RecruitingPhase 2NCT07043972

Gemcitabine and Carboplatin After Progression on Enfortumab Vedotin and Pembrolizumab in Advanced/Metastatic Urothelial Carcinoma

Phase II Study of Second-line Gemcitabine Plus Carboplatin After Progression on Enfortumab Vedotin With Pembrolizumab in Advanced or Metastatic Urothelial Carcinoma


Sponsor

Fox Chase Cancer Center

Enrollment

55 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if a chemotherapy combination called gemcitabine and carboplatin (GC) works to treat advanced urothelial cancer in people who have already been treated with enfortumab vedotin and pembrolizumab (EVP). It will also learn about the efficacy and safety of GC in these patients. The main questions it aims to answer are: * Does GC shrink the cancer or stop it from growing? * What medical side effects do participants have while receiving GC? Researchers will study how GC affects survival, cancer control, and quality of life. They will also collect blood samples to look at health-related markers and cancer DNA in the blood. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Participants will: * Receive the GC chemotherapy (gemcitabine and cisplatin) after having been treated with EVP * Visit the clinic regularly for checkups, lab tests, and scans * Answer questions about their health, quality of life, and daily function * Provide blood samples for research This study may help researchers find better ways to treat advanced bladder and urinary tract cancer in the future-especially for older adults or those who have already tried other treatments.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Carboplatin and a drug called Gemcitabine for people with urothelial carcinoma. The study is currently recruiting participants at 2 locations.

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

DRUGGemcitabine

IV over 30 minutes given on days 1 and 8 of a 21 day cycle

DRUGCarboplatin

IV over 30 minutes given on day 1 of a 21 day cycle


Locations(2)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Temple University Hospital at Broad Street

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT07043972


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