Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-27 @ 11:27 AM
Study NCT ID:
NCT05574504
Status:
WITHDRAWN
Last Update Posted:
2024-08-01
First Post:
2022-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy
Sponsor:
AdventHealth
Organization:
Study Overview
Official Title:
Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy for Metastatic Urothelial Carcinoma With Stable or Responding Disease Following Platinum-based Chemotherapy
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Decision based on no enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A nonrandomized phase II trial is proposed combining avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin as switch maintenance therapy for mUC following stable or responding disease on 4-6 cycles of first line platinum-based chemotherapy
Detailed Description:
The purpose of this research is to study benefit of the combination of lurbinectedin chemotherapy with maintenance avelumab immunotherapy in patients with advanced cancer of the urinary tract who have completed platinum-based chemotherapy. Avelumab alone is the usual approach and is already approved by the US FDA for the treatments of patients with this type of cancer. Lurbinectedin is approved for a type of lung cancer, but is not approved for urinary tract cancer.
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?: