🏛️ Verified NIH Record • Updated 2026-06-12
Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE) (NCT06434350)
🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: M.D. Anderson Cancer Center
🩺 Plain-English Summary (8th-Grade Level)
To learn if the combination of enfortumab vedotin plus radiation therapy could help to control the disease.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (18 items).
Location: MD Anderson Cancer Center — Houston, Texas
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
- Has ongoing clinically significant toxicity (Grade 2 or higher with exception of alopecia) associated with prior systemic therapy
- History of uncontrolled diabetes mellitus within 3 months of enrollment. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7 and \< 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
- Has estimated life expectancy of less than 12 weeks
- Has preexisting sensory or motor neuropathy Grade ≥ 2
- Participants receiving ongoing systemic intravenous antimicrobial treatment for active infection at time of randomization
- Participants have a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. No testing for hepatitis B and hepatitis C is required unless mandated by local health authority.
- Has a known history of human immunodeficiency virus (HIV) infection. Testing is not required unless mandated by the local health authority.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- MD Anderson Cancer Center — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.