Status:
ACTIVE_NOT_RECRUITING
A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy
Lead Sponsor:
University Health Network, Toronto
Conditions:
Penile Cancer
Advanced Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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-bas...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Major surgery ≤4 weeks or major radiation therapy ≤2 weeks prior to enrollment
- Known symptomatic central nervous system (CNS) metastases requiring steroids
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy
Key Trial Info
Start Date :
August 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03391479
Start Date
August 15 2018
End Date
December 31 2026
Last Update
December 18 2025
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9