Lay Title: Enfortumab vedotin and pembrolizumab, with or without chemotherapy, vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer
Technical Title: An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab with or without chemotherapy, versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer
Disease Type: Metastatic Urothelial cancer
Basic information: The purpose of this study is to compare the combination of Enfortumav Vedotin with Pembrolizumab to standard of care chemotherapy in patients with metastatic urothelial cancer
Research Procedures (not a complete list): Once you begin treatment, you will need to come to clinic weekly, 2 weeks on, one week off. More details upon entering study will be provided.
Eligibility Criteria (not a complete list):
a.Subjects that received neoadjuvant chemotherapy with recurrence >12 months from completion of therapy are permitted.
b.Subjects that received adjuvant chemotherapy following cystectomy with recurrence >12 months from completion of therapy are permitted
Subjects will be considered cisplatin-ineligible, and will receive carboplatin, if they meet at least one of the following criteria:
Subjects with a GFR ≥50 mL/min and no other cisplatin ineligibility criteria may be considered cisplatin-eligible based on the investigator’s clinical judgment.
ii.ECOG or WHO performance status of 2
iii.NCI CTCAE Grade ≥2 audiometric hearing loss
iv.NYHA Class III heart failure
For More Detailed Information, Contact:
ClinicalTrials.gov Identifier: NCT04223856