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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
| 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 |
| Accrual Closure Date: | 14 August 2018 |
| Last Patient Last Visit: | - |
Trial Organisation |
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| 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
