2026-04-17T14:11:51Zhttps://recercat.cat/oai/request

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

urn:hdl:11351/11187 UV1 telomerase vaccine with ipilimumab and nivolumab as second line treatment for pleural mesothelioma – A phase II randomised trial Haakensen, Vilde Drageset Öjlert, Åsa Kristina Farooqi, Saima Jamil Nowak, Anna Chin, Wee L. cedres, susana Thunold, Solfrid 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 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. 2024-03-14T09:47:23Z 2024-03-14T09:47:23Z 2024-03-01 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion European Journal of Cancer;202 https://doi.org/10.1016/j.ejca.2024.113973 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess Elsevier Scientia