Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT04749602
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2021-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
Sponsor:
Kidney Cancer Research Bureau
Organization:
Study Overview
Official Title:
A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
Status:
COMPLETED
Status Verified Date:
2023-03
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:
None
Brief Summary:
Patients with advanced cancers who have pleural effusion, especially those requiring pleural evacuation, experienced poorer survival when treated with immunotherapy. The pleura also acts as a natural barrier that can limit the penetration of immune checkpoint inhibitors. In this multicenter phase 2 study, the preliminary efficacy and toxicity of intrapleural instillation of the nivolumab in patients with immune-sensitive metastatic cancers will be accessed.
Detailed Description:
Patients ≥18 years old who have large volume of pleural effusion, required evacuation, and received systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor) for metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) will be eligible. Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.
Study Oversight
Has Oversight DMC:
False
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?: