EV + Toripalimab vs GC as Neoadjuvant Therapy in Locally Advanced/High-Risk MIBC

The purpose of this Phase II, open-label, multicenter, randomized controlled study is to evaluate the efficacy and safety of Enfortumab Vedotin in combination with Toripalimab compared to Gemcitabine plus Cisplatin. This regimen is evaluated as a neoadjuvant treatment for patients with locally advanced or high-risk muscle-invasive bladder cancer. Participants will be randomly assigned in a 1:1 ratio to one of two cohorts. Cohort A will receive Enfortumab Vedotin and Toripalimab for 3 treatment cycles. Cohort B will receive Gemcitabine and Cisplatin for 3 treatment cycles. Following the neoadju

Trial Details

NCT ID
NCT07647289
Phase
PHASE2
Sponsor
Peking University Third Hospital
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • enfortumab vedotin (EV)
  • Toripalimab
  • Gemcitabine (Chemotherapy)
  • Cisplatin
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • Voluntarily agree to participate in the study and sign the informed consent form (ICF).
  • Age ≥ 18 and ≤ 80 years at the time of signing the ICF.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, with variant histology components comprising \< 50%.

For full eligibility, visit ClinicalTrials.gov.

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