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A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)

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Trial Profile

A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2024

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At a glance

  • Drugs Durvalumab (Primary) ; Enfortumab vedotin (Primary) ; Tremelimumab (Primary)
  • Indications Bladder cancer; Urogenital cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms VOLGA
  • Sponsors AstraZeneca; AstraZeneca AB

    • Most Recent Events

    • 05 Jan 2023 The study has been restarted in Italy, According to European Clinical Trials Database record.
    • 19 Feb 2022 Post radical cystectomy (Arm 1) 1 cycle of T on Day 1 plus 9 cycles of D Q4W; (Arm 2) 9 cycles of D Q4W, or (Arm 3), either no adjuvant treatment (observation only) or adjuvant nivolumab in high-risk patients where available and approved (planned amendment) as per the study design presented at the 2022 Genitourinary Cancers Symposium
    • 19 Feb 2022 Study design presented at the 2022 Genitourinary Cancers Symposium
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