Urothelial CarcinomaPhase 2NCT07043972
Gemcitabine and Carboplatin After Progression on Enfortumab Vedotin and Pembrolizumab in Advanced/Metastatic Urothelial Carcinoma
A Phase 2 study testing Gemcitabine and Carboplatin in people with Urothelial Carcinoma, run by Fox Chase Cancer Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Gemcitabine and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jul 2025to 1 Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Daniel Geynisman, MD, 888-369-2427, Daniel.Geynisman@fccc.edu
Ryan Romasko, MBA, (888) 369-2427, protocoldev@fccc.edu
- Recruiting
Temple University Hospital at Broad Street
Philadelphia, Pennsylvania, 19140
Daniel Geynisman, MD, 888-369-2427, Daniel.Geynisman@fccc.edu
Ryan Romasko, MBA, protocoldev@fccc.edu
About this study
Official title: Phase II Study of Second-line Gemcitabine Plus Carboplatin After Progression on Enfortumab Vedotin With Pembrolizumab in Advanced or Metastatic Urothelial Carcinoma
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.
Read more
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.
Read the detailed description
This is a non-randomized single arm, two stage, open-label phase 2 efficacy study in adult patients with locally advanced or metastatic urothelial cancer. Subjects must have had one prior line of therapy consisting of EVP and have RECIST measurable disease prior to study entry. Patients will be treated with standard of care doses of all the chemotherapeutic drugs. Each cycle will consist of gemcitabine 1,000 mg/m2 administered over 30 minutes IV on days 1 and 8, followed by carboplatin AUC 5 on day 1, every 3 weeks. Patients will be treated until disease progression or any of the conditions listed in the protocol applies. Response to treatment will be evaluated by investigator determined CT scan or MRI every 9 weeks and the tumor will be assessed using RECIST v1.1 criteria. The study will be analyzed for futility after treatment of 19 patients. Patients who are not evaluable for the primary endpoint will be replaced.
- Conditions
- Urothelial Carcinoma
- Being tested
- Gemcitabine, Carboplatin
- Keywords
- phase II, locally advanced urothelial cancer, gemcitabine plus carboplatin, enfortumab vedotin plus pembrolizumab, metastatic urothelial cancer
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
IV over 30 minutes given on days 1 and 8 of a 21 day cycle
CarboplatinDrug
IV over 30 minutes given on day 1 of a 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine plus carboplatin | Experimental | Patients will be treated with gemcitabine 1,000 mg/m2 administered over 30 minutes IV on days 1 and 8, followed by carboplatin area under the curve (AUC) 5 on day 1, every 3 weeks. Receives: Drug: Gemcitabine; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
From the start of the treatment until disease progression/recurrence
Measured: 3 years
Secondary outcomes (4)
To evaluate progression free survival (PFS) as a function of time since study enrollment in patients receiving GC after prior exposure to EVP
From initiation of study treatment until progression or death with patients who are still alive and progression free at the end of the follow-up period considered censored at their last contact.
Measured: 3 years
To evaluate overall survival (OS) as a function of time since study enrollment in patients receiving GC after prior exposure to EVP
From initiation of study treatment until death with patients still alive at the end of follow-up censored at their last contact date
Measured: 3 years
To evaluate the frequency and severity of toxicities attributed to GC after prior exposure to EVP
From the start of study treatment until the patient either begins survival follow-up, starts a new cancer therapy, or die, whichever occurs first
Measured: 3 years
To evaluate the disease control rate (DCR) of gemcitabine plus carboplatin after prior exposure to EVP
From initiation of study treatment until progression or death with patients who are still alive and progression free at the end of the follow-up period considered censored at their last contact
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start9 Jul 2025
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Geynisman, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043972
- Sponsor's protocol ID
- GU-230
- Other IDs
- 25-1008
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Second-line Gemcitabine Plus Carboplatin After Progression on Enfortumab Vedotin With Pembrolizumab in Advanced or Metastatic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT07043972
- Acronym / sponsor ID
- GU-230
- Conditions
- Urothelial Carcinoma
- Keywords
- phase II, locally advanced urothelial cancer, gemcitabine plus carboplatin, enfortumab vedotin plus pembrolizumab, metastatic urothelial cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a non-randomized single arm, two stage, open-label phase 2 efficacy study in adult patients with locally advanced or metastatic urothelial cancer. Subjects must have had one prior line of therapy consisting of EVP and have RECIST measurable disease prior to study entry. Patients will be treated with standard of care doses of all the chemotherapeutic drugs. Each cycle will consist of gemcitabine 1,000 mg/m2 administered over 30 minutes IV on days 1 and 8, followed by carboplatin AUC 5 on day 1, every 3 weeks. Patients will be treated until disease progression or any of the conditions listed in the protocol applies. Response to treatment will be evaluated by investigator determined CT scan or MRI every 9 weeks and the tumor will be assessed using RECIST v1.1 criteria. The study will be analyzed for futility after treatment of 19 patients. Patients who are not evaluable for the primary endpoint will be replaced.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine plus carboplatin | Experimental | Drug: Gemcitabine, Drug: CarboplatinPatients will be treated with gemcitabine 1,000 mg/m2 administered over 30 minutes IV on days 1 and 8, followed by carboplatin area under the curve (AUC) 5 on day 1, every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineIV over 30 minutes given on days 1 and 8 of a 21 day cycle | Drug | Gemcitabine plus carboplatin |
| CarboplatinIV over 30 minutes given on day 1 of a 21 day cycle | Drug | Gemcitabine plus carboplatin |
Primary outcome
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
Time frame: 3 years
From the start of the treatment until disease progression/recurrence
4 secondary outcomes
To evaluate progression free survival (PFS) as a function of time since study enrollment in patients receiving GC after prior exposure to EVP
Time frame: 3 years
To evaluate overall survival (OS) as a function of time since study enrollment in patients receiving GC after prior exposure to EVP
Time frame: 3 years
To evaluate the frequency and severity of toxicities attributed to GC after prior exposure to EVP
Time frame: 3 years
To evaluate the disease control rate (DCR) of gemcitabine plus carboplatin after prior exposure to EVP
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Geynisman, MD principal investigator
Fox Chase Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and Carboplatin in people with Urothelial Carcinoma, run by Fox Chase Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Geynisman, MD ((888) 369-2427, Daniel.Geynisman@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.