Enfortumab Vedotin with Radiation for Locally Advanced Bladder Cancer

This study is looking at whether combining enfortumab vedotin (a drug given through an IV) with radiation therapy can help control advanced bladder cancer. Researchers want to see how safe this combination is and if it helps people live longer without their cancer getting worse. You might be able to join if you are 18 or older, have a confirmed diagnosis of advanced urothelial carcinoma (a type of bladder cancer), and meet other health criteria. The study aims to enroll 41 participants. The main goal is to understand the safety and side effects of this treatment combination over about one year. The current status of this study is unclear.

Study design
This study is an interventional study with a planned enrollment of 41 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events (side effects) will be measured throughout study completion, which is an average of one year.

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NCT06434350

Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~41 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Enfortumab VedotinRadiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year.
Advanced Bladder Cancer
1 sites across 1 states
Texas1
  • Comron Hassanzadeh, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Eligibility criteria

Inclusion

Female participants of childbearing potential should have a negative urine or serum pregnancy within 6 weeks prior to study registration up to the first fraction of radiation.
Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Safety and adverse events (AEs)Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0