NCT03391479

A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy

A Phase 2, Multi-centre, Open-label Study of Avelumab (MSB0010718C) in Locally Advanced or Metastatic Penile Cancer Patients Unfit for Platinum-based Chemotherapy or Progressed On or After Platinum-based Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study whose purpose is see how useful investigational drug, avelumab, is in patients with locally advanced or metastatic penile cancer who are unfit for or progressed on platinum-based chemotherapy. The usefulness of avelumab in this study population will be determined by anti-tumor activity assessed by objective response rate. Avelumab is a monoclonal antibody that binds to a protein called programmed death-ligand 1 (PD-L1) and blocks its communication with another protein called programmed death protein 1 (PD-1). The communication of these proteins are thought to be important in the growth of tumors. Blocking these proteins from communicating may stop or shrink tumors.

Conditions

• Penile Cancer
• Advanced Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Avelumab	Avelumab is a fully human monoclonal antibody (mAb) of the immunoglobulin (Ig) G1 isotype. Avelumab selectively binds to programmed death-ligand 1 (PD-L1) and competitively blocks its interaction with programmed death protein 1 (PD-1).
OTHER	Best Supportive Care	As required.

Timeline

• Start date: 2018-08-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2018-01-05
• Last updated: 2025-12-18

Locations

1 site across 1 country: Canada