Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-28 @ 4:58 AM
Study NCT ID:
NCT02644369
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2015-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effects of Pembrolizumab in Patients With Advanced Solid Tumors
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Investigator-initiated Phase II Study of Pembrolizumab Immunological Response Evaluation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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:
INSPIRE
Brief Summary:
This is a phase 2 study whose main purpose is to evaluate gene changes and immune biomarkers in patients with solid tumors during treatment with pembrolizumab and in relation to response to treatment.
Pembrolizumab is a monoclonal antibody that is designed to block a protein called programmed cell death 1 ligand 1 (PD-L1) which will allow the body's immune system to kill the cancer cells.
Pembrolizumab is a monoclonal antibody that is designed to block a protein called programmed cell death 1 ligand 1 (PD-L1) which will allow the body's immune system to kill the cancer cells.
Detailed Description:
This study will involve treatment with pembrolizumab, tests and procedures done for safety, and the collection of archival tumor tissue, fresh tumor biopsies, and blood samples for biomarker research (including genetic testing).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: