Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876313
Status:
RECRUITING
Last Update Posted:
2022-04-06
First Post:
2021-04-28
Brief Title:
An Open Label Single-arm Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer NURE-Combo
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
An Open Label Single-arm Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Before Radical Cystectomy for Patients With Muscle-invasive Bladder Cancer
Status:
RECRUITING
Status Verified Date:
2022-03
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:
NURE-Combo
Brief Summary:
To assess whether nivolumabnab-paclitaxel combination results in patients with muscle-invasive bladder cancer
Detailed Description:
This is a Phase 2 single-center open-label non-randomized study in patients with muscle-invasive urothelial carcinoma of the bladder
The general framework of the study will be as follows
A transurethral resection of the bladder for biopsy histological characterization and local staging will be executed first With the aim to improve the sensitivity of CT scan in assessing pelvic lymph-nodes and better assess the local extent of bladder tumor computed tomography CT scan 18FDG-PETCT scan and multiparametric bladder MRI mpMRI will be done during screening and before cystectomy to stage and evaluate response
Eligible patients will receive neoadjuvant treatment 360 mg nivolumab IV on Day 1 plus 125 mgm2 nab-paclitaxel on Day 1 and 8 in a 21-day cycle
A total of 4 cycles are planned before surgery Surgery will be planned at the time of study inclusion to be done within 3 weeks of the last dose of study drug
Dose reductions will be applied depending on the severity of AEs and treatment interruption or discontinuation criteria will be fully described in the protocol
After surgery patients will receive 12-month adjuvant therapy with nivolumab 360 mg IV every 3 weeks
RECIST v11 criteria will be used to assess patient response to treatment by determining tumor size and PFS Screening assessments should be performed no more than 21 days prior to the start of study treatment Following the screening assessment subsequent assessments will be carried out after the administration of the study drugs prior to cystectomy If an unscheduled assessment is performed and the patient has not progressed the results should be reported at the next scheduled visit The method of tumor assessment used at baseline eg CT or MRI scans chest abdomen pelvis must be used at each sub-sequent follow-up assessment
Patients will be monitored carefully for the development of adverse events and will be monitored for clinical andor radiographic evidence of disease progression according to usual standards of clinical practice Adverse experiences will be evaluated according to criteria outlined in the NCI Common Terminology Criteria for Adverse Events CTCAE version 50
The general framework of the study will be as follows
A transurethral resection of the bladder for biopsy histological characterization and local staging will be executed first With the aim to improve the sensitivity of CT scan in assessing pelvic lymph-nodes and better assess the local extent of bladder tumor computed tomography CT scan 18FDG-PETCT scan and multiparametric bladder MRI mpMRI will be done during screening and before cystectomy to stage and evaluate response
Eligible patients will receive neoadjuvant treatment 360 mg nivolumab IV on Day 1 plus 125 mgm2 nab-paclitaxel on Day 1 and 8 in a 21-day cycle
A total of 4 cycles are planned before surgery Surgery will be planned at the time of study inclusion to be done within 3 weeks of the last dose of study drug
Dose reductions will be applied depending on the severity of AEs and treatment interruption or discontinuation criteria will be fully described in the protocol
After surgery patients will receive 12-month adjuvant therapy with nivolumab 360 mg IV every 3 weeks
RECIST v11 criteria will be used to assess patient response to treatment by determining tumor size and PFS Screening assessments should be performed no more than 21 days prior to the start of study treatment Following the screening assessment subsequent assessments will be carried out after the administration of the study drugs prior to cystectomy If an unscheduled assessment is performed and the patient has not progressed the results should be reported at the next scheduled visit The method of tumor assessment used at baseline eg CT or MRI scans chest abdomen pelvis must be used at each sub-sequent follow-up assessment
Patients will be monitored carefully for the development of adverse events and will be monitored for clinical andor radiographic evidence of disease progression according to usual standards of clinical practice Adverse experiences will be evaluated according to criteria outlined in the NCI Common Terminology Criteria for Adverse Events CTCAE version 50
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005050-20 | EUDRACT_NUMBER | None | None |