Advanced Cancer, Metastatic Cancer, Penile Cancer
Conditions
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.
Interventions
DRUGAvelumab
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).
OTHERBest Supportive Care
As required.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORSrikala Sridhar, M.D.
Princess Margaret Cancer Centre
Outcome results
None listed