OncoMatch/Clinical Trials/NCT06764095
Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial
Is NCT06764095 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Pembrolizumab and Enfortumab Vedotin for locally advanced bladder urothelial carcinoma.
Treatment: Enfortumab Vedotin · Pembrolizumab — This phase IV trial tests the impact of standard of care enfortumab vedotin and pembrolizumab followed by removal of all or part of the bladder (cytoreductive cystectomy) and/or removal of all or part of the tube that carriers urine from the kidneys to the bladder (ureterectomy) on outcomes in patients with bladder and upper urothelial tract that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. Giving standard of care enfortumab vedotin and pembrolizumab followed by cytoreductive cystectomy and/or ureterectomy (CC/U) may improve outcomes in patients with locally advanced or metastatic bladder or upper urothelial tract cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage M+, STAGE III BLADDER CANCER AJCC V8, STAGE IV BLADDER CANCER AJCC V8, STAGE IV RENAL PELVIS AND URETER CANCER AJCC V8 (AJCC v8)
Metastatic disease required
N+ and/or M+. Stage III/IV Bladder Cancer AJCC v8; Stage IV Renal Pelvis and Ureter Cancer AJCC v8
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic chemotherapy
Exception: for indications other than urothelial cell carcinoma of the bladder is permitted if interval > 24 months
Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time (excluding intravesicular therapies)
Cannot have received: systemic chemotherapy or targeted small molecule therapy
Exception: excluding hormonal therapy; permitted if > 2 years prior to starting study treatment
Received prior systemic chemotherapy or targeted small molecule therapy (excluding hormonal therapy) within 2 years prior to starting study treatment
Cannot have received: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Cannot have received: pelvic radiotherapy
Pelvic radiotherapy administered at any time
Lab requirements
Blood counts
hemoglobin ≥ 8.0 g/dl; anc ≥ 1500/mm^3; platelet count ≥ 80,000/mm^3
Kidney function
estimated glomerular filtration rate ≥ 15 ml/min
Liver function
alt or ast ≤ 3.5 x uln; total bilirubin ≤ 3 x uln or direct bilirubin ≤ 3 x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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