New Indication: Neoadjuvant Durvalumab with CISplatin/Gemcitabine for Upper GU Tract Cancer

  • Study

    Phase 2, multicenter, open-label, nonrandomized trial (iNDUCT-GETUG V08)
    High-risk, operable upper tract urothelial carcinoma (UTUC), M0, eligible for radical nephroureterectomy
    Durvalumab + gemcitabine/cisplatin (cohort 1) or durvalumab + gemcitabine/carboplatin (cohort 2) every 3 wks × 4 cycles

  • Efficacy

    pCR (ypT0): 13% vs. 5% (cisplatin vs. carboplatin). Did not meet study endpoint
    Downstaging to low-risk residual tumors: frequent, especially in cohort 1
    No increase in surgical risk

  • Safety

    Grade ≥3 AEs: neutropenia (4 pts grade 3, 1 pt grade 4), thrombopenia (1 pt grade 3, 1 pt grade 4), anemia (4 pts grade 3)
    No grade 3–4 immune-related AEs
    Other TRAEs: heart failure (3 pts), renal failure (2 pts), erysipelas, acute dyspnea
    No grade 5 AEs


    • J Clin Oncol 2025;43:1578-86

    Houédé N,Chevallier T,Audenet F 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

    http://doi.org/10.1200/JCO-25-00179

    Reviewed by Ulas D. Bayraktar, MD on May 5, 2025

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