Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571708
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
GemcitabineCisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer NeoSTOP-IT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Open-label Study of GemcitabineCisplatin Plus Cemiplimab REGN2810 Anti-PD-1 With or Without Fianlimab REGN3767 Anti-LAG-3 for Organ Preservation in Patients With Localized Muscle-invasive Bladder Cancer NeoSTOP-IT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeoSTOP-IT
Brief Summary:
The goal of this clinical trial is to learn if gemcitabinecisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults The main question it aims to answer is Can gemcitabine cisplatin and cemiplimab with or without fianlimab treat bladder cancer
Participants will be randomly selected like the loss of a coin to treatment with gemcitabine cisplatin cemiplimab and fianlimab or gemcitabine cisplatin and cemiplimab
Participants will
Undergo transurethral resection of bladder tumor TURBT followed by the start of treatment receive 4 cycles of treatment 21 day cycles
After 4 cycles of treatment patients will undergo repeat maximal TURBT with imaging
Participants with a complete response will continue maintenance cemiplimab or cemiplimabfianlimab for 13 more cycles with imaging every 3 months
Participants without a complete clinical response will undergo cystectomy bladder surgery
Participants will be randomly selected like the loss of a coin to treatment with gemcitabine cisplatin cemiplimab and fianlimab or gemcitabine cisplatin and cemiplimab
Participants will
Undergo transurethral resection of bladder tumor TURBT followed by the start of treatment receive 4 cycles of treatment 21 day cycles
After 4 cycles of treatment patients will undergo repeat maximal TURBT with imaging
Participants with a complete response will continue maintenance cemiplimab or cemiplimabfianlimab for 13 more cycles with imaging every 3 months
Participants without a complete clinical response will undergo cystectomy bladder surgery
Detailed Description:
This is a phase 2 open-label randomized trial with continuous toxicity monitoring to ensure safety using Bayesian toxicity monitoring which will evaluate treatment with doublet platinum-based chemotherapy gemcitabine and cisplatin plus cemiplimab REGN2810 with or without fianlimab REGN3767 for localized muscle-invasive bladder cancer MIBC Participants will be randomized to 4 cycles of 3 weeks each 12 weeks total with gemcitabine cisplatin and cemiplimab with or without fianlimab Participants achieving a clinical complete response will continue 13 more cycles of immunotherapy 39 weeks total The total duration of systemic treatment including neoadjuvant therapy will be 52 weeks
In addition to the actual time on treatment there will be time off treatment for recovery after neoadjuvant treatment and before adjuvant treatment First between the neoadjuvant phase and cystoscopy with TURBT for residual disease there will be up to 4 weeks off treatment In between the cystoscopyTURBT and start of adjuvant immunotherapy there will be an additional up to 4 week interval for recovery Participants will have regularly scheduled study visits at the clinical site on Day 1 and Day 8 of every three-week cycle in the neoadjuvant setting where continuous assessment including treatment response and safety assessments will be performed These will include laboratory tests taking of vital signs and physical examinations In the adjuvant setting for participants who continue to maintenance immunotherapy participants will have regularly scheduled study visits at the clinical site on Day 1 of every three-week cycle
Response to treatment will be determined by three modalities First CT scans chest abdomen and pelvis with and without contrast to ensure no metastatic disease For participants who are unable to get a CT scan w contrast due to renal function or any other reason an MRI with and without contrast may be used instead Scans are required at baseline and every 3 months in the adjuvant setting for participants who continue on with maintenance immunotherapy Second all participants will undergo post-treatment cystoscopy every 3 months while on treatment Third all participants will undergo post-treatment urine cytology every 3 months while on treatment
In addition to the actual time on treatment there will be time off treatment for recovery after neoadjuvant treatment and before adjuvant treatment First between the neoadjuvant phase and cystoscopy with TURBT for residual disease there will be up to 4 weeks off treatment In between the cystoscopyTURBT and start of adjuvant immunotherapy there will be an additional up to 4 week interval for recovery Participants will have regularly scheduled study visits at the clinical site on Day 1 and Day 8 of every three-week cycle in the neoadjuvant setting where continuous assessment including treatment response and safety assessments will be performed These will include laboratory tests taking of vital signs and physical examinations In the adjuvant setting for participants who continue to maintenance immunotherapy participants will have regularly scheduled study visits at the clinical site on Day 1 of every three-week cycle
Response to treatment will be determined by three modalities First CT scans chest abdomen and pelvis with and without contrast to ensure no metastatic disease For participants who are unable to get a CT scan w contrast due to renal function or any other reason an MRI with and without contrast may be used instead Scans are required at baseline and every 3 months in the adjuvant setting for participants who continue on with maintenance immunotherapy Second all participants will undergo post-treatment cystoscopy every 3 months while on treatment Third all participants will undergo post-treatment urine cytology every 3 months while on treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None