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Study on Avelumab for Patients with Advanced or Metastatic Squamous Cell Penile Cancer After Initial Chemotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as squamous cell penile carcinoma, which affects the skin cells of the penis. The study is investigating the use of a treatment called avelumab, which is a type of immunotherapy. Immunotherapy is a treatment that helps the body's immune system fight cancer. Avelumab is given to patients through an infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how well avelumab works in maintaining the health of patients who have already received initial chemotherapy that includes a drug called cisplatin. Patients participating in the study will receive avelumab after their first round of chemotherapy if their cancer has not worsened. The study will monitor patients over a period to see how long they remain free from cancer progression and to assess their overall survival.

Throughout the study, researchers will also look at the safety of avelumab by observing any side effects that occur. Additionally, the study will evaluate the quality of life of patients using questionnaires. The trial aims to provide valuable information on the effectiveness and safety of avelumab as a maintenance treatment for this type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the clinical trial, eligibility is confirmed based on specific criteria. This includes being a male aged 18 or older with a confirmed diagnosis of locally advanced or metastatic squamous cell penile carcinoma. Previous treatment with a specific type of chemotherapy is required, and the disease must not have progressed after this treatment.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate overall health and ensure all eligibility criteria are met. This includes checking blood counts, liver and kidney function, and overall physical condition.

  3. Step 3

    Avelumab treatment

    The treatment involves receiving **avelumab**, a type of immunotherapy. This medication is administered through an **infusion**, which means it is given directly into the bloodstream through a vein.

    The infusion is typically scheduled every two weeks. The duration of the treatment depends on individual response and tolerance.

  4. Step 4

    Regular monitoring

    Regular monitoring is conducted to assess the response to the treatment and to check for any side effects. This includes physical examinations, blood tests, and imaging studies like CT or MRI scans.

    The frequency of these assessments is determined by the healthcare team and is crucial for ensuring the treatment is working effectively and safely.

  5. Step 5

    Quality of life assessments

    Quality of life is evaluated using specific questionnaires at the start of the trial, during each treatment cycle, and at the end of the study. These assessments help understand the impact of the treatment on daily life and overall well-being.

  6. Step 6

    End of treatment

    The treatment with **avelumab** continues until there is evidence of disease progression, unacceptable side effects, or a decision is made to stop the treatment for other reasons.

    At the end of the treatment, a final assessment is conducted to evaluate the overall outcome and any long-term effects.

Who can join the trial?

12 criteria

  • Men who are 18 years old and older.
  • Have a diagnosis of unresectable locally advanced or metastatic squamous cell penile carcinoma. This means the cancer cannot be removed by surgery and has spread locally or to other parts of the body.
  • Have completed 3 to 6 cycles of chemotherapy that includes a drug called a platinum salt, such as cisplatin or carboplatin, as their first treatment. If treated with cisplatin, they must have received a total dose of at least 210 mg/m². If treated with carboplatin, they must have received a dose equal to 3 cycles of carboplatin AUC5.
  • The cancer has not progressed after the chemotherapy, meaning it is either completely or partially responding to treatment or is stable. This will be checked by the doctor using scans like CT or MRI.
  • Have an estimated life expectancy of at least 3 months.
  • Have an ECOG performance status of 0 to 1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
  • Have adequate bone marrow function, which includes:
    • An absolute neutrophil count of at least 1500/mm³.
    • Platelet count of at least 100,000/mm³.
    • Hemoglobin level of at least 9 g/dL (transfusions are allowed).
    • Have adequate kidney function, with a creatinine clearance of at least 30 mL/min. This measures how well the kidneys are working.
    • Have adequate liver function, which includes:
      • Total serum bilirubin level of no more than 1.5 times the upper limit of normal, except for those with Gilbert's disease, where the limit is 2 times the upper limit.
      • AST and ALT levels no more than 2.5 times the upper limit of normal, or 5 times if there are liver metastases.

Who cannot join the trial?

4 criteria

  • Patients who have not completed their first line of chemotherapy treatment, which includes a drug called cisplatin, cannot participate.
  • Patients whose disease has progressed after the first line of chemotherapy treatment cannot participate.
  • Only male patients are eligible for this study, so female patients cannot participate.
  • Patients who are considered part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
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Investigated drugs

  • Avelumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, avelumab is used as a maintenance treatment, which means it is given after the initial chemotherapy to help keep the cancer from coming back or getting worse. The goal is to see if avelumab can help patients live longer without their disease progressing.

  • Cisplatin

    is a chemotherapy drug that is often used to treat various types of cancer. It works by damaging the DNA of cancer cells, which stops them from growing and dividing. In this trial, cisplatin is part of the first line of treatment, meaning it is one of the initial drugs given to try to shrink the cancer or slow its growth before using avelumab as a maintenance therapy.

What is already known about the treatment

Avelumab – Avelumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating squamous cell penile carcinoma, a type of cancer. The main therapeutic use of avelumab is to help the immune system recognize and attack cancer cells, potentially improving disease-free survival in patients whose cancer has not progressed after initial chemotherapy. At the molecular level, avelumab works by blocking a protein called PD-L1, which can help cancer cells hide from the immune system. It is classified as an immunotherapy drug.

Investigated diseases

Penile Squamous Cell Carcinoma – Penile squamous cell carcinoma is a type of cancer that originates in the flat cells lining the penis. It typically begins as a small lesion or sore on the skin of the penis, which may grow larger over time. As the disease progresses, it can invade deeper tissues and spread to nearby lymph nodes. In advanced stages, it may metastasize to distant organs. The progression of the disease can vary, with some cases remaining localized for extended periods, while others may advance more rapidly. The disease is often associated with certain risk factors, including human papillomavirus (HPV) infection and poor hygiene.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514997-27-00Protocol codeP/2017/337Estimated enrolment28 patientsSponsorCentre Hospitalier Regional Universitaire

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).