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Clinical trial of TAR-200 in combination with cetrelimab and cetrelimab monotherapy in participants with muscle-invasive urothelial carcinoma of the bladder to be treated with radical cystectomy.

THE OBJECTIVE OF THIS STUDY IS TO TEST WHETHER AN INVESTIGATIONAL DRUG DELIVERY SYSTEM (GEMCITABINE/TAR-200) IN COMBINATION WITH INTRAVENOUS CETRELIMAB AND INTRAVENOUS CETRELIMAB IN MONOTHERAPY CAN IMPROVE THE RESULTS OF BLADDER REMOVAL IN PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE UNABLE TO RECEIVE PREOPERATIVE PLATINUM-BASED CHEMOTHERAPY.

Status
In recruitment
headquarters
Madrid

Technical Summary

  • PHASE 2, MULTICENTER, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF TAR-200 IN COMBINATION WITH CETRELIMAB AND CETRELIMAB MONOTHERAPY IN PARTICIPANTS WITH MUSCLE-INVASIVE UROTHELIAL CARCINOMA OF THE BLADDER WHO ARE TO BE TREATED WITH RADICAL CYSTECTOMY AND ARE INELIGIBLE FOR OR DECLINE TREATMENT WITH NEOADJUVANT PLATINUM-BASED CHEMOTHERAPY. IMMUNOTHERAPY.
  • Code EudraCT: 2020-005565-13
  • Protocol number: 17000139BLC2002
  • Promoter: Janssen Research & Development
  • Link to Clinical Trials

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