Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394570
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-27
Brief Title:
Enfortumab Vedotin and Stereotactic Radiation for Localized Cisplatin Ineligible Muscle Invasive Bladder Cancer
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Stereotactic Treatment with NeoAdjuvant Radiotherapy and Enfortumab Vedotin a Phase III Study with Safety Lead-In for Localized Cisplatin Ineligible Muscle Invasive Bladder Cancer STAR-EV
Status:
RECRUITING
Status Verified Date:
2024-09
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:
STAR-EV
Brief Summary:
STAR-EV will evaluate the combination of enfortumab vedotin plus radiotherapy RT as neoadjuvant treatment for muscle invasive bladder cancer prior to radical cystectomy surgery The study will use dose escalation to evaluate the safety and efficacy of study treatment at three dose regimens
Level 0 EV treatment followed by RT to the bladder Level 1 EV treatment with RT starting on Cycle 2 Day 15 Level 2 EV treatment with RT starting on Cycle 1 Day 15
Following completion of EVRT neoadjuvant therapy all subjects will undergo surgery as part of routine care
Level 0 EV treatment followed by RT to the bladder Level 1 EV treatment with RT starting on Cycle 2 Day 15 Level 2 EV treatment with RT starting on Cycle 1 Day 15
Following completion of EVRT neoadjuvant therapy all subjects will undergo surgery as part of routine care
Detailed Description:
STAR EV is a phase III trial with safety lead in designed to assess safety and preliminary efficacy signal in improving pathologic complete response by adding stereotactic radiation to neoadjuvant enfortumab vedotin Participants will be adult patients with urothelial predominant bladder cancer ineligible for neoadjuvant cisplatin-based therapy based on provider assessment and planned for radical cystectomy
All participants will undergo the same treatment
Enfortumab vedotin PADCEV 125mgkg max 125mg IV Day 1 8 q21 day cycle x 3 cycles
Radiation Stereotactic radiotherapy to bladder partial bladder volume preferred 5 fractions either sequential to EV treatment or concurrent with EV treatment
Surgery Standard of care radical cystectomy and pelvic lymph node dissection with urinary diversion per surgeon discretion
The study will use a patient safety lead-in incorporating escalation of EV-RT from sequential to concurrent use with pre-defined stopping rules according to treatment-related adverse event TRAE rate of grade 3 or above Primary endpoints are related to safety maximum tolerated dose regimen based on dose limiting toxicities DLTs observed and pathologic complete response rate at the time of surgery Subjects will be followed for one year following cystectomy or completion of neoadjuvant therapy for any subject who does not undergo cystectomy for any reason
All participants will undergo the same treatment
Enfortumab vedotin PADCEV 125mgkg max 125mg IV Day 1 8 q21 day cycle x 3 cycles
Radiation Stereotactic radiotherapy to bladder partial bladder volume preferred 5 fractions either sequential to EV treatment or concurrent with EV treatment
Surgery Standard of care radical cystectomy and pelvic lymph node dissection with urinary diversion per surgeon discretion
The study will use a patient safety lead-in incorporating escalation of EV-RT from sequential to concurrent use with pre-defined stopping rules according to treatment-related adverse event TRAE rate of grade 3 or above Primary endpoints are related to safety maximum tolerated dose regimen based on dose limiting toxicities DLTs observed and pathologic complete response rate at the time of surgery Subjects will be followed for one year following cystectomy or completion of neoadjuvant therapy for any subject who does not undergo cystectomy for any reason
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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