OncoMatch/Clinical Trials/NCT05756569
Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology
Is NCT05756569 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Enfortumab Vedotin for bladder squamous cell carcinoma.
Treatment: Enfortumab Vedotin · Pembrolizumab — This phase II trial tests how well enfortumab vedotin (EV) and pembrolizumab works in treating patients with bladder cancer of variant histology (a group of less common types of bladder cancer) that have 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. Enfortumab attaches to a protein called nectin-4 on cancer 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 cancer, and may interfere with the ability of tumor cells to grow and spread. Giving enfortumab vedotin and pembrolizumab may kill more tumor cells in patients with locally advanced or metastatic bladder cancer of variant histology.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage III, IV (AJCC v8)
Metastatic disease or unresectable locally advanced disease; Stage III Bladder Cancer AJCC v8; Stage IV Bladder Cancer AJCC v8
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antibody-drug conjugate (enfortumab vedotin)
Prior treatment or enrollment in a study with EV
Cannot have received: anti-PD-1 therapy
Prior treatment or enrollment in a study with PD1/PD-L1 immune checkpoint inhibitor (including maintenance therapy)
Cannot have received: anti-PD-L1 therapy
Prior treatment or enrollment in a study with PD1/PD-L1 immune checkpoint inhibitor (including maintenance therapy)
Lab requirements
Blood counts
adequate organ and marrow function, within 28 days of cycle 1 day 1, at the discretion of the investigator
Kidney function
adequate organ and marrow function, within 28 days of cycle 1 day 1, at the discretion of the investigator
Liver function
adequate organ and marrow function, within 28 days of cycle 1 day 1, at the discretion of the investigator
Patients must have adequate organ and marrow function, within 28 days of cycle 1 day 1, at the discretion of the investigator
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Grady Health System · Atlanta, Georgia
- Emory University Hospital Midtown · Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia
- Emory Saint Joseph's Hospital · Atlanta, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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