BMC Cancer (Dec 2021)

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)

  • 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

DOI
https://doi.org/10.1186/s12885-021-08990-3
Journal volume & issue
Vol. 21, no. 1
pp. 1 – 8

Abstract

Read online

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).

Keywords