OncoMatch/Clinical Trials/NCT07043972
Gemcitabine and Carboplatin After Progression on Enfortumab Vedotin and Pembrolizumab in Advanced/Metastatic Urothelial Carcinoma
Is NCT07043972 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Gemcitabine and Carboplatin for urothelial carcinoma.
Treatment: Gemcitabine · Carboplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: antibody-drug conjugate (enfortumab vedotin) — first line
Patients must have received treatment with enfortumab vedotin plus pembrolizumab in the first line setting
Must have received: anti-PD-1 therapy (pembrolizumab) — first line
Patients must have received treatment with enfortumab vedotin plus pembrolizumab in the first line setting
Cannot have received: platinum-based chemotherapy
Exception: neoadjuvant platinum-based therapy including cisplatin is allowed
prior platinum-based chemotherapy for locally advanced or metastatic urothelial carcinoma (neoadjuvant platinum-based therapy including cisplatin is allowed)
Cannot have received: systemic therapy
Exception: no more than one line of prior therapy
Patients who have received more than one line of prior therapy
Lab requirements
Blood counts
absolute neutrophil count > 1,000/mm3 unless patient has constitutional neutropenia; platelets > 80,000/ul; hemoglobin > 8.0 g/dl
Kidney function
creatinine clearance >20 ml/min
Liver function
alt and ast <2.5 x uln or <3.5 x uln if liver metastases
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fox Chase Cancer Center · Philadelphia, Pennsylvania
- Temple University Hospital at Broad Street · Philadelphia, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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