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Brief Title: Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

INTRODUCTION

  • Org Study ID: 3475-B15
  • Secondary ID: MK-3475-B15, KEYNOTE-B15, EV-304, 2020-003106-31, jRCT2041210011
  • NTC ID: NCT04700124
  • Sponsor: Merck Sharp & Dohme Corp.

BRIEF SUMMARY

The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

  • Overall Status
    Recruiting
  • Start Date
    April 21, 2021
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Pathologic Complete Response (pCR) Rate

Primary Outcome 1 - Timeframe: Up to approximately 42 months

Primary Outcome 2 - Measure: Event-Free Survival (EFS)

Primary Outcome 2 - Timeframe: Up to approximately 5 years

CONDITION

  • Muscle Invasive Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology

- Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis

- Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)

- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Have adequate organ function
Exclusion Criteria:
Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions

- Has received any prior systemic treatment for MIBC or non-invasive muscle bladder cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (PD-1), anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)

- Has ≥N2 disease or metastatic disease (M1) as identified by imaging

- Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol

- Has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder

- Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC

- Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention

- Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (HIV) infection. Hepatitis B infection or known active Hepatitis C infection

- Has a known psychiatric or substance abuse disorder

- Has had an allogenic tissue/solid organ transplant

- Has ongoing sensory or motor neuropathy Grade 2 or higher

- Has active keratitis (superficial punctate keratitis) or corneal ulcerations

- Has a history of uncontrolled diabetes defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to <8% with associated diabetes symptoms

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme Corp.

Overall Contact

Name: Medical Director

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION

Facility Status Contact
Facility: St Joseph Heritage Healthcare-Oncology ( Site 0035)
Fullerton, California 92835
United States
Status: Recruiting Contact: Contact
Study Coordinator
714-446-5177
Facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
Los Angeles, California 90095
United States
Status: Recruiting Contact: Contact
Study Coordinator
310-451-8751
Facility: UF Health ( Site 0031)
Gainesville, Florida 32608
United States
Status: Recruiting Contact: Contact
Study Coordinator
352-265-0725
Facility: University of Louisville, James Graham Brown Cancer Center ( Site 0022)
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: Contact
Study Coordinator
502-562-3429
Facility: Icahn School of Medicine at Mount Sinai ( Site 0011)
New York, New York 10029
United States
Status: Recruiting Contact: Contact
Study Coordinator
212-659-5452
Facility: White Plains Hospital ( Site 0039)
White Plains, New York 10601
United States
Status: Recruiting Contact: Contact
Study Coordinator
914-849-7630
Facility: Wake Forest Baptist Health ( Site 0014)
Winston-Salem, North Carolina 27157
United States
Status: Recruiting Contact: Contact
Study Coordinator
336-713-5440
Facility: MidLantic Urology ( Site 0002)
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: Contact
Study Coordinator
999-999-9999
Facility: Saint Francis Cancer Center ( Site 0008)
Greenville, South Carolina 29607
United States
Status: Recruiting Contact: Contact
Study Coordinator
863-603-6300
Facility: The University of Tennessee Medical Center ( Site 0034)
Knoxville, Tennessee 37920
United States
Status: Recruiting Contact: Contact
Study Coordinator
865-305-8780
Facility: UT Southwestern Medical Center ( Site 0003)
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Study Coordinator
999-999-9999
Facility: Houston Methodist Urology Associates ( Site 0033)
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Study Coordinator
346-238-6123
Facility: Urology of San Antonio ( Site 0020)
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Study Coordinator
210-614-4116
Facility: University of Wisconsin Hospital and Clinics ( Site 0037)
Madison, Wisconsin 53792
United States
Status: Recruiting Contact: Contact
Study Coordinator
800-622-8922
Facility: Lyell McEwin Hospital ( Site 1252)
Elizabeth Vale, South Australia 5112
Australia
Status: Recruiting Contact: Contact
Study Coordinator
+61882820833
Facility: Moncton Hospital ( Site 0107)
Moncton, New Brunswick E1C 6Z8
Canada
Status: Recruiting Contact: Contact
Study Coordinator
506-857-5669
Facility: Ottawa Hospital Research Institute ( Site 0109)
Ottawa, Ontario K1H 8L6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
613-737-7700
Facility: Fakultni nemocnice u sv. Anny v Brne ( Site 0253)
Brno, Brno-mesto 656 91
Czechia
Status: Recruiting Contact: Contact
Study Coordinator
+420543183073
Facility: Fakultni Nemocnice Olomouc ( Site 0251)
Olomouc, Finistere 779 00
Czechia
Status: Recruiting Contact: Contact
Study Coordinator
+420588444288
Facility: Fakultni Thomayerova nemocnice ( Site 0252)
Praha 4, Haute-Garonne 140 59
Czechia
Status: Recruiting Contact: Contact
Study Coordinator
00420261083530
Facility: CHU de Brest -Site Hopital Morvan ( Site 0461)
Brest, Haute-Vienne 29200
France
Status: Recruiting Contact: Contact
Study Coordinator
+33298223395
Facility: Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)
Toulouse, Loiret 31059
France
Status: Recruiting Contact: Contact
Study Coordinator
+33531155993
Facility: CHU Limoges Hopital Dupuytren ( Site 0459)
Limoges, Nord 87042
France
Status: Recruiting Contact: Contact
Study Coordinator
+33555056396
Facility: Centre Hospitalier Regional du Orleans ( Site 0463)
Orleans, Bayern 45067
France
Status: Recruiting Contact: Contact
Study Coordinator
+33238514444
Facility: Polyclinique du Bois ( Site 0458)
Lille, Nordrhein-Westfalen 59000
France
Status: Recruiting Contact: Contact
Study Coordinator
+33 320009757
Facility: Hopital Diaconesses Croix Saint Simon ( Site 0465)
Paris, Nordrhein-Westfalen 75020
France
Status: Recruiting Contact: Contact
Study Coordinator
+33144742839
Facility: Caritas Krankenhaus St. Josef ( Site 0502)
Regensburg, Sachsen-Anhalt 93053
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+499417820
Facility: Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)
Herne, Sachsen 44625
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4923234991660
Facility: Universitaetsklinikum Muenster ( Site 0516)
Muenster, Napoli 48149
Germany
Status: Recruiting Contact: Contact
Study Coordinator
492518348001
Facility: Krankenhaus Martha Maria Halle-Doelau ( Site 0507)
Halle, Torino 06120
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+493455591449
Facility: Universitaetsklinikum Carl Gustav Carus ( Site 0509)
Dresden, Veneto 01307
Germany
Status: Recruiting Contact: Contact
Study Coordinator
00493514582157
Facility: Rambam Health Care Campus-Oncology ( Site 0751)
Haifa, Aichi 3109601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+972-4-7776400
Facility: Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)
Pozzuoli, Aichi 80078
Italy
Status: Recruiting Contact: Contact
Study Coordinator
335 444645
Facility: AOU San Luigi Gonzaga di Orbassano ( Site 0595)
Orbassano, Aomori 10043
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390119026993
Facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)
Verona, Ishikawa 1932
Italy
Status: Recruiting Contact: Contact
Study Coordinator
390458122768
Facility: Ospedali Riuniti Umberto I GM Lancis G Salesi ( Site 0593)
Ancona, Kanagawa 60126
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390715964169
Facility: IRCCS Ospedale San Raffaele ( Site 0596)
Milano, Kanagawa 20132
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390226435789
Facility: Gifu University Hospital ( Site 1513)
Gifu, Miyagi 501-1194
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-58-230-6000
Facility: Nagoya University Hospital ( Site 1512)
Nagoya, Shizuoka 466-8560
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-52-741-2111
Facility: Hirosaki University Hospital ( Site 1501)
Hirosaki, Jeonranamdo 036-8563
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-172-33-5111
Facility: Kanazawa University Hospital ( Site 1509)
Kanazawa, Kyonggi-do 920-8641
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-76-265-2000
Facility: Yokohama City University Medical Center ( Site 1508)
Yokohama, Seoul 232-0024
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-45-261-5656
Facility: Kanagawa Cancer Center ( Site 1507)
Yokohama, Taegu-Kwangyokshi 241-8515
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-45-520-2222
Facility: Tohoku University Hospital ( Site 1503)
Sendai, Sarawak 980-8574
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-22-717-7000
Facility: Hamamatsu University Hospital ( Site 1511)
Hamamatsu, Mazowieckie 431-3192
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-53-435-2111
Facility: Nagasaki University Hospital ( Site 1517)
Nagasaki, Podkarpackie 852-8501
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-95-819-7200
Facility: Okayama University Hospital ( Site 1516)
Okayama, Zachodniopomorskie 700-8558
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-86-223-7151
Facility: Osaka International Cancer Institute ( Site 1514)
Osaka, Altayskiy Kray 541-8567
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-6-6945-1181
Facility: Osaka City University Hospital ( Site 1515)
Osaka, Kaluzskaja Oblast 545-8586
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-6-6645-2121
Facility: Tokyo Medical and Dental University Hospital ( Site 1505)
Tokyo, Moskva 113-8519
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-3-3813-6111
Facility: Keio University Hospital ( Site 1504)
Tokyo, Moskva 160-8582
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-3-3353-1211
Facility: Toyama University Hospital ( Site 1510)
Toyama, Sankt-Peterburg 930-0194
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-76-434-2281
Facility: Chonnam National University Hwasun Hospital ( Site 1353)
Jeollanam-do, Sankt-Peterburg 58128
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82613797745
Facility: Seoul National University Bundang Hospital ( Site 1355)
Gyeonggi-do, Sankt-Peterburg 13620
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82317877351
Facility: Asan Medical Center ( Site 1352)
Songpagu, Sverdlovskaya Oblast 05505
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
82230103980
Facility: Kyungpook National University Chilgok Hospital ( Site 1354)
Daegu, Sverdlovskaya Oblast 41404
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82532002672
Facility: Gachon University Gil Medical Center ( Site 1356)
Incheon, Volgogradskaya Oblast 21565
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82324603231
Facility: Seoul National University Hospital ( Site 1351)
Seoul, Gauteng 03080
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82220720361
Facility: Sarawak General Hospital ( Site 0351)
Kuching, Asturias, Principado De 93586
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+6082-276666 ext. 6030
Facility: Narodowy Instytut Onkologii ( Site 1051)
Warszawa, Barcelona 02-781
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48225462331
Facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)
Przemysl, Barcelona 37-700
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48 16 677 55 11
Facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)
Koszalin, Cataluna 75-581
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48502204953
Facility: CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0401)
Lisboa, La Coruna 1449-005
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+351210431704
Facility: Altay Regional Oncology Dispensary ( Site 0851)
Barnaul, Las Palmas 656045
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+73852507399
Facility: National Medical Research Radiology Centre ( Site 0869)
Obninsk, Dnipropetrovska Oblast 249036
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+7484399330
Facility: National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865)
Moscow, Kharkivska Oblast 115230
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+79169982318
Facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871)
Moscow, Kharkivska Oblast 119991
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+74955177926
Facility: St.Petersburg Clinical Hospital RAS ( Site 0864)
Saint Petersburg, Kharkivska Oblast 194017
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+78122933300
Facility: St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856)
Saint Petersburg, Lvivska Oblast 197101
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
8(812) 338 60 00
Facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852)
Saint Petersburg, Zhytomyrska Oblast 197758
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
78125968947
Facility: Sverdlovsk Regional Oncology Hospital ( Site 0867)
Ekaterinburg, 620036
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+79022715868
Facility: Sverdlovsky Regional Clinical hospital #1 ( Site 0868)
Ekaterinburg, 620102
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+73433511573
Facility: Volgograd Regional Uronephrological Center ( Site 0870)
Volzhsky, 404120
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+78443274477
Facility: Steve Biko Academic Hospital ( Site 0601)
Pretoria, 0002
South Africa
Status: Recruiting Contact: Contact
Study Coordinator
+27123466701
Facility: Hospital Universitario Central de Asturias ( Site 0654)
Oviedo, 33011
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34985106121
Facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)
Badalona, 08916
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34934651200
Facility: Xarxa Assistencial Universitaria Manresa ( Site 0655)
Manresa, 08243
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34938759300
Facility: Hospital Universitari de Girona Doctor Josep Trueta ( Site 0653)
Girona, 17007
Spain
Status: Recruiting Contact: Contact
Study Coordinator
972225832
Facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)
Santiago de Compostela, 15706
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34981950511
Facility: Hospital Universitario Insular de Gran Canaria ( Site 0657)
Las Palmas de Gran Canaria, 35001
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34961452191
Facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)
Barcelona, 08035
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34934894350
Facility: Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)
Madrid, 28040
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34913303000 x7554
Facility: Hospital Virgen del Rocio ( Site 0659)
Sevilla, 41013
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34955012000
Facility: MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954)
Dnipro, 49055
Ukraine
Status: Recruiting Contact: Contact
Study Coordinator
380567209700
Facility: MNPE Regional Center of Oncology ( Site 0955)
Kharkiv, 61070
Ukraine
Status: Recruiting Contact: Contact
Study Coordinator
+380573151591
Facility: Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965)
Kharkiv, 61166
Ukraine
Status: Recruiting Contact: Contact
Study Coordinator
380577003209
Facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952)
Kharkiv, 79031
Ukraine
Status: Recruiting Contact: Contact
Study Coordinator
380577387155
Facility: Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)
Lviv, 10002
Ukraine
Status: Recruiting Contact: Contact
Study Coordinator
+380322234440
Facility: Zhytomyr Regional Oncology Center ( Site 0961)
Zhytomyr,
Ukraine
Status: Recruiting Contact: Contact
Study Coordinator
+380675885098