Clin2
NCT04879329Possibly a fitRecruiting

Study for HER2-positive bladder cancer after limited treatment

Urothelial Carcinoma

Treatments studied

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

This Phase 2 trial tests disitamab vedotin alone or with pembrolizumab for urothelial (bladder/urinary tract) cancer that has HER2-positive tumors. It aims to shrink tumors and improve outcomes, including for people who have had limited prior treatment or specific prior drug exposures.

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

Phase
Phase 2
Enrollment
372 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have urothelial cancer that is locally advanced/unresectable or metastatic (cannot be removed by surgery).
  • Your tumor is HER2-positive (IHC 1+, 2+, or 3+) based on a central lab test of tumor tissue.
  • You have at least one measurable tumor spot on scan that the study doctor can track (RECIST 1.1).
  • Your general functioning score (ECOG) is usually 0–1, or sometimes up to 2 depending on the cohort.
  • You must have had the right amount/type of prior treatment for your cohort (for example, 0, 1–2 lines, or specific drugs like platinum, PD-(L)1, or enfortumab vedotin).
  • You should not have had recent major treatment or lingering side effects above mild levels (typically must be back to Grade 0–1).

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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