Study on Gemcitabine and Carboplatin for Advanced Urothelial Cancer After Treatment with Enfortumab Vedotin and Pembrolizumab

Sponsor: Fox Chase Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07043972

Provider View

This clinical trial is testing a chemotherapy combination of gemcitabine and carboplatin to see if it can help treat advanced urothelial cancer in patients who have already received enfortumab vedotin and pembrolizumab. The study will also look at the safety and effectiveness of this treatment.

Patient Parameters

Program Overview

The purpose of this study is to find out if a chemotherapy combination called gemcitabine and carboplatin (GC) can help control advanced urothelial cancer in patients who have already been treated with enfortumab vedotin and pembrolizumab (EVP). Researchers want to know if GC can shrink the cancer or stop it from growing, and what side effects patients might experience. They will also study how GC affects survival, cancer control, and quality of life. Blood samples will be collected to look at health markers and cancer DNA.

Description

This study involves treating patients with advanced urothelial cancer using a chemotherapy combination of gemcitabine and carboplatin. Patients must have previously been treated with enfortumab vedotin and pembrolizumab. The treatment will be given in cycles, with gemcitabine administered on days 1 and 8, and carboplatin on day 1, every 3 weeks. Patients will continue treatment until the cancer progresses or other conditions apply. The response to treatment will be evaluated using scans every 9 weeks. The study will initially treat 19 patients to assess its effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic urothelial cancer confirmed by tests.
  • Have at least one tumor that can be measured by scans.
  • Previously treated with enfortumab vedotin and pembrolizumab.
  • Be 18 years or older.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have normal organ and bone marrow function, including:
    • Neutrophil count above 1,000/mm3
    • Platelet count above 80,000/ul
    • Hemoglobin above 8.0 g/dL
    • Liver enzymes within specified limits
    • Creatinine clearance above 20 mL/min
  • Understand and agree to sign informed consent.
  • Optional: Provide a tumor sample for research if available.

Exclusion Criteria

  • Have had recent systemic treatment or radiotherapy within 2 weeks before the study.
  • Have received more than one prior treatment or prior platinum-based chemotherapy for advanced cancer.
  • Have not recovered from previous treatment side effects to less than Grade 2.
  • Be receiving other investigational treatments.
  • Have uncontrolled or untreated brain metastases.
  • Have serious illnesses or conditions that could interfere with the study.
  • Have had another invasive cancer within the last 3 years that requires treatment.
  • Be receiving treatment for an active infection at the start of chemotherapy.
  • Be pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Fox Chase Cancer Center19111PhiladelphiaPennsylvania
Temple University Hospital at Broad Street19140PhiladelphiaPennsylvania

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