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

Conditions

• Unresectable Pleural or Peritoneal Malignant Mesothelioma

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Tremelimumab — DRUG
  Tremelimumab is to be administered as an IV solution, followed by observation.
• Placebo — DRUG
  Placebo is to be administered as an IV solution, followed by observation.

Study Details

This is a Phase 2b, 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. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.

Key Dates

Start date

May 17, 2013

Status verified

Feb 2026

Primary completion

Jan 24, 2016

Completion

Jun 30, 2026

Study Design

Enrollment

571 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tremelimumab
  Tremelimumab
• Placebo Comparator: Placebo
  Placebo

Primary Outcome Measure

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

Locations (21)

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