About this trial
To learn if the combination of enfortumab vedotin plus radiation therapy could help to control the disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed diagnosis of urothelial carcinoma of the bladder including patients with T4N0 and T1-4N2-3 disease. Participants with mixed urothelial carcinoma of bladder will also be included.
Be ≥ 18 years of age on the day of signing informed consent.
ECOG performance status 0-2. NOTE: If participants is unable to walk due to paralysis, but is mobile in a wheelchair, participants is ambulatory for the purpose of assessing their performance status.
Hemoglobin ≥ 9 g/dL
Disqualifiers
Has a diagnosis of active scleroderma, lupus, ulcerative colitis, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial as determined by the treating physician and/or member of the study team.
Distant metastatic disease beyond lymph node metastases, which by the discretion of the treating physician cannot be treated definitively in a radiation field
Has history of prior pelvic radiation therapy
Trial design
Single group
Treatments tested in this trial
Enfortumab Vedotin
DrugGiven by IV
Radiation Therapy
RadiationGiven by Radiation Therapy
Treatment groups
Trial outcomes
Primary outcomes
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Sponsors and contacts
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