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Neoadjuvant Immune Checkpoint Inhibitor Treatment in Urothelial Cancer

Study acronym: ABACUS-2
StatusCompleted
PhasePhase 2
Started
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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Final enrollment: 32 participants (planned 58)
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Site details revised
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Notable Primary completion date: Jul 1, 2023 to May 30, 2026
    • Study completion date: Dec 1, 2024 to May 30, 2026
    • Start date: Jul 13, 2021 to Jun 17, 2021
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Jul 1, 2022 to Jul 1, 2023
    • Start date changed from estimate of Dec 1, 2020 to Jul 13, 2021
    • Study sites: 6 to 1
    • Study description shortened, about 621 words
    • Study title shortened, about 3 words
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is being carried out to see if the drug atezolizumab can reduce the size of tumours in patients with types of urothelial cancer before surgery. Atezolizumab is designed to stop a protein called PD-L1 (programmed death-ligand 1) being expressed on the cancer, allowing the immune system to recognise the tumour cells as foreign bodies and attack them. Atezolizumab has been shown to have activity in urothelial cancer which has spread. There two cohorts for this trial. One cohort will investigate the most common histological type of urothelial cancer (transitional cell carcinoma) outside the bladder, for example in the upper urinary tract. The other cohort will investigate rarer histological subtypes (such as such as squamous cell or adenocarcinoma) of urothelial cancer throughout the entire urinary system. This study will be recruiting patients from hospitals in the UK, France and Spain. If a patient is eligible for the study and decides to take part, they will receive up to two 3-weekly cycles of atezolizumab. 4-8 weeks after being enrolled, the patient will have an operation to remove the bladder (cystectomy) or the kidney, ureter and part of the bladder (nephroureterectomy or distal ureteral resection) as per normal practice. Following surgery, they will attend three hospital visits (4,12 and 24 weeks after surgery) and their disease progress/survival will be followed over the next 2 years. The clinical team will compare the patient's tumour tissue samples,scan results and blood results from before and after treatment with atezolizumab in order to see how well the drug works and if it is safe. Many of the procedures involved in this study are offered as standard care and participation in this trial will not delay surgery.
Trial Details
NCT Number NCT04624399
Lead Sponsor Queen Mary University of London
Collaborators: Hoffmann-La Roche
Conditions
(from sponsor)
Urogenital Cancer
Related terms Urogenital Neoplasms
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov