Locally Advanced or Metastatic Urothelial Carcinoma (UC) Clinical Trial
Official title:
A Multicenter, Open-label, Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma (EV-901)
The primary purpose of this expanded access program is to evaluate safety and tolerability of enfortumab vedotin (EV) in participants in the United States with locally advanced or metastatic urothelial carcinoma (UC) who have exhausted standard of care therapies and are not eligible to participate in an ongoing EV clinical study. This program will also evaluate the efficacy of EV.
This treatment protocol is being conducted while a phase 3 enfortumab vedotin (EV) study is
ongoing for participants with previously treated locally advanced or metastatic urothelial
carcinoma (UC).
This is an expanded access program to provide EV to participants with locally advanced or
metastatic UC who have previously been treated with a programmed cell death protein 1 (PD-1)
or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum containing regimen and for
whom, in the judgment of the investigator, there is no available standard of care therapy.
The participants must not be eligible for an ongoing EV clinical study. Participants who have
previously participated in any EV studies or studies that included EV as one of the treatment
options are not eligible, even if the participants was not given or assigned EV. To request
enrollment, the investigator or designee will submit the candidate participant's relevant
medical history and other records in order to support the participant's protocol eligibility.
Safety of EV will be assessed through evaluation of adverse events (AEs), serious adverse
events (SAEs), Eastern Cooperative Oncology Group (ECOG) performance status, laboratory
measurements, vital signs and physical examinations.
Participants will be provided with study medication until FDA approval and commercial
availability of enfortumab vedotin (EV) or termination by the sponsor.
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