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

University Health Network, Toronto

Status and phase: Active, not recruiting; Phase 2

Conditions: Metastatic Cancer; Advanced Cancer; Penile Cancer

Treatments: Other: Best Supportive Care; Drug: Avelumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03391479

ALPACA

17-6013

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Avelumab and Best Supportive Care

Experimental group

Description:

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.

Treatment:

Drug: Avelumab

Other: Best Supportive Care