Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-02-28 @ 11:15 AM
Study NCT ID:
NCT02153151
Status:
COMPLETED
Last Update Posted:
2025-05-02
First Post:
2014-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Biomarker Response to AMP-514 in Blood Samples From Patients With Solid Tumors Undergoing Radiotherapy
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Study Overview
Official Title:
A Pilot Study to Evaluate the In-vitro Effect of AMP-514, a PD-1 Inhibitor, on Peripheral Blood T Cell Proliferation and Cytokine Production From Patients With Solid Malignancies Treated With Radiotherapy (RT)
Status:
COMPLETED
Status Verified Date:
2025-05
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:
This pilot research trial studies the response in blood cells to AMP-514, a drug shown to increase immune response (capacity to fight against infections and cancer) against cancer in patients with solid tumors undergoing radiotherapy. Measuring changes in biomarkers may help doctors decide if AMP-514 should be combined with radiotherapy and when is the best time to combine the drug with radiation.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the in-vitro effect of AMP-514, a programmed cell death 1 (PD-1) inhibitor, on peripheral blood T cell proliferation and cytokine production from patients with solid malignancies, treated with radiotherapy (RT).
OUTLINE:
Patients undergo blood sample collection at baseline, during the second week of RT, at the end of RT, and at 1 month after the end of RT.
I. To evaluate the in-vitro effect of AMP-514, a programmed cell death 1 (PD-1) inhibitor, on peripheral blood T cell proliferation and cytokine production from patients with solid malignancies, treated with radiotherapy (RT).
OUTLINE:
Patients undergo blood sample collection at baseline, during the second week of RT, at the end of RT, and at 1 month after the end of RT.
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?: