Gemcitabine and Carboplatin After Progression on Enfortumab Vedotin and Pembrolizumab in A
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. T
| Condition(s) | Urothelial Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 (g |
| Who can participate | Inclusion Criteria: * Patients must have metastatic or locally advanced histologically and radiographically confirmed urothelial carcinoma * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v1.1 * Patients must have received treatment with enfortumab vedotin plus pembrolizumab in the first line setting. Study treatment may be started within 28 days of last treatment with EV-P or with continuing toxicities if considered by the Sponsor-Investigator to be safe and within the best interest of the patient. * Age \> 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patients must have normal organ and marrow function as defined below. * Absolute neutrophil |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fox Chase Cancer Center |
| Locations | Philadelphia, Pennsylvania, United States; Philadelphia, Pennsylvania, United States |
| Start date | 2025-07-09 |
| NCT ID | NCT07043972 |
| Official listing | https://clinicaltrials.gov/study/NCT07043972 |