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Penile Cancer
+2

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

Sponsored by University Health Network, Toronto

About this trial

Last updated 8 months ago

Study ID

ALPACA

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
Male
Male

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 months ago

What is this trial 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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting