Gemcitabine and Carboplatin for Advanced Urothelial Carcinoma
This study is looking at whether a chemotherapy combination of gemcitabine and carboplatin (GC) can help people with advanced urothelial carcinoma (a type of bladder cancer) whose cancer has progressed after treatment with enfortumab vedotin and pembrolizumab. Researchers want to see if GC can shrink the cancer or stop it from growing, and what side effects people might experience. They will also study how GC affects survival, cancer control, and quality of life. You may be able to join if you are an adult with advanced urothelial carcinoma that has measurable disease and you have already received enfortumab vedotin and pembrolizumab.
- Study design
- This is a single-arm, open-label Phase 2 study, meaning all participants will receive the same treatment, and both you and the study team will know what treatment you are getting. The study plans to enroll 55 adult patients.
- What's involved
- You would receive gemcitabine and carboplatin intravenously (into a vein) over 30 minutes on specific days within a 21-day cycle. Treatment will continue until your disease progresses or other specific conditions are met. Your tumor will be assessed with CT scans or MRIs every 9 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal of the study, looking at how well the treatment works, will be measured at 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07043972
Gemcitabine and Carboplatin After Progression on Enfortumab Vedotin and Pembrolizumab in Advanced/Metastatic Urothelial Carcinoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentFox Chase Cancer CenterInvestigator-initiated
~55 participants
Updated 2025-07-20 on ClinicalTrials.gov
What's tested:GemcitabineCarboplatin
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best overall response (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) to gemcitabine plus carboplatin defined per RECIST v 1.1
Measured over 3 years
Conditions
Where it's being run
2 sites across 1 statesPennsylvania2
Study leadership
- Daniel Geynisman, MD · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 count \> 1,000/mm3 unless patient has constitutional neutropenia
Platelets \> 80,000/ul
Hemoglobin \> 8.0 g/dL
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 x ULN or \<3.5 x upper limit of normal (ULN) if liver metastases
Creatinine Clearance \>20 mL/min
Ability to understand and willingness to sign a written informed consent and HIPAA consent document
Optional: Archival tumor biospecimen, when available, must be procured for correlative evaluation. If tumor tissue is not available or accessible despite good faith efforts, patient may still be treated on study. Formalin fixed paraffin embedded (FFPE) tissue block(s) or at least 15 unbaked, unstained slides are required. Tissue samples taken from a metastatic lesion prior to the start of screening are acceptable.
Exclusion
Patients who have had systemic treatment including EV-P or radiotherapy within 2 weeks prior to entering the study
Patients who have had systemic treatment including EV-P or radiotherapy within 2 weeks prior to entering the study
Patients who have received more than one line of prior therapy or prior platinum-based chemotherapy for locally advanced or metastatic urothelial carcinoma (neoadjuvant platinum-based therapy including cisplatin is allowed)
Patients who have not recovered from adverse events to less than Grade 2 secondary to agents administered more than 2 weeks prior to treatment initiation.
Patients may not be receiving any other investigational agents
Patients with uncontrolled and untreated CNS metastases:
Prior radiation to central nervous system (CNS) metastases is permitted
Prior history of CNS disease that has responded to previous systemic therapy is permitted only if no recurrence
Patient should not have leptomeningeal disease
CNS metastases have been clinically stable for at least 6 weeks prior to screening and baseline scans show no evidence of new or enlarged metastases
Uncontrolled intercurrent illness including, but not limited to ongoing or active untreated infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit adherence with study requirements
Subjects with a history of another invasive malignancy within 3 years before the first dose of study drug that cannot be watched and requires tumor- directed treatment, or any evidence of residual disease from a previously diagnosed malignancy that cannot be watched and requires treatment (adjuvant hormonal therapy for breast cancer is allowed)
Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of chemotherapy (routine antimicrobial prophylaxis is permitted)
Pregnant or breast feeding.
What this trial measures
- Best overall response (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) to gemcitabine plus carboplatin defined per RECIST v 1.13 years
From the start of the treatment until disease progression/recurrence