Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial)

Abstract Introduction Cisplatin-based neoadjuvant chemotherapy (NAC) followed by surgery is the standard treatment for patients with non-metastatic muscle invasive bladder cancer (MIBC). Unfortunately, many patients are not candidates to receive cisplatin due to renal impairment. Additionally, no pr...

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Autores principales:	Nieves Martinez Chanza, Louisa Soukane, Philippe Barthelemy, Aurélien Carnot, Thierry Gil, Vinciane Casert, Vincent Vanhaudenarde, Brieuc Sautois, Lionel Staudacher, Jan Van den Brande, Stephane Culine, Emmanuel Seront, Marco Gizzi, Simone Albisinni, Thibault Tricard, Jean Christophe Fantoni, Marianne Paesmans, Rafael Caparica, Thierry Roumeguere, Ahmad Awada
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Avelumab Bladder cancer Checkpoint inhibitor Immunotherapy Neoadjuvant PD-1 blockade Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/ed1c1c1bbabd472db077410bfa15798e
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spelling	oai:doaj.org-article:ed1c1c1bbabd472db077410bfa15798e2021-12-05T12:19:32ZAvelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial)10.1186/s12885-021-08990-31471-2407https://doaj.org/article/ed1c1c1bbabd472db077410bfa15798e2021-12-01T00:00:00Zhttps://doi.org/10.1186/s12885-021-08990-3https://doaj.org/toc/1471-2407Abstract Introduction Cisplatin-based neoadjuvant chemotherapy (NAC) followed by surgery is the standard treatment for patients with non-metastatic muscle invasive bladder cancer (MIBC). Unfortunately, many patients are not candidates to receive cisplatin due to renal impairment. Additionally, no predictive biomarkers for pathological complete response (pCR) are currently validated in clinical practice. Studies evaluating immune checkpoint inhibitors in the peri-operative setting are emerging with promising results. Clinical trials are clearly required in the neoadjuvant setting in order to improve therapeutic strategies. Methods and analysis Oncodistinct 004 – AURA is an ongoing multicenter phase II randomized trial assessing the efficacy and safety of avelumab single-agent or combined to different NAC regimens in patients with non-metastatic MIBC. Patients are enrolled in two distinct cohorts according to their eligibility to receive cisplatin-based NAC. In the cisplatin eligible cohort, patients are randomized in a 1:1 fashion to receive avelumab combined with cisplatin-gemcitabine or with dose-dense methotrexate-vinblastine-doxorubicin-cisplatin. In the cisplatin ineligible cohort, patients are randomized at a 1:1 ratio to paclitaxel-gemcitabine associated to avelumab or avelumab alone. Primary endpoint is pCR. Secondary endpoints are pathological response and safety. Ethics and dissemination The study is approved by ethics committee from all participating centers. All participants provide informed consent prior inclusion to the study. Once completed, results will be published in peer-reviewed journals. Trial registration number ClinicalTrials.gov (NCT03674424).Nieves Martinez ChanzaLouisa SoukanePhilippe BarthelemyAurélien CarnotThierry GilVinciane CasertVincent VanhaudenardeBrieuc SautoisLionel StaudacherJan Van den BrandeStephane CulineEmmanuel SerontMarco GizziSimone AlbisinniThibault TricardJean Christophe FantoniMarianne PaesmansRafael CaparicaThierry RoumeguereAhmad AwadaBMCarticleAvelumabBladder cancerCheckpoint inhibitorImmunotherapyNeoadjuvantPD-1 blockadeNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENBMC Cancer, Vol 21, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Avelumab Bladder cancer Checkpoint inhibitor Immunotherapy Neoadjuvant PD-1 blockade Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Avelumab Bladder cancer Checkpoint inhibitor Immunotherapy Neoadjuvant PD-1 blockade Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Nieves Martinez Chanza Louisa Soukane Philippe Barthelemy Aurélien Carnot Thierry Gil Vinciane Casert Vincent Vanhaudenarde Brieuc Sautois Lionel Staudacher Jan Van den Brande Stephane Culine Emmanuel Seront Marco Gizzi Simone Albisinni Thibault Tricard Jean Christophe Fantoni Marianne Paesmans Rafael Caparica Thierry Roumeguere Ahmad Awada Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial)
description	Abstract Introduction Cisplatin-based neoadjuvant chemotherapy (NAC) followed by surgery is the standard treatment for patients with non-metastatic muscle invasive bladder cancer (MIBC). Unfortunately, many patients are not candidates to receive cisplatin due to renal impairment. Additionally, no predictive biomarkers for pathological complete response (pCR) are currently validated in clinical practice. Studies evaluating immune checkpoint inhibitors in the peri-operative setting are emerging with promising results. Clinical trials are clearly required in the neoadjuvant setting in order to improve therapeutic strategies. Methods and analysis Oncodistinct 004 – AURA is an ongoing multicenter phase II randomized trial assessing the efficacy and safety of avelumab single-agent or combined to different NAC regimens in patients with non-metastatic MIBC. Patients are enrolled in two distinct cohorts according to their eligibility to receive cisplatin-based NAC. In the cisplatin eligible cohort, patients are randomized in a 1:1 fashion to receive avelumab combined with cisplatin-gemcitabine or with dose-dense methotrexate-vinblastine-doxorubicin-cisplatin. In the cisplatin ineligible cohort, patients are randomized at a 1:1 ratio to paclitaxel-gemcitabine associated to avelumab or avelumab alone. Primary endpoint is pCR. Secondary endpoints are pathological response and safety. Ethics and dissemination The study is approved by ethics committee from all participating centers. All participants provide informed consent prior inclusion to the study. Once completed, results will be published in peer-reviewed journals. Trial registration number ClinicalTrials.gov (NCT03674424).
format	article
author	Nieves Martinez Chanza Louisa Soukane Philippe Barthelemy Aurélien Carnot Thierry Gil Vinciane Casert Vincent Vanhaudenarde Brieuc Sautois Lionel Staudacher Jan Van den Brande Stephane Culine Emmanuel Seront Marco Gizzi Simone Albisinni Thibault Tricard Jean Christophe Fantoni Marianne Paesmans Rafael Caparica Thierry Roumeguere Ahmad Awada
author_facet	Nieves Martinez Chanza Louisa Soukane Philippe Barthelemy Aurélien Carnot Thierry Gil Vinciane Casert Vincent Vanhaudenarde Brieuc Sautois Lionel Staudacher Jan Van den Brande Stephane Culine Emmanuel Seront Marco Gizzi Simone Albisinni Thibault Tricard Jean Christophe Fantoni Marianne Paesmans Rafael Caparica Thierry Roumeguere Ahmad Awada
author_sort	Nieves Martinez Chanza
title	Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial)
title_short	Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial)
title_full	Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial)
title_fullStr	Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial)
title_full_unstemmed	Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial)
title_sort	avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase ii study (oncodistinct 004 - aura trial)
publisher	BMC
publishDate	2021
url	https://doaj.org/article/ed1c1c1bbabd472db077410bfa15798e
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Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial)

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