Penile squamous cell carcinoma Trials in Disease

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

This clinical trial is investigating avelumab, an immunotherapy treatment that helps the body's immune system fight cancer. The study focuses on patients with advanced or metastatic squamous cell penile carcinoma who have already received initial chemotherapy.

Main inclusion criteria:

• Men aged 18 years or older
• Confirmed diagnosis of squamous cell penile carcinoma that cannot be removed by surgery and has spread locally or to other parts of the body
• Completed 3 to 6 cycles of chemotherapy containing a platinum drug such as cisplatin or carboplatin as first-line treatment
• Cancer has not progressed after chemotherapy, meaning it is responding to treatment, partially responding, or stable
• Life expectancy of at least 3 months
• Good overall physical condition, able to carry out normal activities or having only some symptoms but not bedridden for more than half the day
• Adequate bone marrow, kidney, and liver function as measured by blood tests

Main exclusion criteria:

• Patients who have not completed their first line of chemotherapy
• Patients whose disease has progressed after initial chemotherapy
• Female patients (only men are eligible for this study)
• Vulnerable populations who cannot make decisions for themselves

Focus and goal of the trial:

The main goal of this study is to evaluate how well avelumab works as a maintenance treatment after initial chemotherapy. Maintenance treatment means the medication is given after the first round of chemotherapy to help prevent the cancer from coming back or getting worse. The trial will monitor how long patients remain free from cancer progression and will assess their overall survival. Researchers will also carefully observe any side effects to evaluate the safety of avelumab and will use questionnaires to assess patients' quality of life throughout the study.

Investigational drugs:

The trial uses avelumab, which is delivered directly into the bloodstream through a vein in a process called infusion. Avelumab is a type of immunotherapy that works by blocking a protein called PD-L1, which can help cancer cells hide from the immune system. By blocking this protein, avelumab helps the immune system recognize and attack cancer cells more effectively.

Patients in this trial will have previously received cisplatin, a chemotherapy drug that damages the DNA of cancer cells to stop them from growing and dividing. Cisplatin is used as part of the initial treatment before avelumab maintenance therapy begins.

The avelumab infusion is typically given every two weeks, and treatment continues until there is evidence of disease progression, unacceptable side effects occur, or a decision is made to stop treatment for other reasons. Throughout the trial, patients undergo regular monitoring including physical examinations, blood tests, and imaging studies such as CT or MRI scans to assess how well the treatment is working.