Avelumab for Penile Cancer

Overseen By Srikala Sridhar, M.D.

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Must not be taking: Immunotherapy, Steroids

Disqualifiers: CNS metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not explicitly stated

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Srikala Sridhar, M.D.

Principal Investigator

Princess Margaret Cancer Centre

Eligibility Criteria

This trial is for adults over 18 with advanced penile cancer that can't be treated with surgery or has worsened after platinum-based chemotherapy. Participants should have a performance status indicating they are fully active or at most, require some assistance.

Inclusion Criteria

My cancer cannot be removed by surgery and does not respond to or is unfit for platinum-based chemotherapy.

My cancer is a type of skin cancer called squamous cell carcinoma, located on the penis.

My cancer can be measured by specific immune-related criteria.

Exclusion Criteria

I have not had major surgery in the last 4 weeks or major radiation in the last 2 weeks.

I need steroids for my brain metastases symptoms.

I have an autoimmune disease that could worsen with immune-boosting treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive avelumab intravenously at a dose of 10 mg/kg once every 2 weeks along with best supportive care as required

Duration not explicitly stated

Bi-weekly visits for avelumab administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• Avelumab

Trial Overview The study tests Avelumab's effectiveness against penile cancer by observing tumor response rates. Avelumab is an antibody drug designed to block proteins (PD-L1 and PD-1) that may help tumors grow, potentially stopping or shrinking them.

Participant Groups

Group I: Avelumab and Best Supportive Care Experimental Treatment 2 Interventions

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 is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as Bavencio for:

• Merkel cell carcinoma
• Renal cell carcinoma
• Urothelial carcinoma

Approved in United States as Bavencio for:

• Merkel cell carcinoma
• Renal cell carcinoma
• Urothelial carcinoma

Approved in Japan as Bavencio for:

• Merkel cell carcinoma
• Renal cell carcinoma
• Urothelial carcinoma

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+