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Brief Title: Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma
Official Title: Phase II Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma Following Previous Chemotherapy
Study ID: NCT02837042
Brief Summary: Penile squamous cell carcinoma (PSCC) is relatively rare but exhibits higher incidences in less developed countries. PSCC is a highly aggressive malignancy characterized by early spread. Pembrolizumab has recently been FDA-approved for the treatment of melanoma but will serve as the investigational agent for this penile cancer study.
Detailed Description: This is a multicenter trial to evaluate Pembrolizumab for patients with advanced penile squamous cell carcinoma following prior chemotherapy. Participating institutions are the University of Alabama at Birmingham (coordinating center), M.D. Anderson Cancer Center, University of Michigan, University of Minnesota, and Emory University. Patients will receive intravenous Pembrolizumab every 3 weeks and undergo a clinical exam. Radiographic scans will be done at baseline and every 9 weeks. Therapy will continue until disease progression or there are intolerable toxicities.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Southern California, Los Angeles, California, United States
Winship Cancer Institute at Emory University, Atlanta, Georgia, United States
Name: Lisle Nabell, MD
Affiliation: University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR