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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, jRCT2041210011, PHRR221021-005086, 2020-003106-31
  • NTC ID: NCT04700124
  • Sponsor: Merck Sharp & Dohme LLC
Merck Oncology Clinical Trials Information

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 primary hypothesis is 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: Event-Free Survival (EFS)

Primary Outcome 1 - Timeframe: Up to ~68 months

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 LLC

Overall Contact

Name: Medical Director

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION

Facility Status Contact
Facility: Mayo Clinic in Arizona - Phoenix ( Site 0043)
Phoenix, Arizona 85054
United States
Status: Recruiting Contact: Contact
Study Coordinator
480-342-2000
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
773-837-0783
Facility: University of California San Francisco ( Site 0010)
San Francisco, California 94158
United States
Status: Recruiting Contact: Contact
Study Coordinator
650-725-2078
Facility: Stanford University ( Site 0023)
Stanford, California 94305
United States
Status: Recruiting Contact: Contact
Study Coordinator
303-724-0499
Facility: University of Colorado, Anschutz Cancer Pavilion ( Site 0009)
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
Study Coordinator
352-265-0725
Facility: UF Health ( Site 0031)
Gainesville, Florida 32608
United States
Status: Recruiting Contact: Contact
Study Coordinator
317-944-5349
Facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 0050)
Indianapolis, Indiana 46202
United States
Status: Recruiting Contact: Contact
Study Coordinator
319-384-8076
Facility: University of Iowa Hospital and Clinics ( Site 0029)
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: Contact
Study Coordinator
502-562-3429
Facility: University of Louisville, James Graham Brown Cancer Center ( Site 0022)
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: Contact
Study Coordinator
212-659-5452
Facility: Icahn School of Medicine at Mount Sinai ( Site 0011)
New York, New York 10029
United States
Status: Recruiting Contact: Contact
Study Coordinator
914-849-7630
Facility: White Plains Hospital ( Site 0039)
White Plains, New York 10601
United States
Status: Recruiting Contact: Contact
Study Coordinator
919-613-4494
Facility: Duke University Medical Center ( Site 0017)
Durham, North Carolina 27710
United States
Status: Recruiting Contact: Contact
Study Coordinator
336-713-5440
Facility: Wake Forest Baptist Health ( Site 0014)
Winston-Salem, North Carolina 27157
United States
Status: Recruiting Contact: Contact
Study Coordinator
503-346-8089
Facility: Oregon Health and Science University ( Site 0028)
Portland, Oregon 97239-3011
United States
Status: Recruiting Contact: Contact
Study Coordinator
610-667-0458
Facility: MidLantic Urology ( Site 0002)
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: Contact
Study Coordinator
863-603-6300
Facility: Saint Francis Cancer Center ( Site 0008)
Greenville, South Carolina 29607
United States
Status: Recruiting Contact: Contact
Study Coordinator
214-648-6585
Facility: UT Southwestern Medical Center ( Site 0003)
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Study Coordinator
210-614-4116
Facility: Houston Methodist Urology Associates ( Site 0033)
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Study Coordinator
800-622-8922
Facility: Urology of San Antonio ( Site 0020)
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Study Coordinator
+54 11 4309-6400
Facility: University of Wisconsin Hospital and Clinics ( Site 0037)
Madison, Wisconsin 53792
United States
Status: Recruiting Contact: Contact
Study Coordinator
+541149590200
Facility: Hospital Británico de Buenos Aires-Oncology ( Site 1551)
Ciudad autónoma de Buenos Aires, Buenos Aires 1280
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
541152990100
Facility: Hospital Italiano de Buenos Aires ( Site 1554)
ABB, Caba C1199ABB
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+5493469699922
Facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1558)
Buenos Aires, Caba C1431FWO
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
54 11 4574-4343
Facility: Fundacion Estudios Clinicos-Oncology ( Site 1557)
Rosario, Santa Fe 2000
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+61882820833
Facility: Asociación de Beneficencia Hospital Sirio Libanés ( Site 1553)
Buenos Aires, Queensland C1419AHN
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+61425733507
Facility: Lyell McEwin Hospital ( Site 1252)
Elizabeth Vale, Victoria 5112
Australia
Status: Recruiting Contact: Contact
Study Coordinator
+359899822788
Facility: Frankston Hospital-Oncology and Haematology ( Site 1258)
Frankston, Pazardzhik 3199
Australia
Status: Recruiting Contact: Contact
Study Coordinator
+359888431354
Facility: MHAT "Uni Hospital" OOD ( Site 1154)
Panagyurishte, British Columbia 4500
Bulgaria
Status: Recruiting Contact: Contact
Study Coordinator
+359888223107
Facility: Complex Oncology Center Plovdiv ( Site 1151)
Plovdiv, New Brunswick 4000
Bulgaria
Status: Recruiting Contact: Contact
Study Coordinator
6048776000
Facility: MHAT Central Onco Hospital OOD ( Site 1158)
Plovdiv, Ontario 4000
Bulgaria
Status: Recruiting Contact: Contact
Study Coordinator
506-857-5669
Facility: MHAT Serdika ( Site 1152)
Sofia, Quebec 1632
Bulgaria
Status: Recruiting Contact: Contact
Study Coordinator
613-737-7700
Facility: BC Cancer - Vancouver Center ( Site 0110)
Vancouver, Guangdong V5Z 4E6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
514-340-8222
Facility: Moncton Hospital ( Site 0107)
Moncton, Guangdong E1C 6Z8
Canada
Status: Recruiting Contact: Contact
Study Coordinator
020-87343585
Facility: Ottawa Hospital Research Institute ( Site 0109)
Ottawa, Hunan K1H 8L6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
020-34071255
Facility: Jewish General Hospital ( Site 0106)
Montreal, Jiangsu H3T 1E2
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+86073188651900
Facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1406)
Guangzhou, Jiangsu 510060
China
Status: Recruiting Contact: Contact
Study Coordinator
02568182222
Facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1413)
Guangzhou, Shanghai 510120
China
Status: Recruiting Contact: Contact
Study Coordinator
15950868500
Facility: Hunan Cancer Hospital ( Site 1403)
Changsha, Shanghai 410013
China
Status: Recruiting Contact: Contact
Study Coordinator
13701663571
Facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
Nanjing, Antioquia 210000
China
Status: Recruiting Contact: Contact
Study Coordinator
02158752345
Facility: Nantong Tumor Hospital-Urology ( Site 1405)
Nantong, Cordoba 226361
China
Status: Recruiting Contact: Contact
Study Coordinator
57 (604) 4480016 Ext.2404
Facility: Fudan University Shanghai Cancer Center-Urology department ( Site 1401)
Shanghai, Distrito Capital De Bogota 200032
China
Status: Recruiting Contact: Contact
Study Coordinator
+57 (604) 7862333 Ext: 4007
Facility: Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1402)
Shanghai, Santander 200127
China
Status: Recruiting Contact: Contact
Study Coordinator
573103469453
Facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 1653)
Medellin, Valle Del Cauca 050030
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+573203400438
Facility: Oncomédica S.A.S ( Site 1652)
Montería, Splitsko-dalmatinska Zupanija 230002
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
57233190904022
Facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1654)
Bogota, Jihomoravsky Kraj 111321
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
385915297299
Facility: Fundación Cardiovascular de Colombia-Santander ( Site 1657)
Piedecuesta, Bouches-du-Rhone 681017
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+420543183073
Facility: Fundacion Valle del Lili- CIC ( Site 1656)
Cali, Doubs 760032
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+420495834980
Facility: Klinički Bolnički Centar Split-Oncology and Radiotherapy ( Site 1702)
Split, Finistere 21000
Croatia
Status: Recruiting Contact: Contact
Study Coordinator
+420588444288
Facility: Fakultni nemocnice u sv. Anny v Brne ( Site 0253)
Brno, Haute-Garonne 656 91
Czechia
Status: Recruiting Contact: Contact
Study Coordinator
00420261083530
Facility: Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254)
Hradec Kralove, Haute-Vienne 500 05
Czechia
Status: Recruiting Contact: Contact
Study Coordinator
+33491385708
Facility: Fakultni Nemocnice Olomouc ( Site 0251)
Olomouc, Ile-de-France 77900
Czechia
Status: Recruiting Contact: Contact
Study Coordinator
+33370632403
Facility: Fakultni Thomayerova nemocnice ( Site 0252)
Praha 4, Isere 140 59
Czechia
Status: Recruiting Contact: Contact
Study Coordinator
+33298223395
Facility: CHU La Timone ( Site 0456)
Marseille, Loiret 13005
France
Status: Recruiting Contact: Contact
Study Coordinator
+33531155993
Facility: CHU Jean Minjoz ( Site 0453)
Besancon, Nord 25000
France
Status: Recruiting Contact: Contact
Study Coordinator
+33555056396
Facility: CHU de Brest -Site Hopital Morvan ( Site 0461)
Brest, Baden-Wurttemberg 29200
France
Status: Recruiting Contact: Contact
Study Coordinator
+33142115348
Facility: Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)
Toulouse, Baden-Wurttemberg 31059
France
Status: Recruiting Contact: Contact
Study Coordinator
+33476767971
Facility: CHU Limoges Hopital Dupuytren ( Site 0459)
Limoges, Bayern 87042
France
Status: Recruiting Contact: Contact
Study Coordinator
+33238514444
Facility: Gustave Roussy ( Site 0467)
Villejuif, Bayern 94800
France
Status: Recruiting Contact: Contact
Study Coordinator
+33 320009757
Facility: CHU GRENOBLE ALPES ( Site 0468)
La Tronche, Nordrhein-Westfalen 38700
France
Status: Recruiting Contact: Contact
Study Coordinator
+33144742839
Facility: Centre Hospitalier Regional du Orleans ( Site 0463)
Orleans, Nordrhein-Westfalen 45067
France
Status: Recruiting Contact: Contact
Study Coordinator
4976127028930
Facility: Polyclinique du Bois ( Site 0458)
Lille, Sachsen-Anhalt 59000
France
Status: Recruiting Contact: Contact
Study Coordinator
+4970712985268
Facility: Hopital Diaconesses Croix Saint Simon ( Site 0465)
Paris, Sachsen 75020
France
Status: Recruiting Contact: Contact
Study Coordinator
+499417820
Facility: Universitaetsklinikum Freiburg ( Site 0512)
Freiburg, Achaia 79106
Germany
Status: Recruiting Contact: Contact
Study Coordinator
49 931 201 32001
Facility: Universitaetsklinik fuer Urologie ( Site 0501)
Tuebingen, Attiki 72076
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4923234991660
Facility: Caritas Krankenhaus St. Josef ( Site 0502)
Regensburg, Attiki 93053
Germany
Status: Recruiting Contact: Contact
Study Coordinator
492518348001
Facility: Universitaetsklinikum Wuerzburg ( Site 0520)
Wuerzburg, Attiki 97080
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+493455591449
Facility: Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)
Herne, Thessalia 44625
Germany
Status: Recruiting Contact: Contact
Study Coordinator
00493514582157
Facility: Universitaetsklinikum Muenster ( Site 0516)
Muenster, Csongrad 48149
Germany
Status: Recruiting Contact: Contact
Study Coordinator
004930130226365
Facility: Krankenhaus Martha Maria Halle-Doelau ( Site 0507)
Halle, Jasz-Nagykun-Szolnok 06120
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+302610999791
Facility: Universitaetsklinikum Carl Gustav Carus ( Site 0509)
Dresden, Napoli 01307
Germany
Status: Recruiting Contact: Contact
Study Coordinator
0302132162513
Facility: Vivantes Klinikum Am Urban ( Site 0519)
Berlin, Torino 10967
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+302106157392
Facility: UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0305)
Patras, Veneto 26504
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+302105831255
Facility: General Hospital of Athens "Alexandra" ( Site 0303)
Athens, Aichi 115 28
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+302413502027
Facility: Athens Medical Center ( Site 0304)
Athens, Aomori 151 25
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+3662545405
Facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)
Chaidari, Ibaraki 124 62
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+36209323256
Facility: University General Hospital of Larissa ( Site 0302)
Larissa, Ishikawa 411 10
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+3652255585
Facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1010)
Szeged, Kanagawa 6720
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+972-4-7776400
Facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház ( Site 1002)
Szolnok, Kanagawa 5004
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
972505172315
Facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen, Miyagi 4032
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
97297472337
Facility: Rambam Health Care Campus-Oncology ( Site 0751)
Haifa, Shizuoka 3109601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
97239378074
Facility: Hadassah Medical Center-Oncology ( Site 0757)
Jerusalem, Jeonranamdo 9112001
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+972-3-5302191
Facility: Meir Medical Center-oncology ( Site 0754)
Kfar Saba, Kyonggi-do 4428164
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+97236947616
Facility: Rabin Medical Center-Oncology ( Site 0752)
Petah-Tikva, Seoul 4941492
Israel
Status: Recruiting Contact: Contact
Study Coordinator
972 8 9779715
Facility: Sheba Medical Center-ONCOLOGY ( Site 0753)
Ramat Gan, Taegu-Kwangyokshi 5265601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
08118844048
Facility: Sourasky Medical Center-Oncology ( Site 0755)
Tel Aviv, Kuala Lumpur 6423906
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390119026993
Facility: Yitzhak Shamir Medical Center-Oncology ( Site 0756)
Zerifin, Pulau Pinang 70300
Israel
Status: Recruiting Contact: Contact
Study Coordinator
390458122768
Facility: Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)
Pozzuoli, Sarawak 80078
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390715964169
Facility: AOU San Luigi Gonzaga di Orbassano ( Site 0595)
Orbassano, Selangor 10043
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+39 3487142015
Facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)
Verona, Iloilo 37126
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390226435789
Facility: Ospedali Riuniti Umberto I GM Lancis G Salesi ( Site 0593)
Ancona, Dolnoslaskie 60126
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390498215908
Facility: Ospedale Cannizzaro ( Site 0590)
Catania, Mazowieckie 95126
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81-52-741-2111
Facility: IRCCS Ospedale San Raffaele ( Site 0596)
Milano, Mazowieckie 20132
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81-172-33-5111
Facility: Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)
Padova, Podkarpackie 35128
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81-29-853-3900
Facility: Nagoya University Hospital ( Site 1512)
Nagoya, Wielkopolskie 466-8560
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-76-265-2000
Facility: Hirosaki University Hospital ( Site 1501)
Hirosaki, Zachodniopomorskie 036-8563
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-45-520-2222
Facility: University of Tsukuba Hospital ( Site 1502)
Tsukuba, Cluj 305-8576
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-22-717-7000
Facility: Kanazawa University Hospital ( Site 1509)
Kanazawa, Cluj 920-8641
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-53-435-2111
Facility: Kanagawa Cancer Center ( Site 1507)
Yokohama, Cluj 241-8515
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-95-819-7200
Facility: Tohoku University Hospital ( Site 1503)
Sendai, Dolj 980-8574
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-86-223-7151
Facility: Hamamatsu University Hospital ( Site 1511)
Hamamatsu, Timis 431-3192
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-6-6945-1181
Facility: Gifu University Hospital ( Site 1513)
Gifu, Altayskiy Kray 501-1194
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-6-6645-2121
Facility: Nagasaki University Hospital ( Site 1517)
Nagasaki, Kaluzskaja Oblast 852-8510
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-3-3813-6111
Facility: Okayama University Hospital ( Site 1516)
Okayama, Moskva 7008558
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-3-3353-1211
Facility: Osaka International Cancer Institute ( Site 1514)
Osaka, Moskva 541-8567
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-76-434-2281
Facility: Osaka Metropolitan University Hospital ( Site 1515)
Osaka, Nizhegorodskaya Oblast 545-8586
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82613797745
Facility: Tokyo Medical and Dental University Hospital ( Site 1505)
Tokyo, Sankt-Peterburg 113-8519
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82317877351
Facility: Keio University Hospital ( Site 1504)
Tokyo, Sankt-Peterburg 160-8582
Japan
Status: Recruiting Contact: Contact
Study Coordinator
82230103980
Facility: Toyama University Hospital ( Site 1510)
Toyama, Sankt-Peterburg 930-0194
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82532002672
Facility: Chonnam National University Hwasun Hospital ( Site 1353)
Jeollanam-do, Sverdlovskaya Oblast 58128
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82324603231
Facility: Seoul National University Bundang Hospital ( Site 1355)
Gyeonggi-do, Sverdlovskaya Oblast 13620
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+8229205530
Facility: Asan Medical Center ( Site 1352)
Songpagu, Volgogradskaya Oblast 05505
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82220720361
Facility: Kyungpook National University Chilgok Hospital ( Site 1354)
Daegu, Central Singapore 41404
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+60379492120
Facility: Gachon University Gil Medical Center ( Site 1356)
Incheon, Gauteng 21565
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+604 222 5711
Facility: Korea University Anam Hospital ( Site 1357)
Seoul, Gauteng 02841
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+6082-276666 ext. 6030
Facility: Seoul National University Hospital ( Site 1351)
Seoul, Western Cape 03080
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+603 7491 9191
Facility: University Malaya Medical Centre ( Site 0352)
Lembah Pantai, Asturias 59100
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+639274761729
Facility: Hospital Pulau Pinang ( Site 0355)
George Town, Barcelona 10990
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
48601143281
Facility: Sarawak General Hospital ( Site 0351)
Kuching, Barcelona 93586
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+48 25 64 03 485
Facility: Sunway Medical Centre ( Site 0353)
Petaling Jaya, Gerona 47500
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+48225462331
Facility: THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo
Iloilo City, La Coruna 5000
Philippines
Status: Recruiting Contact: Contact
Study Coordinator
+48 16 677 55 11
Facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1058)
Wrocław, Las Palmas 50-556
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48500799053
Facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1057)
Siedlce, Valenciana, Comunitat 08-110
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48502204953
Facility: Narodowy Instytut Onkologii ( Site 1051)
Warszawa, Kaohsiung 02-781
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+351239400457
Facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)
Przemysl, Dnipropetrovska Oblast 37-700
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+351217229800
Facility: Clinical Research Center Medic-R ( Site 1061)
Poznan, Dnipropetrovska Oblast 61-731
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+351210431704
Facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)
Koszalin, Kharkivska Oblast 75-581
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+351222077500
Facility: Centro Hospitalar e Universitario de Coimbra ( Site 0406)
Coimbra, Kharkivska Oblast 3000-075
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+40745976913
Facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409)
Lisboa, Kharkivska Oblast 1099-023
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+40721254415
Facility: CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0401)
Lisboa, Lvivska Oblast 1449-005
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+4026459831
Facility: Hospital Geral de Santo Antonio ( Site 0408)
Porto, Zhytomyrska Oblast 4099-001
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+40742206212
Facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102)
Cluj Napoca, 400015
Romania
Status: Recruiting Contact: Contact
Study Coordinator
40727774974
Facility: Cardiomed SRL Cluj-Napoca ( Site 1101)
Cluj-Napoca, 400015
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+40256495403
Facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103)
Cluj-Napoca, 400015
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+40721298677
Facility: SC Radiotherapy Center Cluj SRL ( Site 1108)
Comuna Floresti, 407280
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+6562566011
Facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107)
Craiova, 200542
Romania
Status: Recruiting Contact: Contact
Study Coordinator
27113390600
Facility: Policlinica Oncomed SRL ( Site 1106)
Timisoara, 300239
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+27123466701
Facility: SC Focus Lab Plus SRL ( Site 1104)
Bucuresti, 022548
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+27(0)214044265
Facility: Tan Tock Seng Hospital ( Site 0704)
Singapore, 308442
Singapore
Status: Recruiting Contact: Contact
Study Coordinator
04-22052121 #2955
Facility: Wits Clinical Research ( Site 0603)
Johannesburg, 2193
South Africa
Status: Recruiting Contact: Contact
Study Coordinator
886-2-28757519 ext. 306
Facility: Steve Biko Academic Hospital ( Site 0601)
Pretoria, 0002
South Africa
Status: Recruiting Contact: Contact
Study Coordinator
+380573151591
Facility: Groote Schuur Hospital ( Site 0602)
Cape Town, 7925
South Africa
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Central de Asturias ( Site 0654)
Oviedo, 33011
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)
Badalona, 08916
Spain
Status: Recruiting Contact: N/A
Facility: Xarxa Assistencial Universitaria Manresa ( Site 0655)
Manresa, 08243
Spain
Status: Recruiting Contact: N/A
Facility: Institut Català d'Oncologia (ICO) - Girona ( Site 0653)
Girona, 17007
Spain
Status: Recruiting Contact: N/A
Facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)
Santiago de Compostela, 15706
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Insular de Gran Canaria ( Site 0657)
Las Palmas de Gran Canaria, 35001
Spain
Status: Recruiting Contact: N/A
Facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0662)
Valencia, 46009
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)
Barcelona, 08035
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)
Madrid, 28040
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Virgen del Rocio ( Site 0659)
Sevilla, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 1203)
Kaohsiung Niao Sung Dist, 83301
Taiwan
Status: Recruiting Contact: N/A
Facility: China Medical University Hospital ( Site 1202)
Taichung, 404332
Taiwan
Status: Recruiting Contact: N/A
Facility: Taipei Veterans General Hospital ( Site 1201)
Taipei, 11217
Taiwan
Status: Recruiting Contact: N/A
Facility: MNPE Regional Center of Oncology ( Site 0955)
Kharkiv, 61070
Ukraine
Status: Recruiting Contact: N/A