Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers (AURA Trial)

Summary

Open-label, interventional, multi-centre, randomized phase II study. Cancer studied is non-metastatic muscle invasive bladder cancer (MIBC). Avelumab administered every 2 weeks is used as neoadjuvant therapy in subjects with urothelial muscle invasive bladder cancers in combination with standard chemotherapy or alone.

Timeline

Start

2018-06-01

Primary completion

2021-12-07

Completion

2025-01-30

Publications

• Blanc J, Carnot A, Barthelemy P, Casert V, Sautois B, Van den Brande J, Vanhaudenarde V, Staudacher L, Seront E, Debien V, Ameye L, Kotecki N, Rothe F, Rorive S, Fantoni JC, Tricard T, Roumeguere T, Awada A, Martinez Chanza N. Avelumab-based neoadjuvant therapy in patients with muscle-invasive bladder cancer (AURA Oncodistinct-004): a phase 2 multicenter clinical trial. J Immunother Cancer. 2025 May 24;13(5):e012045. doi: 10.1136/jitc-2025-012045.
• Martinez Chanza N, Soukane L, Barthelemy P, Carnot A, Gil T, Casert V, Vanhaudenarde V, Sautois B, Staudacher L, Van den Brande J, Culine S, Seront E, Gizzi M, Albisinni S, Tricard T, Fantoni JC, Paesmans M, Caparica R, Roumeguere T, Awada A. 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). BMC Cancer. 2021 Dec 2;21(1):1292. doi: 10.1186/s12885-021-08990-3.

Drugs

Indications