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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Dec 29, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called avelumab for men with advanced penile cancer who cannot receive standard chemotherapy or whose cancer has not improved after that treatment. The goal is to find out if avelumab can help shrink or stabilize the tumors. Avelumab works by blocking certain signals that cancer cells use to grow, potentially helping the body's immune system fight the cancer more effectively.

To participate in this trial, men must be at least 18 years old and have a confirmed diagnosis of squamous cell carcinoma of the penis that is either unable to be surgically removed or has spread to other parts of the body. They should not have received certain prior treatments like immunotherapy or have major health issues, such as active autoimmune diseases. Participants will receive the investigational drug and be monitored for how well it works and any side effects. This trial is currently recruiting participants, and it's a chance to try a new treatment that might be beneficial for those with limited options.

Gender

MALE

Eligibility criteria

• 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