Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624399
Status:
RECRUITING
Last Update Posted:
2022-08-12
First Post:
2020-11-05
Brief Title:
Neoadjuvant Immune Checkpoint Inhibitor Treatment in Urothelial Cancer
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
Phase 2 Study of Neoadjuvant Immune Checkpoint Inhibitors in Urothelial Cancer
Status:
RECRUITING
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABACUS-2
Brief Summary:
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 412 and 24 weeks after surgery and their disease progresssurvival will be followed over the next 2 years The clinical team will compare the patients tumour tissue samplesscan 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
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 412 and 24 weeks after surgery and their disease progresssurvival will be followed over the next 2 years The clinical team will compare the patients tumour tissue samplesscan 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None