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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new treatment called avelumab for individuals with advanced penile cancer unresponsive to standard chemotherapy. Avelumab helps the immune system combat cancer by blocking proteins that aid tumor growth. Suitable candidates have penile cancer that cannot be surgically removed or has spread and does not respond to standard platinum-based chemotherapy. The trial aims to determine if avelumab can shrink or halt tumors in this specific group. Participants will receive avelumab through an IV every two weeks, along with regular supportive care. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have had prior immunotherapy or are on immunosuppressive therapy, you may not be eligible to participate.

Is there any evidence suggesting that avelumab is likely to be safe for humans?

Research has shown that avelumab is generally well-tolerated in patients with advanced penile cancer. In one study, 17% of patients responded to the treatment, with their tumors either shrinking or ceasing to grow. Another study found that many patients lived for more than a year after starting treatment.

Importantly, avelumab was well-tolerated, meaning that while some side effects might occur, they are usually manageable. Patients in the studies continued receiving treatment, indicating a positive safety profile. For those considering this treatment, doctors will closely monitor to manage any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for penile cancer?

Unlike the standard treatment options for penile cancer, which typically involve surgery, radiation, or chemotherapy, Avelumab offers a novel approach by harnessing the power of immunotherapy. Avelumab is a monoclonal antibody that works by targeting the PD-L1 protein on cancer cells, effectively helping the immune system recognize and attack these cells. Researchers are excited about Avelumab because it has the potential to provide a more targeted treatment with fewer side effects compared to traditional methods. This innovative approach could lead to improved outcomes for patients with penile cancer.

What evidence suggests that avelumab might be an effective treatment for penile cancer?

Research suggests that avelumab, the treatment under study in this trial, might help treat penile cancer by blocking proteins that promote tumor growth. These proteins, PD-L1 and PD-1, interact to encourage tumor growth. Avelumab may help shrink or stop tumors by disrupting this interaction. In studies, some patients have shown partial or complete responses to avelumab. However, other studies indicate that the drug does not significantly extend the time patients live without cancer worsening. While avelumab shows promise, its effectiveness can vary, and ongoing research aims to better understand its benefits. ^{1 2 4 6 7}

Who Is on the Research Team?

Srikala Sridhar, M.D.

Principal Investigator

Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. renalandurologynews.com renalandurologynews.com/news/penile-cancer-avelumab-meaningfully-prolong-survival-treatment-risk/

Avelumab Does Not Meaningfully Prolong Survival in ... The median progression-free survival (PFS) was 1.7 months (95% CI, 1.5-1.8) and median overall survival (OS) was 3.9 months (95% CI, 2.6-9.9).

2. urotoday.com urotoday.com/conference-highlights/esmo-2025/esmo-2025-testicular-and-penile-cancer/164007-esmo-2025-a-phase-2-study-of-avelumab-in-locally-advanced-or-metastatic-penile-cancer-patients-unfit-for-platinum-based-chemotherapy-or-progressed-on-or-after-platinum-based-chemotherapy-alpaca.html

ESMO 2025: A Phase 2 Study of Avelumab in Locally ... Platinum-based chemotherapy provides only modest benefit, with an objective response rate of about 30%, a median progression-free survival of around three ...

3. urologytimes.com urologytimes.com/view/srikala-sridhar-md-on-avelumab-for-locally-advanced-or-metastatic-penile-cancer

Srikala Sridhar, MD, on avelumab for locally advanced or ... At a median follow-up of 15 months, the median progression-free survival was 1.7 months (95% CI, 1.5 to 1.8), and the median overall survival ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.6_suppl.8

Activity and tolerability of maintenance avelumab (AVE) ... Median duration of chemotherapy was 3.7 mo [1.2; 11.7]. At AVE initiation, 5 pts (56%) had partial or complete response and 4 pts (44%) had ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11898862/

Immunotherapy in the Management of Penile Cancer—A ... Maintenance avelumab resulted in a 63.5% PFS rate at 3, 6, and 12 months, and 42.3% at 15 months. The OS rate at 12 and 15 months was 88.9%. The median duration ...

6. urologytimes.com urologytimes.com/view/avelumab-demonstrates-activity-in-refractory-penile-cancer

Avelumab demonstrates activity in refractory penile cancer Key Takeaways. Avelumab demonstrated a 17% objective response rate in advanced penile cancer patients unfit for platinum-based chemotherapy.

7. hmpgloballearningnetwork.com hmpgloballearningnetwork.com/site/onc/videos/avelumab-shows-durable-response-patients-advanced-penile-cancer

Avelumab Shows Durable Response in Advanced Penile ... Results demonstrated that avelumab was well tolerated and achieved durable responses in a subset of patients, despite modest overall response ...