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Intravesical Recombinant BCG (Bacillus Calmette Guerin) Followed by Perioperative Chemo-immunotherapy for Patients With Muscle-invasive Bladder Cancer (MIBC). A Multicenter, Single-arm Phase II Trial

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Trial Profile

Intravesical Recombinant BCG (Bacillus Calmette Guerin) Followed by Perioperative Chemo-immunotherapy for Patients With Muscle-invasive Bladder Cancer (MIBC). A Multicenter, Single-arm Phase II Trial

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Mar 2024

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At a glance

  • Drugs Atezolizumab (Primary) ; BCG vaccine (Primary) ; Cisplatin (Primary) ; Gemcitabine (Primary)
  • Indications Bladder cancer
  • Focus Therapeutic Use
  • Most Recent Events

    • 11 Mar 2024 Planned number of patients changed from 5 to 46.
    • 27 Jan 2024 According to the trial design presented at the 2024 Genitourinary Cancers Symposium, an interim safety analysis will be performed after the first 12 pts have completed neoadjuvant treatment, and an interim efficacy analysis will be performed after the first 21 pts have undergone surgery. Accrual to the study is currently ongoing.
    • 27 Jan 2024 Trial design presented at the 2024 Genitourinary Cancers Symposium.

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