A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
- Histologically documented urothelial carcinoma (squamous differentiation or mixed cell types allowed).
- Metastatic disease or locally advanced disease that is not resectable.
- Must have received prior treatment with a CPI in the locally advanced or metastatic urothelial cancer setting. A CPI is defined as a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Patients who received CPI therapy in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or within 3 months of therapy completion are eligible.
- Must either have prior treatment with platinum-containing chemotherapy (Cohort 1) or be platinum-naïve and ineligible for treatment with cisplatin at time of enrollment (Cohort 2).
- Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
- Tumor tissue samples must be available for submission to the sponsor prior to study treatment.
- Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1 for Cohort 1 or ≤2 for Cohort 2.
- Anticipated life expectancy of ≥3 months as assessed by the investigator.
- Ongoing sensory or motor neuropathy Grade ≥2.
- Active central nervous system (CNS) metastases.
- Immunotherapy related myocarditis, colitis, uveitis, or pneumonitis.
- Prior enrollment in an enfortumab vedotin study or prior treatment with other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
- Uncontrolled tumor-related pain or impending spinal cord compression.
Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial
cancer. The study will continue as a post marketing study in Japan.
This study will examine the safety and anticancer activity of enfortumab vedotin given
intravenously to patients with locally advanced or metastatic urothelial cancer who
previously received a CPI and either previously received platinum-containing chemotherapy
(Cohort 1) or are platinum-naïve and cisplatin-ineligible (Cohort 2). Patients who received
platinum in the adjuvant/neoadjuvant setting and did not progress within 12 months of
completion will be considered platinum-naïve. Approximately 100 patients are expected to be
enrolled in each cohort. The primary goal of the study is to determine the confirmed ORR of
Trial Phase Phase II
Trial Type Treatment
Astellas Pharma Global Development, Inc.
- Primary ID SGN22E-001
- Secondary IDs NCI-2017-01866
- Clinicaltrials.gov ID NCT03219333