Phase 2 Study of Induction Carboplatin, Paclitaxel, and Pembrolizumab Followed by Surgery for Advanced Penile Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness of induction chemo-immunotherapy in adult men with locoregionally advanced squamous cell carcinoma of the penis that is suitable for surgical removal. This phase II trial includes patients with specific nodal involvement or lymph node recurrence, some with limited distant metastases that can be locally treated. The study aims to assess the pathological complete response after treatment and investigate correlations with tumor markers and quality of life. Participants will receive three 21-day cycles of chemotherapy with carboplatin and paclitaxel, combined with two doses of pembrolizumab during the first and third cycles. After completing induction therapy, a CT scan will evaluate response, followed by surgical removal of visible or suspected tumors within 3 to 9 weeks. Subsequently, patients enter an adjuvant phase with up to seven cycles of pembrolizumab every 6 weeks. Treatment monitoring includes physical exams, adverse event tracking, and blood tests before each cycle. Throughout the study, disease status will be monitored by CT scans at several intervals up to 24 months after surgery, followed by standard follow-up visits every 6 months. Quality of life will be assessed using questionnaires at multiple time points during the first two years. The primary outcome is the pathological complete response immediately after surgery, with secondary outcomes including treatment toxicity, progression-free and overall survival at two years, and correlations between clinical outcomes and tumor characteristics.

Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer