Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529718
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomised Phase II Trial to Evaluate the Efficacy of Ivonescimab a PD 1VEGF Bispecific Antibody Versus FOLFOX as Second Line Therapy for Locally AdvancedMetastatic Biliary Cancers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
SEVILLA
Brief Summary:
The object of this trial is to test whether ivonescimab is superior to standard chemotherapy FOLFOX regimen for the treatment of patients with advanced biliary tract cancer after failure of a first line of chemotherapy It is only open to patients who participated in the SAFIR-ABC10 trial NCT05615818 but did not receive experimental treatment
Eligible patients will be randomised 21 to receive either ivonescimab or FOLFOX Treatment will be continued until disease progression or a maximum of 34 cycles of ivonescimab experimental arm whichever occurs first
Eligible patients will be randomised 21 to receive either ivonescimab or FOLFOX Treatment will be continued until disease progression or a maximum of 34 cycles of ivonescimab experimental arm whichever occurs first
Detailed Description:
This is a Phase 2 multicentre randomised two-arm open-label trial to evaluate whether ivonescimab is superior to standard second-line chemotherapy in the treatment of patients with advanced biliary tract cancer
The trial will be open to patients who participated in the screening phase of the SAFIR-ABC10 protocol NCT05615818 and who experienced disease progression on or following the first-line standard of care CISGEM regimen
A total of 72 patients will be enrolled and randomly assigned 21 to receive treatment with either
Experimental arm Ivonescimab 20 mgkg by intravenous infusion IV once every 3 weeks Q3W
Control arm Standard second-line chemotherapy - FOLFOX regimen Response to treatment will be assessed according to RECIST v11 by radiographic exams performed every 42 7 days Patients will continue treatment until disease progression or for a maximum of 34 cycles of ivonescimab experimental arm whichever occurs first
The trial will be open to patients who participated in the screening phase of the SAFIR-ABC10 protocol NCT05615818 and who experienced disease progression on or following the first-line standard of care CISGEM regimen
A total of 72 patients will be enrolled and randomly assigned 21 to receive treatment with either
Experimental arm Ivonescimab 20 mgkg by intravenous infusion IV once every 3 weeks Q3W
Control arm Standard second-line chemotherapy - FOLFOX regimen Response to treatment will be assessed according to RECIST v11 by radiographic exams performed every 42 7 days Patients will continue treatment until disease progression or for a maximum of 34 cycles of ivonescimab experimental arm whichever occurs first
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