A multicentre randomised phase III trial comparing pembrolizumab versus standard chemotherapy for advanced pre-treated malignant pleural mesothelioma

PROMISE-meso: PembROlizuMab Immunotherapy versus Standard chemotherapy for advanced prE-treated malignant pleural mesothelioma

Systemic chemotherapy is currently the international standard care of treatment for patients with advanced pleural mesothelioma, where surgery is not possible. However, the median survival for these patients is only 9-12 month and there is unmet need for an effective therapy for patients with relapsed pleural mesothelioma.

Pembrolizumab is a potent and highly selective antibody, designed to directly block the interaction between PD-1 and its ligands.

The aim of the PROMISE-meso trial is to investigate whether treatment with pembrolizumab improves progression-free survival (PFS) compared to standard chemotherapy (gemcitabine or vinorelbine).

Trial Scheme

Trial design webpage

 

 

Primary Endpoint: Progression-free survival based on independent review
Secondary Endpoints:

Objective response

Overall survival

Time to treatment failure

Investigator assessed progression-free survival

Tolerability of treatment

Target Sample Size: 142 Patients 
Final Accrual: 144 Patients
   
Protocol Release Date: 15 November 2016
Trial Activation Date: 02 May 2017
First Patient In: 12 September 2017
Accrual Closure Date: 14 August 2018
Global Trial End Date: -

Trial Organisation

Trial Chairs: Sanjay Popat and Alessandra Curioni-Fontecedro
Sponsor: ETOP
Coordinating Group: ETOP
Participating Groups: SAKK and SLCG
Participating Countries:
Spain, Switzerland and United Kingdom
Registrations:

EudraCT number: 2016-002062-31

ClinicalTrials.gov: NCT02991482

 

Contact

Virginia Rodriguez Martinez (Trial Manager)

Tel: +41 31 511 94 48

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European Thoracic Oncology Platform
c/o IBCSG
Effingerstrasse 40
3008 Bern, Switzerland
Tel: +41 31 511 94 00