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Clinical Research & Trials

USO 25235

A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY

 

Disease Types: Genitourinary Cancer Research

Eligibility Requirements:

• Histologically confirmed MIBC (cT2-T4aN0M0) with predominant (≥50%)
urothelial carcinoma by BICR
• Subjects must have a maxTURBT 60 days (+ 14 days) prior to
randomization
• Subjects should not have been previously treated with systemic therapy or
radiotherapy for bladder cancer
• Subjects should be fit for systemic therapy and elect bladder
preservation
• Subjects must be eligible for and agree to receive chemoradiotherapy and
one of the protocol-specified radiosensitizing chemotherapy regimens
• ECOG ≤2
• Subjects with advanced or metastatic disease, non-urothelial carcinoma,
diffuse or multifocal CIS.

For more information on this trial CLICK HERE .

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