Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871594
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2021-04-29
Brief Title:
Pre-operative Immunotherapy in Stage II-III Urothelial Cancer
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
A Phase 1b Trial in Stage II-III Urothelial Cancer to Explore Pre-operative Immunotherapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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:
TURANDOT
Brief Summary:
This is a phase 1b feasibility study of pre-operative immunotherapy in PD-L1 positive resectable stage II-III urothelial cancer patients This study can be adapted or expanded based on the results obtained
Detailed Description:
This is a phase 1b feasibility study of pre-operative immunotherapy in PD-L1 positive resectable stage II-III urothelial cancer patients
Urothelial cancer patients will be included that are diagnosed with either
cT2-4aN0M0 OR
cT1-4aN1-3M0
PD-L1 status will be determined When PD-L1 CPS is 10 patients will be treated with three cycles nivolumab 240 mg q3wk on day 1 22 43
The primary endpoint is feasibility of pre-operative nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients
After surgery patients attend study visits at day 8 and at day 29 Their final study visit for physical examination and laboratory testing is at day 57 - 7 days which is scheduled to anticipate late-onset adverse events 90 days postoperative surgical complications according to the Clavien-dindo classification will be evaluated Thereafter patients will be followed according to standard clinical guidelines Tumor biopsiesmaterial preservation is required at baseline and during surgery
Main secondary endpoints are
To identify pathological complete response rates of nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients
To describe immune-related grade 34 and all grade toxicities
To describe RFS and OS
Translational Effects of immunotherapy on the tumor microenvironment based on RNA signatures and changes in immune infiltrates between baseline and resection
Urothelial cancer patients will be included that are diagnosed with either
cT2-4aN0M0 OR
cT1-4aN1-3M0
PD-L1 status will be determined When PD-L1 CPS is 10 patients will be treated with three cycles nivolumab 240 mg q3wk on day 1 22 43
The primary endpoint is feasibility of pre-operative nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients
After surgery patients attend study visits at day 8 and at day 29 Their final study visit for physical examination and laboratory testing is at day 57 - 7 days which is scheduled to anticipate late-onset adverse events 90 days postoperative surgical complications according to the Clavien-dindo classification will be evaluated Thereafter patients will be followed according to standard clinical guidelines Tumor biopsiesmaterial preservation is required at baseline and during surgery
Main secondary endpoints are
To identify pathological complete response rates of nivolumab in PD-L1 positive resectable stage II-III urothelial cancer patients
To describe immune-related grade 34 and all grade toxicities
To describe RFS and OS
Translational Effects of immunotherapy on the tumor microenvironment based on RNA signatures and changes in immune infiltrates between baseline and resection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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