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Brief Title: Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ 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)

INTRODUCTION

  • Org Study ID: 7902-011
  • Secondary ID: 2018-003752-21, MK-7902-011, E7080-G000-317, LEAP-011, 194808
  • NTC ID: NCT03898180
  • Sponsor: Merck Sharp & Dohme Corp.
Merck Oncology Clinical Trial Information

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:

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
Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS).

  • Overall Status
    Recruiting
  • Start Date
    May 6, 2019
  • Phase
    Phase 3
  • Study Type
    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 - Timeframe: Up to approximately 40 months

Primary Outcome 2 - Measure: Overall Survival (OS)

Primary Outcome 2 - Timeframe: Up to approximately 40 months

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY

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.

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: Banner MD Anderson Cancer Center ( Site 0016)
Gilbert, Arizona 85234
United States
Status: Recruiting Contact: Contact
Study Coordinator
480-256-3425
Facility: John Wayne Cancer Institute ( Site 0017)
Santa Monica, California 90404
United States
Status: Recruiting Contact: Contact
Study Coordinator
770-281-5131
Facility: Northwest Georgia Oncology Centers PC ( Site 0707)
Marietta, Georgia 30060
United States
Status: Recruiting Contact: Contact
Study Coordinator
773-834-1580
Facility: University of Chicago ( Site 0039)
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Contact
Study Coordinator
815-730-3098
Facility: Joliet Oncology Hematology ( Site 0091)
Joliet, Illinois 60436
United States
Status: Recruiting Contact: Contact
Study Coordinator
217-222-6550
Facility: Quincy Medical Group ( Site 0022)
Quincy, Illinois 62301
United States
Status: Recruiting Contact: Contact
Study Coordinator
207-844-5628
Facility: New England Cancer Specialists ( Site 0047)
Scarborough, Maine 04074
United States
Status: Recruiting Contact: Contact
Study Coordinator
800-527-6266
Facility: Karmanos Cancer Institute ( Site 0712)
Detroit, Michigan 48201
United States
Status: Recruiting Contact: Contact
Study Coordinator
314-251-7061
Facility: Mercy Hospital Saint Louis - David C. Pratt Cancer Center ( Site 0095)
Saint Louis, Missouri 63141
United States
Status: Recruiting Contact: Contact
Study Coordinator
702-952-3400
Facility: Comprehensive Cancer Centers of Nevada ( Site 0005)
Las Vegas, Nevada 89169
United States
Status: Recruiting Contact: Contact
Study Coordinator
518-525-6418
Facility: St. Peter's Hospital Cancer Care Center ( Site 0042)
Albany, New York 12208
United States
Status: Recruiting Contact: Contact
Study Coordinator
212-731-5820
Facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0002)
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Study Coordinator
918-505-3200
Facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0774)
Tulsa, Oklahoma 74146
United States
Status: Recruiting Contact: Contact
Study Coordinator
843-972-8113
Facility: Medical University of South Carolina-Hollings Cancer Center ( Site 0029)
Charleston, South Carolina 29425
United States
Status: Recruiting Contact: Contact
Study Coordinator
206-606-7486
Facility: Baylor Scott & White Medical Center - Temple ( Site 0706)
Temple, Texas 76508
United States
Status: Recruiting Contact: Contact
Study Coordinator
+541142262013
Facility: Seattle Cancer Care Alliance ( Site 0003)
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Study Coordinator
5432218900
Facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0577)
Berazategui, Buenos Aires B1884BBF
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+543414218909
Facility: Centro de Urología CDU ( Site 0590)
Buenos Aires, Caba C1120AAT
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+541150319700
Facility: Instituto Medico Alexander Fleming ( Site 0578)
Buenos Aires, Caba C1426ANZ
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+541151082017
Facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0585)
Viedma, Rio Negro R8500ACE
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+5493516212584
Facility: Centro Oncológico de Rosario ( Site 0584)
Rosario, Santa Fe S2000KZE
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+542614252575
Facility: Instituto de Investigaciones Metabolicas ( Site 0589)
Buenos Aires, New South Wales C1012AAR
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+61298459553
Facility: Centro Medico Dra De Salvo ( Site 0593)
Buenos Aires, Queensland C1426ANZ
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+61731635222
Facility: CEMAIC ( Site 0581)
Cordoba, Victoria X5008HHW
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+61397847777
Facility: Centro Oncologico de Integracion Regional. COIR ( Site 0576)
Mendoza, Victoria M5500AYB
Argentina
Status: Recruiting Contact: Contact
Study Coordinator
+610420381848
Facility: Macquarie University ( Site 0151)
North Ryde, Victoria 2109
Australia
Status: Recruiting Contact: Contact
Study Coordinator
9053879495
Facility: Mater Misericordiae Ltd ( Site 0158)
South Brisbane, Ontario 4101
Australia
Status: Recruiting Contact: Contact
Study Coordinator
9055768711
Facility: Peninsula Health Frankston Hospital ( Site 0153)
Frankston, Ontario 3199
Australia
Status: Recruiting Contact: Contact
Study Coordinator
819346111012811
Facility: Austin Health-Austin Hospital ( Site 0154)
Heidelberg, Quebec 3084
Australia
Status: Recruiting Contact: Contact
Study Coordinator
418525444420414
Facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0101)
Hamilton, Beijing L8V 5C2
Canada
Status: Recruiting Contact: Contact
Study Coordinator
13910688432
Facility: Lakeridge Health ( Site 0103)
Oshawa, Beijing L1G 2B9
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+86 010 66947797
Facility: Sunnybrook Research Institute ( Site 0106)
Toronto, Beijing M4N 3M5
Canada
Status: Recruiting Contact: Contact
Study Coordinator
010-8226699
Facility: CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0102)
Sherbrooke, Chongqing J1H5N4
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+86 23 65311341
Facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0104)
Quebec, Fujian G1R 2J6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+86592-2137572
Facility: Peking University First Hospital ( Site 0726)
Beijing, Guangdong 100034
China
Status: Recruiting Contact: Contact
Study Coordinator
+8602087343064
Facility: Fifth Medical Center of CPLA General Hospital ( Site 0732)
Beijing, Guangdong 100071
China
Status: Recruiting Contact: Contact
Study Coordinator
8602083062338
Facility: Peking University Third Hospital ( Site 0727)
Beijing, Guangdong 100089
China
Status: Recruiting Contact: Contact
Study Coordinator
13600054833
Facility: Chongqing Cancer Hospital ( Site 0741)
Chongging, Heilongjiang 400030
China
Status: Recruiting Contact: Contact
Study Coordinator
13603612355
Facility: The First Affiliated Hospital of Xiamen University ( Site 0743)
Xiamen, Hubei 361003
China
Status: Recruiting Contact: Contact
Study Coordinator
+8613907110640
Facility: Sun Yat-Sen University Cancer Center ( Site 0752)
Guangdong, Hunan 510060
China
Status: Recruiting Contact: Contact
Study Coordinator
+8613875825253
Facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 0749)
Guangzhou, Jiangsu 510230
China
Status: Recruiting Contact: Contact
Study Coordinator
86-13605171690
Facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 0746)
Guangzhou, Shanghai 510289
China
Status: Recruiting Contact: Contact
Study Coordinator
+86021-64175590-88217
Facility: Harbin Medical University Cancer Hospital ( Site 0750)
Harbin, Shanghai 150081
China
Status: Recruiting Contact: Contact
Study Coordinator
+8613681971306
Facility: Hubei Cancer Hospital ( Site 0744)
Wuhan, Shanxi 430079
China
Status: Recruiting Contact: Contact
Study Coordinator
8613991288221
Facility: Hunan Cancer Hospital ( Site 0745)
Changsha, Xinjiang 410013
China
Status: Recruiting Contact: Contact
Study Coordinator
+869117968111
Facility: Nanjing Drum Tower Hospital ( Site 0737)
Nanjing, Zhejiang 210008
China
Status: Recruiting Contact: Contact
Study Coordinator
+86057187783759
Facility: Fudan University Shanghai Cancer Center ( Site 0721)
Shanghai, Zhejiang 200032
China
Status: Recruiting Contact: Contact
Study Coordinator
+86-0571-85893646
Facility: Zhongshan Hospital Fudan University ( Site 0725)
Shanghai, Hovedstaden 200032
China
Status: Recruiting Contact: Contact
Study Coordinator
+4535453545
Facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0738)
Xian, Hovedstaden 710061
China
Status: Recruiting Contact: Contact
Study Coordinator
+4538683868
Facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0751)
Urumqi, Midtjylland 830011
China
Status: Recruiting Contact: Contact
Study Coordinator
+4578450000
Facility: Second Affiliated Hospital, Zhejiang University ( Site 0734)
Hangzhou, Nordjylland 310009
China
Status: Recruiting Contact: Contact
Study Coordinator
+4597660000
Facility: Zhejiang Provincial People's Hospital ( Site 0735)
Hangzhou, Syddanmark 310014
China
Status: Recruiting Contact: Contact
Study Coordinator
+4566113333
Facility: Rigshospitalet ( Site 0680)
Copenhagen, Ain 2100
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+33549441496
Facility: Herlev Hospital ( Site 0681)
Herlev, Alsace 2730
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+33388116768
Facility: Aarhus Universitets hospital ( Site 0683)
Aarhus N, Bouches-du-Rhone 8200
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+33491385708
Facility: Aalborg Universitets Hospital ( Site 0684)
Aalborg, Finistere 9000
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+33251446161
Facility: Odense Universitetshospital ( Site 0682)
Odense, Gironde 5000
Denmark
Status: Recruiting Contact: Contact
Study Coordinator
+33556795808
Facility: CHU Poitiers ( Site 0253)
Poitiers, Haute-Garonne 86021
France
Status: Recruiting Contact: Contact
Study Coordinator
+33467926155
Facility: Institut de Cancerologie Strasbourg Europe ( Site 0232)
Strasbourg, Languedoc-Roussillon 67033
France
Status: Recruiting Contact: Contact
Study Coordinator
+33240679976
Facility: Hopital de la Timone ( Site 0246)
Marseille, Loire-Atlantique 13005
France
Status: Recruiting Contact: Contact
Study Coordinator
+33243479493
Facility: CHIC Quimper ( Site 0245)
Quimper, Maine-et-Loire 29107
France
Status: Recruiting Contact: Contact
Study Coordinator
+33383935005
Facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0235)
Bordeaux, Meurthe-et-Moselle 33075
France
Status: Recruiting Contact: Contact
Study Coordinator
+33559443535
Facility: Centre de Cancerologie du Grand Montpellier ( Site 0249)
Montpellier, Rhone 34070
France
Status: Recruiting Contact: Contact
Study Coordinator
+33142115216
Facility: Centre Rene Gauducheau ICO ( Site 0250)
Saint Herblain, Val-de-Marne 44805
France
Status: Recruiting Contact: Contact
Study Coordinator
+33251446141
Facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0236)
Angers, Vendee 49055
France
Status: Recruiting Contact: Contact
Study Coordinator
+33144324675
Facility: Centre D Oncologie de Gentilly ( Site 0240)
Nancy, Baden-Wurttemberg 54100
France
Status: Recruiting Contact: Contact
Study Coordinator
+4970712987235
Facility: Centre Hospitalier de la Cote Basque ( Site 0239)
Bayonne, Hessen 64109
France
Status: Recruiting Contact: Contact
Study Coordinator
+49642158621836
Facility: Centre Leon Berard ( Site 0244)
Lyon, Mecklenburg-Vorpommern 69373
France
Status: Recruiting Contact: Contact
Study Coordinator
+493855202120
Facility: Institut Gustave Roussy ( Site 0243)
Villejuif, Niedersachsen 94805
France
Status: Recruiting Contact: Contact
Study Coordinator
+4955139175669
Facility: CHD Vendee-onco-hematologie ( Site 0251)
La Roche sur Yon, Nordrhein-Westfalen 85925
France
Status: Recruiting Contact: Contact
Study Coordinator
+495115322301
Facility: Institut Curie ( Site 0237)
Paris, Schleswig-Holstein 75005
France
Status: Recruiting Contact: Contact
Study Coordinator
+4943116971272
Facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0271)
Tuebingen, Schleswig-Holstein 72076
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4945150043616
Facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 0284)
Marburg, Bacs-Kiskun 35032
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4940741058774
Facility: Helios Kliniken Schwerin GmbH ( Site 0278)
Schwerin, Borsod-Abauj-Zemplen 19049
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+36304913443
Facility: Universitaetsmedizin Goettingen ( Site 0281)
Gottingen, Jasz-Nagykun-Szolnok 37075
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+36302780644
Facility: Universitaetsklinikum Essen ( Site 0274)
Essen, Vas 45147
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+36209323256
Facility: Staedtisches Krankenhaus Kiel GmbH ( Site 0285)
Kiel, Lombardia 24116
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+3694515665
Facility: Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0277)
Luebeck, Lombardia 23538
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+36703815172
Facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0282)
Hamburg, Pordenone 20246
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+3612248600
Facility: Bacs-Kiskun Megyei Korhaz ( Site 0510)
Kecskemet, Aomori 6000
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+36209674709
Facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
Miskolc, Chiba 3526
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+36304805269
Facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0507)
Szolnok, Ehime 5000
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97246495723
Facility: Markusovszky Egyetemi Oktatokorhaz ( Site 0502)
Szombathely, Hokkaido 9400
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+972723398127
Facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 0509)
Budapest, Ibaraki 1106
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97247776750
Facility: Orszagos Onkologiai Intezet ( Site 0503)
Budapest, Kanagawa 1122
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97226555727
Facility: Uzsoki Utcai Korhaz ( Site 0508)
Budapest, Nara 1145
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+972505172315
Facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0504)
Kaposvar, Saitama 7400
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+97297471606
Facility: Ha Emek Medical Center ( Site 0560)
Afula, Yamaguchi 1834111
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+97239378074
Facility: Assuta Ashdod Public ( Site 0562)
Ashdod, Jeonranamdo 7747629
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+97236947284
Facility: Rambam Medical Center ( Site 0552)
Haifa, Kyonggi-do 3109601
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+97289779715
Facility: Shaare Zedek Medical Center ( Site 0559)
Jerusalem, Taejon-Kwangyokshi 9103102
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390226435668
Facility: Hadassah Ein Kerem Medical Center ( Site 0558)
Jerusalem, Gelderland 9112001
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390264443695
Facility: Meir Medical Center ( Site 0554)
Kfar Saba, Limburg 4428164
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390434659048
Facility: Rabin Medical Center ( Site 0553)
Petach-Tikwa, Limburg 4941492
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390805555420
Facility: Sourasky Medical Center ( Site 0561)
Tel Aviv, Overijssel 6423906
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390957262082
Facility: Assaf Harofeh Medical Center ( Site 0556)
Zerifin, Zuid-Holland 70300
Israel
Status: Recruiting Contact: Contact
Study Coordinator
+390223903818
Facility: Ospedale San Raffaele-Oncologia Medica ( Site 0309)
Milano, Zuid-Holland 20132
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390744205410
Facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0307)
Milano, Dolnoslaskie 20162
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390458128120
Facility: Centro di Riferimento Oncologico CRO ( Site 0304)
Aviano, Malopolskie 33081
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81172335111
Facility: Istituto Tumori Giovanni Paolo II ( Site 0306)
Bari, Mazowieckie 70124
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81471331111
Facility: Policlinico S. Orsola - Malpighi (Bologna) ( Site 0302)
Bologna, Mazowieckie 40138
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81899645111
Facility: Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0305)
Catania, Mazowieckie 95126
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81116112111
Facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0301)
Milano, Slaskie 20133
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81298533900
Facility: Azienda Ospedaliera Santa Maria ( Site 0303)
Terni, Leningradskaya Oblast 05100
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81427788111
Facility: Ospedale Borgo Roma-Oncologia ( Site 0308)
Verona, Moskva 37134
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81744223051
Facility: Hirosaki University Hospital ( Site 0123)
Hirosaki, Moskva 036-8563
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81429844111
Facility: National Cancer Center Hospital East ( Site 0128)
Kashiwa, Moskva 277-8577
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81836222111
Facility: Ehime University Hospital ( Site 0137)
Toon, Murmanskaya Oblast 791-0295
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81188341111
Facility: Sapporo Medical University Hospital ( Site 0122)
Sapporo, Nizhegorodskaya Oblast 060-8543
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81432645431
Facility: University of Tsukuba Hospital ( Site 0126)
Tsukuba, Omskaya Oblast 305-8576
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81958197200
Facility: Kitasato University Hospital ( Site 0129)
Sagamihara, Sankt-Peterburg 252-0375
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81666452121
Facility: Nara Medical University Hospital ( Site 0133)
Kashihara, Yaroslavskaya Oblast 634-8522
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81886313111
Facility: Saitama Medical University International Medical Center ( Site 0125)
Hidaka, Barcelona 350-1298
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81338136111
Facility: Yamaguchi University Hospital ( Site 0135)
Ube, Barcelona 755-8505
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82-61-379-7700
Facility: Akita University Hospital ( Site 0124)
Akita, Barcelona 010-8543
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82319201678
Facility: Chiba Cancer Center ( Site 0127)
Chiba, La Coruna 260-8717
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82613797623
Facility: Nagasaki University Hospital ( Site 0136)
Nagasaki, Kaohsiung 852-8501
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82613797623
Facility: Osaka City University Hospital ( Site 0132)
Osaka, Derbyshire 545-8586
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82220722216
Facility: Tokushima University Hospital ( Site 0134)
Tokushima, Essex 770-8503
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82-2-2228-8054
Facility: Medical Hospital, Tokyo Medical And Dental University ( Site 0130)
Tokyo, Hertfordshire 113-8519
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+82222251669
Facility: Chonnam National University Hwasun Hospital ( Site 0194)
Hwasun Gun, Kent 58128
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82234101767
Facility: National Cancer Center ( Site 0196)
Goyang-si, Lancashire 10408
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
31880056735
Facility: Chungnam National University Hospital ( Site 0195)
Daejeon, London, City Of 35015
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+31433876543
Facility: Korea University Anam Hospital ( Site 0197)
Seoul, London, City Of 02841
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+31773205555
Facility: Seoul National University Hospital ( Site 0191)
Seoul, London, City Of 03080
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+31765951130
Facility: Severance Hospital ( Site 0192)
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+31570535070
Facility: Veterans Health Service Medical Center ( Site 0198)
Seoul, 05368
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+31702102605
Facility: Samsung Medical Center ( Site 0193)
Seoul, 06351
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+31107041505
Facility: Ziekenhuis Rijnstate ( Site 0342)
Arnhem, 6815 AD
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+31883204741
Facility: Maastricht Universitair Medisch Centrum - MUMC ( Site 0334)
Maastricht, 6229 HX
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+48601772623
Facility: VieCuri Medisch Centrum ( Site 0340)
Venlo, 5912 BL
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+48602280826
Facility: Amphia Ziekenhuis Breda ( Site 0331)
Breda, 4819 EV
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+48504283093
Facility: Deventer Ziekenhuis ( Site 0341)
Deventer, 7416 SE
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+48691666578
Facility: Haga Ziekenhuis ( Site 0333)
Den Haag, 2545 AA
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+48603075937
Facility: Erasmus MC ( Site 0332)
Rotterdam, 3015 GD
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+79817217460
Facility: St. Antonius Ziekenhuis ( Site 0335)
Utrecht, 3543 AZ
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+79166590224
Facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0535)
Wroclaw, 50-556
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+74955300891
Facility: Szpital Wojewodzki ( Site 1062)
Tarnow, 33-100
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+79264375889
Facility: Urologica Praktyka Lekarska Adam Marcheluk ( Site 0543)
Siedlce, 08-110
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+78314216977
Facility: Luxmed Onkologia sp. z o. o. ( Site 0541)
Warszawa, 01-748
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+73812601724
Facility: Szpital Miejski im. Jana Pawła II w Bielsku-Białej ( Site 0542)
Bielsko-Biala, 43-300
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+79217252994
Facility: GBUZ Leningrad Regional Clinical Oncology Dispensary ( Site 0426)
Kuzmolovskiy Settlement, 188663
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+79106654167
Facility: Russian Scientific Center of Roentgenoradiology ( Site 0424)
Moscow, 117485
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+34934978925
Facility: Central Clinical Hospital with Polyclinic ( Site 0415)
Moscow, 121359
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
932607333
Facility: Medical Rehabilitation Center ( Site 0411)
Moscow, 125367
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+34938759300 Ext.5512
Facility: Murmansk Regional Oncology Dispensary ( Site 0420)
Murmansk, 183057
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+34981178000EXT292072
Facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0413)
Nizhny Novgorod, 603074
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+34924218040 Ext.48350
Facility: Omsk Clinical Oncology Dispensary ( Site 0418)
Omsk, 644013
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
915202200 ext.16104
Facility: Clinical Hospital Saint Luka ( Site 0421)
Saint-Petersburg, 194044
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+34914269393
Facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0414)
Yaroslavl, 150054
Russian Federation
Status: Recruiting Contact: Contact
Study Coordinator
+34917567984
Facility: Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0351)
Badalona, 08916
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+886931199148
Facility: ICO L Hospitalet ( Site 0361)
Hospitalet de Llobregat, 08908
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+886773171233267
Facility: Xarxa Assistencial Universitaria Manresa ( Site 0354)
Manresa, 08243
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+886422052121
Facility: Hospital Teresa Herrera - Chuac ( Site 0357)
A Coruna, 15006
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+886423741215
Facility: Hospital Infanta Cristina ( Site 0355)
Badajoz, 06080
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+88662353535
Facility: Hospital La Princesa ( Site 0862)
Madrid, 28006
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+886228757519#315
Facility: Hospital Universitario Gregorio Maranon ( Site 0352)
Madrid, 28009
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+905555306271
Facility: Hospital Universitario HM Sanchinarro ( Site 0356)
Madrid, 28050
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+905076397700
Facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0216)
Kaoshiung, 807
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+905324167355
Facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0217)
Kaohsiung, 83301
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+905063509061
Facility: China Medical University Hospital ( Site 0213)
Taichung, 40447
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+905332117153
Facility: Taichung Veterans General Hospital ( Site 0214)
Taichung, 40705
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+905322679838
Facility: National Cheng Kung University Hospital ( Site 0215)
Tainan, 70403
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+905323233799
Facility: National Taiwan University Hospital ( Site 0211)
Taipei, 100229
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+441142265072
Facility: Taipei Veterans General Hospital ( Site 0212)
Taipei, 11217
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+441705435000
Facility: Ankara Sehir Hastanesi ( Site 0455)
Ankara, 06800
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+441227766877
Facility: Antalya Memorial Hospital Department of Medical Oncology ( Site 0461)
Antalya, 07020
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+441772524656
Facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0454)
Istanbul, 34098
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+442078828505
Facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0459)
Istanbul, 34722
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+448451555000
Facility: Ege Universitesi Tulay Aktas Onkoloji Hastanesi ( Site 0462)
İzmir, 35100
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+442033117627
Facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0456)
Konya, 42080
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+441159691169
Facility: Sakarya Universitesi Tip Fakultesi Arastirma Hastanesi ( Site 0460)
Sakarya, 54290
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+441752430138
Facility: Weston Park Hospital ( Site 0387)
Sheffield, S10 2SJ
United Kingdom
Status: Recruiting Contact: Contact
Study Coordinator
+441782672426
Facility: Queens Hospital-Purple Zone ( Site 0377)
Romford, RM7 0AG
United Kingdom
Status: Recruiting Contact: N/A
Facility: Lister Hospital ( Site 0376)
Stevenage, SG1 4AB
United Kingdom
Status: Recruiting Contact: N/A
Facility: Kent and Canterbury Hospital ( Site 0390)
Canterbury, CT1 3NG
United Kingdom
Status: Recruiting Contact: N/A
Facility: Royal Preston Hospital ( Site 0379)
Preston, PR2 9HT
United Kingdom
Status: Recruiting Contact: N/A
Facility: Saint Bartholomew s Hospital - London ( Site 0386)
London, EC1A 7BE
United Kingdom
Status: Recruiting Contact: N/A
Facility: University College London Hospital NHS Foundation Trust ( Site 0380)
London, NW1 2PG
United Kingdom
Status: Recruiting Contact: N/A
Facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 0378)
London, W6 8RF
United Kingdom
Status: Recruiting Contact: N/A
Facility: Nottingham University Hospital NHS Trust ( Site 0383)
Nottingham, NG5 1PB
United Kingdom
Status: Recruiting Contact: N/A
Facility: Derriford Hospital ( Site 0388)
Plymouth, PL6 8DH
United Kingdom
Status: Recruiting Contact: N/A
Facility: Royal Stoke University Hospital Univ. Hosps of North Midlands NHST ( Site 0392)
Stoke-on-Trent, ST4 6QG
United Kingdom
Status: Recruiting Contact: N/A