2026-04-13T02:23:28Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/111872025-03-05T04:46:16Zcom_2072_378070com_2072_378040col_2072_378092

00925njm 22002777a 4500 dc Haakensen, Vilde Drageset author Öjlert, Åsa Kristina author Farooqi, Saima Jamil author Nowak, Anna author Chin, Wee L. author cedres, susana author Thunold, Solfrid author 2024-03-14T09:47:23Z 2024-03-14T09:47:23Z 2024-03-01 Immunotherapy; Pleural mesothelioma; Telomerase vaccine Immunoteràpia; Mesotelioma pleural; Vacuna de telomerasa Inmunoterapia; Mesotelioma pleural; Vacuna de telomerasa Purpose The NIPU-trial investigates the effect of adding the telomerase vaccine UV1 to treatment with ipilimumab and nivolumab for patients with pleural mesothelioma (PM). Methods In this phase 2 open-label trial, patients with PM progressing after first-line chemotherapy were randomised to receive ipilimumab and nivolumab alone (arm B) or combined with UV1 (arm A). The primary endpoint was progression-free survival (PFS) as determined by BICR. It was estimated that 69 PFS events were needed to detect a hazard ratio (HR) of 0.60 with 80% power and a one-sided alpha level of 0.10. Results 118 patients were randomised. The median PFS determined by blinded independent central review (BICR) was 4.2 months (95%CI 2.9–9.8) in arm A and 4.7 months (95%CI 3.9–7.0) in arm B (HR 1.01, 80%CI 0.75–1.36 P = 0.979), after a median follow-up of 12.5 months (95%CI 9.7–15.6). The investigator-determined median PFS was 4.3 months (95%CI 3.0–6.8) in arm A and 2.9 months (95%CI 2.4–5.5) in arm B (HR 0.60, 80%CI 0.45–0.81 P = 0.025). Confirmed objective response rate (ORR) by BICR was 31% in arm A and 16% in arm B (odds ratio 2.44 80%CI 1.35–4.49 P = 0.056). After a median follow-up time of 17.3 months (95%CI 15.8–22.9), the OS was 15.4 months (95%CI 11.1–22.6) in arm A and 11.1 months (95%CI 8.8–18.1) in arm B, (HR 0.73, 80%CI 0.53–1.0, P = 0.197). Conclusion The primary endpoint was not met. Predefined analyses of response rates are in favour of adding the vaccine. The trial was researcher-initiated and funded by grants from the South-Eastern Norway Regional Health Authorities (grant number 2020077 and 2021083). Study medication was provided by Ultimovacs and Bristol Myers Squibb. Ultimovacs also provided funding for study procedures. Pleura - Càncer - Tractament Quimioteràpia combinada Mesotelioma - Tractament DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Adenoma::Mesothelioma DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Pleural Neoplasms ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::adenoma::mesotelioma ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pleurales TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada UV1 telomerase vaccine with ipilimumab and nivolumab as second line treatment for pleural mesothelioma – A phase II randomised trial