NCT03407170

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	pembrolizumab	200 mg by IV infusion Q3W for up to 24 months

Timeline

• Start date: 2018-06-28
• Primary completion: 2019-08-14
• Completion: 2019-08-14
• First posted: 2018-01-23
• Last updated: 2020-07-15
• Results posted: 2020-07-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study