Condition
Unresectable Pleural or Peritoneal Malignant Mesothelioma
Estimated Enrollment: 658
Age Group: 18 Years to 99 Years (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Participant, Care Provider, Investigator, Outcomes Assessor|Primary Purpose: Treatment
Study ID Numbers: D4880C00003
Study First Received: April 22, 2013
Last Updated: January 24, 2017
Estimated Primary Completion Date: January 2016
Primary Outcome Measures:
Overall survival (OS) time by treatment arm|Durable disease control rate by treatment arm|Length of progression-free survival by treatment arm|Overall response rate by treatment arm|Duration of response by treatment arm|Number of participants reporting any adverse event|Number of participants with changes in patient-reported outcomes|Number of participants reporting any serious adverse events|Number of participants with anti-drug antibodies|Tremelimumab blood concentration|OS rate at 18 months
Sponsors and Collaborators:
MedImmune LLC
Website Link: https://ClinicalTrials.gov/show/NCT01843374