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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To learn if the combination of enfortumab vedotin plus radiation therapy could help to control the disease.

Eligibility criteria

Qualifiers

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

Treatments tested in this trial

  • Enfortumab Vedotin
  • Radiation Therapy

Treatment groups

41 Participants
are divided into 1 treatment group

Sponsors and collaborators