What question did this study set out to answer?

To evaluate the effectiveness of cytoreductive cystectomy combined with systemic therapy in advanced urothelial carcinoma.

March 4, 2026

CAST-AI: Cystectomy after systemic therapy with ADC and immunotherapy.

Key Points

To evaluate the effectiveness of cytoreductive cystectomy combined with systemic therapy in advanced urothelial carcinoma.
Conducted as a decentralized phase II single-arm trial.
Enrolling patients with advanced urothelial carcinoma and ECOG performance score of 0-2.
Administering enfortumab vedotin and pembrolizumab before surgery, with monitoring every 9-12 weeks for response assessment.
Analyzing biomarkers in blood and urine, including circulating tumor DNA and exosomal Nectin-4.
30% complete response rate with enfortumab vedotin and pembrolizumab.
Post-cystectomy maintenance therapy with EV/Pembro encouraged based on surgical results.
Primary endpoint focuses on 12-month progression-free survival.

Abstract

TPS892 Background: Enfortumab Vedotin (EV) plus pembrolizumab (Pembro) is now first-line therapy for advanced urothelial carcinoma (UC), yielding ~30% complete response (CR) rates; nevertheless, most patients (pts) progress within 1 year and median overall survival (OS) remains 20% variant histology or disallowed subtypes (e.g., micropapillary, plasmacytoid, sarcomatoid, neuroendocrine); prior chemotherapy for UC; contraindications to surgery/EV/ICI; or active uncontrolled comorbidities/infections. Status: Enrollment is open and ongoing, with 25 of 75 pts enrolled as of September 2025. The trial uses a decentralized model, allowing pts to receive EV/Pembro at their local facility, with central coordination, biospecimen shipping, and surgical evaluation at Mayo Clinic or affiliated sites. ClinicalTrials.gov: NCT06764095. Clinical trial information: NCT06764095 .

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Cite This Study

Zarka et al. (Sun,) studied this question.

synapsesocial.com/papers/69a7cd3dd48f933b5eed973e https://doi.org/https://doi.org/10.1200/jco.2026.44.7_suppl.tps892

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