Conditions: Penile Squamous Cell Carcinoma
Keywords: penile cancer Pembrolizumab penile squamous cell carcinoma squamous cell cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

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.

Arms:
arm 1: Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks.

Interventions: intervention 1: Pembrolizumab
Intervention descriptions: intervention 1: Pembrolizumab will be administered intravenously every 3 weeks.

Protocol document:
Prot_SAP_000.pdf: