia  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Hypokalaemia  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Hyponatraemia  1  2/189 (1.06%)  2 0/380 (0.00%)  0
Hypophosphataemia  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Musculoskeletal and connective tissue disorders     
Autoimmune arthritis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Back pain  1  3/189 (1.59%)  3 0/380 (0.00%)  0
Bone pain  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Flank pain  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Muscular weakness  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Musculoskeletal chest pain  1  2/189 (1.06%)  2 7/380 (1.84%)  7
Musculoskeletal pain  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Myalgia  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Osteoporosis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Pain in extremity  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Cancer pain  1  3/189 (1.59%)  3 2/380 (0.53%)  2
Colon cancer  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Gastric cancer  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Malignant pleural effusion  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Mesothelioma  1  2/189 (1.06%)  2 3/380 (0.79%)  3
Mesothelioma malignant  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Metastases to central nervous system  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Metastases to spine  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Tumour associated fever  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Tumour pain  1  2/189 (1.06%)  2 4/380 (1.05%)  4
Nervous system disorders     
Ataxia  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Brain oedema  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Dizziness  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Epilepsy  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Guillain-Barre syndrome  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Headache  1  1/189 (0.53%)  1 2/380 (0.53%)  2
Hyperaesthesia  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Lethargy  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Neuritis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Paraesthesia  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Paraparesis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Peripheral motor neuropathy  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Seizure  1  1/189 (0.53%)  1 1/380 (0.26%)  2
Syncope  1  3/189 (1.59%)  4 0/380 (0.00%)  0
Psychiatric disorders     
Confusional state  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Delirium  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Mental status changes  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/189 (0.53%)  1 5/380 (1.32%)  5
Haematuria  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Nephrotic syndrome  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Renal failure  1  1/189 (0.53%)  1 2/380 (0.53%)  2
Renal pain  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Reproductive system and breast disorders     
Uterine polyp  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Asthma  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Cough  1  2/189 (1.06%)  2 2/380 (0.53%)  2
Dyspnoea  1  24/189 (12.70%)  31 29/380 (7.63%)  33
Dyspnoea exertional  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Hypoxia  1  1/189 (0.53%)  1 2/380 (0.53%)  2
Lung disorder  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Pharyngeal oedema  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Pleural effusion  1  6/189 (3.17%)  7 6/380 (1.58%)  8
Pleuritic pain  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Pneumonia aspiration  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Pneumonitis  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Productive cough  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Pulmonary embolism  1  2/189 (1.06%)  2 7/380 (1.84%)  7
Respiratory failure  1  4/189 (2.12%)  7 3/380 (0.79%)  4
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Rash  1  0/189 (0.00%)  0 3/380 (0.79%)  3
Rash generalised  1  0/189 (0.00%)  0 2/380 (0.53%)  2
Skin ulcer  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Social circumstances     
Social problem  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Vascular disorders     
Deep vein thrombosis  1  2/189 (1.06%)  2 0/380 (0.00%)  0
Embolism  1  0/189 (0.00%)  0 1/380 (0.26%)  2
Hypotension  1  1/189 (0.53%)  1 3/380 (0.79%)  3
Inferior vena cava stenosis  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Inferior vena cava syndrome  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Jugular vein thrombosis  1  0/189 (0.00%)  0 1/380 (0.26%)  1
Superior vena cava syndrome  1  1/189 (0.53%)  1 1/380 (0.26%)  1
Vena cava thrombosis  1  1/189 (0.53%)  1 0/380 (0.00%)  0
Venous stenosis  1  1/189 (0.53%)  1 0/380 (0.00%)  0
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PLACEBO TREMELIMUMAB
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   159/189 (84.13%)      338/380 (88.95%)    
Blood and lymphatic system disorders     
Anaemia  1  23/189 (12.17%)  37 54/380 (14.21%)  76
Gastrointestinal disorders     
Abdominal distension  1  13/189 (6.88%)  14 16/380 (4.21%)  18
Abdominal pain  1  22/189 (11.64%)  31 44/380 (11.58%)  54
Constipation  1  53/189 (28.04%)  62 65/380 (17.11%)  82
Diarrhoea  1  35/189 (18.52%)  49 168/380 (44.21%)  368
Nausea  1  38/189 (20.11%)  50 103/380 (27.11%)  126
Vomiting  1  16/189 (8.47%)  17 71/380 (18.68%)  91
General disorders     
Asthenia  1  24/189 (12.70%)  28 52/380 (13.68%)  75
Fatigue  1  60/189 (31.75%)  72 91/380 (23.95%)  119
Non-cardiac chest pain  1  10/189 (5.29%)  13 17/380 (4.47%)  21
Oedema peripheral  1  16/189 (8.47%)  16 39/380 (10.26%)  45
Pyrexia  1  16/189 (8.47%)  18 53/380 (13.95%)  81
Infections and infestations     
Urinary tract infection  1  4/189 (2.12%)  5 21/380 (5.53%)  24
Investigations     
Weight decreased  1  17/189 (8.99%)  18 47/380 (12.37%)  54
Metabolism and nutrition disorders     
Decreased appetite  1  45/189 (23.81%)  52 110/380 (28.95%)  139
Dehydration  1  2/189 (1.06%)  2 21/380 (5.53%)  21
Hypokalaemia  1  5/189 (2.65%)  8 25/380 (6.58%)  33
Musculoskeletal and connective tissue disorders     
Back pain  1  18/189 (9.52%)  18 21/380 (5.53%)  24
Musculoskeletal chest pain  1  33/189 (17.46%)  41 47/380 (12.37%)  64
Nervous system disorders     
Headache  1  6/189 (3.17%)  8 20/380 (5.26%)  23
Psychiatric disorders     
Anxiety  1  13/189 (6.88%)  13 20/380 (5.26%)  20
Insomnia  1  13/189 (6.88%)  13 29/380 (7.63%)  30
Respiratory, thoracic and mediastinal disorders     
Cough  1  29/189 (15.34%)  34 66/380 (17.37%)  83
Dyspnoea  1  60/189 (31.75%)  79 103/380 (27.11%)  127
Dyspnoea exertional  1  10/189 (5.29%)  15 17/380 (4.47%)  18
Skin and subcutaneous tissue disorders     
Night sweats  1  10/189 (5.29%)  10 13/380 (3.42%)  13
Pruritus  1  15/189 (7.94%)  19 103/380 (27.11%)  157
Rash  1  14/189 (7.41%)  16 76/380 (20.00%)  113
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Baseline characteristics and efficacy outcomes are from the primary analysis reported in the main CSR based on a DCO of 24th January 2016. Participant flow and AE results are from the CSR Addendum based on a DBL of 23 January 2017.
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.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the communication of results, it being understood that results shall be published regardless of outcome
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul Stockman, MD, PhD
Organization: AstraZeneca
Phone: +44 162-523-1815
EMail: Paul.Stockman@astrazeneca.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01843374     History of Changes
Other Study ID Numbers: D4880C00003
First Submitted: April 22, 2013
First Posted: April 30, 2013
Results First Submitted: April 10, 2017
Results First Posted: August 17, 2017
Last Update Posted: October 15, 2019