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New treatment option for Urothelial Carcinoma
Official title Gemcitabine and Carboplatin After Progression on Enfortumab Vedotin and Pembrolizumab in Advanced/Metastatic Urothelial Carcinoma
ClinicalTrials.gov ID: NCT07043972
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for urothelial carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients must have received treatment with enfortumab vedotin plus pembrolizumab in the first line setting. Study treatment may be started within 28...
- Age \> 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
You likely can't join if
- 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...
- Patients who have not recovered from adverse events to less than Grade 2 secondary to agents administered more than 2 weeks prior to treatment...
- Patients may not be receiving any other investigational agents
- Patients with uncontrolled and untreated CNS metastases:
See the full eligibility 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...
- 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...
- 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...
- 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...
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.