RecruitingPhase 2NCT05756569

Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology

Phase II Single-Arm Study of Enfortumab Vedotin (EV) Plus Pembrolizumab in the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology


Sponsor

Emory University

Enrollment

25 participants

Start Date

Sep 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the combination of enfortumab vedotin (an antibody-drug conjugate) and pembrolizumab (an immunotherapy) in people with locally advanced or metastatic bladder cancer that has unusual or rare cell types, which are typically harder to treat than standard bladder cancer. **You may be eligible if...** - You are 18 or older - You have bladder cancer that has spread or cannot be surgically removed - Your cancer has been confirmed as a variant histology type (e.g., micropapillary, plasmacytoid, sarcomatoid, squamous cell) or a non-urothelial bladder cancer - Your general health is sufficient for treatment (ECOG 0–1) **You may NOT be eligible if...** - You have standard urothelial bladder cancer without variant features - Your health status does not meet the required minimum - You have conditions that make either drug unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood

PROCEDUREComputed Tomography

Undergo CT

DRUGEnfortumab Vedotin

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALPembrolizumab

Given IV

OTHERQuestionnaire Administration

Ancillary studies


Locations(4)

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT05756569


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