SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)

A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)


  • Org Study ID: 7902-011
  • Secondary ID: 2018-003752-21,MK-7902-011,E7080-G000-317,LEAP-011,194808
  • NCT ID: NCT03898180
  • NCT Alias:
  • Sponsor: Merck Sharp & Dohme Corp. - Industry
  • Source: Merck Sharp & Dohme Corp.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC). The primary hypotheses for this study are that: 1. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and 2. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS).

Overal Status Start Date Phase Study Type
Recruiting May 6, 2019 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Primary Outcome 1 - Time Frame: Up to approximately 40 months

Primary Outcome 2 - Measure: Overall Survival (OS)

Primary Outcome 2 - Time Frame: Up to approximately 40 months

Condition:

  • Urothelial Carcinoma

Eligibility

Criteria:
Inclusion Criteria:

- Has a histologically or cytologically confirmed diagnosis of advanced/unresectable
(inoperable) or metastatic urothelial carcinoma (UC) of the renal pelvis, ureter
(upper urinary tract), bladder, or urethra.
>
- Has ≥1 measurable target lesion per RECIST 1.1 as assessed by the local site
investigator/radiologist.

- Has provided an archival tumor tissue sample or newly obtained core or excisional
biopsy of a tumor lesion not previously irradiated and adequate for Programmed
Death-Ligand 1 (PD-L1) evaluation.

- Has received no prior systemic chemotherapy for advanced or metastatic UC with the
following exceptions:

- Neoadjuvant (prior to surgery) platinum-based chemotherapy for treatment of
muscle-invasive bladder cancer with recurrence >12 months from completion of the
therapy is permitted.

- Adjuvant (following surgery) platinum-based chemotherapy following radical cystectomy,
with recurrence >12 months from completion of the therapy, is permitted.

- Meets criteria for either option a or option b (below):

- a. Has a tumor(s) with PD-L1 combined positive score (CPS) ≥10 and is considered
ineligible to receive cisplatin-based combination therapy, based on 1 of the
following:

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2 within 7
days prior to randomization

- National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Version 4.0 Grade ≥2 audiometric hearing loss

- NCI CTCAE Version 4.0 Grade ≥2 peripheral neuropathy OR

- b. In the opinion of the investigator, is considered ineligible to receive any
platinum-based chemotherapy (i.e., ineligible for cisplatin and carboplatin) based on:

- ECOG PS of 2 within 7 days prior to randomization. and ≥1 of the following:

- Documented visceral metastatic disease

- NCI CTCAE Version 4.0 Grade ≥2 audiometric hearing loss

- NCI CTCAE Version 4.0 Grade ≥2 peripheral neuropathy

- Other reason for the participant's being unable to receive both cisplatin and
carboplatin safely. Additional criteria for platinum ineligibility will be considered
and allowed on a case-by-case basis, following consultation with the Sponsor. Note:
Participants considered ineligible for any platinum-based chemotherapy are eligible
for this study regardless of their tumor PD-L1 status.

- Has ECOG PS 0, 1, or 2 within 7 days prior to randomization and a life expectancy of
≥3 months.

- Male participants are eligible to participate if they agree to the following during
the treatment period and for ≥30 days after the last dose of pembrolizumab or
lenvatinib/placebo:

- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and
agree to remain abstinent, OR

- Must agree to use contraception unless confirmed to be azoospermic (vasectomized or
secondary to medical cause as detailed below:

- Agrees to use a male condom plus partner use of an additional contraceptive method
when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP)
who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must
agree to remain abstinent from penile-vaginal intercourse or use a male condom during
each episode of penile-vaginal penetration.

- A female participant is eligible to participate if she is not pregnant or
breastfeeding and if she is not a WOCBP OR is a WOCBP and is using a contraceptive
method that is highly effective (with a failure rate of <1% per year) with low user
dependency, or is abstinent from heterosexual intercourse as her preferred and usual
lifestyle during the intervention period and for ≥120 days post pembrolizumab or ≥30
days post lenvatinib/placebo.

- Has adequately controlled blood pressure (BP) with or without antihypertensive
medications, defined as BP ≤150/90 mm Hg at screening and no change in
antihypertensive medications within 1 week prior to randomization.

- Has adequate organ function.

Exclusion Criteria:

- Has disease that is suitable for local therapy administered with curative intent (e.g.
chemotherapy and radiation for Stage 3 disease).

- Has tumor with any neuroendocrine or small cell component.

- Has a history of a gastrointestinal condition or procedure (e.g. gastric bypass,
malabsorption) that, in the opinion of the investigator, may affect oral drug
absorption.

- Has had major surgery within 3 weeks prior to the first dose of study treatment

- Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.

- Has radiographic evidence of major blood vessel invasion/infiltration, or has had
clinically significant hemoptysis (≥0.5 teaspoon of bright red blood) or tumor
bleeding within 2 weeks prior to the first dose of study treatment.

- Has had significant cardiovascular impairment within 12 months of the first dose of
study treatment, such as history of New York Heart Association (NYHA) >Class II
congestive heart failure, unstable angina, myocardial infarction or cerebrovascular
accident (CVA)/stroke, cardiac revascularization procedure, or cardiac arrhythmia
associated with hemodynamic instability.

- Has known intolerance or severe hypersensitivity (Grade ≥3) to pembrolizumab or
lenvatinib or any of their excipients

- Has received lenvatinib as monotherapy or in combination with a programmed cell
death-1/programmed cell death-ligand 1 (PD-1/PD-L1) inhibitor or has previously been
enrolled in a clinical study evaluating lenvatinib for bladder cancer, regardless of
the treatment received.

- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 inhibitor,
indoleamine-pyrrole 2,3 dioxygenase (IDO1) inhibitor, or agent directed to another
stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated
antigen 4 [CTLA-4], OX 40, CD137), or any other antibody or drug targeting T-cell
costimulatory pathways in the adjuvant or advanced/metastatic setting.

- Has received prior radiotherapy to a metastatic site without the use of chemotherapy
radiosensitization within 3 weeks of the first dose of study treatment, with the
exception of palliative radiotherapy to bone lesions, which is allowed if completed 2
weeks before the start of study treatment. Participants must have recovered from all
radiation-related toxicities, and must not require corticosteroids.

- Has received a live vaccine within 30 days prior to the first dose of study treatment.

- In the investigator's judgment, has not recovered from toxicity or other complications
from any major surgery prior to starting study treatment.

- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose of
study treatment. Note: Participants who have entered the follow-up phase of an
investigational study may participate as long as it has been 4 weeks after the last
dose of the previous investigational agent.

- Has history or presence of an abnormal electrocardiogram (ECG) that, in the
investigator's opinion, is clinically meaningful.

- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a
dose exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to randomization.

- Has had an active malignancy (except locally advanced or metastatic UC) within the
past 36 months. Note: Participants with basal cell carcinoma of the skin, squamous
cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical
cancer in situ) who have undergone potentially curative therapy are not excluded.

- Has a history of prostate cancer (T2NXMX or lower with Gleason score ≤7) treated with
definitive intent (surgically or with radiation therapy) ≥1 year prior to study entry
is acceptable, provided that the participant is considered prostate cancer-free.

- Has central nervous system (CNS) metastases, unless the participant has completed
local therapy (e.g. whole brain radiation therapy, surgery, or radiosurgery) and has
discontinued use of corticosteroids for this indication for ≥4 weeks before starting
study treatment. Any signs (e.g. radiologic) or symptoms of CNS metastases must be
stable for ≥4 weeks before starting study treatment.

- Has an active autoimmune disease that has required systemic treatment in the past 2
years (i.e, with disease-modifying agents, corticosteroids, or immunosuppressive
drugs).

- Has a history of (non-infectious) pneumonitis that required systemic steroids, or
current pneumonitis.

- Has an active infection requiring systemic therapy.

- Has a known history of human immunodeficiency virus (HIV) infection.

- Has a known history of or is positive for active hepatitis B virus (HBV) or has active
hepatitis C virus (HCV).

- Has active tuberculosis (TB).

- Is receiving hemodialysis.

- Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of pembrolizumab and lenvatinib/placebo.

- Has had an allogeneic tissue/solid organ transplant.
Show More

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: Toll Free Number

Phone: 1-888-577-8839

Email: Trialsites@merck.com

Link: Merck Oncology Clinical Trial Information

Locations

Facility Status Contact
Banner MD Anderson Cancer Center ( Site 0016)
Gilbert, Arizona 85234
United States
Recruiting Study Coordinator
480-256-3425
University of California Irvine Medical Center ( Site 0078)
Orange, California 92868
United States
Recruiting Study Coordinator
714-456-8148
John Wayne Cancer Institute ( Site 0017)
Santa Monica, California 90404
United States
Recruiting Study Coordinator
310-449-5224
Northwest Georgia Oncology Centers PC ( Site 0707)
Marietta, Georgia 30060
United States
Recruiting Study Coordinator
770-281-5131
University of Chicago ( Site 0039)
Chicago, Illinois 60637
United States
Recruiting Study Coordinator
773-834-1580
Joliet Oncology Hematology ( Site 0091)
Joliet, Illinois 60436
United States
Recruiting Study Coordinator
815-730-3098
Quincy Medical Group ( Site 0022)
Quincy, Illinois 62301
United States
Recruiting Study Coordinator
217-222-6550
New England Cancer Specialists ( Site 0047)
Scarborough, Maine 04074
United States
Recruiting Study Coordinator
207-844-5628
Mercy Hospital Saint Louis - David C. Pratt Cancer Center ( Site 0095)
Saint Louis, Missouri 63141
United States
Recruiting Study Coordinator
314-251-7061
Comprehensive Cancer Centers of Nevada ( Site 0005)
Las Vegas, Nevada 89169
United States
Recruiting Study Coordinator
702-952-3400
St. Peter's Hospital Cancer Care Center ( Site 0042)
Albany, New York 12208
United States
Recruiting Study Coordinator
518-525-6418
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0002)
New York, New York 10016
United States
Recruiting Study Coordinator
212-731-5820
Thomas Jefferson University Hospital ( Site 0051)
Philadelphia, Pennsylvania 19107
United States
Completed
Medical University of South Carolina-Hollings Cancer Center ( Site 0029)
Charleston, South Carolina 29425
United States
Recruiting Study Coordinator
843-972-8113
Baylor Scott & White Medical Center - Temple ( Site 0706)
Temple, Texas 76508
United States
Recruiting Study Coordinator
254-724-5939
Virginia Cancer Institute ( Site 0099)
Richmond, Virginia 23230
United States
Recruiting Study Coordinator
804-287-3000
Seattle Cancer Care Alliance ( Site 0003)
Seattle, Washington 98109
United States
Recruiting Study Coordinator
206-606-7486
Cancer Care Northwest ( Site 0009)
Spokane, Washington 99218
United States
Recruiting Study Coordinator
509-228-1680
Centro de Urología CDU ( Site 0590)
Buenos Aires, Ciudad Autonoma De Buenos Aires C1120AAT
Argentina
Recruiting Study Coordinator
+541149642424
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0585)
Viedma, Rio Negro R8500ACE
Argentina
Recruiting Study Coordinator
+5492920601693
Centro Oncológico de Rosario ( Site 0584)
Rosario, Santa Fe S2000KZE
Argentina
Recruiting Study Coordinator
+543414218909
Instituto de Investigaciones Metabolicas ( Site 0589)
Buenos Aires, C1012AAR
Argentina
Recruiting Study Coordinator
+541150319700
Instituto Medico Alexander Fleming ( Site 0578)
Buenos Aires, C1426ANZ
Argentina
Recruiting Study Coordinator
5491153288346
CEMAIC ( Site 0581)
Cordoba, X5008HHW
Argentina
Recruiting Study Coordinator
+5493516212584
Centro Oncologico de Integracion Regional. COIR ( Site 0576)
Mendoza, M5500AYB
Argentina
Recruiting Study Coordinator
+542614252575
Macquarie University ( Site 0151)
North Ryde, New South Wales 2109
Australia
Recruiting Study Coordinator
+61298459553
Mater Misericordiae Ltd ( Site 0158)
South Brisbane, Queensland 4101
Australia
Recruiting Study Coordinator
+61731635222
Monash Health ( Site 0160)
Clayton, Victoria 3168
Australia
Recruiting Study Coordinator
+61395086161
Austin Health-Austin Hospital ( Site 0154)
Heidelberg, Victoria 3084
Australia
Recruiting Study Coordinator
+610420381848
Juravinski Cancer Centre ( Site 0101)
Hamilton, Ontario L8V 1C3
Canada
Recruiting Study Coordinator
9053879495
Lakeridge Health ( Site 0103)
Oshawa, Ontario L1G 2B9
Canada
Recruiting Study Coordinator
9055768711
Sunnybrook Research Institute ( Site 0106)
Toronto, Ontario M4N 3M5
Canada
Recruiting Study Coordinator
41648050005739
CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0102)
Sherbrooke, Quebec J1H 5N4
Canada
Recruiting Study Coordinator
819346111012811
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0104)
Quebec, G1R 2J6
Canada
Recruiting Study Coordinator
418525444420414
Zhongshan Hospital Fudan University ( Site 0725)
Shanghai, Shanghai 200032
China
Recruiting Study Coordinator
+8613681971306
Zhejiang Provincial People's Hospital ( Site 0735)
Hangzhou, Zhejiang 310014
China
Recruiting Study Coordinator
+86-0571-85893646
Rigshospitalet ( Site 0680)
Copenhagen, Hovedstaden 2100
Denmark
Recruiting Study Coordinator
+4535453545
Herlev Hospital ( Site 0681)
Herlev, Hovedstaden 2730
Denmark
Recruiting Study Coordinator
+4538682200
Aarhus Universitets hospital ( Site 0683)
Aarhus N, Midtjylland 8200
Denmark
Recruiting Study Coordinator
+4578450000
Aalborg Universitets Hospital ( Site 0684)
Aalborg, Nordjylland 9100
Denmark
Recruiting Study Coordinator
+4597660000
Odense Universitetshospital ( Site 0682)
Odense, Syddanmark 5000
Denmark
Recruiting Study Coordinator
+4566113333
Centre Leon Berard ( Site 0244)
Lyon, Auvergne 69008
France
Recruiting Study Coordinator
+33478782643
Institut de Cancerologie Strasbourg Europe ( Site 0232)
Strasbourg, Bas-Rhin 67200
France
Recruiting Study Coordinator
+33388116768
Hopital de la Timone ( Site 0246)
Marseille, Bouches-du-Rhone 13005
France
Recruiting Study Coordinator
+33491385708
CHIC Quimper ( Site 0245)
Quimper, Finistere 29107
France
Recruiting Study Coordinator
+33251446161
CHU de Bordeaux- Hopital Saint Andre ( Site 0235)
Bordeaux, Gironde 33075
France
Recruiting Study Coordinator
+33556795808
Clinique Pasteur ( Site 0252)
Tolouse, Haute-Garonne 31076
France
Recruiting Study Coordinator
+33562213131
Centre de Cancerologie du Grand Montpellier ( Site 0249)
Montpellier, Herault 34070
France
Recruiting Study Coordinator
+33467926155
Centre Rene Gauducheau ICO ( Site 0250)
Saint Herblain, Loire-Atlantique 44805
France
Recruiting Study Coordinator
+33240679976
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0236)
Angers, Maine-et-Loire 49055
France
Recruiting Study Coordinator
+33243479493
Centre D Oncologie de Gentilly ( Site 0240)
Nancy, Meurthe-et-Moselle 54100
France
Recruiting Study Coordinator
+33383935005
Centre Hospitalier de la Cote Basque ( Site 0239)
Bayonne, Pyrenees-Atlantiques 64109
France
Recruiting Study Coordinator
+33559443535
Institut Gustave Roussy ( Site 0243)
Villejuif, Val-de-Marne 94805
France
Recruiting Study Coordinator
+33142115216
CHD Vendee ( Site 0251)
La Roche sur Yon, Vendee 85925
France
Recruiting Study Coordinator
+33251446141
CHU Poitiers ( Site 0253)
Poitiers, Vienne 86021
France
Recruiting Study Coordinator
+33549441496
Institut Curie ( Site 0237)
Paris, 75005
France
Recruiting Study Coordinator
+33144324675
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0271)
Tuebingen, Baden-Wurttemberg 72076
Germany
Recruiting Study Coordinator
+4970712987235
Universitaetsklinikum Giessen und Marburg GmbH ( Site 0284)
Marburg, Hessen 35032
Germany
Recruiting Study Coordinator
+49642158621836
Helios Kliniken Schwerin ( Site 0278)
Schwerin, Mecklenburg-Vorpommern 19049
Germany
Recruiting Study Coordinator
+493855202120
Universitaetsmedizin Goettingen ( Site 0281)
Gottingen, Niedersachsen 37075
Germany
Recruiting Study Coordinator
+4955139175669
Staedtisches Krankenhaus Kiel GmbH ( Site 0285)
Kiel, Schleswig-Holstein 24116
Germany
Recruiting Study Coordinator
+4943116971272
Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0277)
Luebeck, Schleswig-Holstein 23538
Germany
Recruiting Study Coordinator
+4945150043616
Universitaetsklinikum Hamburg-Eppendorf ( Site 0282)
Hamburg, 20246
Germany
Recruiting Study Coordinator
+4940741058774
Bacs-Kiskun Megyei Korhaz ( Site 0510)
Kecskemet, Bacs-Kiskun 6000
Hungary
Recruiting Study Coordinator
+36304913443
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0506)
Miskolc, Borsod-Abauj-Zemplen 3526
Hungary
Recruiting Study Coordinator
+36302780644
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0507)
Szolnok, Jasz-Nagykun-Szolnok 5000
Hungary
Recruiting Study Coordinator
+36209323256
Markusovszky Egyetemi Oktatokorhaz ( Site 0502)
Szombathely, Vas 9400
Hungary
Recruiting Study Coordinator
+3694515665
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 0509)
Budapest, 1106
Hungary
Recruiting Study Coordinator
+36703815172
Orszagos Onkologiai Intezet ( Site 0503)
Budapest, 1122
Hungary
Recruiting Study Coordinator
+3612248600
Uzsoki Utcai Korhaz ( Site 0508)
Budapest, 1145
Hungary
Recruiting Study Coordinator
+36209674709
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0504)
Kaposvar, 7400
Hungary
Recruiting Study Coordinator
+36304805269
Assuta Ashdod Public ( Site 0562)
Ashdod, HaDarom 7747629
Israel
Recruiting Study Coordinator
+972723398127
Meir Medical Center ( Site 0554)
Kfar Saba, HaMerkaz 4428164
Israel
Recruiting Study Coordinator
+97297471606
Rabin Medical Center ( Site 0553)
Petach-Tikwa, HaMerkaz 4941492
Israel
Recruiting Study Coordinator
+97239378074
Assaf Harofeh Medical Center ( Site 0556)
Zerifin, HaMerkaz 7030001
Israel
Recruiting Study Coordinator
+97289779715
Ha Emek Medical Center ( Site 0560)
Afula, HaTsafon 1834111
Israel
Recruiting Study Coordinator
+97246495723
Rambam Medical Center ( Site 0552)
Haifa, Heifa 3525408
Israel
Recruiting Study Coordinator
+97247776750
Sheba Medical Center ( Site 0551)
Ramat Gan, Tell Abib 5265601
Israel
Completed
Sourasky Medical Center ( Site 0561)
Tel Aviv, Tell Abib 6423906
Israel
Recruiting Study Coordinator
+97236947284
Shaare Zedek Medical Center ( Site 0559)
Jerusalem, Yerushalayim 9103102
Israel
Recruiting Study Coordinator
+97226555727
Hadassah Ein Kerem Medical Center ( Site 0558)
Jerusalem, Yerushalayim 9112001
Israel
Recruiting Study Coordinator
+972505172315
Centro di Riferimento Oncologico CRO ( Site 0304)
Aviano, Pordenone 33081
Italy
Recruiting Study Coordinator
+390434659048
Istituto Tumori Giovanni Paolo II ( Site 0306)
Bari, 70124
Italy
Recruiting Study Coordinator
+390805555420
Policlinico S. Orsola - Malpighi (Bologna) ( Site 0302)
Bologna, 40138
Italy
Recruiting Study Coordinator
+390512142204
Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0305)
Catania, 95126
Italy
Recruiting Study Coordinator
+390957262082
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0301)
Milano, 20133
Italy
Recruiting Study Coordinator
+390223902402
ASST Grande Ospedale Metropolitano Niguarda ( Site 0307)
Milano, 20162
Italy
Recruiting Study Coordinator
+390264442291
Azienda Ospedaliera Santa Maria ( Site 0303)
Terni, 05100
Italy
Recruiting Study Coordinator
+390744205410
Ospedale Borgo Roma-Oncologia ( Site 0308)
Verona, 37134
Italy
Recruiting Study Coordinator
+390458122768
Hirosaki University Hospital ( Site 0123)
Hirosaki, Aomori 036-8563
Japan
Recruiting Study Coordinator
+81172335111
National Cancer Center Hospital East ( Site 0128)
Kashiwa, Chiba 277-8577
Japan
Recruiting Study Coordinator
+81471331111
Ehime University Hospital ( Site 0137)
Toon, Ehime 791-0295
Japan
Recruiting Study Coordinator
+81899645111
Sapporo Medical University Hospital ( Site 0122)
Sapporo, Hokkaido 060-8543
Japan
Recruiting Study Coordinator
+81116112111
University of Tsukuba Hospital ( Site 0126)
Tsukuba, Ibaraki 305-8576
Japan
Recruiting Study Coordinator
+81298533900
Kitasato University Hospital ( Site 0129)
Sagamihara, Kanagawa 252-0375
Japan
Recruiting Study Coordinator
+81427788111
Nara Medical University Hospital ( Site 0133)
Kashihara, Nara 634-8522
Japan
Recruiting Study Coordinator
+81744223051
Saitama Medical University International Medical Center ( Site 0125)
Hidaka, Saitama 350-1298
Japan
Recruiting Study Coordinator
+81429844111
Yamaguchi University Hospital ( Site 0135)
Ube, Yamaguchi 755-8505
Japan
Recruiting Study Coordinator
+81836222111
Akita University Hospital ( Site 0124)
Akita, 010-8543
Japan
Recruiting Study Coordinator
+81188341111
Chiba Cancer Center ( Site 0127)
Chiba, 260-8717
Japan
Recruiting Study Coordinator
+81432645431
Nagasaki University Hospital ( Site 0136)
Nagasaki, 852-8501
Japan
Recruiting Study Coordinator
+81958197200
Osaka City University Hospital ( Site 0132)
Osaka, 545-8586
Japan
Recruiting Study Coordinator
+81666452121
Tokushima University Hospital ( Site 0134)
Tokushima, 770-8503
Japan
Recruiting Study Coordinator
+81886313111
Medical Hospital, Tokyo Medical And Dental University ( Site 0130)
Tokyo, 113-8519
Japan
Recruiting Study Coordinator
+81338136111
Chonnam National University Hwasun Hospital ( Site 0194)
Hwasun Gun, Jeonranamdo 58128
Korea, Republic of
Recruiting Study Coordinator
+82613797623
National Cancer Center ( Site 0196)
Goyang-si, Kyonggi-do 10408
Korea, Republic of
Recruiting Study Coordinator
+82319201678
Korea University Anam Hospital ( Site 0197)
Seoul, Seoul-teukbyeolsi [Seoul] 02841
Korea, Republic of
Recruiting Study Coordinator
+82613797623
Seoul National University Hospital ( Site 0191)
Seoul, Seoul-teukbyeolsi [Seoul] 03080
Korea, Republic of
Recruiting Study Coordinator
+82220722216
Severance Hospital ( Site 0192)
Seoul, Seoul-teukbyeolsi [Seoul] 03722
Korea, Republic of
Recruiting Study Coordinator
+82222288137
Veterans Health Service Medical Center ( Site 0198)
Seoul, Seoul-teukbyeolsi [Seoul] 05368
Korea, Republic of
Recruiting Study Coordinator
+82222251669
Samsung Medical Center ( Site 0193)
Seoul, Seoul-teukbyeolsi [Seoul] 06351
Korea, Republic of
Recruiting Study Coordinator
+82234101767
Chungnam National University Hospital ( Site 0195)
Daejeon, Taejon-Kwangyokshi 35015
Korea, Republic of
Recruiting Study Coordinator
+82613797623
Ziekenhuis Rijnstate ( Site 0342)
Arnhem, Gelderland 6815 AD
Netherlands
Recruiting Study Coordinator
31880056735
Maastricht Universitair Medisch Centrum - MUMC ( Site 0334)
Maastricht, Limburg 6229 HX
Netherlands
Recruiting Study Coordinator
+31433876543
VieCuri Medisch Centrum ( Site 0340)
Venlo, Limburg 5912 BL
Netherlands
Recruiting Study Coordinator
+31773205555
Amphia Ziekenhuis Breda ( Site 0331)
Breda, Noord-Brabant 4819 EV
Netherlands
Recruiting Study Coordinator
+31765951130
Deventer Ziekenhuis ( Site 0341)
Deventer, Overijssel 7416 SE
Netherlands
Recruiting Study Coordinator
+31570535070
Haga Ziekenhuis ( Site 0333)
Den Haag, Zuid-Holland 2545 AA
Netherlands
Recruiting Study Coordinator
+31702102605
Erasmus MC ( Site 0332)
Rotterdam, Zuid-Holland 3015 GD
Netherlands
Recruiting Study Coordinator
+31107041505
St. Antonius Ziekenhuis ( Site 0335)
Utrecht, 3543 EM
Netherlands
Recruiting Study Coordinator
+31883204741
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0535)
Wroclaw, Dolnoslaskie 50-556
Poland
Recruiting Study Coordinator
+48601772623
Szpital Wojewodzki ( Site 1062)
Tarnow, Malopolskie 33-100
Poland
Recruiting Study Coordinator
+48602280826
Europejskie Centrum Zdrowia Otwock ( Site 0532)
Otwock, Mazowieckie 05-400
Poland
Recruiting Study Coordinator
+48601200599
Urologica Praktyka Lekarska Adam Marcheluk ( Site 0543)
Siedlce, Mazowieckie 08-110
Poland
Recruiting Study Coordinator
+48504283093
Magodent Szpital Elblaska ( Site 0541)
Warszawa, Mazowieckie 01-748
Poland
Recruiting Study Coordinator
+48691666578
Szpital Miejski im. Jana Pawła II w Bielsku-Białej ( Site 0542)
Bielsko-Biala, Slaskie 43-300
Poland
Recruiting Study Coordinator
+48603075937
Central Clinical Hospital with Polyclinic ( Site 0415)
Moscow, Moskva 121359
Russian Federation
Recruiting Study Coordinator
+74955300891
Medical Rehabilitation Center ( Site 0411)
Moscow, Moskva 125367
Russian Federation
Recruiting Study Coordinator
+79264375889
EMC ( Site 0424)
Moscow, Moskva 129090
Russian Federation
Recruiting Study Coordinator
+79166590224
Murmansk Regional Oncology Dispensary ( Site 0420)
Murmansk, Murmanskaya Oblast' 183057
Russian Federation
Recruiting Study Coordinator
+79217252994
Volga District Medical Center Federal Medical and Biological Agency ( Site 0413)
Nizhny Novgorod, Nizhegorodskaya Oblast' 603074
Russian Federation
Recruiting Study Coordinator
+78314216977
Omsk Clinical Oncology Dispensary ( Site 0418)
Omsk, Omskaya Oblast 644013
Russian Federation
Recruiting Study Coordinator
+73812601724
Clinical Hospital Saint Luka ( Site 0421)
Saint-Petersburg, Sankt-Peterburg 194044
Russian Federation
Recruiting Study Coordinator
+79217252994
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0414)
Yaroslavl, Yaroslavskaya Oblast' 150054
Russian Federation
Recruiting Study Coordinator
+79106654167
Hospital Teresa Herrera - Chuac ( Site 0357)
A Coruna, A Coruna [La Coruna] 15006
Spain
Recruiting Study Coordinator
+34981178000EXT292072
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0351)
Badalona, Barcelona [Barcelona] 08916
Spain
Recruiting Study Coordinator
+34934978925
Hospital General Universitari Vall d Hebron ( Site 0358)
Barcelona, Barcelona [Barcelona] 08035
Spain
Completed
ICO L Hospitalet ( Site 0361)
Hospitalet de Llobregat, Barcelona [Barcelona] 08908
Spain
Recruiting Study Coordinator
932607333
Xarxa Assistencial Universitaria Manresa ( Site 0354)
Manresa, Barcelona [Barcelona] 08243
Spain
Recruiting Study Coordinator
+34938759300 Ext.5512
Hospital Infanta Cristina ( Site 0355)
Badajoz, 06080
Spain
Recruiting Study Coordinator
+34924218040 Ext.48350
Hospital La Princesa ( Site 0862)
Madrid, 28006
Spain
Recruiting Study Coordinator
915202200 ext.16104
Hospital Universitario Gregorio Maranon ( Site 0352)
Madrid, 28007
Spain
Recruiting Study Coordinator
+34914269393
Hospital Universitario HM Sanchinarro ( Site 0356)
Madrid, 28050
Spain
Recruiting Study Coordinator
+34917567984
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0216)
Kaoshiung, Kaohsiung 807
Taiwan
Recruiting Study Coordinator
+886931199148
Kaohsiung Chang Gung Memorial Hospital ( Site 0217)
Kaohsiung, 83301
Taiwan
Recruiting Study Coordinator
+886773171233267
China Medical University Hospital ( Site 0213)
Taichung, 40447
Taiwan
Recruiting Study Coordinator
+886422052121
Taichung Veterans General Hospital ( Site 0214)
Taichung, 40705
Taiwan
Recruiting Study Coordinator
+886423741215
National Cheng Kung University Hospital ( Site 0215)
Tainan, 70403
Taiwan
Recruiting Study Coordinator
+88662353535
National Taiwan University Hospital ( Site 0211)
Taipei, 10048
Taiwan
Recruiting Study Coordinator
+88622312345665238
Taipei Veterans General Hospital ( Site 0212)
Taipei, 11217
Taiwan
Recruiting Study Coordinator
+886228757519#315
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0457)
Adana, 01330
Turkey
Recruiting Study Coordinator
+905317625936
Ankara Sehir Hastanesi ( Site 0455)
Ankara, 06800
Turkey
Recruiting Study Coordinator
+905555306271
Antalya Memorial Hospital Department of Medical Oncology ( Site 0461)
Antalya, 07020
Turkey
Recruiting Study Coordinator
+905076397700
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0454)
Istanbul, 34098
Turkey
Recruiting Study Coordinator
+905324167355
Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 0459)
Istanbul, 34722
Turkey
Recruiting Study Coordinator
+905063509061
Ege Universitesi Tulay Aktas Onkoloji Hastanesi ( Site 0462)
İzmir, 35100
Turkey
Recruiting Study Coordinator
+905332117153
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0456)
Konya, 42080
Turkey
Recruiting Study Coordinator
+905322679838
Sakarya Universitesi Tip Fakultesi Arastirma Hastanesi ( Site 0460)
Sakarya, 54290
Turkey
Recruiting Study Coordinator
+905323233799
Queens Hospital-Purple Zone ( Site 0377)
Romford, Essex RM7 0AG
United Kingdom
Recruiting Study Coordinator
+441705435000
Lister Hospital ( Site 0376)
Stevenage, Hertfordshire SG1 4AB
United Kingdom
Recruiting Study Coordinator
+441438284298
Kent and Canterbury Hospital ( Site 0390)
Canterbury, Kent CT1 3NG
United Kingdom
Recruiting Study Coordinator
+441227766877
Royal Preston Hospital ( Site 0379)
Preston, Lancashire PR2 9HT
United Kingdom
Recruiting Study Coordinator
+441772524656
Saint Bartholomew s Hospital - London ( Site 0386)
London, London, City Of EC1A 7BE
United Kingdom
Recruiting Study Coordinator
+442078828505
University College London Hospital NHS Foundation Trust ( Site 0380)
London, London, City Of NW1 2PG
United Kingdom
Recruiting Study Coordinator
+448451555000
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 0378)
London, London, City Of W6 8RF
United Kingdom
Recruiting Study Coordinator
+442033117627
Nottingham University Hospital NHS Trust ( Site 0383)
Nottingham, Nottinghamshire NG5 1PB
United Kingdom
Recruiting Study Coordinator
+441159691169
Derriford Hospital ( Site 0388)
Plymouth, PL6 8DH
United Kingdom
Recruiting Study Coordinator
+441752430138
Weston Park Hospital ( Site 0387)
Sheffield, S10 2SJ
United Kingdom
Recruiting Study Coordinator
+441142265072
Royal Stoke University Hospital Univ. Hosps of North Midlands NHST ( Site 0392)
Stoke-on-Trent, ST4 6QG
United Kingdom
Recruiting Study Coordinator
+441782672426