NCT02964559

Pembrolizumab in Patients With Locally Advanced or Metastatic Skin Cancer

A Phase II Trial of Pembrolizumab (MK-3475) in Metastatic Cutaneous Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well pembrolizumab works in treating patients with skin cancer that has spread from where it started to nearby tissue, lymph nodes, or other parts of the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVE: -To establish the response rate of pembrolizumab in metastatic cutaneous squamous cell carcinoma. SECONDARY OBJECTIVES: -To determine the 6-month progression-free survival and 1 year overall survival of metastatic cutaneous squamous cell carcinoma of the skin (cSCC) treated with pembrolizumab. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 8-12 weeks.

Conditions

• Recurrent Skin Carcinoma
• Skin Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2017-01-27
• Primary completion: 2021-05-18
• Completion: 2021-05-18
• First posted: 2016-11-16
• Last updated: 2024-06-26
• Results posted: 2024-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study