Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04506554
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2020-07-30
Brief Title:
A Study of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase II Trial of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slot availability
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neoadjuvant accelerated methotrexatevinblastineadriamycincisplatin AMVAC in combination with nivolumab is under evaluation for the treatment of muscle invasive bladder cancer MIBC Patients with pre-specified tumor mutations and complete clinical response with neoadjuvant therapy will preserve their bladders and go on active surveillance
Detailed Description:
Muscle invasive bladder cancer MIBC constitutes 20-25 of all cases with 5 year survival estimated at 45 regardless of treatment1-4 Although neoadjuvant cisplatin-based chemotherapy NAC followed by a radical cystectomy or cystoprostatectomy with a lymph node dissection is the preferred treatment choice for MIBC in the United States there are several drawbacks and challenges with this approach Patients must be fit to undergo a surgical intervention Grade 2 through 5 complications have been documented in 53 of patients undergoing cystectomy at a tertiary care center and the surgical mortality rate is 155 6 Furthermore urinary diversion commonly requires an ileal conduit and an external appliance impacting patients quality of life
By incorporating neoadjuvant nivolumab with AMVAC our goal in RETAIN-2 is to increase the number of patients who would be eligible for bladder preservation while maintaining the long-term oncologic outcomes Nivolumab an anti-PD1 therapy is FDA approved for treatment of metastatic urothelial carcinoma post platinum-based chemotherapy20 Recently neoadjuvant pembrolizumab anti-PD1 and atezolizumab anti-PDL1 was tested in MIBC in the PURE-01 and ABACUS studies and a pT0 rate of 386 and 29 respectively was achieved21 22 Additionally recent work by Kim et al presented at AACR 2019 demonstrated that AMVAC induces gene signatures in luminal tumors and may have a synergistic response with immunotherapy Given the impressive activity of both AMVAC and nivolumab in the neoadjuvant setting in this study the investigators hypothesize that using the combination of neoadjuvant nivolumab and AMVAC will lead to higher cT0 rate and metastasis-free survival at 2 years At the same time by using the risk adapted strategy a select group of patients will be able to preserve their bladders and significantly improve their quality-of-life
By incorporating neoadjuvant nivolumab with AMVAC our goal in RETAIN-2 is to increase the number of patients who would be eligible for bladder preservation while maintaining the long-term oncologic outcomes Nivolumab an anti-PD1 therapy is FDA approved for treatment of metastatic urothelial carcinoma post platinum-based chemotherapy20 Recently neoadjuvant pembrolizumab anti-PD1 and atezolizumab anti-PDL1 was tested in MIBC in the PURE-01 and ABACUS studies and a pT0 rate of 386 and 29 respectively was achieved21 22 Additionally recent work by Kim et al presented at AACR 2019 demonstrated that AMVAC induces gene signatures in luminal tumors and may have a synergistic response with immunotherapy Given the impressive activity of both AMVAC and nivolumab in the neoadjuvant setting in this study the investigators hypothesize that using the combination of neoadjuvant nivolumab and AMVAC will lead to higher cT0 rate and metastasis-free survival at 2 years At the same time by using the risk adapted strategy a select group of patients will be able to preserve their bladders and significantly improve their quality-of-life
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 |
|---|---|---|---|
| 20-1047 | OTHER | Fox Chase Cancer Center IRB | None |