Clin2
NCT07608224Likely a fitNot yet recruiting

HER2-Positive Bladder Cancer: New Drug vs Standard Chemotherapy

Urinary Bladder Neoplasms

Treatments studied

Part of Cancer, Kidney & urinary, Women’s health & pregnancy clinical trials.

This trial tests a new targeted drug (disitamab vedotin) combined with immunotherapy against the standard chemotherapy-immunotherapy combination for muscle-invasive bladder cancer that expresses HER2 protein. The goal is to see if the new approach works better and is safer for patients before bladder removal surgery.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2/Phase 3
Enrollment
240 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • Diagnosed with muscle-invasive bladder cancer (cancer has grown into the muscle layer of the bladder) at stage cT2-T4aN0/1M0, with leftover cancer after initial TURBT procedure
  • Your cancer cells must show HER2 protein (tested by immunohistochemistry) at level 1+ or higher
  • No prior chemotherapy or immunotherapy treatments for this bladder cancer
  • Blood work shows adequate kidney, liver, and heart function, with kidney function clearance >40 mL/min
  • Good overall health status (ECOG 0-1: able to do normal activities or mildly limited)
  • Willing to use effective birth control for 6 months after treatment (applies to men and women of childbearing age)

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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