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 was to investigate whether treatment with pembrolizumab improves progression-free survival (PFS) compared to standard chemotherapy (gemcitabine or vinorelbine).

Trial Scheme

Trial Information

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:
04 September 2017
First Patient In:
12 September 2017
Accrual Closure Date:
16 August 2018
Global Trial Completion Date:
29 November 2021

Trial Organisation

Trial Chairs:
Sanjay Popat and Alessandra Curioni-Fontecedro
ETOP IBCSG Partners Foundation
Coordinating Group:
ETOP IBCSG Partners Foundation
Participating Groups:
Swiss Group for Clinical Cancer Research (SAKK) and Spanish Lung Cancer Group (SLCG)
Participating Countries:
Spain, Switzerland, United Kingdom
EudraCT number: 2016-002062-31
ClinicalTrials.gov: NCT02991482


ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland