Back to Clinical Trials

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: N/A
  • NCT ID: NCT03924895
  • Sponsor: Merck Sharp & Dohme LLC

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: Georgetown University Medical Center ( Site 0022)
Washington, District of Columbia 20007
United States
Status: Recruiting Contact: Contact
Study Coordinator
202-444-2198

Facility: John H. Stroger Jr. Hospital of Cook County ( Site 1551)
Chicago, Illinois 60612
United States
Status: Recruiting Contact: Contact
Study Coordinator
312-864-6000

Facility: Parkview Cancer Institute ( Site 0077)
Fort Wayne, Indiana 46845
United States
Status: Recruiting Contact: Contact
Study Coordinator
833-724-8326

Facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004)
Indianapolis, Indiana 46202
United States
Status: Recruiting Contact: Contact
Study Coordinator
317-274-7477

Facility: Icahn School of Medicine at Mount Sinai ( Site 0031)
New York, New York 10029
United States
Status: Recruiting Contact: Contact
Study Coordinator
212-659-5452

Facility: Cleveland Clinic ( Site 1576)
Cleveland, Ohio 44195
United States
Status: Recruiting Contact: Contact
Study Coordinator
866-223-8100

Facility: Carolina Urologic Research Center ( Site 0062)
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Study Coordinator
8434491010257

Facility: Urology Associates [Nashville, TN] ( Site 0053)
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Study Coordinator
615-250-9268

Facility: Inova Schar Cancer Institute ( Site 0007)
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
Study Coordinator
571-472-0623

Facility: Asociación de Beneficencia Hospital Sirio Libanés ( Site 2102)
Buenos Aires, C1419AHN
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+5491157654803

Facility: UCL Saint-Luc - Oncologie Medicale ( Site 0357)
Bruxelles, Bruxelles-Capitale, Region De 1200
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+3227649457

Facility: AZ Maria Middelares Gent ( Site 0353)
Gent, Oost-Vlaanderen 9000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+3292469522

Facility: AZ Sint-Jan Brugge ( Site 0352)
Brugge, West-Vlaanderen 8000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+3250452806

Facility: AZ Delta vzw-Oncology ( Site 0362)
Roeselare, West-Vlaanderen 8800
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+3251237511

Facility: Tom Baker Cancer Centre ( Site 0100)
Calgary, Alberta T2N 4N2
Canada
Status: Recruiting Contact: Contact
Study Coordinator
4034762543

Facility: BC Cancer Vancouver-Clinical Trials Unit ( Site 0121)
Vancouver, British Columbia V5Z 4E6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
6048776000

Facility: Moncton Hospital - Horizon Health Network ( Site 0112)
Moncton, New Brunswick E1C 6Z8
Canada
Status: Recruiting Contact: Contact
Study Coordinator
5068575669

Facility: Sunnybrook Research Institute ( Site 0110)
Toronto, Ontario M4N 3M5
Canada
Status: Recruiting Contact: Contact
Study Coordinator
4164804928

Facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)
Chicoutimi, Quebec G7H 5H6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
4185411000

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
5142523400x5766

Facility: Jewish General Hospital ( Site 0120)
Montreal, Quebec H3T 1E2
Canada
Status: Recruiting Contact: Contact
Study Coordinator
5143408222

Facility: McGill University Health Centre ( Site 0123)
Montréal, Quebec H4A 3J1
Canada
Status: Recruiting Contact: Contact
Study Coordinator
5149341934 x35800

Facility: CIUSSS de l'Estrie-CHUS ( Site 0106)
Sherbrooke, Quebec J1H 5N4
Canada
Status: Recruiting Contact: Contact
Study Coordinator
819346111012827

Facility: Herlev og Gentofte Hospital. ( Site 0412)
Herlev, Hovedstaden 2730
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+45 38683868

Facility: Rigshospitalet University Hospital ( Site 0411)
Kobenhavn, Hovedstaden 2100
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+45 35453545

Facility: Aarhus University Hospital Skejby ( Site 0418)
Aarhus, Midtjylland 8200
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
78450000

Facility: Odense Universitetshospital ( Site 0413)
Odense, Syddanmark 5000
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+4524998173

Facility: Hopital de la Timone ( Site 0489)
Marseille, Bouches-du-Rhone 13005
France
Status: Recruiting Contact: Contact
Study Coordinator
+3391387658

Facility: Centre Francois Baclesse ( Site 0459)
Caen, Calvados 14075
France
Status: Recruiting Contact: Contact
Study Coordinator
+33231455002

Facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)
Nimes, Gard 30029
France
Status: Recruiting Contact: Contact
Study Coordinator
+33466683301

Facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
Montpellier, Languedoc-Roussillon 34295
France
Status: Recruiting Contact: Contact
Study Coordinator
+33467332309

Facility: CHU Hotel Dieu Nantes ( Site 0458)
Nantes, Loire-Atlantique 44093
France
Status: Recruiting Contact: Contact
Study Coordinator
33244765930

Facility: Hopital Belle Isle ( Site 0452)
Vantoux, Moselle 57070
France
Status: Recruiting Contact: Contact
Study Coordinator
+0357841650

Facility: Hopital Bichat du Paris ( Site 0462)
Paris, 75018
France
Status: Recruiting Contact: Contact
Study Coordinator
33158412754

Facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)
Tuebingen, Baden-Wurttemberg 72076
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4970712987235

Facility: Universitaetsklinikum Erlangen ( Site 0546)
Erlangen, Bayern 91058
Germany
Status: Recruiting Contact: Contact
Study Coordinator
4991318223122

Facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)
Muenchen, Bayern 81377
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+498944000

Facility: Universitaetsklinikum Wuerzburg ( Site 0547)
Wuerzburg, Bayern 97080
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4993120132091

Facility: Universitaetsklinikum Bonn ( Site 0550)
Bonn, Nordrhein-Westfalen 53127
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4922828714184

Facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)
Magdeburg, Sachsen-Anhalt 39120
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+493916715034

Facility: SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 0533)
Gera, Thuringen 07548
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+493658287758

Facility: Vivantes Klinikum am Urban ( Site 0529)
Berlin, 10967
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4930130226301

Facility: Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0528)
Hamburg, 20246
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+49 15222815585

Facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
Szeged, Csongrad 6720
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+3662545405

Facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
Budapest, 1106
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+36703815172

Facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)
Debrecen, 4032
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+3652255585

Facility: Tallaght University Hospital ( Site 0734)
Dublin, D24 NR0A
Ireland
Status: Recruiting Contact: Contact
Study Coordinator
+35314144259

Facility: University Hospital Waterford ( Site 0747)
Waterford, X91ER8E
Ireland
Status: Recruiting Contact: Contact
Study Coordinator
+35351848934

Facility: Soroka Medical Center ( Site 0849)
Beer Sheva, 8410101
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+972523514527

Facility: Rambam Health Care Campus-Oncology Division ( Site 0845)
Haifa, 3109601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+97247776750

Facility: Shaare Zedek Medical Center ( Site 0842)
Jerusalem, 9103102
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+97226666331

Facility: Hadassah Ein Kerem Medical Center ( Site 0841)
Jerusalem, 9112001
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+972505172315

Facility: Meir Medical Center ( Site 0846)
Kfar Saba, 4428164
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+97297471606

Facility: Rabin Medical Center ( Site 0847)
Petach Tikva, 4941492
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+97239378074

Facility: Sheba Medical Center ( Site 0844)
Ramat Gan, 5265601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+97235302191

Facility: Sourasky Medical Center ( Site 0850)
Tel Aviv, 6423906
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+97236973413

Facility: Yitzhak Shamir Medical Center ( Site 0848)
Zerifin, 70300
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+97289779715

Facility: Policlinico Gemelli di Roma ( Site 0558)
Roma, Abruzzo 00168
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390630154953

Facility: Ospedale San Raffaele-Oncologia Medica ( Site 0561)
Milano, Lombardia 20132
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390226435668

Facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 0563)
Orbassano, Piemonte 10043
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390119026993

Facility: Azienda USL 8 di Arezzo-Medical Oncology ( Site 0565)
Arezzo, 52100
Italy
Status: Recruiting Contact: Contact
Study Coordinator
390575255446

Facility: A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
Catania, 95123
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390953781518

Facility: Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
Milano, 20133
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390223902402

Facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
Napoli, 80131
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+39815903637

Facility: Azienda Ospedaliera Santa Maria Terni-S.C. Oncologia Medica e Traslazionale ( Site 0564)
Terni, 05100
Italy
Status: Recruiting Contact: Contact
Study Coordinator
390744205410

Facility: National Cancer Center Hospital East ( Site 2305)
Kashiwa, Chiba 277-8577
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81471331111

Facility: St. Marianna University Hospital ( Site 2321)
Kawasaki, Kanagawa 216-8511
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81449778111

Facility: Kitasato University Hospital ( Site 2306)
Sagamihara, Kanagawa 252-0375
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81427788111

Facility: Yokosukakyosai ( Site 2307)
Yokosuka, Kanagawa 238-8558
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81468222710

Facility: Tohoku University Hospital ( Site 2301)
Sendai-shi, Miyagi 980-8574
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-22-717-7278

Facility: Nagano Municipal Hospital ( Site 2309)
Tomitake, Nagano 381-8551
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81262951199

Facility: Nara Medical University Hospital ( Site 2312)
Kashihara, Nara 634-8522
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81744223051

Facility: Osaka Rosai Hospital ( Site 2320)
Sakai, Osaka 591-8025
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81722523561

Facility: Saitama Prefectural Cancer Center ( Site 2319)
Ina-machi, Saitama 362-0806
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81487221111

Facility: Dokkyo Medical University Saitama Medical Center ( Site 2304)
Koshigaya, Saitama 343-8555
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81489651111

Facility: Hamamatsu University Hospital ( Site 2311)
Hamamatsu, Shizuoka 431-3192
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81534352306

Facility: Tokyo Medical and Dental University Hospital ( Site 2303)
Bunkyō, Tokyo 113-8519
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81358035295

Facility: Toranomon Hospital ( Site 2322)
Minato-ku, Tokyo 105-8470
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81335881111

Facility: Toyama University Hospital ( Site 2308)
Toyoma, Toyama 930-0194
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81764347372

Facility: Gifu University Hospital ( Site 2310)
Gifu, 501
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-58-230-6338

Facility: Kagoshima University Hospital ( Site 2317)
Kagoshima, 8900053
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-99-275-5553

Facility: Nagasaki University Hospital ( Site 2315)
Nagasaki, 852-8501
Japan
Status: Recruiting Contact: Contact
Study Coordinator
81958197200

Facility: National Cancer Center ( Site 1354)
Goyang-si, Kyonggi-do 10408
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82319201678

Facility: Seoul National University Bundang Hospital ( Site 1356)
Seongnam-si, Kyonggi-do 13620
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82317877351

Facility: Kyungpook National University Chilgok Hospital-Urology ( Site 1357)
Deagu, Taegu-Kwangyokshi 41404
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82-53-200-3027

Facility: Korea University Anam Hospital ( Site 1351)
Seoul, 02841
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+8229206610

Facility: Seoul National University Hospital ( Site 1352)
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82220720361

Facility: Samsung Medical Center ( Site 1353)
Seoul, 06351
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82234103557

Facility: University Malaya Medical Centre ( Site 1702)
Lembah Pantai, Kuala Lumpur 59100
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+60379492120

Facility: Hospital Pulau Pinang ( Site 1703)
Georgetown, Pulau Pinang 10990
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+604 222 5711

Facility: Sarawak General Hospital ( Site 1701)
Kuching, Sarawak 93586
Malaysia
Status: Recruiting Contact: Contact
Study Coordinator
+6082-276666

Facility: THE MEDICAL CITY ILOILO ( Site 1756)
Iloilo City, Iloilo 5000
Philippines
Status: Recruiting Contact: Contact
Study Coordinator
09274761729

Facility: The Medical City ( Site 1752)
Pasig City, National Capital Region 1605
Philippines
Status: Recruiting Contact: Contact
Study Coordinator
+639178448605

Facility: St. Luke s Medical Center ( Site 1751)
Quezon City, National Capital Region 1112
Philippines
Status: Recruiting Contact: Contact
Study Coordinator
+639285030641

Facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)
Wroclaw, Dolnoslaskie 50-556
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48601143281

Facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
Bydgoszcz, Kujawsko-pomorskie 85-796
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48605680944

Facility: Szpital Wojewodzki ( Site 1062)
Tarnow, Malopolskie 33-100
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48728355694

Facility: Luxmed Onkologia sp. z o. o. ( Site 1051)
Warszawa, Mazowieckie 01-748
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48224308700

Facility: Bialostockie Centrum Onkologii ( Site 1072)
Bialystok, Podlaskie 15-027
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48733100715

Facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)
Slupsk, Pomorskie 76-200
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48598460705

Facility: Clinical Research Center Medic-R ( Site 1073)
Poznań, Wielkopolskie 60-848
Poland
Status: Recruiting Contact: Contact
Study Coordinator
48 508 109 295

Facility: National University Hospital ( Site 1802)
Singapore, Central Singapore 119074
Singapore
Status: Recruiting Contact: Contact
Study Coordinator
+6567795555

Facility: Tan Tock Seng Hospital ( Site 1804)
Singapore, Central Singapore 398442
Singapore
Status: Recruiting Contact: Contact
Study Coordinator
+6563596554

Facility: Steve Biko Academic Hospital-Medical Oncology ( Site 1601)
Pretoria, Gauteng 0001
South Africa
Status: Recruiting Contact: Contact
Study Coordinator
+27123541771

Facility: Groote Schuur Hospital ( Site 1602)
Cape Town, Western Cape 7925
South Africa
Status: Recruiting Contact: Contact
Study Coordinator
+27 214485707

Facility: Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)
Badalona, Barcelona 08916
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+349334978925

Facility: Hospital Clinic i Provincial ( Site 0674)
Barcelona, Cataluna 08036
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34932275400

Facility: Hospital San Pedro de Alcantara ( Site 0697)
Caceres, Extremadura 10003
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34927256200

Facility: Institut Català d'Oncologia (ICO) - Girona ( Site 0700)
Girona, Gerona 17007
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+349722258284028

Facility: Instituto Valenciano de Oncologia - IVO ( Site 0679)
Valencia, Valenciana, Comunitat 46009
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34961114605

Facility: Hospital del Mar ( Site 0698)
Barcelona, 08003
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34932483139

Facility: Hospital Universitario Ramon y Cajal ( Site 0691)
Madrid, 28034
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34913368263

Facility: Hospital Universitario San Carlos ( Site 0678)
Madrid, 28040
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34913303000ext7554

Facility: Hospital Universitario la Paz ( Site 0690)
Madrid, 28046
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34912071138

Facility: Hospital de Nuestra Senora de Valme ( Site 0693)
Sevilla, 41014
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34955015000

Facility: Laenssjukhuset Ryhov ( Site 1215)
Jonkoping, Jonkopings Lan 551 85
Sweden
Status: Recruiting Contact: Contact
Study Coordinator
+46102410000

Facility: Karolinska Universitetssjukhuset Solna ( Site 1212)
Stockholm, Stockholms Lan 171 76
Sweden
Status: Recruiting Contact: Contact
Study Coordinator
+46851770000

Facility: Akademiska Sjukhuset ( Site 1211)
Uppsala, Uppsala Lan 751 85
Sweden
Status: Recruiting Contact: Contact
Study Coordinator
+46186110000

Facility: Onkologiska kliniken ( Site 1217)
Goteborg, Vastra Gotalands Lan 413 45
Sweden
Status: Recruiting Contact: Contact
Study Coordinator
46313421000

Facility: Ramathibodi Hospital. ( Site 1451)
Bangkok, Krung Thep Maha Nakhon 10400
Thailand
Status: Recruiting Contact: Contact
Study Coordinator
+6622011671

Facility: Faculty of Medicine Siriraj Hospital ( Site 1452)
Bangkok, Krung Thep Maha Nakhon 10700
Thailand
Status: Recruiting Contact: Contact
Study Coordinator
+6624194488

Facility: Maharaj Nakorn Chiangmai Hospital ( Site 1453)
Chiang Mai, 50200
Thailand
Status: Recruiting Contact: Contact
Study Coordinator
+66539455324

Facility: Srinagarind Hospital ( Site 1454)
Khon Kaen, 40002
Thailand
Status: Recruiting Contact: Contact
Study Coordinator
+6643363225

Facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0931)
Ankara, Adana 06100
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+903123055000

Facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)
Istanbul, 34096
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+905324167355

Facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926)
Istanbul, 34722
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+905323430723

Facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921)
Istanbul, 34899
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+905333832234

Facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929)
Konya, 42080
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+903322236000

Facility: Sakarya Universitesi Tip Fakultesi ( Site 0933)
Sakarya, 54290
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+905054785576

Facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924)
Trabzon, 61080
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+905052292035

Facility: Regional Oncology Center of Kharkiv ( Site 0958)
Kharkiv, Kharkivska Oblast 61000
Ukraine
Status: Recruiting Contact: Contact
Study Coordinator
+380508266088

Facility: The James Cook University Hospital ( Site 0730)
Middlesbrough, England TS4 3BW
United Kingdom
Status: Recruiting Contact: Contact
Study Coordinator
+441642 850850

Facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)
London, London, City Of EC1A 7BE
United Kingdom
Status: Recruiting Contact: Contact
Study Coordinator
+442078828505

Facility: The Royal Marsden Foundation Trust ( Site 0726)
London, London, City Of SW3 6JJ
United Kingdom
Status: Recruiting Contact: Contact
Study Coordinator
+4402078082911

Facility: Imperial College Healthcare NHS Trust ( Site 0745)
London, London, City Of W6 8RF
United Kingdom
Status: Recruiting Contact: Contact
Study Coordinator
+442033117627

Facility: Western General Hospital ( Site 0749)
Edinburgh, Midlothian EH42XU
United Kingdom
Status: Recruiting Contact: Contact
Study Coordinator
+441315372211

Facility: Clatterbridge Oncology Centre ( Site 0731)
Wirral, CH63 4JY
United Kingdom
Status: Recruiting Contact: Contact
Study Coordinator
+441513341155