A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction

Status: Completed
Location: See all (200) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female participants greater than or equal to (\>=) 18 years

• Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

• Participants with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ)

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

• Estimated life expectancy of more than 12 weeks

• Adequate haematological, hepatic and renal functions defined by the protocol

• Negative blood pregnancy test at Screening for women of childbearing potential

• Highly effective contraception for both male and female participants if the risk of conception exists

• Other protocol defined inclusion criteria could apply

Locations
United States
California
Comprehensive Blood & Cancer Center
Bakersfield
Virginia Crosson Cancer Center
Fullerton
UCLA Medical Center
Los Angeles
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage
Sansum Clinic
Santa Barbara
Trio - Central Coast Medical Oncology Corporation
Santa Maria
Connecticut
Norwalk Hospital
Norwalk
Florida
UF Health Cancer Center Orlando
Orlando
Memorial West Cancer Institute
Pembroke Pines
University of South Florida - Parent
Tampa
Iowa
Cedar Rapids Oncology Project
Cedar Rapids
Illinois
Oncology Specialists, S.C.
Park Ridge
Indiana
Franciscan St. Francis Health Cancer Center
Indianapolis
Kansas
Cotton-O'Neil Clinical Research Center, Hematology and Oncology
Topeka
University of Kansas Medical Center Research Institute, Inc.
Westwood
Minnesota
Virginia Piper Cancer Institute
Minneapolis
Nevada
Nevada Cancer Research Foundation
Las Vegas
New York
Mount Sinai - PRIME
Jamaica
Clinical Research Alliance, Inc
New York
University of Rochester
Rochester
Ohio
TriHealth Hatton Institute
Cincinnati
UC Health Clinical Trials Office
Cincinnati
Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
Columbus
Oregon
Oregon Health & Science University
Portland
Pennsylvania
St. Luke's Hospital
Bethlehem
Thomas Jefferson University Hospital
Philadelphia
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Greenville Hospital System University Medical Center (ITOR)
Greenville
Texas
University of Texas Southwestern Medical Center
Dallas
Oncology Consultants, P.A.
Houston
University of Texas Health Science Center at San Antonio
San Antonio
Baylor Scott & White Health
Temple
Washington
University of Washington - Seattle Cancer Care Alliance
East Seattle
Northwest Medical Specialties, PLLC
Tacoma
Wenatchee Valley Hospital & Clinics
Wenatchee
Other Locations
Australia
Ballarat Base Hospital
Ballarat
Flinders Medical Centre
Bedford Park
Bendigo Hospital
Bendigo
Monash Medical Centre Clayton
Bentleigh
Box Hill Hospital
Box Hill
Lyell McEwin Hospital
Elizabeth Vale
Greenslopes Private Hospital
Greenslopes
Royal Brisbane and Women's Hospital
Herston
Royal Hobart Hospital
Hobart
St George Hospital
Kogarah
Fiona Stanley Hospital
Murdoch
Royal Melbourne Hospital
Parkville
Royal North Shore Hospital
St Leonards
Border Medical Oncology
Wodonga
Brazil
Hospital Infanta Cristina
Badajoz
Hospital de Câncer de Barretos-Fundação Pio XII
Barretos
Hospital São Lucas da PUCRS
Ijuí
Hospital Bruno Born
Lajeado
Oncosinos - Clínica de Oncologia - Hospital Regina
Novo Hamburgo
Hospital de Clínicas de Porto Alegre
Porto Alegre
Hospital São Lucas da PUCRS
Porto Alegre
IMV - Instituto De Medicina Vascular Hospital Mae de Deus
Porto Alegre
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
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo
Canada
The Royal Victoria Hospital
Barrie
Queen Elizabeth II Health Sciences Centre
Halifax
Cité de la Santé de Laval
Laval
McGill University - Dept. Oncology Clinical Research Program
Montréal
Humber River Hospital
Toronto
Mount Sinai Hospital
Toronto
France
ICO - Site René Gauducheau
Angers Cedex 9
CHU Besancon - Hopital Jean Minjoz
Besancon
CHU Bordeaux
Bordeaux Cedex
Hôpital Morvan
Brest
CHU Tours - Hôpital Trousseau
Chambray Les Tours
CHU Clermont Ferrand
Clermont Ferrand Cedex 1
Centre Georges François Leclerc
Dijon Cedex
Clinique Victor Hugo - Centre Jean Bernard
Le Mans Cedex 02
Hôpital de la Timone
Marseille Cedex 5
Centre Antoine Lacassagne
Nice Cedex 02
Hôpital Cochin
Paris Cedex 14
Hôpital Européen Georges Pompidou
Paris Cedex 15
CRLCC Eugene Marquis
Rennes Cedex
CHU de Toulouse - Hôpital Rangueil
Toulouse Cedex 9
Germany
Klinikum Esslingen GmbH
Esslingen A. N.
Krankenhaus Nordwest GmbH
Frankfurt
Marienkrankenhaus Hamburg
Hamburg
Onkologische Schwerpunktpraxis Eppendorf
Hamburg
SLK-Kliniken Heilbronn GmbH
Heilbronn
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz
Klinikum Bogenhausen
Muenchen
Leopoldina Krankenhaus Schweinfurt
Schweinfurt
Hungary
Magyar Honvedseg Egeszsegugyi
Budapest
Debreceni Egyetem Klinikai Kozpont
Debrecen
Petz Aladar Megyei Oktato Korhaz
Gyor
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza
Pecsi Tudomanyegyetem
Pecs
Tolna Megyei Balassa Janos Korhaz
Szekszard
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg
Italy
Presidio Ospedaliero Garibaldi Nesima
Catania
Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)
Cremona
Azienda Ospedaliera Universitaria Careggi
Firenze
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano
IEO Istituto Europeo di Oncologia
Milano
Ospedale San Raffaele
Milano
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli
Seconda Università degli Studi di Napoli
Napoli
IOV - Istituto Oncologico Veneto IRCCS
Padova
Ospedale degli Infermi
Rimini
Università Campus Bio-Medico di Roma
Roma
Azienda Ospedaliera S. Maria Di Terni
Terni
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
Udine
Japan
Chiba Cancer Center
Chiba-shi
Nat Cancer Ctr Hosp
Chuo-ku
Saitama Medical University International Medical Center
Hidaka-shi
Izumi Municipal Hospital
Izumi-shi
Kagoshima University Medical And Dental Hospital
Kagoshima-shi
Kagawa University Hospital
Kita-gun
Saitama Cancer Center
Kitaadachi-gun
Kumamoto University Hospital
Kumamoto-shi
Toranomon Hospital
Minato-ku
Niigata Cancer Center Hospital
Niigata-shi
Kindai University Hospital
Osakasayama
Tohoku University Hospital
Sendai-shi
Tochigi Cancer Center
Utsunomiya-shi
Kanagawa Cancer Center
Yokohama-shi
Oita University Hospital
Yufu-shi
Republic of Korea
Inje University Haeundae Paik Hospital
Busan
Chungbuk National University Hospital
Cheongju-si
Keimyung University Dongsan Hospital
Daegu
Kyungpook National University Medical Center
Daegu
National Cancer Center
Goyang-si
Chonnam National University Hwasun Hospital
Hwasun-gun
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Yonsei University Health System
Seoul
Romania
S.C Oncopremium Team S.R.L
Baia Mare
Hifu Terramed Conformal SRL
Bucuresti
Institutul Clinic Fundeni
Bucuresti
Spitalul Clinic Coltea
Bucuresti
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
Cluj Napoca
S.C Radiotherapy Center Cluj S.R.L
Comuna Floresti
S.C Centrul de Oncologie Sf. Nectarie S.R.L
Craiova
Institutul Regional de Oncologie Iasi
Iasi
Spital Lotus SRL
Ploiesti
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
LLC Evimed
Chelyabinsk
RBIH Ivanovo Regional Oncological Dispensary
Ivanovo
SBIH Clinical Oncological Dispensary # 1
Krasnodar
FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin
Moscow
BHI of Omsk region Clinical Oncology Dispensary
Omsk
SBIH of Stavropol territory Pyatigorsk Oncological Dispensary
Pyatigorsk
FBI Scientific Research Institute of Oncology n. a. N. N. Petrov
Saint-petersburg
Pavlov First Saint Petersburg State Medical University
Saint-petersburg
SPb SBIH City Clinical Oncological Dispensary
Saint-petersburg
Spain
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital General Universitario de Elche
Elche
ICO l´Hospitalet - Hospital Duran i Reynals
L'hospitalet De Llobregat
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario HM Madrid Sanchinarro
Madrid
Hospital Universitario La Paz
Madrid
Corporacio Sanitaria Parc Tauli
Sabadell
Hospital Universitario Virgen del Rocio
Sevilla
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Mackay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan
Thailand
Siriraj Hospital
Bangkok
Maharaj Nakorn Chiang Mai Hospital
Muang
King Chulalongkorn Memorial Hospital
Patumwan
Turkey
Acibadem Adana Hospital
Adana
Adana Numune Training and Research Hospital
Adana
Hacettepe University Medical Faculty
Ankara
Akdeniz University Medical Faculty
Antalya
Dicle University, Medical faculty
Diyarbakir
Istanbul University Cerrahpasa Medical Faculty
Istanbul
Marmara University Pendik Research and Training Hospital
Istanbul
Kocaeli University Medical Faculty
Kocaeli
Konya Necmettin Erbakan University Meram Medical Faculty
Konya
Inonu Uni. Med. Fac.
Malatya
Mersin University Medical Faculty
Mersin
United Kingdom
Ninewells Hospital
Dundee
Royal Surrey County Hospital
Guildford
St James's University Hospital
Leeds
Barts Hospital
London
University College London Hospitals
London
The Christie
Manchester
Mount Vernon Hospital
Northwood
Derriford Hospital
Torquay
The Clatterbridge Cancer Centre
Wirral
Time Frame
Start Date: 2015-12-24
Completion Date: 2021-06-03
Participants
Target number of participants: 499
Treatments
Experimental: Chemotherapy + Best Supportive Care (BSC)
In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/LV or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion.
Experimental: Avelumab
In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation.
Authors
Chao Yee, Mark Knapp, Dennis Slater, Deborah Wilbur, Stephen Rubenstein, Omar Kayaleh, William Lawler, Howard Safran, Joseph Leach, Jorge Chaves, Gregg Newman, Syma Iqbal, Vic Velanovich, John Ellerton, Lindsay Overton, David Draper, Morton Coleman, Sunnie Kim, Luis Villa, Asim Ali, Ki Chung, Zev Wainberg, Jennifer Chuy, Hugo Hool, Jayne Gurtler, Edward McClay, Pablo Ferraro, David Einspahr, Richard Frank, Lucas Wong, Mark Kozloff, Luke Dreisbach, Thomas Zander, Eray Goekkurt, Julien Taieb, Christophe Borg, Andrew Strickland, Markus Moehler, Denis Smith, Denis Pezet, Gunnar Folprecht, Christopher Steer, Wasat Mansoor, Salah-Eddin Al-Batran, Russell Petty, Thierry Lecomte, Rosine Guimbaud, Michael Geissler, Ayman Madi, Stephan Kanzler, Laetitia Dahan, Martin Fuchs, Olivier Dupuis, Leila Bengrine-Lefevre, Romain Coriat, Gina Vaccaro, Julio Peguero, Mohamedtaki Tejani, Veena Shankaran, Laura Tenner, Jason Suh, Túlio Eduardo Flesch Pfiffer, Hiroshi Tsukuda, Georgy Manikhas, Dawn Ng, Sergio Jobim de Azevedo, Vichien Srimuninnimit, Chris Karapetis, Francesco Di Costanzo, Marcello Ferretti Fanelli, Karoly Mahr, Rosemary Young, Hye-Sook Han, Hasan Senol Coskun, Vittorina Zagonel, Sumitra Ananda, Chia-Jui Yen, Sung Sook Lee, Zsuzsanna Papai, Alan Anthoney, Geoff Chong, Vladimir Vladimirov, Rossana Casaretti, Ronald Burkes, Huseyin Abali, Laszlo Mangel, Luca Gianni, Seigo Yukisawa, Thierry Alcindor, Yung-Jue Bang, Busyamas Chewaskulyong, Kun-Huei Yeh, Jean-Philippe Metges, Tibor Csoszi, Fausto Roila, Hyun Cheol Chung, Oleg Gladkov, Antonio Cubillo Gracian, Akihito Tsuji, Li-Yuan Bai, Rachel Wong, Stephen Clarke, Alan Arrieira Azambuja, Satoshi Otsu, Mustafa Ozguroglu, Alberto Zaniboni, Gianluca Tomasello, Uwe Martens, Emiliano Tamburini, Hakan Harputluoglu, Shin Takahashi, Giuseppe Tonini, Roberto Bordonaro, Matthew Burge, Nicola Fazio, Warren Joubert, Ferdinando De Vita, Yeul Hong Kim, Giovanni Cardellino, Shoji Natsugoe, Shuichi Hironaka, Maria Di Bartolomeo, Rohit Joshi, Mikhail Dvorkin, Min-Hee Ryu, Perran Fulden Yumuk, Suayib Yalcin, Toshimi Takano, Keun-wook Lee, Takaki Yoshikawa, Timucin Cil, Se Hoon Park
Sponsors
Collaborators: Merck KGaA, Darmstadt, Germany
Leads: EMD Serono Research & Development Institute, Inc.

This content was sourced from clinicaltrials.gov