Gemcitabine and Carboplatin After Progression on Enfortumab Vedotin and Pembrolizumab in Advanced/Metastatic Urothelial Carcinoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT07043972
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    IV over 30 minutes given on days 1 and 8 of a 21 day cycle
  • Carboplatin — DRUG
    IV over 30 minutes given on day 1 of a 21 day cycle

Study Details

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.

Key Dates

Start date
Jul 9, 2025
Status verified
Jul 2025
Primary completion
Jan 1, 2030
Completion
Jan 1, 2031

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine plus carboplatin
    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.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Daniel Geynisman, MD
[email protected]
888-369-2427
Ryan Romasko, MBA
[email protected]
(888) 369-2427
Daniel Geynisman, MD (PRINCIPAL_INVESTIGATOR)
Temple University Hospital at Broad StreetPhiladelphiaPennsylvania19140
Daniel Geynisman, MD
[email protected]
888-369-2427
Ryan Romasko, MBA
[email protected]
Daniel Geynisman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Fox Chase Cancer Center· Philadelphia, PATemple University Hospital at Broad Street· Philadelphia, PA

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