Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511648
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor FGFR Gene Alterations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open-label Multi-centre Multi-national Interventional Trial to Evaluate the Efficacy and Safety of Erdafitinib ERDA Monotherapy and Erdafitinib ERDA and Cetrelimab CET Combination as Neoadjuvant Treatment in Cisplatin-ineligible Patients With Muscle-invasive Bladder Cancer MIBC Whose Tumours Express Fibroblast Growth Factor Receptor FGFR Gene Alterations
Status:
RECRUITING
Status Verified Date:
2024-05
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:
SOGUG-NEOWIN
Brief Summary:
Erdafitinib ERDA alone or in combination with cetrelimab CET as neoadjuvant treatment prior to surgery in subjects with muscle-invasive bladder cancer MIBC whose tumours express Fibroblast Growth Factor Receptor FGFR gene alterations and are ineligible for or refuse cisplatin based neoadjuvant chemotherapy
Detailed Description:
The aim of the study is to assess the antitumor activity measured as ypT0 rate defined as no evidence of residual disease based on pathological review of the surgical specimen pCR and tumour downstaging ypT2 Patients must have a MIBC cT2-T4a N0N1 M0 who harbour selected FGFR alterations stated in the protocol and are either ineligible for or refuse cisplatin-based neoadjuvant chemotherapy as defined by consensus criteria see 61 Inclusion criteria
Once it is confirmed that the subjects fulfil the eligibility criteria and have signed the informed consent form they will receive erdafitinib alone cohort 1 or erdafitinib in combination with cetrelimab cohort 2
Patients will receive neoadjuvant treatment with erdafitinib alone cohort 1 or erdafitinib plus cetrelimab cohort 2 before proceeding to Radical Cystectomy RC to be performed within 2 - 6 weeks after the last study drug treatment
Cohort 1 patients will receive erdafitinib Cohort 2 patients will receive erdafitinib in combination with cetrelimab intravenously IV
Radiological assessment A Computed Tomography Magnetic Resonance Imaging andor Positron Emission Tomography per standard local imaging practices will be scheduled as follow
Basal assessment during screening period no more than 28 days before Cycle1 Day 1C1D1
Response assessment At the end of treatment period allowing time for imaging review in advance of Radical cystectomy RC
Follow-up assessment an image evaluation must be done at first follow-up visit and thereafter it will be schedule according to local standards and as clinically indicated
A local pathological assessment will be done on specimens obtained during RC for co-primary endpoints Thereafter during the follow-up period pathological assessments will be scheduled according to local standards and as clinically indicated
Patients with disease progression during the treatment phase will be discontinued from the study and will receive their treatment according to the investigators judgment and monitored to evaluate Overal Survival
Once it is confirmed that the subjects fulfil the eligibility criteria and have signed the informed consent form they will receive erdafitinib alone cohort 1 or erdafitinib in combination with cetrelimab cohort 2
Patients will receive neoadjuvant treatment with erdafitinib alone cohort 1 or erdafitinib plus cetrelimab cohort 2 before proceeding to Radical Cystectomy RC to be performed within 2 - 6 weeks after the last study drug treatment
Cohort 1 patients will receive erdafitinib Cohort 2 patients will receive erdafitinib in combination with cetrelimab intravenously IV
Radiological assessment A Computed Tomography Magnetic Resonance Imaging andor Positron Emission Tomography per standard local imaging practices will be scheduled as follow
Basal assessment during screening period no more than 28 days before Cycle1 Day 1C1D1
Response assessment At the end of treatment period allowing time for imaging review in advance of Radical cystectomy RC
Follow-up assessment an image evaluation must be done at first follow-up visit and thereafter it will be schedule according to local standards and as clinically indicated
A local pathological assessment will be done on specimens obtained during RC for co-primary endpoints Thereafter during the follow-up period pathological assessments will be scheduled according to local standards and as clinically indicated
Patients with disease progression during the treatment phase will be discontinued from the study and will receive their treatment according to the investigators judgment and monitored to evaluate Overal Survival
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