Phase II Study of Induction Therapy with Enfortumab Vedotin Plus Pembrolizumab Followed by Pembrolizumab Maintenance in Treatment-Nave Patients With Metastatic Urothelial Carcinoma

What this Trial Is About

Researchers are studying the effectiveness of a combination treatment using enfortumab vedotin EV and pembrolizumab P followed by pembrolizumab maintenance therapy in patients who have not previously been treated for metastatic urothelial carcinoma mUC. This Phase II trial is designed to evaluate the response to this treatment regimen over time, aiming to improve outcomes for patients with this advanced cancer type. Approximately 97 patients will participate in this open-label, non-randomized study. During the 18-week induction phase, patients receive EV intravenously at 1.25 mgkg on Days 1 and 8 of each 21-day cycle, with a starting dose of 1 mgkg allowed, plus pembrolizumab at 200 mg IV on Day 1 of each cycle. Radiographic scans assess the cancer after 3 and 6 cycles. Patients who respond with complete or partial remission move to a maintenance phase receiving pembrolizumab at 400 mg IV every 6 weeks or 200 mg IV every 3 weeks for up to 2 years. Dose adjustments for EV are permitted, but pembrolizumab doses remain fixed. Treatment continues until the disease progresses, unacceptable side effects occur, or maintenance therapy ends. Participants will have scans and clinical assessments during and after treatment to monitor cancer status, side effects, and quality of life. If treatment is stopped early due to toxicity or near complete response, patients enter long-term follow-up. Those who experience progression may resume original dosing or enter survival follow-up. The primary outcome measured is 18-month progression-free survival, with secondary outcomes including overall survival, response duration, peripheral neuropathy incidence, and quality of life over four years.

Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma