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Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial

StatusRecruiting
PhasePhase 4
Started2025-01-08
View on ClinicalTrials.gov ↗

Amendment history

2026-10-02
Primary completion moved earlier: 2034-12-31 → 2028-07-01
Completion moved earlier: 2034-12-31 → 2032-01-01
2026-02-10
Study Status v5
Re-verified, no change to tracked fields
2025-09-09
Study Status, Study Description, Arms and Interventions, Eligibility v4
Eligibility criteria-381 characters
[...] irubin ≤ 3 x ULN (obtained ≤ 28 days prior to registration) Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN or if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained ≤ 28 days prior to registration) Thyroid function tests within normal range [...] Estimated glomerular filtration rate ≥ 15 ml/min (obtained ≤ [...] urothelial carcinoma with histologic variants comprising > 2050% of histology Any amount: neuroendocrine, micropapillary, or signet ring cell, plasmacytoid, or sarcomatoid feature [...] [...]
Study description+77 characters
[...] otin and pembrolizumab (EV/Pembro) and CC/U with or without metastasis-directed therapy (MDT). SECONDARY OBJECTIVES: I. To evaluate overall response rate [...] ch cycle. Cycles repeat every 3 weeks for at least 4 cycles (12 weeks) in the absence of disease progression or unacceptable toxici [...] mpletion of study treatment, patients are followed up every 129 weeks for up to 18 months, then every 12 weeks up to 5 years.
2025-02-21
Study Identification, Study Status v3
Re-verified, no change to tracked fields
2025-02-17
Study Status, Outcome Measures, Eligibility v2
Eligibility criteria-98 characters
[...] ion The following variant histologic subtypes are permitted ifin urothelialany differentiation is predominant (e.g., < 20% variant histologic subtype)amount Urothelial with squamous differentiation Urothelial with glandularsarcomatoid differentiation The followingMixed variant histologic subtypes are not permitted if urothelial differentiation is predominant (any amount): neuroendocrinee.g., micropapillary,< signet50% ringvariant cell,histologic plasmacytoid, or sarcomatoid featuressubtype) Willing to undergo cytoreductive cystectomy (CC) or uretere [...] e status grade 0, 1, or 2 Hemoglobin ≥ 8.0 g/ [...]
Secondary endpointsdetails revised at 2 of 8 entries
2025-02-10
Not Yet Recruiting→Recruiting Study Identification, Study Status, Conditions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-01-31→confirmed 2025-01-08
Study sitesdetails revised at 1 of 1 site
Study title-24 characters
Enfortumab Vedotin and Pembrolizumab Followed byWith Cystectomy Andand/or Ureterectomy for the Treatment of Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial
2025-01-02
Original filing
Mayo Clinic
1,015 trials monitored
See 115 trials at risk
Bladder Cancer
1,018 trials monitored
See 64 trials at risk
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.
Trial Details
NCT Number NCT06764095
Lead Sponsor Mayo Clinic
Conditions Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Renal Pelvis and Ureter Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Renal Pelvis and Ureter Urothelial Carcinoma, Stage III Bladder Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Stage IV Renal Pelvis and Ureter Cancer AJCC v8
Enrollment 75 participants
Start Date 2025-01-08
Primary Completion 2028-07-01 (estimated)
Study Completion 2032-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-10-01