Chemo combo tested as backup for bladder cancer that outsmarts First-Line therapy
NCT ID NCT07043972
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether a chemotherapy combination called gemcitabine and carboplatin can help people with advanced urothelial cancer whose disease has worsened after treatment with enfortumab vedotin and pembrolizumab. The trial enrolls about 55 participants who receive the two drugs intravenously on a three-week cycle. The main goal is to see if the cancer shrinks or stops growing, and researchers also track side effects, survival, quality of life, and blood markers of cancer DNA.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gemcitabine plus carboplatin chemotherapy
- What this could lead to
- If the combination works, it could give doctors another option for advanced urothelial cancer that has grown after standard first-line treatment.
- What could go wrong
- This is a small phase 2 trial, so any benefit seen here would need confirmation in larger studies. Chemotherapy can cause side effects such as low blood counts, fatigue, and nausea.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fox Chase Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19111, United States
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Temple University Hospital at Broad Street
RECRUITINGPhiladelphia, Pennsylvania, 19140, United States
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