作者
A Helland, VD Haakensen, AK Ojlert, SMH Thunold, AK Nowak, WL Chin, O Grundberg, SJ Farooqi, M Lund-Iversen, WM Szejniuk, SM Cedres Perez, JB Sørensen, MM Bjaanaes
发表日期
2023/10/1
期刊
Annals of Oncology
卷号
34
页码范围
S1337
出版商
Elsevier
简介
Background
Immune checkpoint inhibitors have improved survival for patients with malignant pleural mesothelioma (MPM), but prognosis is still poor. The UV1 telomerase peptide vaccine has demonstrated robust immune response induction and promising clinical activity in several malignancies.
Methods
Patients with MPM progressing after first-line platinum-based chemotherapy were randomized 1: 1 to ipilimumab and nivolumab alone (Arm B) or in combination with telomerase vaccine UV1 (Arm A). The primary endpoint was progression-free survival (PFS) evaluated by blinded, independent central review (BICR) at the time of 69 events. The study was powered to detect an HR of 0.60 in favour of arm A with a 1-sided alpha of 0.1.
Results
A total of 118 patients were included and randomized, well balanced with respect to age, gender, performance status, histology and PD-L1 status. The primary endpoint was …
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