We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01843374
First Posted: April 30, 2013
Last Update Posted: August 17, 2017
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.
Information provided by (Responsible Party):
MedImmune LLC
Results First Submitted: April 10, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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.


Reporting Groups
  Description
PLACEBO Placebo.
TREMELIMUMAB TREMELIMUMAB 10 mg/kg

Participant Flow:   Overall Study
    PLACEBO   TREMELIMUMAB
STARTED   189   382 
RANDOMIZED   189   382 
COMPLETED   25   61 
NOT COMPLETED   164   321 
Death                150                302 
Withdrawal by Subject                14                19 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TREMELIMUMAB TREMELIMUMAB 10 mg/kg
PLACEBO Placebo.
Total Total of all reporting groups

Baseline Measures
   TREMELIMUMAB   PLACEBO   Total 
Overall Participants Analyzed 
[Units: Participants]
 382   189   571 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.2  (9.24)   66.3  (8.8)   65.6  (9.10) 
Age, Customized 
[Units: Participants]
     
< 65 years   162   75   237 
>= 65 years   220   114   334 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      99  25.9%      38  20.1%      137  24.0% 
Male      283  74.1%      151  79.9%      434  76.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: 3 years. ]

2.  Secondary:   OS Rate at 18 Months by Treatment Arm   [ Time Frame: 18 months ]

3.  Secondary:   Progression-free Survival by Treatment Arm   [ Time Frame: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years. ]

4.  Secondary:   Overall Response Rate by Treatment Arm   [ Time Frame: Time from randomization to best response to treatment, assessed up to 3 years. ]

5.  Secondary:   Duration of Response by Treatment Arm   [ 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. ]

6.  Secondary:   Disease Control Rate by Treatment Arm   [ Time Frame: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years. ]

7.  Secondary:   Durable Disease Control Rate by Treatment Arm   [ Time Frame: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years. ]

8.  Secondary:   Number of Participants Reporting Any Adverse Event   [ Time Frame: Day 1- 90 days post dose ]

9.  Secondary:   Number of Participants Reporting Any Serious Adverse Events   [ Time Frame: Day 1 to 90 days post dose ]

10.  Secondary:   Number of Participants With Positive Anti-drug Antibodies   [ Time Frame: Week 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Paul Stockman, MD, PhD
Organization: AstraZeneca
phone: +44 162-523-1815
e-mail: Paul.Stockman@astrazeneca.com



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: August 17, 2017