A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Completed · Phase 2

Conditions studied: Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms, Renal Pelvis Neoplasms, Urothelial Cancer, Ureteral Neoplasms, Urethral Neoplasms

In brief

This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect. Patients who sign up for this trial must also fall into one of these categories: * Patients have already received treatment with platinum-containing chemotherapy * Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.

Key facts

Study ID

NCT03219333

Run by

Astellas Pharma Inc

People needed

219

Starts

2017-10-08

Expected to finish

2023-07-28

Last updated by the study team

2024-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Oncology Associates, PC - HAL — Goodyear, Arizona, United States
• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
• Keck Medical Center / University of Southern California — Los Angeles, California, United States
• Keck Medical Center / Newport Beach — Newport Beach, California, United States
• Kaiser Permanente Oakland — Oakland, California, United States
• Chao Family Comprehensive Cancer Center University of California Irvine — Orange, California, United States
• University of California Irvine - Newport — Orange, California, United States
• Kaiser Permanente Roseville — Roseville, California, United States
• University of California Davis — Sacramento, California, United States
• Kaiser Permanente Sacramento — Sacramento, California, United States
• Kaiser Permanente San Francisco — San Francisco, California, United States
• Kaiser Permanente San Jose — San Jose, California, United States
• Kaiser Permanente San Leandro — San Leandro, California, United States
• Kaiser Permanente Santa Clara — Santa Clara, California, United States
• Kaiser Permanente South San Francisco — South San Francisco, California, United States
• Kaiser Permanente Medical Center Northern California — Vallejo, California, United States
• Kaiser Permanente Walnut Creek — Walnut Creek, California, United States
• Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Ocala Oncology Center — Ocala, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Augusta University — Augusta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Alaska Urological Institute — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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