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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Enfortumab Vedotin

    Drug

    Given by IV

  • Radiation Therapy

    Radiation

    Given by Radiation Therapy

Treatment groups

41 Participants
are divided into 1 treatment group
Group A: Enfortumab Vedotin with RadiationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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