A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer (EV-201)

A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy

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.

Study Overview

• Status: Completed
• Conditions: Urologic Neoplasms; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Ureteral Neoplasms; Urothelial Cancer; Urethral Neoplasms; Renal Pelvis Neoplasms
• Intervention / Treatment: Drug: Enfortumab vedotin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• France
  • Villejuif-Cedex-France, France
    • Site FR33001
• Germany
  • Muenster, Germany
    • Site DE49004
  • Tübingen, Germany
    • Site DE49001
• Italy
  • Milano, Italy
    • Site IT39001
  • Terni, Italy
    • Site IT39003
• Japan
  • Chiba, Japan
    • Site JP81005
  • Fukuoka, Japan
    • Site JP81011
  • Fukuoka, Japan
    • Site JP81012
  • Nigata, Japan
    • Site JP81003
  • Osaka, Japan
    • Site JP81007
  • Tokushima, Japan
    • Site JP81010
  • Aomori
    • Hirosaki, Aomori, Japan
      • Site JP81001
  • Ibaraki
    • Tsukuba, Ibaraki, Japan
      • Site JP81004
  • Iwate
    • Morioka, Iwate, Japan
      • Site JP81002
  • Osaka
    • Osakasayama, Osaka, Japan
      • Site JP81008
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan
      • Site JP81006
  • Yamaguchi
    • Ube, Yamaguchi, Japan
      • Site JP81009
• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Site KR82005
  • Seongnam-si, Korea, Republic of
    • Site KR82003
  • Seoul, Korea, Republic of
    • Site KR82001
  • Seoul, Korea, Republic of
    • Site KR82002
  • Seoul, Korea, Republic of
    • Site KR82004
• Netherlands
  • Amsterdam, Netherlands
    • Site NL31001
• Spain
  • Barcelona, Spain
    • Site ES34002
  • Barcelona, Spain
    • Site ES34005
  • Santander, Spain
    • Site ES34003
  • Sevilla, Spain
    • Site ES34004
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Alaska Urological Institute
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Arizona Oncology Associates, PC - HAL
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
    • Tucson, Arizona, United States, 85710
      • Arizona Oncology Associates, PC - HOPE
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medical Center / University of Southern California
    • Newport Beach, California, United States, 92663
      • Keck Medical Center / Newport Beach
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center University of California Irvine
    • Orange, California, United States, 92868
      • University of California Irvine - Newport
    • Roseville, California, United States, 95661
      • Kaiser Permanente Roseville
    • Sacramento, California, United States, 95817
      • University of California Davis
    • Sacramento, California, United States, 95825
      • Kaiser Permanente Sacramento
    • San Francisco, California, United States, 94115
      • Kaiser Permanente San Francisco
    • San Jose, California, United States, 95119
      • Kaiser Permanente San Jose
    • San Leandro, California, United States, 94577
      • Kaiser Permanente San Leandro
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Santa Clara
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente South San Francisco
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Medical Center Northern California
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente Walnut Creek
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers - Aurora
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Cancer Center
  • Florida
    • Ocala, Florida, United States, 34474
      • Ocala Oncology Center
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center & Research Institute
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute, St. Matthews Campus
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Medical Center
    • Rockville, Maryland, United States, 20850
      • Maryland Oncology Hematology, P.A.
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute / Wayne State University
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St Louis
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • New York
    • Albany, New York, United States, 12208
      • New York Oncology Hematology, P.C.
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • New York, New York, United States, 10016
      • New York University (NYU) Cancer Institute
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center / University of Rochester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • James Cancer Hospital / Ohio State University
  • Oregon
    • Tigard, Oregon, United States, 97223
      • Northwest Cancer Specialists, P.C.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health
  • Tennessee
    • Nashville, Tennessee, United States, 37204
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology - Austin Central
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Sammons Cancer Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Cancer Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98109-1023
      • Seattle Cancer Care Alliance / University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enfortumab vedotin; Enfortumab vedotin on days 1, 8 and 15 every 28 days	Drug: Enfortumab vedotin; Intravenous (IV) infusion on days 1, 8 and 15 every 28 days; Other Names: ASG-22CE; ASG-22ME

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)	The percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.	Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Objective Response (DOR) Per BICR	The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause, whichever comes first. CR and PR are defined in ORR per BICR endpoint. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression. DOR was analyzed using Kaplan-Meier methodology.	Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
Progression-Free Survival (PFS) Per BICR	The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD is defined in the DOR per BICR endpoint.	Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
ORR Per Investigator Assessment	The percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CR and PR are defined in the ORR per BICR endpoint.	Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
DOR Per Investigator Assessment	The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD or to death due to any cause, whichever comes first. CR and PR are defined in ORR per BICR endpoint. PD is defined in the DOR per BICR endpoint.	Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
PFS Per Investigator Assessment	The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD is defined in the DOR per BICR endpoint.	Up to data cut-off date of 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2 (Cohort 1 median follow-up time: 10.15 months [range 0.49, 16.46]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology)	A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose.	Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months]).
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Serum Chemistry)	A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose.	Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]).
Incidence of Antitherapeutic Antibody (ATA)	Participants who were tested positive for ATA at any time post-baseline were considered to be transiently positive or persistently positive if >=2 consecutive samples were confirmed as positive.	Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]).
Disease Control Rate at 16 Weeks (DCR16) Per BICR	Percentage of participants with CR, PR, or stable disease (SD) at Week 16 visit. CR and PR are defined in ORR per BICR endpoint. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.	Up to Week 16. Data cut-off date 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2.
DCR16 Per Investigator Assessment	Percentage of participants with CR, PR, or stable disease (SD) at Week 16 visit. CR and PR are defined in ORR per BICR endpoint. SD is defined in DCR16 per BICR endpoint.	Up to Week 16. Data cut-off date 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2.
Overall Survival (OS) at Time of Primary Analysis	OS is defined as the time from first dose of enfortumab vedotin to death from any cause. This data is part of a pre-specified primary analysis. Updated data will be provided in a separate outcome measure upon study completion.	Up to data cut-off date of 08 Sept 2020 (Cohort 1 median follow-up time: 28.4 months [range 0.49, 32.62]. Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]).
Number of Participants With Adverse Events (AEs) at Time of Primary Analysis	An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as a newly occurring or worsening AE after the first dose of study treatment and within 30 days after the last dose of study treatment. This data is part of a pre-specified primary analysis. Updated data will be provided in a separate outcome measure upon study completion.	Up to data cut-off date of 08 Sept 2020 (The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months]).
Pharmacokinetics (PK) Parameter for Enfortumab Vedotin: Maximum Concentration (Cmax) (Serum)	Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.	Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
PK Parameter for Enfortumab Vedotin: Time to Maximum Concentration (Tmax) (Serum)	Tmax was derived from the PK blood samples collected. Time of maximum concentration corresponds to the end of infusion sample time. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.	Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
PK Parameter for Enfortumab Vedotin: Area Under Concentration-Time Curve (AUC) (Serum)	AUC was derived from the PK blood samples collected.	Up to data cut-off date of 08 Sept 2020. AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose).
PK Parameter for Free Monomethyl Auristatin E (MMAE): Cmax (Plasma)	Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.	Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
PK Parameter for Free MMAE: Tmax (Plasma)	Tmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.	Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
PK Parameter for Free MMAE: AUC (Plasma)	AUC was derived from the PK blood samples collected.	Up to data cut-off date of 08 Sept 2020. AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose).
PK Parameter for Total Antibody (TAb): Cmax (Serum)	Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.	Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
PK Parameter for TAb: Tmax (Serum)	Tmax was derived from the PK blood samples collected. Time of maximum concentration corresponds to the end of infusion sample time. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.	Up to data cut-off date of 08 Sept 2020. Collected during cycle 1 and 2 of treatment (approximately 2 months) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22.
PK Parameter for TAb: AUC (Serum)	AUC was derived from the PK blood samples collected.	Up to data cut-off date of 08 Sept 2020. AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose).
Overall Survival (OS)		Updated Time Frame description will be provided at study completion.
Number of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as a newly occurring or worsening AE after the first dose of study treatment and within 30 days after the last dose of study treatment.	Updated Time Frame description will be provided at study completion.

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Seagen Inc.
• Investigators: Study Director: Janet Trowbridge, MD, PhD, Seagen Inc.

Publications and helpful links

General Publications

• McGregor B, O'Donnell PH, Balar A, Petrylak D, Rosenberg J, Yu EY, Quinn DI, Heath EI, Campbell M, Hepp Z, McKay C, Steinberg J, Regnault A, Mazerolle F, Galsky MD. Health-related Quality of Life of Patients with Locally Advanced or Metastatic Urothelial Cancer Treated with Enfortumab Vedotin after Platinum and PD-1/PD-L1 Inhibitor Therapy: Results from Cohort 1 of the Phase 2 EV-201 Clinical Trial. Eur Urol. 2022 May;81(5):515-522. doi: 10.1016/j.eururo.2022.01.032. Epub 2022 Feb 12.
• Yu EY, Petrylak DP, O'Donnell PH, Lee JL, van der Heijden MS, Loriot Y, Stein MN, Necchi A, Kojima T, Harrison MR, Hoon Park S, Quinn DI, Heath EI, Rosenberg JE, Steinberg J, Liang SY, Trowbridge J, Campbell M, McGregor B, Balar AV. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):872-882. doi: 10.1016/S1470-2045(21)00094-2. Epub 2021 May 12. Erratum In: Lancet Oncol. 2021 Jun;22(6):e239.
• Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, Galsky MD, Hahn NM, Gartner EM, Pinelli JM, Liang SY, Melhem-Bertrandt A, Petrylak DP. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol. 2019 Oct 10;37(29):2592-2600. doi: 10.1200/JCO.19.01140. Epub 2019 Jul 29.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2017
• Primary Completion (Actual): October 27, 2020
• Study Completion (Actual): July 28, 2023

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Drug Therapy; Antibody-Drug Conjugate; Antineoplastic Agents; Enfortumab vedotin; ASG-22CE; Nectin-4; ASG-22ME; Metastatic Urothelial Cancer; Locally Advanced Urothelial Cancer; Platinum-naïve; Cisplatin-ineligible
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Ureteral Diseases; Urethral Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasms; Urinary Bladder Neoplasms; Pelvic Neoplasms; Urologic Neoplasms; Carcinoma, Transitional Cell; Ureteral Neoplasms; Urethral Neoplasms
• Other Study ID Numbers: SGN22E-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No