A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+NSCLC

Who is this study for? Patients with Non-Small Cell Lung Cancer
Status: Active, not recruiting
Location: See all (342) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) subjects with Programmed death ligand 1+ (PD-L1+) tumors

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Male or female subjects aged greater than or equal to (>=) 18 years

• With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry

• At least 1 measurable tumor lesion

• With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC)

• With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6 months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1 week, and suitable for PD-L1 expression assessment

• Subjects must not have received any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12 weeks

• Other protocol defined criteria could apply

Locations
United States
Alabama
Clearview Cancer Institute
Huntsville
Arizona
Arizona Center for Cancer Care
Surprise
California
Sharp Memorial Hospital
San Diego
Florida
University Cancer Institute
Boynton Beach
Georgia
South Georgia Medical Center
Valdosta
Louisiana
Christus Cancer Treatment Center
Shreveport
Michigan
Henry Ford Hospital
Detroit
Montana
St. Vincent Frontier Cancer Center
Billings
North Carolina
Novant Health Oncology Specialists
Kernersville
New Mexico
San Juan Oncology Associates
Farmington
Oklahoma
Mercy Research
Oklahoma City
Oregon
Kaiser Permanente Northwest
Portland
Pennsylvania
Lancaster Cancer Center
Lancaster
Tennessee
Cookeville Regional Medical Center
Cookeville
Thompson Cancer Survival Center
Knoxville
Texas
Coastal Bend Cancer Center
Corpus Christi
Oncology Consultants, P.A.
Houston
Vermont
University of Vermont Medical Center
Burlington
Washington
Northwest Medical Specialties, PLLC
Tacoma
Wyoming
Cheyenne Regional Medical Center
Cheyenne
Other Locations
Australia
Albury Wodonga Regional Cancer Centre
Albury
Ballarat Base Hospital
Ballarat
Bendigo Hospital
Bendigo
Coffs Harbour Health Campus
Coffs Harbour
Gallipoli Medical Research Foundation Ltd
Greenslopes
St George Private Hospital
Kogarah
Lismore Base Hospital
Lismore
Fiona Stanley Hospital
Murdoch
Orange Health Service
Orange
Gold Coast University Hospital
Southport
Royal North Shore Hospital
St Leonards
Calvary Mater Newcastle
Waratah
South West Healthcare
Warrnambool
The Queen Elizabeth Hospital
Woodville South
Belgium
ZNA Middelheim
Antwerpen
A.Z. Klina
Brasschaat
CHU Ambroise Paré
Mons
Brazil
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina
Florianópolis
CRIO - Centro Regional Integrado de Oncologia
Fortaleza
CEBROM - Centro Brasileiro de Radioterapia, Oncologia e Mastologia
Goiânia
Hospital de Caridade de Ijuí
Ijuí
Clínica de Neoplasias Litoral Ltda.
Itajaí
Fundação Doutor Amaral Carvalho
Jaú
Hospital Bruno Born
Lajeado
Hospital São Vicente de Paulo
Passo Fundo
Hospital de Clínicas de Porto Alegre
Porto Alegre
Hospital Nossa Senhora da Conceição
Porto Alegre
Hospital São Lucas da PUCRS
Porto Alegre
IMV-Pesquisa Cardiologica Sociedade Simples - HMD - COR
Porto Alegre
INCA - Instituto Nacional de Câncer
Rio De Janeiro
NOB - Núcleo de Oncologia da Bahia
Salvador
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo Andre
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José Do Rio Preto
IBCC - Instituto Brasileiro de Controle do Câncer
São Paulo
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo
Bulgaria
Complex Oncological Center - Ruse, EODD
Ruse
MHAT for women's health - Nadezhda, OOD
Sofia
Shato, Ead
Sofia
UMHAT Sv. Ivan Rilski, EAD
Sofia
Canada
The Moncton Hospital
Moncton
Mount Sinai Hospital
Toronto
Chile
Clinica Santa Maria
Santiago
FALP - Fundación Arturo López Pérez
Santiago
Hospital Clínico San Borja Arriaran
Santiago
Hospital Clínico Universidad de Chile
Santiago
Hospital Militar de Santiago
Santiago
IRAM - Instituto de Radio Medicina
Santiago
Centro de Investigaciones Clinicas Viña del Mar
Viña Del Mar
Hospital Clinico Viña del Mar
Viña Del Mar
China
Beijing Cancer Hospital
Beijing
Guangdong General Hospital
Guangzhou
Harbin Medical University Cancer Hospital
Harbin
Linyi Cancer Hospital
Linyi
Liaoning Cancer Hospital & Institute
Shenyang
Colombia
Administradora Country S.A.
Bogotá
Fundación Oftalmológica de Santander - FOSCAL
Floridablanca
Hospital Pablo Tobón Uribe
Medellín
IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.
Monteria
Croatia
University Clinic for Pulmonary Diseases
Zagreb
University Hospital Centre Sestre Milosrdnice
Zagreb
Cyprus
Bank of Cyprus Oncology Center
Nicosia
Denmark
Herning Sygehus
Herning
Roskilde Sygehus
Roskilde
Estonia
North Estonia Medical Centre Foundation
Tallinn
France
CHU Angers - Hôpital Hôtel Dieu#
Angers Cedex 9
Institut Sainte Catherine
Avignon Cedex 9
Centre Hospitalier de la Côte Basque
Bayonne
CHU Besançon - Hôpital Jean Minjoz
Besancon Cedex
CHU Brest - Hôpital Morvan
Brest Cedex
Centre Hospitalier Intercommunal de Créteil
Creteil Cedex
Clinique Victor Hugo - Centre Jean Bernard
Le Mans Cedex 02
Centre Hospitalier de la Croix Rousse
Lyon Cedex 04
Hôpital privé Clairval
Marseille
Hôpital Nord - AP-HM Marseille#
Marseille Cedex 20
Centre Antoine Lacassagne
Nice Cedex 02
Hôpital Saint-Louis - Paris
Paris Cedex 10
Hôpital Cochin
Paris Cedex 14
Groupe Hospitalier Sud - Hôpital Haut-Lévêque
Pessac
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg
Germany
LungenClinic Grosshansdorf GmbH
Grosshansdorf
Universitaetsklinikum Heidelberg
Heidelberg
Greece
251 General Air Force Hospital
Athens
General Hospital of Athens of Chest Diseases SOTIRIA
Athens
General Oncology Hospital of Kifissia Agioi Anargyroi
Athens
Metropolitan General Hospital
Athens
University General Hospital Attikon
Athens
University General Hospital of Heraklion
Heraklion
University General Hospital of Patra
Patras
Euromedica General Clinic Thessaloniki
Thessaloniki
Hungary
Orszagos Koranyi Pulmonologiai Intezet
Budapest
Orszagos Koranyi Pulmonologiai Intezet
Budapest
Orszagos Onkologiai Intezet
Budapest
Semmelweis Egyetem
Budapest
Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
Deszk
Petz Aladar Megyei Oktato Korhaz
Györ
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza
Tolna Megyei Balassa Janos Korhaz
Szekszard
Tudogyogyintezet Torokbalint
Torokbalint
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg
Ireland
Cork University Hospital
Cork
Israel
Soroka University Medical Center
Beer Sheva
Rambam Health Care Center
Haifa
Hadassah University Hospital - Ein Kerem
Jerusalem
Sapir Medical Center, Meir Hospital
Kfar-saba
Rabin Medical Center-Beilinson Campus
Petach Tikva
Chaim Sheba Medical Center
Ramat Gan
Kaplan Medical Center
Rechovot
Assaf Harofeh
Rishon Lezion
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia
Presidio Ospedaliero Garibaldi Nesima
Catania
Azienda Ospedaliero Universitaria San Martino
Genova
Ospedale Mater Salutis
Legnago
Seconda Università degli Studi di Napoli
Napoli
Azienda Ospedaliero Universitaria di Parma
Parma
Azienda Ospedaliero Universitaria Pisana
Pisa
Japan
National Cancer Center Hospital
Chuo-ku
Kansai Medical University Hospital
Hirakata-shi
National Cancer Center Hospital East
Kashiwa-shi
Institute of Biomedical Research and Innovation Hospital
Kobe-shi
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe-shi
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe-shi
Kurume University Hospital
Kurume-shi
NHO Hokkaido Cancer Center
Sapporo-shi
Tokyo Medical University Hospital
Shinjuku-ku
Osaka Medical College Hospital
Takatsuki-shi
Toyama University Hospital
Toyama-shi
Kanagawa Cancer Center
Yokohama-shi
Yokohama Municipal Citizen's Hospital
Yokohama-shi
Lebanon
American University of Beirut Medical Center
Beirut
Hotel Dieu de France Hospital
Beirut
Mount Lebanon Hospital
Beirut
Rafik Hariri University Hospital
Beirut
Hammoud Hospital University Medical Center
Saida
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas
Netherlands
Martini Ziekenhuis
Groningen
Westfriesgasthuis - PARENT
Hoorn
ETZ Elisabeth
Tilburg
New Zealand
Auckland City Hospital
Auckland
Dunedin Public Hospital
Dunedin
Waikato Hospital
Hamilton
Palmerston North Hospital
Palmerston North
Tauranga Hospital
Tauranga
Wellington Hospital
Wellington
Peru
Clinica Internacional Sede San Borja
Lima
Instituto Nacional de Enfermedades Neoplásicas
Lima
Oncosalud
Lima
Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
Lodz
Instytut MSF Sp. o.o
Lodz
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Lodz
KO-MED Centra Kliniczne Lublin II
Lublin
SSZZOZ im. Dr Teodora Dunina w Rudce
Mrozy
SP Zespol Gruzlicy i Chorob Pluc w Olsztynie
Olsztyn
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan
Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o.
Szklarska Poręba
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warszawa
Mazowiecki Szpital Onkologiczny
Wieliszew
Portugal
Hospital Garcia de Orta, EPE
Almada
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora-lisbon
Centro Hospitalar De Coimbra-CHUC
Coimbra
Centro Hospitalar e Universitário de Coimbra, E.P.E (CHC)
Coimbra
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos
Lisboa
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente
Lisboa
Centro Hospitalar de São João, E.P.E.
Porto
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
Porto
Hospital CUF Porto
Porto
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto
Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião
Santa Maria Da Feira
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova De Gaia
Republic of Korea
Inje University Haeundae Paik Hospital
Busan
Chungbuk National University Hospital
Cheongju-si
Kyungpook National University Chilgok Hospital
Daegu
National Cancer Center
Goyang-si
Gachon University Gil Medical Center
Incheon
CHA Bundang Medical Center, CHA University
Seongnam-si
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul
Ajou University Hospital
Suwon-si
The Catholic University of Korea, St. Vincent's Hospital
Suwon-si
Ulsan University Hospital
Ulsan
Yonsei University Wonju Severance Christian Hospital
Wonju-si
Romania
Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare
Baia Mare
S.C Policlinica de Diagnostic Rapid S.A
Brasov
Institutul Oncologic Prof. Dr. Al. Trestioreanu
Bucuresti
S.C Gral Medical S.R.L
Bucuresti
Spitalul Clinic Coltea
Bucuresti
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
Cluj Napoca
S.C Medisprof S.R.L
Cluj-napoca
Spitalul Militar de Urgenta Dr.Constantin PapilianCluj -Napoca
Cluj-napoca
S.C Radiotherapy Center Cluj S.R.L
Comuna Floresti
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
Constanta
S.C Centrul de Oncologie Sf. Nectarie S.R.L
Craiova
Institutul Regional de Oncologie Iasi
Iasi
S.C Pelican Impex S.R.L
Oradea
Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea
Oradea
Spitalul Judetean de Urgenta Sf. Ioan cel Nou Suceava
Suceava
S.C Oncocenter Oncologie Clinica S.R.L
Timisoara
S.C Oncomed S.R.L
Timisoara
Russian Federation
SBIH of Arkhangelsk region Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk
Chelyabinsk Regional Oncology Dispensary
Chelyabinsk
LLC Evimed
Chelyabinsk
Irkutsk Regional Oncology Dispensary
Irkutsk
RBIH Ivanovo Regional Oncological Dispensary
Ivanovo
SBHI of Kaluga Region Kaluga regional clinical oncology dispensary
Kaluga
SAIH Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan
Kazan
Kemerovo SPI Regional Clinical Oncology Dispensary
Kemerovo
SBHI Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky
Krasnoyarsk
RBIH Kursk regional clinical oncology dispensary of Kursk Region Healthcare Committee
Kursk
FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin
Moscow
Murmansk Regional Clinical Hospital named after Bayandin
Murmansk
SBHI of Novosibirsk region Novosibirsk Regional Oncological Dispensary
Novosibirsk
SBIH of Stavropol territory Pyatigorsk Oncological Dispensary
Pyatigorsk
Bio Eq LLC
Saint-petersburg
FBI Scientific Research Institute of Oncology n. a. N. N. Petrov
Saint-petersburg
SBIH Leningrad Regional Oncological Dispensary
Saint-petersburg
SBIH Samara Regional Clinical Oncological Dispensary
Samara
SBIH Oncological Dispensary # 2 of the MoH of Krasnodar territory
Sochi
FSBHI Clinical research institute of phthisiopulmonology
St. Petersburg
BHI of Omsk region Clinical Oncology Dispensary
Tomsk
Tomsk Research Instutite of Oncology
Tomsk
Medicinskiy gorod
Tyumen
SBIH of Yaroslavl region Regional Clinical Oncological Hospital
Yaroslavl
Serbia
Clinical Center Bezanijska Kosa
Belgrade
Clinical Center of Serbia
Belgrade
Institute of Oncology and Radiology of Serbia
Belgrade
Military Medical Academy
Belgrade
Clinical Center Nis, Pulmonary Diseases Clinic
Gornji Matejevac
Clinical Center Kragujevac
Kragujevac
Institute for Pulmonary Diseases of Vojvodina
Sremska Kamenica
Singapore
National Cancer Centre
Singapore
National University Cancer Institute
Singapore
Tan Tock Seng Hospital
Singapore
Slovakia
Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov
Bardejov
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava
South Africa
Emery Clinical Services
Alberton
Cape Town Oncology Trials Pty Ltd
Cape Town
Johese Clinical Research
Pretoria
University of Pretoria Oncology Department
Pretoria
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari Quiron Dexeus
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Specialist
Barcelona
ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta
Girona
Fundacion Jimenez Diaz
Madrid
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario La Paz
Madrid
MD Anderson Cancer Centre
Madrid
Hospital Regional Universitario de Malaga
Málaga
Hospital de Mataro
Mataro
Hospital Universitario Donostia
San Sebastian
Complejo Hospitalario Universitario de Santiago
Santiago De Compostela
Hospital Quiron Sagrado Corazon
Sevilla
Hospital Universitario Virgen del Rocio
Sevilla
Hospital Universitario Mutua de Terrassa
Terrassa
Complejo Hospitalario Universitario de Vigo
Vigo
Hospital Txagorritxu
Vitoria
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan County
Thailand
Siriraj Hospital
Bangkok
Songklanagarind Hospital
Hat Yai
Maharaj Nakorn Chiang Mai Hospital
Muang
Naresuan University Hospital
Muang
Srinagarind Hospital
Muang
King Chulalongkorn Memorial Hospital
Patumwan
Rajavithi Hospital
Rajathevee
Turkey
Acibadem Adana Hospital
Adana
Adana City Hospital
Adana
Adana Numune Training and Research Hospital
Adana
Baskent University Adana Application and Research Center
Adana
Cukurova University Medical Faculty
Adana
Ankara University Medical Faculty
Ankara
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara
Hacettepe University Medical Faculty
Ankara
Memorial Antalya Hastanesi
Antalya
Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
Istanbul
Istanbul University Cerrahpasa Medical Faculty
Istanbul
Kartal Lutfi Kirdar Research and Training Hospital
Istanbul
Medipol University Medical Faculty
Istanbul
Okmeydani Research and Training Hospital
Istanbul
Ege University Medical Faculty
Izmir
Inonu Uni. Med. Fac.
Malatya
Mersin University Medical Faculty
Mersin
Sakarya Traning and Research Hospital
Sakarya
Namik Kemal University
Tekirdag
Ukraine
CI Chernivtsi RC Oncological Dispensary Bukovinian SMU Ch of Oncology and Radiology
Chernivtsi
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipro
CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU
Ivano-frankivsk
Communal Non-profit Enterprise Regional Center of Oncology
Kharkiv
SI S.P.Grygoriev Institute of Medical Radiology of NAMSU
Kharkiv
Kherson Regional Oncologic Dispensary
Kherson
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
Kropyvnytskyi
CI Kryvyi Rih Oncological Dispensary of DRC
Kryvyi Rih, Dnipropetrovsk Region
Kyiv City Clinical Oncological Center
Kyiv
Treatment-Prevention Institution Volyn Regional Oncological Dispensary
Lutsk
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv
Odesa Regional Oncologic Dispensary
Odesa
RCI Sumy Regional Clinical Oncological Dispensary
Sumy
CCCH City Oncological Center SHEI Uzhgorod NU
Uzhgorod
Podilskyi Regional Oncological Center
Vinnytsia
Vinnytsia Regional Clinical Oncological Dispensary
Vinnytsia
United Kingdom
Cheltenham General Hospital
Cheltenham
Chelsea and Westminster Hospital
London
Mount Vernon Hospital
Stevenage
Royal Stoke University Hospital
Stoke On Trent
Southend University Hospital
Westcliff On Sea
The Clatterbridge Cancer Centre
Wirral
Time Frame
Start Date: October 29, 2015
Estimated Completion Date: December 31, 2022
Participants
Target number of participants: 1224
Treatments
Experimental: Arm A: Avelumab
Active Comparator: Arm B: Platinum-containing chemotherapy regimen
Platinum-containing chemotherapy regimen: Investigator's choice platinum containing chemotherapy regimen to be administered consisting of one of the following:~Non-squamous tumor histology~Pemetrexed (500 milligram per meter square [mg/m^2]) +cisplatin (75 mg/m^2) or Pemetrexed (500 mg/m^2) + carboplatin (AUC 6 mg/mL*min)~Squamous tumor histology~Paclitaxel (200 mg/m^2) +carboplatin (AUC 6 mg/mL*min)~Gemcitabine (1250 mg/m^2)+ cisplatin (75 mg/m^2)~Gemcitabine (1000 mg/m^2 )+carboplatin (AUC 5 mg/mL*min)
Experimental: Arm C: Avelumab
Authors
James Reeves, Steven Boniol, Surrinder Dang, Archana Srivastava, Franklin Chen, Clarence Adoo, Hyatt Peter DeGreen, Michael Kosty, Arafat Tfayli, Miriam Alonso Garcia, Ralph Boccia, Luis Villa, Patrick Cobb, Ajay Sehgal, Akhil Chopra, Jasotha Sanmugarajah, Jayne Gurtler, Jeffrey Neidhart, Nagendra Tirumali, Natalie Workman, Michael Thomas, Fadi Farhat, Thomas Niederman, Paul Jacquin, Eugeny Gotovkin, Antonio Araujo, Eric Anderson, Lina Daukantiene, Roland Stallaert, Krystyna Folcik, Patrícia Medeiros Milhomem Beato, Andrea Rose, Luis Alberto Schlittler, Jasna Radic, Yousuf Al-Farhat, Razvan Ovidiu Curca, Alexandr Zyryanov, Tunde Nagy, Tatsuhiko Kashii, Ciprian Aldea, Adam Boyce, Nils Gunnar Skare, Artem Poltoratsky, Louise Bremer, Claudia Sette, Gilles Devouassoux, Gairin Dancey, Claude El Kouri, Fabrice Barlesi, Michel Poudenx, Christos Chouaid, Marielle Sabatini, Remi Veillon, Cyril Foa, Vladimir Vladimirov, Pascaline Boudou-Rouquette, Andreas Polychronis, Martin Reck, Selvaraj Giridharan, Thierry Urban, Elisabeth Quoix, Gilles Robinet, Fabrice Denis, Werner Hilgers, Virginie Westeel, Victoria Dvornichenko, Zsuzsanna Mark, Hye Ryun Kim, Mirjana Wollner, Chong Ming Yeo, Edit Csada, Jozef Chovanec, Sergei Orlov, Lydia Dreosti, Galina Kurteva, Alina Simona Muntean, Oleksandr Ivashchuk, Pilar Lianes, Leandro Brust, Jelena Stanic, Amelia Almeida, Andrzej Kazarnowicz, Kunlatida Maneenil, Pamela Salman Boghikian, Malcolm Anderson, Vitezslav Kolek, Vedat Bayoglu, Girish Mallesara, Sinan Yavuz, Guzel Mukhametshina, Pablo González Mella, Anakapong Phunmanee, Marta Soares, Zvonimir Curic, Mari Ishii, Daniel Ciurescu, Maria Francisca Vazquez Rivera, Arnold Cyjon, Rivka Katsnelson, Brendan Luey, Darren Lim, Yeni Veronica Neron, Shoshana Keren, Giuliano Santos Borges, HyunWoo Lee, Ruchan Uslu, Didier Verhoeven, Mahmoud Abdelsalam, Tarkan Yetisyigit, Huseyin Abali, Anghel Adrian Udrea, Olga Barajas Barajas, Jeroen Kloover, Alan Arrieira Azambuja, Seungtaek Lim, Enriqueta Felip Font, Igor Rybkin, Chee Seng Tan, Ricardo Da Luz, Samuel Ariad, Peter Szabo, Mary MacNeil, Volodymyr Shamrai, Ghazi Nsouli, Emel Sezer, Charuwan Akewanlop, Sener Cihan, Gyorgy Losonczy, Vadim Kozlov, Alexandru Calin Grigorescu, Viktor Goldberg, Davorin Radosavljevic, Gustavo Vasconcelos Alves, Erdem Goker, Mahmut Yildirim, In Sook Woo, Eszter Csanky, Sérgio Jobim de Azevedo, Serban Mircea Negru, Stéphane Holbrechts, Rodryg Ramlau, Peter Berzinec, Masao Harada, Berna Oksuzoglu, Irina Rozhkova, Sung Sook Lee, Nick Pavlakis, Gongyan Chen, Felipe José Silva Melo Cruz, Dong-Wan Kim, Helis Pokker, Ahmet Demirkazik, Mikhail Dvorkin, Bozhil Robev, Zhasmina Mihaylova, Haris Charalambous, Jianhua Shi, Hovav Nechushtan, Omer Olmez, Michael Schenker, Zoran Andric, Keunchil Park, Seiji Niho, Eric Armando Orellana Ulunque, Georgeta Crisan, Ludmila Lebedeva, Ani Mihaljevic-Ferrari, Natalia Musaeva, Alina Amalia Herzal, Sylvia Rodrigues, Alla Nasonova, Jaroslava Leskova, Joaquim Bosch Barrera, 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Sponsors
Leads: EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany

This content was sourced from clinicaltrials.gov

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