An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
A Multicenter, Open-label, Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma (EV-901)
1 other identifier
expanded_access
N/A
1 country
15
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.
Trial Health
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15 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2019
CompletedFirst Posted
Study publicly available on registry
October 23, 2019
CompletedJanuary 13, 2020
January 1, 2020
October 21, 2019
January 9, 2020
Conditions
Keywords
Interventions
Participants will receive an intravenously (IV) administered dose once weekly for the first 3 weeks of every 4-week cycle (i.e., on days 1, 8, and 15)
Eligibility Criteria
You may qualify if:
- Subject has locally advanced or metastatic urothelial carcinoma (UC) and has progressed during or after the most recent therapy.
- Subject has previously received a platinum containing regimen (i.e., cisplatin or carboplatin) in the metastatic/locally advanced or neoadjuvant/adjuvant setting.
- If the platinum containing regimen was administered in the adjuvant/neoadjuvant setting, progression on or after this treatment must be ≤ 12 months after treatment completion.
- Subject has previously received treatment with a programmed cell death protein 1 (PD-1) inhibitor or programmed death-ligand 1 (PD-L1) inhibitor (including, but not limited to, atezolizumab, pembrolizumab, durvalumab, avelumab and nivolumab) in the metastatic/locally advanced setting.
- Subject treated with a PD-1 or PD-L1 inhibitor in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or ≤ 3 months of therapy completion may be enrolled.
- Subject has exhausted available standard of care therapies for locally advanced or metastatic UC.
- Subject may have had any number of prior lines of therapy for locally advanced or metastatic UC.
- Subject has the following baseline laboratory data:
- absolute neutrophil count ≥ 1500/mm3
- platelet count ≥ 75 x 109/L
- hemoglobin ≥ 8 g/dL
- serum bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN for subjects with Gilbert's disease
- creatinine clearance (CrCl) ≥ 15 mL/min or ≥ 30 mL/min for subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 2 as estimated per institutional standards or as measured by 24 hour urine collection (glomerular filtration rate can also be used instead of CrCl)
- alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN or ≤ 3 x ULN for subjects with liver metastases
- Subject has ECOG performance status of 0, 1 or 2.
- +9 more criteria
You may not qualify if:
- Subject has ongoing sensory or motor neuropathy grade ≥ 2.
- Subject has ongoing clinically significant toxicity (grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery). Subject with hypothyroidism or panhypopituitarism related to treatment with PD-1 and PD-L1 inhibitors may be enrolled. Subject on hormone replacement therapy may be enrolled if on a stable dose.
- Subject has ongoing immunotherapy related myocarditis, colitis, uveitis or pneumonitis or other immunotherapy related toxicities requiring high doses of steroids (\> 20 mg/day of prednisone or equivalent).
- Subject has previously received EV or enrolled in an EV study or a study that included EV as one of the treatment options (even if the subject was not given EV).
- Subject is a candidate for any ongoing EV clinical studies.
- Subject has known hypersensitivity to EV or to any excipient contained in the drug formulation of EV.
- Subject completed radiotherapy, major surgery or prior anticancer therapy ≤ 2 weeks before first EV dose.
- Subject has history of uncontrolled diabetes mellitus ≤ 3 months of the first EV dose. Uncontrolled diabetes is defined as hemoglobin A1C (HbA1c) ≥ 8% or HbA1c between 7 and \< 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
- Subject is currently receiving systemic antimicrobial treatment for viral, bacterial or fungal infection at the time of first dose of EV. Routine antimicrobial prophylaxis is permitted.
- Subject has recent history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Classes III to IV that is not adequately treated and/or controlled at the time of first EV dose.
- Subject has other underlying medical condition that would impair the ability of the subject to receive or tolerate EV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Global Development, Inc.lead
- Seagen Inc.collaborator
Study Sites (15)
UCLA Hematology Oncology
Los Angeles, California, 90095, United States
John Wayne Cancer Institute
Santa Monica, California, 90404, United States
St. Joseph Heritage Medical Group
Santa Rosa, California, 95403, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32204, United States
Northwestern University Medical Center
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Community Hospital Anderson
Anderson, Indiana, 46011, United States
New England Cancer Specialists
Topsham, Maine, 04086, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
NYU Langone Health
New York, New York, 10016, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development, Inc.
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2019
First Posted
October 23, 2019
Last Updated
January 13, 2020
Record last verified: 2020-01