Bladder Cancer Clinical Trial

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

Summary

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.

View Full Description

Full Description

Japan Pharmaceuticals and Medical Devices Agency (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 enfortumab vedotin.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

219

Study ID:

NCT03219333

Recruitment Status:

Active, not recruiting

Sponsor:

Astellas Pharma Inc

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There are 53 Locations for this study

See Locations Near You

Alaska Urological Institute
Anchorage Alaska, 99503, United States
Arizona Oncology Associates, PC - HAL
Goodyear Arizona, 85395, United States
Mayo Clinic Arizona
Phoenix Arizona, 85054, United States
Arizona Oncology Associates, PC - HOPE
Tucson Arizona, 85710, United States
Keck Medical Center / University of Southern California
Los Angeles California, 90033, United States
Keck Medical Center / Newport Beach
Newport Beach California, 92663, United States
Kaiser Permanente Oakland
Oakland California, 94611, United States
Chao Family Comprehensive Cancer Center University of California Irvine
Orange California, 92868, United States
University of California Irvine - Newport
Orange California, 92868, United States
Kaiser Permanente Roseville
Roseville California, 95661, United States
University of California Davis
Sacramento California, 95817, United States
Kaiser Permanente Sacramento
Sacramento California, 95825, United States
Kaiser Permanente San Francisco
San Francisco California, 94115, United States
Kaiser Permanente San Jose
San Jose California, 95119, United States
Kaiser Permanente San Leandro
San Leandro California, 94577, United States
Kaiser Permanente Santa Clara
Santa Clara California, 95051, United States
Kaiser Permanente South San Francisco
South San Francisco California, 94080, United States
Kaiser Permanente Medical Center Northern California
Vallejo California, 94589, United States
Kaiser Permanente Walnut Creek
Walnut Creek California, 94596, United States
Rocky Mountain Cancer Centers - Aurora
Aurora Colorado, 80012, United States
Yale Cancer Center
New Haven Connecticut, 06520, United States
Ocala Oncology Center
Ocala Florida, 34474, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Augusta University
Augusta Georgia, 30912, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Norton Cancer Institute, St. Matthews Campus
Louisville Kentucky, 40207, United States
Johns Hopkins Medical Center
Baltimore Maryland, 21231, United States
Maryland Oncology Hematology, P.A.
Rockville Maryland, 20850, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute / Wayne State University
Detroit Michigan, 48201, United States
Washington University in St Louis
Saint Louis Missouri, 63110, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
New York Oncology Hematology, P.C.
Albany New York, 12208, United States
New York University (NYU) Cancer Institute
New York New York, 10016, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
James P. Wilmot Cancer Center / University of Rochester Medical Center
Rochester New York, 14642, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
James Cancer Hospital / Ohio State University
Columbus Ohio, 43210, United States
Northwest Cancer Specialists, P.C.
Tigard Oregon, 97223, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Prisma Health
Greenville South Carolina, 29615, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37204, United States
Texas Oncology - Austin Central
Austin Texas, 78731, United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
Houston Methodist Cancer Center
Houston Texas, 77030, United States
University of Virginia
Charlottesville Virginia, 22903, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Seattle Cancer Care Alliance / University of Washington
Seattle Washington, 98109, United States
Site FR33001
Villejuif-Cedex-France , , France
Site DE49004
Muenster , , Germany
Site DE49001
Tübingen , , Germany
Site IT39001
Milano , , Italy
Site IT39003
Terni , , Italy
Site JP81001
Hirosaki Aomori, , Japan
Site JP81004
Tsukuba Ibaraki, , Japan
Site JP81002
Morioka Iwate, , Japan
Site JP81008
Osakasayama Osaka, , Japan
Site JP81006
Shinjuku-ku Tokyo, , Japan
Site JP81009
Ube Yamaguchi, , Japan
Site JP81005
Chiba , , Japan
Site JP81011
Fukuoka , , Japan
Site JP81012
Fukuoka , , Japan
Site JP81003
Nigata , , Japan
Site JP81007
Osaka , , Japan
Site JP81010
Tokushima , , Japan
Site KR82005
Daejeon , , Korea, Republic of
Site KR82003
Seongnam-si , , Korea, Republic of
Site KR82001
Seoul , , Korea, Republic of
Site KR82002
Seoul , , Korea, Republic of
Site KR82004
Seoul , , Korea, Republic of
Site NL31001
Amsterdam , , Netherlands
Site ES34002
Barcelona , , Spain
Site ES34005
Barcelona , , Spain
Site ES34003
Santander , , Spain
Site ES34004
Sevilla , , Spain

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

219

Study ID:

NCT03219333

Recruitment Status:

Active, not recruiting

Sponsor:


Astellas Pharma Inc

How clear is this clinincal trial information?

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