CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 144 enrolled
Drug / intervention
Pembrolizumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02991482
NCT02991482Phase 3Completed

A Multicentre Randomised Phase III Trial Comparing Pembrolizumab Versus Standard Chemotherapy for Advanced Pre-treated Malignant Pleural Mesothelioma

ETOP IBCSG Partners Foundation·interventional·Posted Dec 13, 2016·Updated Aug 24, 2022

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Gemcitabine, and 1 other intervention for Pleural Mesothelioma Malignant Advanced. Completed, enrolled 144 participants across 15 sites in 3 countries.

Detailed Summary

Trial comparing standard treatment (chemotherapy) with pembrolizumab treatment in patients with advanced pretreated malignant mesothelioma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain, Switzerland, United Kingdom

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 13, 2016
Enrollment StartSep 12, 2017
Primary CompletionFeb 20, 2019
Study CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.6 years ago

Interventions

Pembrolizumabdrug

Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.

Gemcitabinedrug

Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").

Vinorelbinedrug

Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.