A Phase 2, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma
This is a Phase 2, randomized, double-blind, parallel-group study. Subjects with
unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio
to receive either tremelimumab or placebo.
Randomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy
(second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the
EORTC to stratify subjects into high or low risk groups in order to ensure balanced
randomization to the different treatment groups. For subjects in whom pemetrexed was
contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma),
prior therapy with a first-line platinum-based regimen is required. Approximately 180
subjects will be enrolled at study centers in multiple countries.
The study consists of a screening period, a treatment period, and a 90-day follow-up period.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall survival (OS) time by treatment arm
The primary analysis of OS will be performed after a number of deaths have occurred among the approximately 180 participants randomized. For participants who are alive at the time of the primary analysis or lost to follow-up, OS will be censored on the last date when participants are known to be alive.
Time from randomization until death due to any cause, assessed up to 3 years.
United States: Food and Drug Administration
|Research Site||Anaheim, California|
|Research Site||Boca Raton, Florida|
|Research Site||Arlington Heights, Illinois|
|Research Site||Battle Kreek, Michigan|
|Research Site||Albany, New York|
|Research Site||Akron, Ohio|
|Research Site||Abilene, Texas|