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Brief Title: Pembrolizumab in Patients With Locally Advanced or Metastatic Skin Cancer
Official Title: A Phase II Trial of Pembrolizumab (MK-3475) in Metastatic Cutaneous Squamous Cell Carcinoma
Study ID: NCT02964559
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
Name: Michael Lowe, MD, MA
Affiliation: Emory University
Role: PRINCIPAL_INVESTIGATOR