Overview
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
Inclusion Criteria:
- 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 Criteria:
- 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