DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma

This Phase 2 trial is testing a combination of two drugs — enfortumab vedotin (a targeted antibody-drug) and avelumab (an immunotherapy) — as a first treatment for men with advanced or metastatic penile cancer. This is a rare cancer with limited treatment options, and this trial aims to see if the combination can be effective. **You may be eligible if...** - You are a man 18 years or older with confirmed penile squamous cell carcinoma - Your cancer is advanced and cannot be cured with surgery (stage 3-4, spread to lymph nodes, or distant metastases) - You have not received prior systemic therapy for this advanced disease - You are in good enough health to tolerate treatment (ECOG performance score of 0-2) - Your blood counts, liver, and kidney function meet required levels - Tumor tissue is available for testing **You may NOT be eligible if...** - You have already received systemic chemotherapy or immunotherapy for advanced penile cancer - Your blood counts, liver, or kidney function are below required thresholds - You have severe peripheral nerve disease (neuropathy) - You have certain serious eye conditions Talk to your doctor to see if this trial is right for you.