NCT02744209

Immune Predictors of Response to Pembrolizumab Therapy in Stage IV Melanoma Patients

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test whether immune functions in individual cancer patients can be characterized in a quantitative manner using new technologies that analyze nucleic acids from peripheral blood cells and whether those quantitations can be used to predict the response outcomes of patients being treated with Pembrolizumab.

Detailed description

The investigators will collect 50 milliliter blood samples from each patient before and after the first cycle of Pembrolizumab therapy. White blood cells will be separated according to cluster of differentiation (CD) markers into CD4+, CD8+, CD14+ populations using magnetic beads. A portion of each cellular fraction will be stimulated in the lab with a lineage-specific agonist cocktail. Ribonucleic acid (RNA) will be purified from both unstimulated and stimulated cell populations from both pre- and post-therapy timepoints for each patient. Lineage-specific transcriptomes will be quantitated and used to derive gene expression profiles for comparisons to clinical phenotypes.

Conditions

• Stage IV Melanoma

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-04-20
• Last updated: 2019-11-07

Locations

1 site across 1 country: United States