Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab)
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| ClinicalTrials.gov Identifier: NCT01843374 |
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Recruitment Status :
Active, not recruiting
First Posted : April 30, 2013
Results First Posted : August 17, 2017
Last Update Posted : January 19, 2024
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Sponsor:
MedImmune LLC
Information provided by (Responsible Party):
MedImmune LLC
- Study Details
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| 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 |
Participant Flow
| 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 |
|---|---|---|
 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 |
Baseline Characteristics
| Arm/Group Title | TREMELIMUMAB | PLACEBO | Total | |
|---|---|---|---|---|
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Arm/Group Description |
TREMELIMUMAB 10 mg/kg | Placebo. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 382 | 189 | 571 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 382 participants | 189 participants | 571 participants | |
| 65.2 (9.24) | 66.3 (8.8) | 65.6 (9.10) | ||
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 382 participants | 189 participants | 571 participants | |
| < 65 years |
162 42.4%
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75 39.7%
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237 41.5%
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| >= 65 years |
220 57.6%
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114 60.3%
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334 58.5%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 382 participants | 189 participants | 571 participants | |
| Female |
99 25.9%
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38 20.1%
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137 24.0%
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| Male |
283 74.1%
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151 79.9%
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434 76.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
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
| Name/Title: | Paul Stockman, MD, PhD |
| Organization: | AstraZeneca |
| Phone: | +44 162-523-1815 |
| EMail: | Paul.Stockman@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT01843374 |
| Other Study ID Numbers: |
D4880C00003 2012-003524-21 ( EudraCT Number ) |
| 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: | January 19, 2024 |