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

NCT07043972 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-07-20

No results posted yet for this study

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.

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.

Conditions

Interventions

DRUG

Gemcitabine

IV over 30 minutes given on days 1 and 8 of a 21 day cycle

DRUG

Carboplatin

IV over 30 minutes given on day 1 of a 21 day cycle

Sponsors & Collaborators

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Daniel Geynisman, MD · Fox Chase Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-09
Primary Completion
2030-01-01
Completion
2031-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043972 on ClinicalTrials.gov