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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 Cisplatin-Ineligible Participants With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

INTRODUCTION

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

BRIEF SUMMARY

A global, randomized phase III study to evaluate perioperative pembrolizumab with radical cystectomy + pelvic lymph node dissection (RC+PLND) versus RC+PLND alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).

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

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: Up to approximately 3 months (Time of surgery)

Primary Outcome 2 - Measure: Pathologic Complete Response Rate in Participants Whose Tumors Express PD-L1 Combined Positive Score (CPS) ≥10

Primary Outcome 2 - Timeframe: Up to approximately 3 months (Time of surgery)

Primary Outcome 3 - Measure: Event-Free Survival (EFS) in All Participants

Primary Outcome 3 - Timeframe: Up to approximately 5.5 years

Primary Outcome 4 - Measure: Event-Free Survival in Participants Whose Tumors Express PD-L1, CPS ≥10

Primary Outcome 4 - Timeframe: Up to approximately 5.5 years

CONDITION

  • Urinary Bladder Cancer
  • Muscle-invasive

ELIGIBILITY

Inclusion Criteria:
Have a histologically confirmed diagnosis of urothelial carcinoma (cT2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology and programmed cell death ligand 1 (PD-L1) expression assessment to be confirmed by Blinded Independent Central Review (BICR) (central pathology and/or imaging).

- Clinically non-metastatic 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:
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 non-urothelial 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 co-inhibitory 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 vaccine within 30 days prior to 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.

- History of uncontrolled diabetes

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

- Active infection requiring systemic therapy

- Has had an allogenic 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 Corp.

Overall Contact

Name: Medical Director

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION

Facility Status Contact
Facility: University of South Alabama, Mitchell Cancer Institute ( Site 1582)
Mobile, Alabama 36604
United States
Status: Recruiting Contact: Contact
Study Coordinator
251-665-8000
Facility: CARTI Cancer Center ( Site 1577)
Little Rock, Arkansas 72205
United States
Status: Recruiting Contact: Contact
Study Coordinator
501-906-3012
Facility: St. Joseph Heritage Healthcare ( Site 0046)
Fullerton, California 92835
United States
Status: Recruiting Contact: Contact
Study Coordinator
714-446-5364
Facility: John Wayne Cancer Institute ( Site 0075)
Santa Monica, California 90404
United States
Status: Recruiting Contact: Contact
Study Coordinator
720-848-8879
Facility: University of Colorado Hospital ( Site 0098)
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
Study Coordinator
202-444-2198
Facility: Georgetown University Medical Center ( Site 0022)
Washington, District of Columbia 20007
United States
Status: Recruiting Contact: Contact
Study Coordinator
404-778-4823
Facility: Emory School of Medicine ( Site 0006)
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Study Coordinator
773-702-1220
Facility: University of Chicago ( Site 0068)
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Contact
Study Coordinator
260-266-9167
Facility: Parkview Cancer Institute ( Site 0077)
Fort Wayne, Indiana 46845
United States
Status: Recruiting Contact: Contact
Study Coordinator
317-274-7477
Facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004)
Indianapolis, Indiana 46202
United States
Status: Recruiting Contact: Contact
Study Coordinator
504-988-6300
Facility: Tulane University ( Site 0088)
New Orleans, Louisiana 70112
United States
Status: Recruiting Contact: Contact
Study Coordinator
443-849-3285
Facility: New England Cancer Specialists ( Site 0070)
Scarborough, Maine 04074
United States
Status: Recruiting Contact: Contact
Study Coordinator
952-836-3645
Facility: Greater Baltimore Medical Center ( Site 0014)
Baltimore, Maryland 21204
United States
Status: Recruiting Contact: Contact
Study Coordinator
973-971-5373
Facility: M Health Fairview Ridges Hospital ( Site 1555)
Burnsville, Minnesota 55337
United States
Status: Recruiting Contact: Contact
Study Coordinator
505-925-0421
Facility: Morristown Medical Center ( Site 0015)
Morristown, New Jersey 07960
United States
Status: Recruiting Contact: Contact
Study Coordinator
516-734-8916
Facility: UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
Albuquerque, New Mexico 87106
United States
Status: Recruiting Contact: Contact
Study Coordinator
212-731-5820
Facility: Northwell Health- Monter Cancer Center ( Site 0083)
Lake Success, New York 11042
United States
Status: Recruiting Contact: Contact
Study Coordinator
212-659-5452
Facility: New York University Perlmutter Cancer Center ( Site 0008)
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Study Coordinator
866-223-8100
Facility: Icahn School of Medicine at Mount Sinai ( Site 0031)
New York, New York 10029
United States
Status: Recruiting Contact: Contact
Study Coordinator
503-215-2614
Facility: Cleveland Clinic ( Site 1576)
Cleveland, Ohio 44195
United States
Status: Recruiting Contact: Contact
Study Coordinator
610-667-0458
Facility: Providence Portland Medical Center [Portland, OR] ( Site 0095)
Portland, Oregon 97213
United States
Status: Recruiting Contact: Contact
Study Coordinator
215-955-8874
Facility: MidLantic Urology ( Site 0089)
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: Contact
Study Coordinator
863-603-6300
Facility: Abramson Cancer Center of the University of Pennsylvania ( Site 0074)
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Study Coordinator
8434491010257
Facility: Thomas Jefferson University ( Site 1579)
Philadelphia, Pennsylvania 19107
United States
Status: Recruiting Contact: Contact
Study Coordinator
615-250-9268
Facility: Bon Secours St. Francis Health System ( Site 1572)
Greenville, South Carolina 29607
United States
Status: Recruiting Contact: Contact
Study Coordinator
571-472-0623
Facility: Carolina Urologic Research Center ( Site 0062)
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Study Coordinator
304-388-9944
Facility: Urology Associates [Nashville, TN] ( Site 0053)
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Study Coordinator
+3227649457
Facility: Vanderbilt University Medical Center ( Site 0017)
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: Contact
Study Coordinator
+3292469522
Facility: Texas Oncology-Baylor Sammons Cancer Center ( Site 1552)
Dallas, Texas 75246
United States
Status: Recruiting Contact: Contact
Study Coordinator
+3216346900
Facility: Inova Schar Cancer Institute ( Site 0007)
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
Study Coordinator
+3250452806
Facility: Charleston Area Medical Center ( Site 0023)
Charleston, West Virginia 25304
United States
Status: Recruiting Contact: Contact
Study Coordinator
4034762543
Facility: UCL Saint-Luc - Oncologie Medicale ( Site 0357)
Bruxelles, Bruxelles-Capitale, Region De 1200
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
819346111012827
Facility: AZ Maria Middelares Gent ( Site 0353)
Gent, Oost-Vlaanderen 9000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+45 35453545
Facility: UZ Leuven ( Site 0361)
Leuven, Vlaams-Brabant 3000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+4524998173
Facility: AZ Sint-Jan Brugge ( Site 0352)
Brugge, West-Vlaanderen 8000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+3391387658
Facility: Tom Baker Cancer Centre ( Site 0100)
Calgary, Alberta T2N 4N2
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+33231455002
Facility: Silverado Resarch Inc. ( Site 0111)
Victoria, British Columbia V8T 2C1
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+33380293761
Facility: Moncton Hospital - Horizon Health Network ( Site 0112)
Moncton, New Brunswick E1C 6Z8
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+33370632403
Facility: Sunnybrook Research Institute ( Site 0110)
Toronto, Ontario M4N 3M5
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+33466683301
Facility: Princess Margaret Cancer Centre ( Site 0107)
Toronto, Ontario M5G 2M9
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+33531155993
Facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)
Chicoutimi, Quebec G7H 5H6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+33467332309
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
+33299284270
Facility: CIUSSS de l'Estrie-CHUS ( Site 0106)
Sherbrooke, Quebec J1H 5N4
Canada
Status: Recruiting Contact: Contact
Study Coordinator
33244765930
Facility: Herlev og Gentofte Hospital. ( Site 0412)
Herlev, Hovedstaden 2730
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+0357841650
Facility: Rigshospitalet University Hospital ( Site 0411)
Kobenhavn, Hovedstaden 2100
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+33478864324
Facility: Odense Universitetshospital ( Site 0413)
Odense, Syddanmark 5000
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+33142115348
Facility: Hopital de la Timone ( Site 0489)
Marseille, Bouches-du-Rhone 13005
France
Status: Recruiting Contact: Contact
Study Coordinator
+33158411439
Facility: Centre Francois Baclesse ( Site 0459)
Caen, Calvados 14076
France
Status: Recruiting Contact: Contact
Study Coordinator
+33156093447
Facility: Centre Georges Francois Leclerc ( Site 0488)
Dijon, Cote-d Or 21000
France
Status: Recruiting Contact: Contact
Study Coordinator
33158412754
Facility: CHU Jean Minjoz ( Site 0455)
Besancon, Doubs 25000
France
Status: Recruiting Contact: Contact
Study Coordinator
+4970712987235
Facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)
Nimes, Gard 30029
France
Status: Recruiting Contact: Contact
Study Coordinator
+498944000
Facility: Institut Claudius Regaud IUCT Oncopole ( Site 0486)
Toulouse, Haute-Garonne 31059
France
Status: Recruiting Contact: Contact
Study Coordinator
+493916715034
Facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
Montpellier, Herault 34295
France
Status: Recruiting Contact: Contact
Study Coordinator
+493514582447
Facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0492)
Rennes, Ille-et-Vilaine 35033
France
Status: Recruiting Contact: Contact
Study Coordinator
+4930130226301
Facility: CHU Hotel Dieu Nantes ( Site 0458)
Nantes, Loire-Atlantique 44093
France
Status: Recruiting Contact: Contact
Study Coordinator
+3662545405
Facility: Hopital Belle Isle ( Site 0452)
Vantoux, Moselle 57070
France
Status: Recruiting Contact: Contact
Study Coordinator
+36703815172
Facility: C.H.U. Lyon Sud ( Site 0466)
Pierre Benite, Rhone 69310
France
Status: Recruiting Contact: Contact
Study Coordinator
+3652255585
Facility: Institut Gustave Roussy ( Site 0487)
Villejuif, Val-de-Marne 94805
France
Status: Recruiting Contact: Contact
Study Coordinator
+36203310075
Facility: CHU Cochin ( Site 0475)
Paris, Baden-Wurttemberg 75014
France
Status: Recruiting Contact: Contact
Study Coordinator
+3682501300
Facility: Hopital Europeen Georges Pompidou ( Site 0476)
Paris, Bayern 75015
France
Status: Recruiting Contact: Contact
Study Coordinator
+35314144259
Facility: Hopital Bichat du Paris ( Site 0462)
Paris, Nordrhein-Westfalen 75018
France
Status: Recruiting Contact: Contact
Study Coordinator
+35351848934
Facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)
Tuebingen, Sachsen-Anhalt 72076
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+97246495723
Facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)
Muenchen, Sachsen 81377
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+972523514527
Facility: Universitaetsklinikum Bonn ( Site 0550)
Bonn, Csongrad 53127
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+97247776750
Facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)
Magdeburg, Lombardia 39120
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+97226666331
Facility: Universitaetsklinikum Carl Gustav Carus ( Site 0532)
Dresden, Kyonggi-do 01307
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+972505172315
Facility: Vivantes Klinikum am Urban ( Site 0529)
Berlin, Kyonggi-do 10967
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+97297471606
Facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
Szeged, Seoul 6720
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97239378074
Facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
Budapest, Nuevo Leon 1106
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97235302191
Facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen, Dolnoslaskie 4032
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97236973413
Facility: Petz Aladar Megyei Oktato Korhaz ( Site 1012)
Gyor, Kujawsko-pomorskie 9023
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97289779715
Facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
Kaposvar, Malopolskie 7400
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+390226435668
Facility: Tallaght University Hospital ( Site 0734)
Dublin, Mazowieckie D24 NR0A
Ireland
Status: Recruiting Contact: Contact
Study Coordinator
+390953781518
Facility: University Hospital Waterford ( Site 0747)
Waterford, Mazowieckie X91ER8E
Ireland
Status: Recruiting Contact: Contact
Study Coordinator
+390223902402
Facility: Ha Emek Medical Center ( Site 0843)
Afula, Pomorskie 1834111
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+39815903637
Facility: Soroka Medical Center ( Site 0849)
Beer Sheva, Slaskie 8410101
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390630154953
Facility: Rambam Medical Center ( Site 0845)
Haifa, Baskortostan, Respublika 3109601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+82319201678
Facility: Shaare Zedek Medical Center ( Site 0842)
Jerusalem, Ivanovskaya Oblast 9103102
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+82317877351
Facility: Hadassah Ein Kerem Medical Center ( Site 0841)
Jerusalem, Krasnoyarskiy Kray 9112001
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+8229206610
Facility: Meir Medical Center ( Site 0846)
Kfar Saba, Kurskaya Oblast 4428164
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+82220720361
Facility: Rabin Medical Center ( Site 0847)
Petach Tikva, Moskva 4941492
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+82234103557
Facility: Sheba Medical Center ( Site 0844)
Ramat Gan, Moskva 5265601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+52818631717
Facility: Sourasky Medical Center ( Site 0850)
Tel Aviv, Moskva 6423906
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+524494735100
Facility: Assaf Harofeh Medical Center ( Site 0848)
Zerifin, Murmanskaya Oblast 70300
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+52 614 410 4214
Facility: Ospedale San Raffaele-Oncologia Medica ( Site 0561)
Milano, Nizhegorodskaya Oblast 20132
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+52 55 5265 3000
Facility: A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania, Omskaya Oblast 95123
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+48601143281
Facility: Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
Milano, Sankt-Peterburg 20133
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+48605680944
Facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Napoli, Sankt-Peterburg 80131
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+48602280826
Facility: Policlinico Gemelli di Roma ( Site 0558)
Roma, Sankt-Peterburg 00168
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+48598460705
Facility: National Cancer Center ( Site 1354)
Goyang-si, Saratovskaya Oblast 10408
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+48606399091
Facility: Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si, Sverdlovskaya Oblast 13620
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+79373535306
Facility: Korea University Anam Hospital ( Site 1351)
Seoul, Extremadura 02841
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+79037380779
Facility: Seoul National University Hospital ( Site 1352)
Seoul, La Coruna 03080
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+79255177926
Facility: Samsung Medical Center ( Site 1353)
Seoul, Madrid, Comunidad De 06351
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+78314216977
Facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253)
Monterrey, Valenciana, Comunitat 66269
Mexico
Status: Recruiting Contact: Contact
Study Coordinator
+73812601724
Facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
Aguascalientes, Stockholms Lan 20010
Mexico
Status: Recruiting Contact: Contact
Study Coordinator
+7 812 6482408
Facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0254)
Chihuahua, Uppsala Lan 31000
Mexico
Status: Recruiting Contact: Contact
Study Coordinator
+78125968947
Facility: Hospital Angeles Roma ( Site 0262)
Mexico City, Krung Thep Maha Nakhon 06700
Mexico
Status: Recruiting Contact: Contact
Study Coordinator
+349334978925
Facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)
Wroclaw, Krung Thep Maha Nakhon 50-556
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+34927256200
Facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz, Adana 85-796
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+349722258284028
Facility: Szpital Wojewodzki ( Site 1062)
Tarnow, Cherkaska Oblast 33-100
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+34961114605
Facility: Luxmed Onkologia sp. z o. o. ( Site 1051)
Warszawa, Dnipropetrovska Oblast 01-748
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+34932275400
Facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)
Slupsk, Kharkivska Oblast 76-200
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+34913368263
Facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061)
Bielsko-Biala, Kharkivska Oblast 43-300
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+34913303000ext7554
Facility: Clinic of Bashkortostan State Medical University ( Site 0873)
Ufa, Kharkivska Oblast 450081
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+34912071138
Facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
Krasnoyarsk, Kyivska Oblast 660133
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+4646768936655
Facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 0878)
Moscow, Lvivska Oblast 115478
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+46907853296
Facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0884)
Moscow, Zhytomyrska Oblast 119991
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+6622011671
Facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
Nizhny Novgorod, Liverpool 603074
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+903123055000
Facility: Omsk Clinical Oncology Dispensary ( Site 0865)
Omsk, London, City Of 644013
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+905324167355
Facility: First St. Petersburg State Medical University n.a. acad. I.P. Pavlov ( Site 0872)
Saint-Petersburg, London, City Of 197022
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+905333832234
Facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0860)
Saint-Petersburg, Midlothian 197758
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+903322236000
Facility: Sverdlovsk Regional Oncology Hospital ( Site 0874)
Ekaterinburg, 620036
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+380501606360
Facility: Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)
Badalona, 08916
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+380567134785
Facility: Hospital San Pedro de Alcantara ( Site 0697)
Caceres, 10003
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+380675625054
Facility: Hospital Universitario de Girona Doctor Josep Trueta ( Site 0700)
Girona, 17007
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+380508266088
Facility: Instituto Valenciano de Oncologia - IVO ( Site 0679)
Valencia, 46009
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+380505805447
Facility: Hospital del Mar ( Site 0698)
Barcelona, 08003
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+380509015487
Facility: Hospital Clinic i Provincial ( Site 0674)
Barcelona, 08036
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+380667027558
Facility: Hospital Universitario Ramon y Cajal ( Site 0691)
Madrid, 28034
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+380677280861
Facility: Hospital Universitario San Carlos ( Site 0678)
Madrid, 28040
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+380973317578
Facility: Hospital Universitario la Paz ( Site 0690)
Madrid, 28046
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+380675885098
Facility: Hospital de Nuestra Senora de Valme ( Site 0693)
Sevilla, 41014
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+380672365175
Facility: Karolinska Universitetssjukhuset Solna ( Site 1212)
Stockholm, 171 76
Sweden
Status: Recruiting Contact: Contact
Study Coordinator
+441227766877
Facility: Akademiska Sjukhuset ( Site 1211)
Uppsala, 751 85
Sweden
Status: Recruiting Contact: Contact
Study Coordinator
+441438284298
Facility: Cancercentrum ( Site 1214)
Umea, 901 89
Sweden
Status: Recruiting Contact: Contact
Study Coordinator
+441513341155
Facility: Ramathibodi Hospital. ( Site 1451)
Bangkok, 10400
Thailand
Status: Recruiting Contact: Contact
Study Coordinator
+442078828505
Facility: Faculty of Medicine Siriraj Hospital ( Site 1452)
Bangkok, 10700
Thailand
Status: Recruiting Contact: Contact
Study Coordinator
+4402078082911
Facility: Maharaj Nakorn Chiangmai Hospital ( Site 1453)
Chiang Mai, 50200
Thailand
Status: Recruiting Contact: Contact
Study Coordinator
+442033117627
Facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0931)
Ankara, 06100
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
01922 605718
Facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)
Istanbul, 34096
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
4418722500
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: Cherkasy Regional Oncology Dispensary ( Site 0959)
Cherkasy, 18009
Ukraine
Status: Recruiting Contact: N/A
Facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
Dnipropetrovsk, 49005
Ukraine
Status: Recruiting Contact: N/A
Facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
Dnipro, 49102
Ukraine
Status: Recruiting Contact: N/A
Facility: Regional Oncology Center of Kharkiv ( Site 0958)
Kharkiv, 61000
Ukraine
Status: Recruiting Contact: N/A
Facility: Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
Kharkiv, 61037
Ukraine
Status: Recruiting Contact: N/A
Facility: Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0973)
Kharkiv, 61166
Ukraine
Status: Recruiting Contact: N/A
Facility: MI KhRC Kherson Regional Oncology Dispensary ( Site 0976)
Antonivka Village, 73000
Ukraine
Status: Recruiting Contact: N/A
Facility: Kyiv City Clinical Oncology Center ( Site 0960)
Kyiv, 03115
Ukraine
Status: Recruiting Contact: N/A
Facility: Lviv Regional Clinical Hospital ( Site 0955)
Lviv, 79000
Ukraine
Status: Recruiting Contact: N/A
Facility: Lviv State Regional Oncological Center ( Site 0967)
Lviv, 79031
Ukraine
Status: Recruiting Contact: N/A
Facility: Zhytomyr Regional Oncology Center ( Site 0971)
Zhytomyr, 10002
Ukraine
Status: Recruiting Contact: N/A
Facility: National Cancer Institute of the MoH of Ukraine ( Site 0962)
Kyiv, 03022
Ukraine
Status: Recruiting Contact: N/A
Facility: Kent and Canterbury Hospital ( Site 0733)
Canterbury, CT1 3NG
United Kingdom
Status: Recruiting Contact: N/A
Facility: Lister Hospital ( Site 0739)
Stevenage, SG1 4AB
United Kingdom
Status: Recruiting Contact: N/A
Facility: Clatterbridge Oncology Centre ( Site 0731)
Wirral, CH63 4JY
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: Royal Cornwall Hospital ( Site 0727)
Truro, TR1 3LJ
United Kingdom
Status: Recruiting Contact: N/A