A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy
- Conditions
- Penile CancerAdvanced CancerMetastatic Cancer
- Interventions
- Other: Best Supportive Care
- Registration Number
- NCT03391479
- Lead Sponsor
- University Health Network, Toronto
- 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-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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Avelumab and Best Supportive Care Avelumab 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. Avelumab and Best Supportive Care 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Progression-free Survival Rate 3 years Assess the progression free survival (PFS) of avelumab in patients determined to have PD-L1-positive tumors (including infiltrating immune cells) by the GMP verified Dako PD-L1 IHC 22C3 pharmDx test with thresholds of \<1%, 1-49%, and ≥ 50% to define PD-L1 positivity, and in all enrolled patients
Overall Survival Rate 3 years Assess the overall survival (OS) of avelumab in patients determined to have PD-L1-positive tumors (including infiltrating immune cells) by the GMP verified Dako PD-L1 IHC 22C3 pharmDx test with thresholds of \<1%, 1-49%, and ≥ 50% to define PD-L1 positivity, and in all enrolled patients
Trial Locations
- Locations (1)
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada