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Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)

Advanced Melanoma Clinical Trial

Official title:
An Open-Label, Phase II Study to Determine the Immunologic Correlates of Pembrolizumab-Mediated Tumor Regression in Subjects With Advanced Melanoma (KEYNOTE-161)

Clinical Trial Summary

In this study, participants with advanced melanoma will be treated with pembrolizumab (MK-3475) and their tumors and blood will be analyzed for changes related to pembrolizumab therapy.

The primary hypotheses are that participants who respond to pembrolizumab have:

1. a higher fraction of cytotoxic tumor-infiltrating T-lymphocytes (FCT) at baseline compared to those who do not respond to pembrolizumab

2. a higher fold-increase in FCT compared to baseline than those who do not respond to pembrolizumab

3. a higher Average Specific Cytotoxic T-lymphocyte Frequency Ratio (ASCTFR) compared to those who do not respond to pembrolizumab

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03407170
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Terminated
Phase Phase 2
Start date June 28, 2018
Completion date August 14, 2019
View Details
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