Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract

Summary

Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year recurrence-free and cancer specific survival probabilities of 69% and 73% respectively. The primary objective of this study is to assess the pathological complete response rate to combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin) before surgery in patients with high-risk, localized, non-metastatic urothelial carcinomas of the upper tract.

Timeline

Start

2021-09-29

Primary completion

2025-01-01

Completion

2026-10-01

Outcome

Missed primary endpoint

paper Although our negative study did not meet its primary end point in either cohort PMID 39951246 ↗

Publications

• Houede N, Chevallier T, Audenet F, Thibault C, Neuzillet Y, Abraham C, Masson-Lecomte A, Gauthier H, Gravis G, Pignot G, Tartas S, Ruffion A, Pouessel D, Roumiguie M, Laguerre B, Bensalah K, Xylinas E, Jaffrelot L, Droupy S, Luquiens G, Roupret M. Safety and Efficacy of Neoadjuvant Durvalumab Plus Gemcitabine/Cisplatin or Carboplatin in Patients With Operable High-Risk Upper Tract Urothelial Carcinoma: The iNDUCT-GETUG V08 Trial. J Clin Oncol. 2025 May;43(13):1578-1586. doi: 10.1200/JCO-25-00179. Epub 2025 Feb 14.
• Calleris G, Roupret M, Seisen T, Bendjeddou L, Chevallier T, Masson-Lecomte A, Thibault C, Neuzillet Y, Audenet F, Xylinas E, Houede N. Design and rationale of a single-arm phase II study of neoadjuvant Durvalumab and Gemcitabine associated with Cisplatin or Carboplatin for upper urinary tract urothelial cancer: the iNDUCT trial (NCT04617756). World J Urol. 2023 Dec;41(12):3413-3420. doi: 10.1007/s00345-023-04596-5. Epub 2023 Sep 12.

Drugs

Indications