The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
Official Title: A Multicenter, Open-label, Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma (EV-901)
Study ID: NCT04136808
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCLA Hematology Oncology, Los Angeles, California, United States
John Wayne Cancer Institute, Santa Monica, California, United States
St. Joseph Heritage Medical Group, Santa Rosa, California, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Northwestern University Medical Center, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Community Hospital Anderson, Anderson, Indiana, United States
New England Cancer Specialists, Topsham, Maine, United States
Johns Hopkins University, Baltimore, Maryland, United States
NYU Langone Health, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Name: Medical Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR