Immunotherapy drug avelumab takes on rare penile cancer
NCT ID NCT03391479
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether avelumab, an immunotherapy drug, can shrink tumors in 25 people with advanced penile cancer who cannot take platinum chemotherapy or whose cancer worsened after it. Avelumab works by blocking a protein that helps tumors hide from the immune system. The main goal is to see how many patients respond to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- avelumab (an immunotherapy drug that helps the immune system attack cancer cells)
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced penile cancer who have few alternatives.
- What could go wrong
- This is a small, early-phase trial with only 25 participants, so results may not apply to everyone. The drug may not shrink tumors or could cause side effects like immune-related inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
25 people
The number who actually took part.
- Started
-
Aug 2018
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
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