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

Study identifier:D4880C00003

ClinicalTrials.gov identifier:NCT01843374

EudraCT identifier:2012-003524-21

CTIS identifier:2024-511841-20-00

Recruitment Complete

Official Title

A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma

Medical condition

Unresectable Pleural or Peritoneal Malignant Mesothelioma

Phase

Phase 2

Healthy volunteers

No

Study drug

Tremelimumab, Placebo

Sex

All

Actual Enrollment

571

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 17 May 2013
Primary Completion Date: 24 Jan 2016
Estimated Study Completion Date: 24 Apr 2025

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria