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

Who is this study for? Patients with locally advanced or metastatic penile cancer unfit for platinum-based chemotherapy or progressed on or after platinum-based chemotherapy
What treatments are being studied? Avelumab
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed squamous cell carcinoma of the penis

• Measurable disease per Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)

• Unresectable/metastatic disease that is unfit for platinum-based chemotherapy OR disease that has progressed on or after treatment with platinum-based chemotherapy

• ≥18 years of age

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Locations
Other Locations
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Srikala Sridhar, M.D.
srikala.sridhar@uhn.ca
416-946-4501
Time Frame
Start Date: 2018-08-15
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 24
Treatments
Experimental: Avelumab and Best Supportive Care
Avelumab will be given intravenously (by vein) at a dose of 10 mg/kg, once every 2 weeks~Best supportive care will be provided as required.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov