Actively Recruiting
Gemcitabine and Carboplatin After Progression on Enfortumab Vedotin and Pembrolizumab in Advanced/Metastatic Urothelial Carcinoma
Led by Fox Chase Cancer Center · Updated on 2025-07-20
55
Participants Needed
2
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gemcitabine and Carboplatin After Progression on Enfortumab Vedotin and Pembrolizumab in Advanced/Metastatic Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have metastatic or locally advanced histologically and radiographically confirmed urothelial carcinoma
- Patients must have measurable disease with at least one lesion measurable per RECIST criteria v1.1
- Patients must have received treatment with enfortumab vedotin plus pembrolizumab in the first line setting
- Study treatment may start within 28 days of last EVP treatment or with continuing toxicities if deemed safe
- Age greater than 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Normal organ and marrow function including: absolute neutrophil count > 1,000/mm3 unless constitutional neutropenia, platelets > 80,000/ul, hemoglobin > 8.0 g/dL, ALT and AST <2.5 x ULN or <3.5 x ULN if liver metastases, creatinine clearance > 20 mL/min
- Ability to understand and willing to sign informed consent and HIPAA documents
- Optional archival tumor biospecimen available for evaluation; if unavailable, patient may still be treated
You will not qualify if you...
- Systemic treatment including EVP or radiotherapy within 2 weeks prior to entering the study
- More than one prior line of therapy or prior platinum-based chemotherapy for locally advanced or metastatic urothelial carcinoma (neoadjuvant platinum therapy allowed)
- Not recovered from adverse events to less than Grade 2 from agents given more than 2 weeks before treatment
- Receiving any other investigational agents
- Uncontrolled or untreated CNS metastases or leptomeningeal disease
- CNS metastases must be stable for at least 6 weeks with no new or enlarged metastases
- Uncontrolled intercurrent illness including untreated infection, symptomatic heart failure, unstable angina, uncontrolled arrhythmia, or psychiatric/social issues limiting adherence
- History of another invasive malignancy within 3 years requiring treatment or residual disease requiring treatment (adjuvant hormonal therapy allowed)
- Currently receiving systemic antimicrobial treatment for active infection
- Pregnant or breastfeeding
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Trial Site Locations
Total: 2 locations
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
2
Temple University Hospital at Broad Street
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
Research Team
D
Daniel Geynisman, MD
CONTACT
R
Ryan Romasko, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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