2026-04-17T00:52:43Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/111872025-03-05T04:46:16Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Haakensen, Vilde Drageset
author
Öjlert, Åsa Kristina
author
Farooqi, Saima Jamil
author
Nowak, Anna
author
Chin, Wee L.
author
cedres, susana
author
Thunold, Solfrid
2024-03-14T09:47:23Z2024-03-14T09:47:23Z2024-03-01
Immunotherapy; Pleural mesothelioma; Telomerase vaccineImmunoteràpia; Mesotelioma pleural; Vacuna de telomerasaInmunoterapia; Mesotelioma pleural; Vacuna de telomerasaPurpose
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.
Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
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
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion