Phase II trial evaluates induction therapy with EV/P for better outcomes in metastatic urothelial carcinoma, suggesting improved quality of life.
Key Points
The study aims to assess the effectiveness of enfortumab vedotin plus pembrolizumab followed by pembrolizumab maintenance in improving outcomes for metastatic urothelial carcinoma.
Single-arm, open-label, nonrandomized phase II trial
Enrollment of 97 previously untreated patients
Induction treatment with EV and pembrolizumab for 6 cycles, followed by maintenance pembrolizumab
Assessment of primary endpoint: 18-month progression-free survival (PFS)
Exploratory ctDNA analysis from baseline through progression.
Significant improvements in overall survival and progression-free survival compared to chemotherapy
Induction therapy is hypothesized to reduce cumulative toxicity and maintain oncologic control
High percentage of patients maintaining disease control post-treatment suggests potential durable benefits.
Endpoints include peripheral neuropathy incidence and quality of life indices.