Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
EV-302
An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
6 other identifiers
interventional
886
25 countries
260
Brief Summary
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2020
Longer than P75 for phase_3
260 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2020
CompletedFirst Posted
Study publicly available on registry
January 10, 2020
CompletedStudy Start
First participant enrolled
March 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2023
CompletedResults Posted
Study results publicly available
September 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
ExpectedMay 29, 2026
May 1, 2026
3.4 years
January 6, 2020
July 30, 2024
May 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR)
PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis.
From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months)
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause. In the absence of death, OS was censored at the date the participant was last known to be alive. Kaplan-Meier method was used for analysis.
From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months)
Secondary Outcomes (19)
Percentage of Participants With Objective Response Rate (ORR) Per RECIST v1.1 by BICR
From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)
Time to Pain Progression (TTPP)
From the date of randomization to date of pain progression (maximum up to approximately 7.4 years)
Change From Baseline in Worst Pain Using BPI-SF at Week 26
Baseline, Week 26
PFS Per RECIST v1.1 by Investigator Assessment
From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 7.4 years)
ORR Per RECIST v1.1 by Investigator Assessment
From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)
- +14 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALEnfortumab vedotin + pembrolizumab
Arm B
ACTIVE COMPARATORGemcitabine + cisplatin or carboplatin
Interventions
Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle
Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle
Eligibility Criteria
You may qualify if:
- Histologically documented, unresectable locally advanced or metastatic urothelial carcinoma
- Measurable disease by investigator assessment according to RECIST v1.1
- Participants with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy
- Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:
- Participants that received neoadjuvant chemotherapy with recurrence \>12 months from completion of therapy are permitted
- Participants that received adjuvant chemotherapy following cystectomy with recurrence \>12 months from completion of therapy are permitted
- Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment
- Archival tumor tissue comprising muscle-invasive urothelial carcinoma or a biopsy of metastatic urothelial carcinoma must be provided for PD-L1 testing prior to randomization
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- Adequate hematologic and organ function
You may not qualify if:
- Previously received enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugate (ADCs)
- Received prior treatment with a programmed cell death ligand-1 (PD-(L)-1) inhibitor for any malignancy, including earlier stage urothelial cancer (UC), defined as a PD-1 inhibitor or PD-L1 inhibitor
- Received prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor
- Uncontrolled diabetes
- Estimated life expectancy of less than 12 weeks
- Active central nervous system (CNS) metastases
- Ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1 or returned to baseline
- Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted.
- Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
- History of another invasive malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy
- Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class IV within 6 months prior to randomization
- Receipt of radiotherapy within 2 weeks prior to randomization
- Received major surgery (defined as requiring general anesthesia and \>24 hour inpatient hospitalization) within 4 weeks prior to randomization
- Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin
- Active keratitis or corneal ulcerations
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Global Development, Inc.lead
- Merck Sharp & Dohme LLCcollaborator
- Seagen Inc.collaborator
Study Sites (260)
Ironwood Cancer & Research Centers - Chandler
Chandler, Arizona, 85224, United States
Arizona Oncology Associates PD - HOPE
Tucson, Arizona, 85710, United States
Providence St Joseph Medical Center
Burbank, California, 91505, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
University of California Los Angeles Medical Center
Los Angeles, California, 90095, United States
University of California Irvine - Newport
Orange, California, 92868, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80012, United States
University of Colorado Hospital / University of Colorado
Aurora, Colorado, 80045, United States
Cancer Centers of Colorado - Denver
Denver, Colorado, 80218, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
Lombardi Cancer Center / Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Georgia Cancer Specialists / Northside Hospital Cancer Institute
Marietta, Georgia, 30060, United States
Louisiana State University/ East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
Maine Health Cancer Care
Biddeford, Maine, 04046, United States
Johns Hopkins Medical Center
Baltimore, Maryland, 21231, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
New Mexico Cancer Center
Albuquerque, New Mexico, 87109, 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
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Vidant Medical Center
Greenville, North Carolina, 27834, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Toledo Clinic Cancer Center
Toledo, Ohio, 43623, United States
Hillman Cancer Center / University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Saint Francis Hospital / Bon Secours - South Carolina
Greenville, South Carolina, 29607, United States
West Cancer Center & Research Institute
Germantown, Tennessee, 38138, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
UT Health East Texas Hope Cancer Center
Tyler, Texas, 75701, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109, United States
Site AR54008
Buenos Aire, C1019ABS, Argentina
Site AR54011
CABA, C1426ANZ, Argentina
Site AR54005
Córdoba, X5004FHP, Argentina
Site AR54006
La Rioja, 5300, Argentina
Site AR54004
Mendoza, M5500AYB, Argentina
Site AR54001
Rosario, 2000, Argentina
Site AR54002
San Miguel, T400GTB, Argentina
Site AR54012
San Miguel de Tucumán, T4000IAK, Argentina
Site AR54003
Viedma, 8500, Argentina
Site AU61003
Box Hill, 3128, Australia
Site AUS61001
Douglas, 4814, Australia
Site AUS61004
Heidelberg, 3084, Australia
Site AUS61002
Macquarie Park, 2109, Australia
Site AUS61006
South Australia, 5112, Australia
Site AU61005
South Brisbane, 4101, Australia
Site BE32003
Brussels, 1200, Belgium
Site BE32002
Ghent, 9000, Belgium
Site BE32001
Liège, 4000, Belgium
Site BE32007
Lueven, 3000, Belgium
Site BE32006
Roeselare, 8800, Belgium
Site CA11004
Calgary, Alberta, T2N 4N2, Canada
Site CA11003
Edmonton, Alberta, T6G 1Z2, Canada
Site CA11006
Vancouver, British Columbia, V5Z 4E6, Canada
Site CA11002
Hamilton, Ontario, L8V 1C3, Canada
Site CA11009
London, Ontario, N6A 5A5, Canada
Site CA11011
Oshawa, Ontario, L1G 2B9, Canada
Site CA11012
Toronto, Ontario, M4N 3M5, Canada
Site CA11005
Toronto, Ontario, M5G 2M9, Canada
Site CA11010
Montreal, Quebec, H2X 0A9, Canada
Site CA11001
Montreal, Quebec, H3T 1E2, Canada
Site CA11008
Québec, G1R 2J6, Canada
Site CN86009
Beijing, 100021, China
Site CN86001
Beijing, 100036, China
Site CN86004
Beijing, 100050, China
Site CN86005
Beijing, 100191, China
Site CN86015
Bengbu, 233000, China
Site CN86003
Changchun, 130021, China
Site CN86006
Changsha, 410013, China
Site CN86016
Changsha, 410013, China
Site CN86010
Chengdu, 610041, China
Site CN86024
Chongqing, 400030, China
Site CN86007
Chongqing, 400038, China
Site CN86028
Fuzhou, 350005, China
Site CN86002
Guangzhou, 510120, China
Site CN86020
Gunagzhou, 510280, China
Site CN86018
Hangzhou, 0571, China
Site CN86013
Hangzhou, 310014, China
Site CN86022
Hangzhou, 310016, China
Site CN86025
Hefei, 400030, China
Site CN86027
Jinan, 250021, China
Site CN86017
Nanjing, 210008, China
Site CN86012
Nanjing, 210029, China
Site CN86021
Ningbo, 315016, China
Site CN86014
Shanghai, 200040, China
Site CN86011
Shenyang, 110022, China
Site CN86023
Tianjin, 300052, China
Site CN86019
Tianjin, 453000, China
Site CN86029
Wenzhou, 325000, China
Site CN86008
Wuhan, 430030, China
Site CN86030
Xicheng District, 100034, China
Site CN86026
Xuzhou, 221009, China
Site CZ42006
Brno, 656 91, Czechia
Site CZ42001
Hradec Králové, 500 05, Czechia
Site CZ42004
Olomouc, 779 00, Czechia
Site CZ42005
Praha 4-Krc, 140 59, Czechia
Site DK45001
Aalborg, 9100, Denmark
Site DK45003
Aarhus N, 8200, Denmark
Site FR33014
Bordeaux, 33000, France
Site FR33016
Lyon, 69373, France
Site FR33003
Nice, 06189, France
Site FR33020
Pierre-Bénite, 69495, France
Site FR33013
Strasbourg, 67200, France
Site FR33017
Tours, 37044, France
Site FR33011
Villejuif-Cedex-France, 94805, France
Site DE49003
Berlin, 10117, Germany
Site DE49013
Bielefeld, 33611, Germany
Site DE49016
Düsseldorf, 40225, Germany
Site DE49014
Erlangen, 91054, Germany
Site DE49011
Essen, 45147, Germany
Site DE49007
Frankfurt am Main, 60488, Germany
Site DE49015
Göttingen, 37099, Germany
Site DE49005
Heidelberg, 69120, Germany
Site DE49009
Herne, 44649, Germany
Site DE49006
Jena, 07747, Germany
Site DE49001
Lübeck, 23538, Germany
Site DE49008
Magdeburg, 39120, Germany
Site DE49012
Mannheim, 68167, Germany
Site DE49002
München, 81675, Germany
Site DE49004
Tübingen, 72076, Germany
Site DE49010
Ulm, 89081, Germany
Site HU36003
Budapest, 1083, Hungary
Site HU36002
Budapest, 1122, Hungary
Site HU36006
Debrecen, 4032, Hungary
Site HU36001
Nyíregyháza, 4400, Hungary
Site HU36005
Szolnok, 5004, Hungary
Site IL97203
Beersheba, 84101, Israel
Site IL97201
Haifa, 31096, Israel
Site IL97209
Holon, 58100, Israel
Site IL97206
Jerusalem, 91120, Israel
Site IL97202
Kfar Saba, 44281, Israel
Site IL97208
Petah Tikva, 49414, Israel
Site IL97211
Rehovot, 76100, Israel
Site IL97210
Tel Aviv, 64239, Israel
Site IL97204
Tel Litwinsky, 52621, Israel
Site IL97205
Ẕerifin, 70300, Israel
Site IT39005
Areezo, 52100, Italy
Site IT39008
Candiolo, 10060, Italy
Site IT39009
Cremona, 26100, Italy
Site IT39006
Genova, 16132, Italy
Site IT39003
Meldola, 47014, Italy
Site IT39014
Milan, 20132, Italy
Site IT39007
Milan, 20141, Italy
Site IT39004
Pisa, 56126, Italy
Site IT39002
Terni, 05100, Italy
Site IT39011
Torrette, 60126, Italy
Site IT39001
Verona, 37134, Italy
Site JP81002
Bunkyō City, Japan
Site JP81009
Chiba, Japan
Site JP81018
Chiba, Japan
Site JP81013
Fukuoka, Japan
Site JP81020
Fukuoka, Japan
Site JP81011
Hirosaki, Japan
Site JP81006
Kawasaki-shi, Japan
Site JP81001
Kōtoku, Japan
Site JP81017
Kyoto, Japan
Site JP81015
Niigata, Japan
Site JP81005
Okayama, Japan
Site JP81008
Osaka, Japan
Site JP81016
Osakasayama-Shi, Japan
Site JP81007
Sapporo, Japan
Site JP81012
Sendai, Japan
Site JP81014
Tokushima, Japan
Site JP81019
Tokyo, Japan
Site JP81003
Toyama, Japan
Site JP81004
Tsukuba, Japan
Site JP81010
Ube, Japan
Site NL31002
Amsterdam, 1066 CX, Netherlands
Site NL31001
Amsterdam, 1081 HV, Netherlands
Site NL31005
Amsterdam, Noord-Holland, 1066 CX, Netherlands
Site NL31007
Leeuwarden, 8934 AD, Netherlands
Site NL31004
Nieuwegein, 3435 CM, Netherlands
Site NL31003
Rotterdam, 3075 EA, Netherlands
Site NL31006
Utrecht, 3584 CX, Netherlands
Site PL48002
Warsaw, 01-748, Poland
Site RU70016
Arkhangelsk, 163045, Russia
Site RU70013
Barnaul, 656049, Russia
Site RU70020
Ivanovo, 153040, Russia
Site RU70014
Krasnoyarsk, 660133, Russia
Site RU70006
Leningradskaya Oblast', 188663, Russia
Site RU70004
Moscow, 105077, Russia
Site RU70011
Moscow, 123056, Russia
Site RU70003
Moscow, 125284, Russia
Site RU70017
Nizhny Novgorod, 603074, Russia
Site RU70002
Omsk, 644013, Russia
Site RU70019
Pyatigorsk, 357502, Russia
Site RU70010
Saint Petersburg, 195271, Russia
Site RU70007
Saint Petersburg, 197082, Russia
Site RU70008
Saint Petersburg, 197758, Russia
Site RU70012
Saint Petersburg, 197758, Russia
Site RU70009
Saransk, 430032, Russia
Site RU70015
Tyumen, 625041, Russia
Site RU70005
Ufa, 450000, Russia
Site SG65001
Singapore, 119074, Singapore
Site SG65002
Singapore, 169610, Singapore
Site SG65003
Singapore, 308433, Singapore
Site KR82001
Daejeon, 301-721, South Korea
Site KR82002
Goyang-si, 10408, South Korea
Site KR82008
Hwasun, 519-763, South Korea
Site KR82004
Seongnam-si, 13605, South Korea
Site KR82003
Seoul, 03722, South Korea
Site KR82005
Seoul, 05505, South Korea
Site KR82007
Seoul, 135-710, South Korea
Site KR82006
Seoul, 137-701, South Korea
Site ES34017
Barcelona, 08003, Spain
Site ES34010
Barcelona, 08035, Spain
Site ES34006
Barcelona, 08036, Spain
Site ES34001
Barcelona, 08041, Spain
Site ES34008
Barcelona, 08907, Spain
Site ES34013
Córdoba, 14004, Spain
Site ES34021
Lugo, 27003, Spain
Site ES34018
Madrid, 28007, Spain
Site ES34002
Madrid, 28034, Spain
Site ES34003
Madrid, 28040, Spain
Site ES34015
Madrid, 28041, Spain
Site ES34004
Manresa, 08243, Spain
Site ES34020
Pamplona, 31008, Spain
Site ES34016
Sabadell, 08208, Spain
Site ES34012
Santander, 39008, Spain
Site ES34007
Seville, 41013, Spain
Site ES34019
Valencia, 46009, Spain
Site ES34009
Valencia, 46014, Spain
Site CH41004
Basel, 4031, Switzerland
Site CH41002
Bern, 3010, Switzerland
Site CH41001
Chur, 7000, Switzerland
Site CH41003
Winterthur, 8401, Switzerland
Site TW88603
Kaohsiung City, 83301, Taiwan
Site TW88602
Kweishan, 333, Taiwan
Site TW88607
Taichung, 40447, Taiwan
Site TW88606
Taichung, 40705, Taiwan
Site TW88604
Tainan, 70403, Taiwan
Site TW88605
Taipei, 10002, Taiwan
Site TW88601
Taipei, 11217, Taiwan
Site TH66004
Bangkok, 10330, Thailand
Site TH66003
Bangkok, 10400, Thailand
Site TH66006
Bangkok, 10700, Thailand
Site TH66005
Chiang Mai, 50200, Thailand
Site TH66002
Hat Yai, 90110, Thailand
Site TH66007
Muang, 40002, Thailand
Site TH66001
Ratchathewi, 10400, Thailand
Site TR90007
Ankara, 6100, Turkey (Türkiye)
Site TR90009
Ankara, 6230, Turkey (Türkiye)
Site TR90005
Antalya, 07059, Turkey (Türkiye)
Site TR90004
Edirne, 22030, Turkey (Türkiye)
Site TR90008
Istanbul, 34093, Turkey (Türkiye)
Site TR90003
Istanbul, 34214, Turkey (Türkiye)
Site TR90002
Istanbul, 81450, Turkey (Türkiye)
Site TR90001
Konya, 42080, Turkey (Türkiye)
Site TR90006
Malatya, 44280, Turkey (Türkiye)
Site UK44005
Glasgow, G12 0YN, United Kingdom
Site UK44001
London, EC1M 6BQ, United Kingdom
Site UK44009
London, W6 8RF, United Kingdom
Site UK44006
Oxford, OX3 7LE, United Kingdom
Site UK44010
Plymouth, PL6 8DH, United Kingdom
Site UK44002
Preston, PR2 9HT, United Kingdom
Site UK44003
Sheffield, S10 2RX, United Kingdom
Site UK44008
Southampton, SO16 6YD, United Kingdom
Related Publications (7)
Gupta S, Loriot Y, Van der Heijden MS, Bedke J, Valderrama BP, Kikuchi E, Flechon A, Petrylak D, De Santis M, Galsky MD, Lee JL, Swami U, Sridhar SS, De Giorgi U, Wright P, Shih V, Lu YT, Guan X, Dillon R, Shetty A, Homet Moreno B, Beaumont JL, Purnajo I, McManus S, Powles T. How enfortumab vedotin plus pembrolizumab affects the quality of life of people with advanced urothelial cancer compared with platinum-based chemotherapy: a plain language summary of patient-reported outcomes from the EV-302 study. Future Oncol. 2026 Apr;22(9):1015-1029. doi: 10.1080/14796694.2026.2645984. Epub 2026 Apr 2.
PMID: 41925239DERIVEDKikuchi E, Van der Heijden MS, Valderrama BP, Gupta S, Bedke J, Shin SJ, Li JR, Guo J, Danchaivijitr P, Kanesvaran R, Park SH, Su WP, Kandori S, Bae WK, Wong A, Gorla S, Bavle A, Yu X, Lu YT, Powles T. Pan-Asian subgroup analysis of EV-302/KEYNOTE-A39: a phase 3 study to evaluate enfortumab vedotin and pembrolizumab in patients with untreated advanced urothelial carcinoma. Int J Clin Oncol. 2026 Mar;31(3):436-446. doi: 10.1007/s10147-025-02950-8. Epub 2026 Jan 21.
PMID: 41563650DERIVEDMeng Y, Zhang S, Aout M, Babcock A, Li H, Lai Y, Brand-Wiita S, Notinger S, Bavle A, Mamtani R. Cost-effectiveness of enfortumab vedotin plus pembrolizumab as a first-line treatment of locally advanced or metastatic urothelial carcinoma in the United States. J Med Econ. 2025 Dec;28(1):1779-1797. doi: 10.1080/13696998.2025.2567190. Epub 2025 Oct 14.
PMID: 41039930DERIVEDGupta S, Loriot Y, Van der Heijden MS, Bedke J, Valderrama BP, Kikuchi E, Flechon A, Petrylak D, De Santis M, Galsky MD, Lee JL, Swami U, Sridhar SS, De Giorgi U, Wright P, Shih V, Lu YT, Guan X, Dillon R, Shetty A, Moreno BH, Beaumont JL, Purnajo I, McManus S, Powles T. Enfortumab vedotin plus pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (EV-302): patient-reported outcomes from an open-label, randomised, controlled, phase 3 study. Lancet Oncol. 2025 Jun;26(6):795-805. doi: 10.1016/S1470-2045(25)00158-5.
PMID: 40449498DERIVEDNiegisch G. Enfortumab Vedotin and Pembrolizumab - A New Perspective on Urothelial Cancer. N Engl J Med. 2024 Mar 7;390(10):944-946. doi: 10.1056/NEJMe2400311. No abstract available.
PMID: 38446680DERIVEDPowles T, Valderrama BP, Gupta S, Bedke J, Kikuchi E, Hoffman-Censits J, Iyer G, Vulsteke C, Park SH, Shin SJ, Castellano D, Fornarini G, Li JR, Gumus M, Mar N, Loriot Y, Flechon A, Duran I, Drakaki A, Narayanan S, Yu X, Gorla S, Homet Moreno B, van der Heijden MS; EV-302 Trial Investigators. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024 Mar 7;390(10):875-888. doi: 10.1056/NEJMoa2312117.
PMID: 38446675DERIVEDHoimes CJ, Flaig TW, Milowsky MI, Friedlander TW, Bilen MA, Gupta S, Srinivas S, Merchan JR, McKay RR, Petrylak DP, Sasse C, Moreno BH, Yu Y, Carret AS, Rosenberg JE. Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer. J Clin Oncol. 2023 Jan 1;41(1):22-31. doi: 10.1200/JCO.22.01643. Epub 2022 Aug 30.
PMID: 36041086DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Seagen Inc.
Study Officials
- STUDY DIRECTOR
Zejing Wang, MD, PhD
Seagen Inc.
- STUDY DIRECTOR
John Lu, MD
Seagen Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 6, 2020
First Posted
January 10, 2020
Study Start
March 30, 2020
Primary Completion
August 8, 2023
Study Completion (Estimated)
March 1, 2028
Last Updated
May 29, 2026
Results First Posted
September 27, 2024
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share