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Brief Title: Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

INTRODUCTION

  • Org Study ID: 3475-905
  • Secondary ID: MK-3475-905, KEYNOTE-905, EV-303, PHRR210911-003890, 2018-003809-26
  • NTC ID: NCT03924895
  • Sponsor: Merck Sharp & Dohme LLC
Merck Oncology Clinical Trials Information

BRIEF SUMMARY

This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).

The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone.

With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed.

With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.

  • Overall Status
    Recruiting
  • Start Date
    July 24, 2019
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Event-Free Survival (EFS) between Arm C and Arm B

Primary Outcome 1 - Timeframe: Up to approximately 7.7 years

CONDITION

  • Urinary Bladder Cancer
  • Muscle-invasive

ELIGIBILITY

Inclusion Criteria:
Have a histologically confirmed diagnosis of urothelial carcinoma/muscle-invasive bladder cancer [MIBC] (cT2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology to be confirmed by Blinded Independent Central Review (BICR) (central pathology and/or imaging).

- Clinically nonmetastatic bladder cancer determined by imaging

- Eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy if applicable)
Ineligible for treatment with cisplatin, as defined by meeting at least one of the following criteria OR be eligible for treatment with cisplatin but decline treatment with cisplatin-based chemotherapy:
Impaired renal function with measured or calculated creatinine clearance (CrCl) 30 to 59 mL/min (calculated by Cockcroft-Gault method, Modification of Diet of Renal Disease [MDRD] equations, or measured by 24-hour urine collection)

- Eastern Cooperative Oncology Group (ECOG) Performance Status 2

- Common Terminology Criteria for Adverse Events (CTCAE) v.4 Grade ≥2 audiometric hearing loss

- New York Heart Association (NYHA) Class III heart failure

- Transurethral resection (TUR) of a bladder tumor that is submitted for central pathology assessment and adequate to determine urothelial histology and PD-L1 expression assessment

- ECOG performance status of 0, 1, or 2

- Adequate organ function

- A male participant is eligible to participate if he agrees to use contraception and refrain from donating sperm during the intervention period and for at least 180 days after the last dose of enfortumab vedotin. If the male participants are receiving pembrolizumab only or undergoing surgery only, there are no contraception requirements

- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a (woman of childbearing potential) WOCBP or a WOCBP who agrees to use a highly effective contraceptive method or be abstinent from heterosexual intercourse (as their preferred and usual lifestyle) during the intervention period and for at least 120 days after the last dose of pembrolizumab and at least 180 days after the last dose of enfortumab vedotin; whichever comes last. A female participant must agree not to donate eggs during this period as well

- A WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
Exclusion Criteria:
Known additional nonurothelial malignancy that is progressing or has required active anticancer treatment ≤3 years of study randomization, with certain exceptions

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

- Received any prior systemic treatment, chemoradiation, and/or radiation therapy for for muscle-invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC)

- Received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed cell death 1 ligand 2 (PD-L2), or with an agent directed to another stimulatory or coinhibitory T-cell receptor

- Received prior systemic anticancer therapy including investigational agents within 3 years prior to randomization

- Received any prior radiotherapy to the bladder

- Received a partial cystectomy of the bladder to remove any non-muscle-invasive bladder cancer (NMIBC) or MIBC

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

- Current participation in or participation in a study of an investigational agent or use of an investigational device within 4 weeks prior to the first dose of study intervention

- Ongoing sensory or motor neuropathy Grade 2 or higher

- Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.

- Hypersensitivity to monoclonal antibodies (including pembrolizumab) and/or any of their excipients

- Severe hypersensitivity (≥ Grade 3) to enfortumab vedotin or any excipient contained in the drug formulation of enfortumab vedotin

- Active keratitis or corneal ulcerations. Participants with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator

- Active autoimmune disease that has required systemic therapy in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy and is allowed

- Has uncontrolled diabetes

- History of (noninfectious) pneumonitis that required steroids, or current pneumonitis

- Active infection requiring systemic therapy

- Has had an allogeneic tissue/solid organ transplant

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: University of Colorado Hospital ( Site 0098)
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
Study Coordinator
317-274-7477
Facility: Georgetown University Medical Center ( Site 0022)
Washington, District of Columbia 20007
United States
Status: Recruiting Contact: Contact
Study Coordinator
212-659-5452
Facility: John H. Stroger Jr. Hospital of Cook County ( Site 1551)
Chicago, Illinois 60612
United States
Status: Recruiting Contact: Contact
Study Coordinator
8434491010257
Facility: University of Chicago ( Site 0068)
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Contact
Study Coordinator
615-250-9268
Facility: Parkview Cancer Institute ( Site 0077)
Fort Wayne, Indiana 46845
United States
Status: Recruiting Contact: Contact
Study Coordinator
571-472-0623
Facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004)
Indianapolis, Indiana 46202
United States
Status: Recruiting Contact: Contact
Study Coordinator
+3227649457
Facility: Icahn School of Medicine at Mount Sinai ( Site 0031)
New York, New York 10029
United States
Status: Recruiting Contact: Contact
Study Coordinator
4185411000
Facility: Cleveland Clinic ( Site 1576)
Cleveland, Ohio 44195
United States
Status: Recruiting Contact: Contact
Study Coordinator
5142523400x5766
Facility: Carolina Urologic Research Center ( Site 0062)
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Study Coordinator
+33531155993
Facility: Urology Associates [Nashville, TN] ( Site 0053)
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Study Coordinator
+33467332309
Facility: Inova Schar Cancer Institute ( Site 0007)
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
Study Coordinator
+33142115348
Facility: UCL Saint-Luc - Oncologie Medicale ( Site 0357)
Bruxelles, Bruxelles-Capitale, Region De 1200
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+4930130226301
Facility: AZ Maria Middelares Gent ( Site 0353)
Gent, Oost-Vlaanderen 9000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+36703815172
Facility: UZ Leuven ( Site 0361)
Leuven, Vlaams-Brabant 3000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+3652255585
Facility: AZ Sint-Jan Brugge ( Site 0352)
Brugge, West-Vlaanderen 8000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+35314144259
Facility: AZ Delta vzw-Oncology ( Site 0362)
Roeselare, West-Vlaanderen 8800
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+35351848934
Facility: Tom Baker Cancer Centre ( Site 0100)
Calgary, Alberta T2N 4N2
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+972523514527
Facility: Silverado Resarch Inc. ( Site 0111)
Victoria, British Columbia V8T 2C1
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+97247776750
Facility: Moncton Hospital - Horizon Health Network ( Site 0112)
Moncton, New Brunswick E1C 6Z8
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+97226666331
Facility: Sunnybrook Research Institute ( Site 0110)
Toronto, Ontario M4N 3M5
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+972505172315
Facility: Princess Margaret Cancer Centre ( Site 0107)
Toronto, Ontario M5G 2M9
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+97297471606
Facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)
Chicoutimi, Quebec G7H 5H6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+97239378074
Facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
Montreal, Quebec H1T 2M4
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+97235302191
Facility: CIUSSS de l'Estrie-CHUS ( Site 0106)
Sherbrooke, Quebec J1H 5N4
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+97236973413
Facility: Herlev og Gentofte Hospital. ( Site 0412)
Herlev, Hovedstaden 2730
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+97289779715
Facility: Rigshospitalet University Hospital ( Site 0411)
Kobenhavn, Hovedstaden 2100
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+390630154953
Facility: Aarhus University Hospital Skejby ( Site 0418)
Aarhus, Midtjylland 8200
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+390226435668
Facility: Odense Universitetshospital ( Site 0413)
Odense, Syddanmark 5000
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+390444753836
Facility: Hopital de la Timone ( Site 0489)
Marseille, Bouches-du-Rhone 13005
France
Status: Recruiting Contact: Contact
Study Coordinator
+390953781518
Facility: Centre Francois Baclesse ( Site 0459)
Caen, Calvados 14076
France
Status: Recruiting Contact: Contact
Study Coordinator
+390223902402
Facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)
Nimes, Gard 30029
France
Status: Recruiting Contact: Contact
Study Coordinator
+82317877351
Facility: Institut Claudius Regaud IUCT Oncopole ( Site 0486)
Toulouse, Haute-Garonne 31059
France
Status: Recruiting Contact: Contact
Study Coordinator
+8229206610
Facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
Montpellier, Languedoc-Roussillon 34295
France
Status: Recruiting Contact: Contact
Study Coordinator
+82234103557
Facility: CHU Hotel Dieu Nantes ( Site 0458)
Nantes, Loire-Atlantique 44093
France
Status: Recruiting Contact: Contact
Study Coordinator
+60379492120
Facility: Hopital Belle Isle ( Site 0452)
Vantoux, Moselle 57070
France
Status: Recruiting Contact: Contact
Study Coordinator
+604 222 5711
Facility: Institut Gustave Roussy ( Site 0487)
Villejuif, Val-de-Marne 94805
France
Status: Recruiting Contact: Contact
Study Coordinator
+52818631717
Facility: CHU Cochin ( Site 0475)
Paris, Baden-Wurttemberg 75014
France
Status: Recruiting Contact: Contact
Study Coordinator
+524494735100
Facility: Hopital Europeen Georges Pompidou ( Site 0476)
Paris, Bayern 75015
France
Status: Recruiting Contact: Contact
Study Coordinator
+52 614 410 4214
Facility: Hopital Bichat du Paris ( Site 0462)
Paris, Nordrhein-Westfalen 75018
France
Status: Recruiting Contact: Contact
Study Coordinator
52 722 688 6024
Facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)
Tuebingen, Sachsen-Anhalt 72076
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+52 55 5265 3000
Facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)
Muenchen, Sachsen 81377
Germany
Status: Recruiting Contact: Contact
Study Coordinator
09274761729
Facility: Universitaetsklinikum Bonn ( Site 0550)
Bonn, Csongrad 53127
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+639178448605
Facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)
Magdeburg, Abruzzo 39120
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+639285030641
Facility: Vivantes Klinikum am Urban ( Site 0529)
Berlin, Veneto 10967
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+48605680944
Facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
Szeged, Kyonggi-do 6720
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+48728355694
Facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
Budapest, Kyonggi-do 1106
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+48224308700
Facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen, Seoul 4032
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+48733100715
Facility: Tallaght University Hospital ( Site 0734)
Dublin, Pulau Pinang D24 NR0A
Ireland
Status: Recruiting Contact: Contact
Study Coordinator
+6567795555
Facility: University Hospital Waterford ( Site 0747)
Waterford, Sarawak X91ER8E
Ireland
Status: Recruiting Contact: Contact
Study Coordinator
+6563596554
Facility: Soroka Medical Center ( Site 0849)
Beer Sheva, Iloilo 8410101
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+27 214485707
Facility: Rambam Health Care Campus-Oncology Division ( Site 0845)
Haifa, National Capital Region 3109601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+349334978925
Facility: Shaare Zedek Medical Center ( Site 0842)
Jerusalem, National Capital Region 9103102
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+34932275400
Facility: Hadassah Ein Kerem Medical Center ( Site 0841)
Jerusalem, Dolnoslaskie 9112001
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+34927256200
Facility: Meir Medical Center ( Site 0846)
Kfar Saba, Kujawsko-pomorskie 4428164
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+349722258284028
Facility: Rabin Medical Center ( Site 0847)
Petach Tikva, Malopolskie 4941492
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+34961114605
Facility: Sheba Medical Center ( Site 0844)
Ramat Gan, Mazowieckie 5265601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+34932483139
Facility: Sourasky Medical Center ( Site 0850)
Tel Aviv, Mazowieckie 6423906
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+34913368263
Facility: Yitzhak Shamir Medical Center ( Site 0848)
Zerifin, Podlaskie 7030001
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+34913303000ext7554
Facility: Policlinico Gemelli di Roma ( Site 0558)
Roma, Pomorskie 00168
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+34912071138
Facility: Ospedale San Raffaele-Oncologia Medica ( Site 0561)
Milano, Slaskie 20132
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+34955015000
Facility: AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 0562)
Vicenza, Wielkopolskie 36100
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+46102410000
Facility: A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania, Baskortostan, Respublika 95123
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+46851770000
Facility: Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
Milano, Ivanovskaya Oblast 20133
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+46186110000
Facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Napoli, Krasnoyarskiy Kray 80131
Italy
Status: Recruiting Contact: Contact
Study Coordinator
46313421000
Facility: National Cancer Center ( Site 1354)
Goyang-si, Moskva 10408
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+6624194488
Facility: Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si, Moskva 13620
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+66539455324
Facility: Kyungpook National University Chilgok Hospital-Urology ( Site 1357)
Deagu, Murmanskaya Oblast 41404
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+903123055000
Facility: Korea University Anam Hospital ( Site 1351)
Seoul, Nizhegorodskaya Oblast 02841
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+905324167355
Facility: Seoul National University Hospital ( Site 1352)
Seoul, Omskaya Oblast 03080
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+905323430723
Facility: Samsung Medical Center ( Site 1353)
Seoul, Sankt-Peterburg 06351
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+905333832234
Facility: University Malaya Medical Centre ( Site 1702)
Lembah Pantai, Sankt-Peterburg 59100
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+903322236000
Facility: Hospital Pulau Pinang ( Site 1703)
Georgetown, Sankt-Peterburg 10990
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+905054785576
Facility: Sarawak General Hospital ( Site 1701)
Kuching, Sankt-Peterburg 93586
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+905052292035
Facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253)
Monterrey, Saratovskaya Oblast 66269
Mexico
Status: Recruiting Contact: Contact
Study Coordinator
+380508266088
Facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
Aguascalientes, Sverdlovskaya Oblast 20010
Mexico
Status: Recruiting Contact: Contact
Study Coordinator
+441642 850850
Facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0254)
Chihuahua, Tyumenskaya Oblast 31000
Mexico
Status: Recruiting Contact: Contact
Study Coordinator
+442078828505
Facility: Centro de Tratamiento de Cancer ( Site 0266)
Metepec, Central Singapore 52140
Mexico
Status: Recruiting Contact: Contact
Study Coordinator
+442033117627
Facility: Hospital Angeles Roma ( Site 0262)
Mexico City, Gauteng 06700
Mexico
Status: Recruiting Contact: Contact
Study Coordinator
+441315372211
Facility: THE MEDICAL CITY ILOILO ( Site 1756)
Iloilo City, Western Cape 5000
Philippines
Status: Recruiting Contact: Contact
Study Coordinator
01922 605718
Facility: The Medical City ( Site 1752)
Pasig City, Barcelona 1605
Philippines
Status: Recruiting Contact: Contact
Study Coordinator
+441513341155
Facility: St. Luke s Medical Center ( Site 1751)
Quezon City, Cataluna 1112
Philippines
Status: Recruiting Contact: N/A
Facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)
Wroclaw, Extremadura 50-556
Poland
Status: Recruiting Contact: N/A
Facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz, La Coruna 85-796
Poland
Status: Recruiting Contact: N/A
Facility: Szpital Wojewodzki ( Site 1062)
Tarnow, Madrid, Comunidad De 33-100
Poland
Status: Recruiting Contact: N/A
Facility: Luxmed Onkologia sp. z o. o. ( Site 1051)
Warszawa, Jonkopings Lan 01-748
Poland
Status: Recruiting Contact: N/A
Facility: Bialostockie Centrum Onkologii ( Site 1072)
Bialystok, Stockholms Lan 15-027
Poland
Status: Recruiting Contact: N/A
Facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)
Slupsk, Uppsala Lan 76-200
Poland
Status: Recruiting Contact: N/A
Facility: Clinical Research Center Medic-R ( Site 1073)
Poznań, Vastra Gotalands Lan 60-848
Poland
Status: Recruiting Contact: N/A
Facility: National University Hospital ( Site 1802)
Singapore, London, City Of 119074
Singapore
Status: Recruiting Contact: N/A
Facility: Tan Tock Seng Hospital ( Site 1804)
Singapore, London, City Of 398442
Singapore
Status: Recruiting Contact: N/A
Facility: Steve Biko Academic Hospital ( Site 1601)
Pretoria, London, City Of 0002
South Africa
Status: Recruiting Contact: N/A
Facility: Groote Schuur Hospital ( Site 1602)
Cape Town, Midlothian 7925
South Africa
Status: Recruiting Contact: N/A
Facility: Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)
Badalona, Walsall 08916
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Clinic i Provincial ( Site 0674)
Barcelona, 08036
Spain
Status: Recruiting Contact: N/A
Facility: Hospital San Pedro de Alcantara ( Site 0697)
Caceres, 10003
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario de Girona Doctor Josep Trueta ( Site 0700)
Girona, 17007
Spain
Status: Recruiting Contact: N/A
Facility: Instituto Valenciano de Oncologia - IVO ( Site 0679)
Valencia, 46009
Spain
Status: Recruiting Contact: N/A
Facility: Hospital del Mar ( Site 0698)
Barcelona, 08003
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Ramon y Cajal ( Site 0691)
Madrid, 28034
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario San Carlos ( Site 0678)
Madrid, 28040
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario la Paz ( Site 0690)
Madrid, 28046
Spain
Status: Recruiting Contact: N/A
Facility: Hospital de Nuestra Senora de Valme ( Site 0693)
Sevilla, 41014
Spain
Status: Recruiting Contact: N/A
Facility: Laenssjukhuset Ryhov ( Site 1215)
Jonkoping, 551 85
Sweden
Status: Recruiting Contact: N/A
Facility: Karolinska Universitetssjukhuset Solna ( Site 1212)
Stockholm, 171 76
Sweden
Status: Recruiting Contact: N/A
Facility: Akademiska Sjukhuset ( Site 1211)
Uppsala, 751 85
Sweden
Status: Recruiting Contact: N/A
Facility: Onkologiska kliniken ( Site 1217)
Goteborg, 413 45
Sweden
Status: Recruiting Contact: N/A
Facility: Ramathibodi Hospital. ( Site 1451)
Bangkok, 10400
Thailand
Status: Recruiting Contact: N/A
Facility: Faculty of Medicine Siriraj Hospital ( Site 1452)
Bangkok, 10700
Thailand
Status: Recruiting Contact: N/A
Facility: Maharaj Nakorn Chiangmai Hospital ( Site 1453)
Chiang Mai, 50200
Thailand
Status: Recruiting Contact: N/A
Facility: Srinagarind Hospital ( Site 1454)
Khon Kaen, 40002
Thailand
Status: Recruiting Contact: N/A
Facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0931)
Ankara, 06100
Turkey
Status: Recruiting Contact: N/A
Facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)
Istanbul, 34096
Turkey
Status: Recruiting Contact: N/A
Facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926)
Istanbul, 34722
Turkey
Status: Recruiting Contact: N/A
Facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921)
Istanbul, 34899
Turkey
Status: Recruiting Contact: N/A
Facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929)
Konya, 42080
Turkey
Status: Recruiting Contact: N/A
Facility: Sakarya Universitesi Tip Fakultesi ( Site 0933)
Sakarya, 54290
Turkey
Status: Recruiting Contact: N/A
Facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924)
Trabzon, 61080
Turkey
Status: Recruiting Contact: N/A
Facility: Regional Oncology Center of Kharkiv ( Site 0958)
Kharkiv, 61000
Ukraine
Status: Recruiting Contact: N/A
Facility: The James Cook University Hospital ( Site 0730)
Middlesbrough, TS4 3BW
United Kingdom
Status: Recruiting Contact: N/A
Facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)
London, EC1A 7BE
United Kingdom
Status: Recruiting Contact: N/A
Facility: The Royal Marsden Foundation Trust ( Site 0726)
London, SW3 6JJ
United Kingdom
Status: Recruiting Contact: N/A
Facility: Imperial College Healthcare NHS Trust ( Site 0745)
London, W6 8RF
United Kingdom
Status: Recruiting Contact: N/A
Facility: Western General Hospital ( Site 0749)
Edinburgh, EH4 2XU
United Kingdom
Status: Recruiting Contact: N/A
Facility: Walsall Manor Hospital-Oncology ( Site 0743)
West Midlands, WS2 9PS
United Kingdom
Status: Recruiting Contact: N/A
Facility: Clatterbridge Oncology Centre ( Site 0731)
Wirral, CH63 4JY
United Kingdom
Status: Recruiting Contact: N/A