NCT02837042

Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma

Phase II Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma Following Previous Chemotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Penile Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab will be administered intravenously every 3 weeks.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2016-07-19
• Last updated: 2022-06-21
• Results posted: 2022-06-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study