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.
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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.
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.
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.
Single group
Gemcitabine
DrugIV over 30 minutes given on days 1 and 8 of a 21 day cycle
Carboplatin
DrugIV over 30 minutes given on day 1 of a 21 day cycle
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
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.
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
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
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
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