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

• ClinicalTrials.gov Identifier: NCT03219333
• Recruitment Status: Active, not recruiting
• First Posted: July 17, 2017
• Results First Posted: December 17, 2021
• Last Update Posted: June 15, 2022
• Sponsor: Astellas Pharma Inc
• Collaborator: Seagen Inc.
• Information provided by (Responsible Party): Astellas Pharma Inc

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Urologic Neoplasms; Renal Pelvis Neoplasms; Urothelial Cancer; Ureteral Neoplasms; Urethral Neoplasms	Drug: Enfortumab vedotin	Phase 2

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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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 219 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: single-arm, open-label, multi-cohort, multicenter study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 8, 2017
• Actual Primary Completion Date: October 27, 2020
• Estimated Study Completion Date: May 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) [ Time Frame: 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]). ]
   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.

Secondary Outcome Measures :

1. Duration of Objective Response (DOR) Per BICR [ Time Frame: 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]). ]
   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.
2. Progression-Free Survival (PFS) Per BICR [ Time Frame: 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]). ]
   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.
3. ORR Per Investigator Assessment [ Time Frame: 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]). ]
   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.
4. DOR Per Investigator Assessment [ Time Frame: 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]). ]
   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.
5. PFS Per Investigator Assessment [ Time Frame: 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]). ]
   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.
6. Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology) [ Time Frame: 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]). ]
   A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose.
7. Number of Participants With Treatment-Emergent Laboratory Abnormalities (Serum Chemistry) [ Time Frame: 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]). ]
   A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose.
8. Incidence of Antitherapeutic Antibody (ATA) [ Time Frame: 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]). ]
   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.
9. Disease Control Rate at 16 Weeks (DCR16) Per BICR [ Time Frame: Up to Week 16. Data cut-off date 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2. ]
   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.
10. DCR16 Per Investigator Assessment [ Time Frame: Up to Week 16. Data cut-off date 01 Mar 2019 for cohort 1 and 08 Sept 2020 for cohort 2. ]
    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.
11. Overall Survival (OS) at Time of Primary Analysis [ Time Frame: 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]). ]
    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.
12. Number of Participants With Adverse Events (AEs) at Time of Primary Analysis [ Time Frame: 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]). ]
    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.
13. Pharmacokinetics (PK) Parameter for Enfortumab Vedotin: Maximum Concentration (Cmax) (Serum) [ Time Frame: 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. ]
    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.
14. PK Parameter for Enfortumab Vedotin: Time to Maximum Concentration (Tmax) (Serum) [ Time Frame: 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. ]
    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.
15. PK Parameter for Enfortumab Vedotin: Area Under Concentration-Time Curve (AUC) (Serum) [ Time Frame: 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). ]
    AUC was derived from the PK blood samples collected.
16. PK Parameter for Free Monomethyl Auristatin E (MMAE): Cmax (Plasma) [ Time Frame: 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. ]
    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.
17. PK Parameter for Free MMAE: Tmax (Plasma) [ Time Frame: 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. ]
    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.
18. PK Parameter for Free MMAE: AUC (Plasma) [ Time Frame: 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). ]
    AUC was derived from the PK blood samples collected.
19. PK Parameter for Total Antibody (TAb): Cmax (Serum) [ Time Frame: 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. ]
    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.
20. PK Parameter for TAb: Tmax (Serum) [ Time Frame: 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. ]
    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.
21. PK Parameter for TAb: AUC (Serum) [ Time Frame: 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). ]
    AUC was derived from the PK blood samples collected.
22. Overall Survival (OS) [ Time Frame: Updated Time Frame description will be provided at study completion. ]
23. Number of Participants With Adverse Events (AEs) [ Time Frame: Updated Time Frame description will be provided at study completion. ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Alaska

Alaska Urological Institute

Anchorage, Alaska, United States, 99503

United States, Arizona

Arizona Oncology Associates, PC - HAL

Goodyear, Arizona, United States, 85395

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85054

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, United States, 85710

United States, California

Keck Medical Center / University of Southern California

Los Angeles, California, United States, 90033

Keck Medical Center / Newport Beach

Newport Beach, California, United States, 92663

Kaiser Permanente Oakland

Oakland, California, United States, 94611

Chao Family Comprehensive Cancer Center University of California Irvine

Orange, California, United States, 92868

University of California Irvine - Newport

Orange, California, United States, 92868

Kaiser Permanente Roseville

Roseville, California, United States, 95661

University of California Davis

Sacramento, California, United States, 95817

Kaiser Permanente Sacramento

Sacramento, California, United States, 95825

Kaiser Permanente San Francisco

San Francisco, California, United States, 94115

Kaiser Permanente San Jose

San Jose, California, United States, 95119

Kaiser Permanente San Leandro

San Leandro, California, United States, 94577

Kaiser Permanente Santa Clara

Santa Clara, California, United States, 95051

Kaiser Permanente South San Francisco

South San Francisco, California, United States, 94080

Kaiser Permanente Medical Center Northern California

Vallejo, California, United States, 94589

Kaiser Permanente Walnut Creek

Walnut Creek, California, United States, 94596

United States, Colorado

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, United States, 80012

United States, Connecticut

Yale Cancer Center

New Haven, Connecticut, United States, 06520

United States, Florida

Ocala Oncology Center

Ocala, Florida, United States, 34474

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States, 33612

United States, Georgia

Augusta University

Augusta, Georgia, United States, 30912

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637-1470

United States, Kentucky

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, United States, 40207

United States, Maryland

Johns Hopkins Medical Center

Baltimore, Maryland, United States, 21231

Maryland Oncology Hematology, P.A.

Rockville, Maryland, United States, 20850

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Michigan

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, United States, 48201

United States, Missouri

Washington University in St Louis

Saint Louis, Missouri, United States, 63110

United States, Nevada

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

United States, New York

New York Oncology Hematology, P.C.

Albany, New York, United States, 12208

New York University (NYU) Cancer Institute

New York, New York, United States, 10016

Mount Sinai Medical Center

New York, New York, United States, 10029

Columbia University Medical Center

New York, New York, United States, 10032

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

James P. Wilmot Cancer Center / University of Rochester Medical Center

Rochester, New York, United States, 14642

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

James Cancer Hospital / Ohio State University

Columbus, Ohio, United States, 43210

United States, Oregon

Northwest Cancer Specialists, P.C.

Tigard, Oregon, United States, 97223

United States, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

United States, South Carolina

Prisma Health

Greenville, South Carolina, United States, 29615

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37204

United States, Texas

Texas Oncology - Austin Central

Austin, Texas, United States, 78731

Texas Oncology - Baylor Sammons Cancer Center

Dallas, Texas, United States, 75246

Houston Methodist Cancer Center

Houston, Texas, United States, 77030

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22903

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States, 22031

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

United States, Washington

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, United States, 98109-1023

France

Site FR33001

Villejuif-Cedex-France, France

Germany

Site DE49004

Muenster, Germany

Site DE49001

Tübingen, Germany

Italy

Site IT39001

Milano, Italy

Site IT39003

Terni, Italy

Japan

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

Korea, Republic of

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

Netherlands

Site NL31001

Amsterdam, Netherlands

Spain

Site ES34002

Barcelona, Spain

Site ES34005

Barcelona, Spain

Site ES34003

Santander, Spain

Site ES34004

Sevilla, Spain

Sponsors and Collaborators

Astellas Pharma Inc

Seagen Inc.

Investigators

• Study Director: Janet Trowbridge, MD, PhD; Seagen Inc.

  Study Documents (Full-Text)

Documents provided by Astellas Pharma Inc:

Study Protocol  [PDF] December 5, 2019

Statistical Analysis Plan  [PDF] September 17, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Astellas Pharma Inc
• ClinicalTrials.gov Identifier: NCT03219333
• Other Study ID Numbers: SGN22E-001
• First Posted: July 17, 2017
• Results First Posted: December 17, 2021
• Last Update Posted: June 15, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc:

Enfortumab vedotin; Metastatic Urothelial Cancer; ASG-22CE; Locally Advanced Urothelial Cancer; Antibody-Drug Conjugate; Nectin-4; Platinum-naïve; Cisplatin-ineligible; Antineoplastic Agents; Drug Therapy; ASG-22ME

Additional relevant MeSH terms:

Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Carcinoma, Transitional Cell; Ureteral Neoplasms; Urethral Neoplasms; Pelvic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urinary Bladder Diseases; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ureteral Diseases; Urethral Diseases