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).
Best Supportive Care: As required.
Study 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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Objective Response Rate — 4 weeks To demonstrate the anti-tumor activity of avelumab by objective response rate (ORR) according to Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) in patients with locally advanced or metastatic penile carcinoma unfit for platinum-based chemotherapy or progressed on or after platinum-based chemotherapy.
Trial sites (1)
Facility
City
Region
Status
Princess Margaret Cancer Centre
Toronto
Ontario
More University Health Network, Toronto trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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