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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 10 words
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Jul 1, 2025 to Jul 9, 2025
    • Study description shortened, about 214 words
    • Site details revised at 2 of 2 sites
    • Study title revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07043972
Lead Sponsor Fox Chase Cancer Center
Conditions
(from sponsor)		 Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov