Fed Ghali, MD, highlights trial of consolidative local therapy following EV/P

Enfortumab vedotin plus pembrolizumab (EV/P) has emerged as a standard of care option for patients with locally advanced and metastatic urothelial carcinoma (la/mUC). However, many patients still experience disease progression.

At the 2025 Society of Urology Oncology Annual Meeting in Phoenix, Arizona, investigators shared the background and design of the phase 2 CONSOLIdaTE-01 (NCT07048457). The study is seeking to answer an important question: Rather than continue on with systemic therapy until disease progression, is there an opportunity to intervene earlier with consolidative local therapy following disease control on EV/P? They are particularly assessing this question in the context of patients with limited metastatic burden; this is, in patients with locally advanced or oligometastatic urothelial carcinoma.

In an interview with Urology Times®, presenting author Fed Ghali, MD, discussed the rationale and design behind the trial. Ghali is an assistant professor of urology at the Yale School of Medicine and a urologic oncologist at Yale Cancer Center in New Haven, Connecticut.

The trial will enroll patients with either locally advanced unresectable (T4 and/or cN+) or oligometastatic (5 or more sites) urothelial carcinoma who demonstrate non-progression following at least 3 months of EV/P-based therapy. Patients will receive consolidative therapy, consisting of either radical cystectomy and metastasectomy, or stereotactic body radiation therapy.

The primary endpoint for the trial is progression-free survival at 1 year. Secondary end points incldue overall survival, treatment related adverse events, quality of life, and circulating tumor DNA (ctDNA) dynamics.

Study completion is expected in September 2027.²

REFERENCE

1. Ghali F, Petrylak D, An Y, Kim JW. CONSOLIDATE-01: Phase II trial of consolidative surgery following enfortumab vedotin and pembrolizumab in patients with locally advanced/oligometastatic urothelial carcinoma. Presented at: Society of Urologic Oncology Annual Meeting; December 2-5, 2025; Phoenix, Arizona. Abstract 47. https://suo-abstracts.secure-platform.com/a/gallery/rounds/24/details/4917

2. Enfortumab vedotin with radiation for locally advanced bladder cancer (CONSOLIDATE). ClinicalTrials.gov. Last updated August 14, 2025. Accessed January 14, 2026. https://clinicaltrials.gov/study/NCT06434350