NCT02153151

Measuring Biomarker Response to AMP-514 in Blood Samples From Patients With Solid Tumors Undergoing Radiotherapy

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
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	Cytology specimen	Correlative studies
OTHER	Laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-11-11
• Primary completion: 2016-02-23
• Completion: 2016-07-14
• First posted: 2014-06-02
• Last updated: 2025-05-02

Locations

1 site across 1 country: United States