NCT06764095 - Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 8, 2025

Primary Completion Date

December 31, 2034

Study Completion Date

December 31, 2034

Conditions

Locally Advanced Bladder Urothelial CarcinomaLocally Advanced Renal Pelvis and Ureter Urothelial CarcinomaMetastatic Bladder Urothelial CarcinomaMetastatic Renal Pelvis and Ureter Urothelial CarcinomaStage III Bladder Cancer AJCC v8Stage IV Bladder Cancer AJCC v8Stage IV Renal Pelvis and Ureter Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo urine and blood sample collection

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Cystectomy

Undergo cytoreductive cystectomy

DRUG

Enfortumab Vedotin

Given IV

PROCEDURE

Local Therapy

Undergo MDT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Ureterectomy

Undergo ureterectomy

Trial Locations (1)

55905

RECRUITING

Mayo Clinic in Rochester, Rochester