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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, 2020-003106-31
  • NTC ID: NCT04700124
  • Sponsor: Merck Sharp & Dohme LLC

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 LLC

Overall Contact

Name: Medical Director

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION

Facility Status Contact
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
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
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
United States
Status: Recruiting Contact: Contact
Study Coordinator
999-999-9999
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
999-999-9999
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
+61 7 31636166
Facility: University of Wisconsin Hospital and Clinics ( Site 0037)
Madison, Wisconsin 53792
United States
Status: Recruiting Contact: Contact
Study Coordinator
+61882820833
Facility: Mater Hospital Brisbane ( Site 1257)
South Brisbane, Queensland 4101
Australia
Status: Recruiting Contact: Contact
Study Coordinator
6048776000
Facility: Lyell McEwin Hospital ( Site 1252)
Elizabeth Vale, South Australia 5112
Australia
Status: Recruiting Contact: Contact
Study Coordinator
506-857-5669
Facility: BC Cancer - Vancouver Center ( Site 0110)
Vancouver, British Columbia V5Z 4E6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
613-737-7700
Facility: Moncton Hospital ( Site 0107)
Moncton, New Brunswick E1C 6Z8
Canada
Status: Recruiting Contact: Contact
Study Coordinator
514-340-8222
Facility: Ottawa Hospital Research Institute ( Site 0109)
Ottawa, Ontario K1H 8L6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+86073188651900
Facility: Jewish General Hospital ( Site 0106)
Montreal, Quebec H3T 1E2
Canada
Status: Recruiting Contact: Contact
Study Coordinator
02568182222
Facility: Hunan Cancer Hospital ( Site 1403)
Changsha, Hunan 410013
China
Status: Recruiting Contact: Contact
Study Coordinator
15950868500
Facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
Nanjing, Jiangsu 210008
China
Status: Recruiting Contact: Contact
Study Coordinator
13701663571
Facility: Nantong Tumor Hospital-Urology ( Site 1405)
Nantong, Jiangsu 226361
China
Status: Recruiting Contact: Contact
Study Coordinator
+420543183073
Facility: Fudan University Shanghai Cancer Center-Urology department ( Site 1401)
Shanghai, Shanghai 200032
China
Status: Recruiting Contact: Contact
Study Coordinator
+420495834980
Facility: Fakultni nemocnice u sv. Anny v Brne ( Site 0253)
Brno, Jihomoravsky Kraj 656 91
Czechia
Status: Recruiting Contact: Contact
Study Coordinator
+420588444288
Facility: Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0254)
Hradec Kralove, Bouches-du-Rhone 500 05
Czechia
Status: Recruiting Contact: Contact
Study Coordinator
00420261083530
Facility: Fakultni Nemocnice Olomouc ( Site 0251)
Olomouc, Doubs 779 00
Czechia
Status: Recruiting Contact: Contact
Study Coordinator
+33491385708
Facility: Fakultni Thomayerova nemocnice ( Site 0252)
Praha 4, Finistere 140 59
Czechia
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Study Coordinator
+33370632403
Facility: CHU La Timone ( Site 0456)
Marseille, Haute-Garonne 13005
France
Status: Recruiting Contact: Contact
Study Coordinator
+33298223395
Facility: CHU Jean Minjoz ( Site 0453)
Besancon, Haute-Vienne 25000
France
Status: Recruiting Contact: Contact
Study Coordinator
+33531155993
Facility: CHU de Brest -Site Hopital Morvan ( Site 0461)
Brest, Loiret 29200
France
Status: Recruiting Contact: Contact
Study Coordinator
+33555056396
Facility: Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)
Toulouse, Nord 31059
France
Status: Recruiting Contact: Contact
Study Coordinator
+33238514444
Facility: CHU Limoges Hopital Dupuytren ( Site 0459)
Limoges, Baden-Wurttemberg 87042
France
Status: Recruiting Contact: Contact
Study Coordinator
+33 320009757
Facility: Centre Hospitalier Regional du Orleans ( Site 0463)
Orleans, Baden-Wurttemberg 45067
France
Status: Recruiting Contact: Contact
Study Coordinator
+33144742839
Facility: Polyclinique du Bois ( Site 0458)
Lille, Bayern 59000
France
Status: Recruiting Contact: Contact
Study Coordinator
4976127028930
Facility: Hopital Diaconesses Croix Saint Simon ( Site 0465)
Paris, Nordrhein-Westfalen 75020
France
Status: Recruiting Contact: Contact
Study Coordinator
+4970712985268
Facility: Universitaetsklinikum Freiburg ( Site 0512)
Freiburg, Nordrhein-Westfalen 79106
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+499417820
Facility: Universitaetsklinik fuer Urologie ( Site 0501)
Tuebingen, Sachsen-Anhalt 72076
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4923234991660
Facility: Caritas Krankenhaus St. Josef ( Site 0502)
Regensburg, Sachsen 93053
Germany
Status: Recruiting Contact: Contact
Study Coordinator
492518348001
Facility: Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)
Herne, Attiki 44625
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+493455591449
Facility: Universitaetsklinikum Muenster ( Site 0516)
Muenster, Attiki 48149
Germany
Status: Recruiting Contact: Contact
Study Coordinator
00493514582157
Facility: Krankenhaus Martha Maria Halle-Doelau ( Site 0507)
Halle, Thessalia 06120
Germany
Status: Recruiting Contact: Contact
Study Coordinator
0302132162513
Facility: Universitaetsklinikum Carl Gustav Carus ( Site 0509)
Dresden, Napoli 01307
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+302105831255
Facility: General Hospital of Athens "Alexandra" ( Site 0303)
Athens, Torino 115 28
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+302413502027
Facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)
Chaidari, Veneto 124 62
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+972-4-7776400
Facility: University General Hospital of Larissa ( Site 0302)
Larissa, Veneto 411 10
Greece
Status: Recruiting Contact: Contact
Study Coordinator
97239378074
Facility: Rambam Health Care Campus-Oncology ( Site 0751)
Haifa, Aichi 3109601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+972-3-5302191
Facility: Rabin Medical Center-Oncology ( Site 0752)
Petah-Tikva, Aomori 4941492
Israel
Status: Recruiting Contact: Contact
Study Coordinator
335 444645
Facility: Sheba Medical Center-ONCOLOGY ( Site 0753)
Ramat Gan, Ibaraki 5265601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390119026993
Facility: Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)
Pozzuoli, Ishikawa 80078
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390498215908
Facility: AOU San Luigi Gonzaga di Orbassano ( Site 0595)
Orbassano, Kanagawa 10043
Italy
Status: Recruiting Contact: Contact
Study Coordinator
390458122768
Facility: Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)
Padova, Kanagawa 35128
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390715964169
Facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)
Verona, Miyagi 1932
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390226435789
Facility: Ospedali Riuniti Umberto I GM Lancis G Salesi ( Site 0593)
Ancona, Shizuoka 60126
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81-52-741-2111
Facility: IRCCS Ospedale San Raffaele ( Site 0596)
Milano, Jeonranamdo 20132
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81-172-33-5111
Facility: Nagoya University Hospital ( Site 1512)
Nagoya, Kyonggi-do 466-8560
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-29-853-3900
Facility: Hirosaki University Hospital ( Site 1501)
Hirosaki, Seoul 036-8563
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-76-265-2000
Facility: University of Tsukuba Hospital ( Site 1502)
Tsukuba, Taegu-Kwangyokshi 305-8576
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-45-261-5656
Facility: Kanazawa University Hospital ( Site 1509)
Kanazawa, Kuala Lumpur 920-8641
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-45-520-2222
Facility: Yokohama City University Medical Center ( Site 1508)
Yokohama, Sarawak 232-0024
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-22-717-7000
Facility: Kanagawa Cancer Center ( Site 1507)
Yokohama, Selangor 241-8515
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-53-435-2111
Facility: Tohoku University Hospital ( Site 1503)
Sendai, Mazowieckie 980-8574
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-58-230-6000
Facility: Hamamatsu University Hospital ( Site 1511)
Hamamatsu, Podkarpackie 431-3192
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-95-819-7200
Facility: Gifu University Hospital ( Site 1513)
Gifu, Zachodniopomorskie 501-1194
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-86-223-7151
Facility: Nagasaki University Hospital ( Site 1517)
Nagasaki, Cluj 852-8501
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-6-6945-1181
Facility: Okayama University Hospital ( Site 1516)
Okayama, Cluj 700-8558
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-6-6645-2121
Facility: Osaka International Cancer Institute ( Site 1514)
Osaka, Cluj 541-8567
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-3-3353-1211
Facility: Osaka City University Hospital ( Site 1515)
Osaka, Cluj 545-8586
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-3-3813-6111
Facility: Keio University Hospital ( Site 1504)
Tokyo, Dolj 160-8582
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-76-434-2281
Facility: Tokyo Medical and Dental University Hospital ( Site 1505)
Tokyo, Timis 930-0194
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82613797745
Facility: Toyama University Hospital ( Site 1510)
Toyama, Altayskiy Kray 58128
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82317877351
Facility: Chonnam National University Hwasun Hospital ( Site 1353)
Jeollanam-do, Kaluzskaja Oblast 13620
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
82230103980
Facility: Seoul National University Bundang Hospital ( Site 1355)
Gyeonggi-do, Moskva 05505
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82532002672
Facility: Asan Medical Center ( Site 1352)
Songpagu, Moskva 41404
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82324603231
Facility: Kyungpook National University Chilgok Hospital ( Site 1354)
Daegu, Nizhegorodskaya Oblast 21565
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82220720361
Facility: Gachon University Gil Medical Center ( Site 1356)
Incheon, Sankt-Peterburg 03080
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+60379492120
Facility: Seoul National University Hospital ( Site 1351)
Seoul, Sankt-Peterburg 59100
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+6082-276666 ext. 6030
Facility: University Malaya Medical Centre ( Site 0352)
Lembah Pantai, Sankt-Peterburg 93586
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+603 7491 9191
Facility: Sarawak General Hospital ( Site 0351)
Kuching, Sverdlovskaya Oblast 47500
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+48225462331
Facility: Sunway Medical Centre ( Site 0353)
Petaling Jaya, Sverdlovskaya Oblast 02-781
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+48 16 677 55 11
Facility: Narodowy Instytut Onkologii ( Site 1051)
Warszawa, Volgogradskaya Oblast 37-700
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48502204953
Facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)
Przemysl, Central Singapore 75-581
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+351217229800
Facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)
Koszalin, Gauteng 1099-023
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+351210431704
Facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0409)
Lisboa, Asturias 1449-005
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+351222077500
Facility: CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0401)
Lisboa, Barcelona 4099-001
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+40745976913
Facility: Hospital Geral de Santo Antonio ( Site 0408)
Porto, Barcelona 400015
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+40721254415
Facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1102)
Cluj Napoca, Gerona 400015
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+4026459831
Facility: Cardiomed SRL Cluj-Napoca ( Site 1101)
Cluj-Napoca, La Coruna 400015
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+40742206212
Facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1103)
Cluj-Napoca, Las Palmas 407280
Romania
Status: Recruiting Contact: Contact
Study Coordinator
40727774974
Facility: SC Radiotherapy Center Cluj SRL ( Site 1108)
Comuna Floresti, Dnipropetrovska Oblast 200347
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+40256495403
Facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1107)
Craiova, Dnipropetrovska Oblast 300239
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+6562566011
Facility: Policlinica Oncomed SRL ( Site 1106)
Timisoara, Kharkivska Oblast 656045
Romania
Status: Recruiting Contact: Contact
Study Coordinator
+27123466701
Facility: Tan Tock Seng Hospital ( Site 0704)
Singapore, 0002
Singapore
Status: Recruiting Contact: N/A
Facility: Steve Biko Academic Hospital ( Site 0601)
Pretoria, 33011
South Africa
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Central de Asturias ( Site 0654)
Oviedo, 08916
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)
Badalona, 08243
Spain
Status: Recruiting Contact: N/A
Facility: Xarxa Assistencial Universitaria Manresa ( Site 0655)
Manresa, 17007
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitari de Girona Doctor Josep Trueta ( Site 0653)
Girona, 15706
Spain
Status: Recruiting Contact: N/A
Facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)
Santiago de Compostela, 35001
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Insular de Gran Canaria ( Site 0657)
Las Palmas de Gran Canaria, 08035
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)
Barcelona, 28040
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)
Madrid, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Virgen del Rocio ( Site 0659)
Sevilla, 49005
Spain
Status: Recruiting Contact: N/A