Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263153
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-02-08
Brief Title:
Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy
Sponsor:
Yuanquan Yang
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Trial of Futibatinib in Combination With Durvalumab MEDI4736 Administered to Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer Before Cystectomy
Status:
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:
None
Brief Summary:
This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer MIBC who are ineligible for cisplatin-based therapy Cisplatin-based therapy is the standard of care for patients with MIBC However many patients cannot receive standard therapy due to poor renal function peripheral neuropathy poor functional status or clinically significant heart failure Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy
Detailed Description:
PRIMARY OBJECTIVE
I Determine the pathologic complete response rate of neoadjuvant combination futibatinib and durvalumab in patients with MIBC and fibroblast growth factor receptor FGFR overexpression
SECONDARY OBJECTIVES
I Determine the safety of this neoadjuvant regimen II Assess the pathologic downstaging rate III Evaluate overall survival OS and progression free survival PFS IV Evaluate delay in cystectomy
EXPLORATORY OBJECTIVES
I Evaluate potential predictive biomarkers II Assess changes in the tumor microenvironment in pre- and post-treatment tumor samples in participants
OUTLINE
Patients receive futibatinib orally PO once daily QD on days 1-28 and durvalumab intravenously IV over 60 minutes on day 1 of each cycle Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity Patients then undergo radical cystectomy within 4-12 weeks Patients also undergo computed tomography CT and magnetic resonance imaging MRI during screening and on the trial and also undergo blood sample collection on the trial
After completion of study treatment patients are followed up at 30 days and then every 3 months for 2 years
I Determine the pathologic complete response rate of neoadjuvant combination futibatinib and durvalumab in patients with MIBC and fibroblast growth factor receptor FGFR overexpression
SECONDARY OBJECTIVES
I Determine the safety of this neoadjuvant regimen II Assess the pathologic downstaging rate III Evaluate overall survival OS and progression free survival PFS IV Evaluate delay in cystectomy
EXPLORATORY OBJECTIVES
I Evaluate potential predictive biomarkers II Assess changes in the tumor microenvironment in pre- and post-treatment tumor samples in participants
OUTLINE
Patients receive futibatinib orally PO once daily QD on days 1-28 and durvalumab intravenously IV over 60 minutes on day 1 of each cycle Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity Patients then undergo radical cystectomy within 4-12 weeks Patients also undergo computed tomography CT and magnetic resonance imaging MRI during screening and on the trial and also undergo blood sample collection on the trial
After completion of study treatment patients are followed up at 30 days and then every 3 months for 2 years
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-00002 | REGISTRY | CTRP Clinical Trial Reporting Program | None |