499
Participants
Start Date
December 24, 2015
Primary Completion Date
September 13, 2019
Study Completion Date
June 3, 2021
Avelumab
Maintenance Phase: Intravenous (IV) infusion (10 mg/kg over 1 hour) once every 2 weeks.
Oxaliplatin
"Induction Phase: Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks.~Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation."
5-Fluorouracil
Induction Phase: 5-Fluorouracil was administered at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 (or) 5-FU at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Days 1 and 2) along with oxaliplatin and leucovorin every 2 weeks up to 12 weeks. Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.
Leucovorin
"Induction Phase: Leucovorin was administered at a dose of 200 mg/m\^2 IV (or) Leucovorin 400 mg/m\^2 IV on Day 1 along with oxaliplatin and 5-FU every 2 weeks up to 12 weeks.~Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation."
Capecitabine
"Induction Phase: Capecitabine was administered at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks along with oxaliplatin up to 12 weeks.~Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase every 3 weeks until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation."
Best supportive care
Treatment administered with the intent to maximize Quality of Life (QoL) without a specific antineoplastic regimen. These may include for example antibiotics, analgesics, antiemetics, thoracentesis, paracentesis, blood transfusions, nutritional support (including jejunostomy), and focal external-beam radiation for control of pain, cough, dyspnea, or bleeding. Best supportive care were administered per institutional guidelines and participants were visit the clinic every 3 weeks.
Oxaliplatin
Induction Phase: Oxaliplatin will be administered at a dose of 85 mg per square meter (mg/m\^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m\^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks.
5-Fluorouracil
Induction Phase: 5-Fluorouracil will be administered at a dose of 2600 mg/m\^2 IV continuous infusion over 24 hours on Day 1 (or) 5-FU at 400 mg/m\^2 IV push on Day 1 and 2400 mg/m\^2 IV continuous infusion over 46-48 hours (Days 1 and 2) along with oxaliplatin and leucovorin every 2 weeks up to 12 weeks.
Leucovorin
Induction Phase: Leucovorin will be administered at a dose of 200 mg/m\^2 IV (or) Leucovorin 400 mg/m\^2 IV on Day 1 along with oxaliplatin and 5-FU every 2 weeks up to 12 weeks.
Capecitabine
Induction Phase: Capecitabine will be administered at a dose of 1000 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks along with oxaliplatin up to 12 weeks.
Mackay Memorial Hospital, Taipei
National Cheng Kung University Hospital, Tainan City
Magyar Honvedseg Egeszsegugyi, Budapest
Adana Numune Training and Research Hospital, Adana
Royal North Shore Hospital, St Leonards
St George Hospital, Kogarah
Korea University Anam Hospital, Seoul
Royal Melbourne Hospital, Parkville
Seoul National University Hospital, Seoul
Box Hill Hospital, Box Hill
Ballarat Base Hospital, Ballarat
Bendigo Hospital, Bendigo
Border Medical Oncology, Wodonga
Yonsei University Health System, Seoul
Royal Brisbane and Women's Hospital, Herston
Debreceni Egyetem Klinikai Kozpont, Debrecen
Greenslopes Private Hospital, Greenslopes
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok
Flinders Medical Centre, Bedford Park
Azienda Ospedaliera S. Maria Di Terni, Terni
Lyell McEwin Hospital, Elizabeth Vale
Fiona Stanley Hospital, Murdoch
Norwalk Hospital, Norwalk
Royal Hobart Hospital, Hobart
Akdeniz University Medical Faculty, Antalya
Tolna Megyei Balassa Janos Korhaz, Szekszárd
Pecsi Tudomanyegyetem, Pécs
Hospital de la Santa Creu i Sant Pau, Barcelona
Monash Medical Centre Clayton, Bentleigh
Zala Megyei Szent Rafael Korhaz, Zalaegerszeg
Petz Aladar Megyei Oktato Korhaz, Győr
Clinical Research Alliance, Inc, New York
National Taiwan University Hospital, Taipei
King Chulalongkorn Memorial Hospital, Patumwan
National Cancer Center, Goyang-si
Siriraj Hospital, Bangkok
Taipei Veterans General Hospital, Taipei
Mount Sinai - PRIME, Jamaica
Hôpital de la Timone, Marseille
Seoul National University Bundang Hospital, Seongnam-si
University of Rochester, Rochester
St. Luke's Hospital, Bethlehem
Thomas Jefferson University Hospital, Philadelphia
Ospedale San Raffaele, Milan
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
IEO Istituto Europeo di Oncologia, Milan
Onkologische Schwerpunktpraxis Eppendorf, Hamburg
Centre Georges François Leclerc, Dijon
Dicle University, Medical faculty, Diyarbakır
Marienkrankenhaus Hamburg, Hamburg
CHU Besancon - Hopital Jean Minjoz, Besançon
Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona), Cremona
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario La Paz, Madrid
Hospital Universitario HM Madrid Sanchinarro, Madrid
Chungbuk National University Hospital, Cheongju-si
Hôpital Morvan, Brest
Greenville Hospital System University Medical Center (ITOR), Greenville
CHU de Toulouse - Hôpital Rangueil, Toulouse
UF Health Cancer Center Orlando, Orlando
Memorial West Cancer Institute, Pembroke Pines
CHU Bordeaux, Bordeaux
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia, Udine
Mersin University Medical Faculty, Mersin
Chang Gung Memorial Hospital, Linkou, Taoyuan District
University of South Florida - Parent, Tampa
Istanbul University Cerrahpasa Medical Faculty, Istanbul
Marmara University Pendik Research and Training Hospital, Istanbul
CRLCC Eugene Marquis, Rennes
IOV - Istituto Oncologico Veneto IRCCS, Padua
CHU Tours - Hôpital Trousseau, Chambray-lès-Tours
China Medical University Hospital, Taichung
Taichung Veterans General Hospital, Taichung
Hospital Universitario Virgen del Rocio, Seville
Kocaeli University Medical Faculty, Kocaeli
Kyungpook National University Medical Center, Daegu
Keimyung University Dongsan Hospital, Daegu
Konya Necmettin Erbakan University Meram Medical Faculty, Konya
Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center, Columbus
Inonu Uni. Med. Fac., Malatya
UC Health Clinical Trials Office, Cincinnati
TriHealth Hatton Institute, Cincinnati
Franciscan St. Francis Health Cancer Center, Indianapolis
Ospedale degli Infermi, Rimini
Inje University Haeundae Paik Hospital, Busan
ICO - Site René Gauducheau, Angers
Azienda Ospedaliera Universitaria Careggi, Florence
Maharaj Nakorn Chiang Mai Hospital, Muang
Cedar Rapids Oncology Project, Cedar Rapids
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz
Virginia Piper Cancer Institute, Minneapolis
Chonnam National University Hwasun Hospital, Hwasun-gun
Oncology Specialists, S.C., Park Ridge
Krankenhaus Nordwest GmbH, Frankfurt am Main
CHU Clermont Ferrand, Clermont-Ferrand
University of Kansas Medical Center Research Institute, Inc., Westwood
Cotton-O'Neil Clinical Research Center, Hematology and Oncology, Topeka
Clinique Victor Hugo - Centre Jean Bernard, Le Mans
Klinikum Esslingen GmbH, Esslingen A. N.
SLK-Kliniken Heilbronn GmbH, Heilbronn
Hôpital Européen Georges Pompidou, Paris
Hôpital Cochin, Paris
Baylor Scott & White Health, Temple
Oncology Consultants, P.A., Houston
University of Texas Health Science Center at San Antonio, San Antonio
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli
Seconda Università degli Studi di Napoli, Napoli
Klinikum Bogenhausen, Munich
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City
Nevada Cancer Research Foundation, Las Vegas
UCLA Medical Center, Los Angeles
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage
Virginia Crosson Cancer Center, Fullerton
Sansum Clinic, Santa Barbara
Comprehensive Blood & Cancer Center, Bakersfield
Trio - Central Coast Medical Oncology Corporation, Santa Maria
Presidio Ospedaliero Garibaldi Nesima, Catania
Oregon Health & Science University, Portland
Leopoldina Krankenhaus Schweinfurt, Schweinfurt
University of Washington - Seattle Cancer Care Alliance, East Seattle
Northwest Medical Specialties, PLLC, Tacoma
Wenatchee Valley Hospital & Clinics, Wenatchee
Spital Lotus SRL, Ploieşti
"FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow
"RBIH Ivanovo Regional Oncological Dispensary", Ivanovo
"SBIH of Arkhangelsk region Arkhangelsk Clinical Oncological Dispensary", Arkhangelsk
Pavlov First Saint Petersburg State Medical University, Saint Petersburg
"SPb SBIH City Clinical Oncological Dispensary", Saint Petersburg
"FBI Scientific Research Institute of Oncology n. a. N. N. Petrov", Saint Petersburg
S.C Centrul de Oncologie Sf. Nectarie S.R.L, Craiova
S.C Oncocenter Oncologie Clinica S.R.L, Timișoara
S.C Oncomed S.R.L, Timișoara
"SBIH Clinical Oncological Dispensary # 1", Krasnodar
"SBIH of Stavropol territory Pyatigorsk Oncological Dispensary", Pyatigorsk
"Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca", Cluj-Napoca
S.C Radiotherapy Center Cluj S.R.L, Comuna Floresti
S.C Oncopremium Team S.R.L, Baia Mare
LLC Evimed, Chelyabinsk
"BHI of Omsk region Clinical Oncology Dispensary", Omsk
Institutul Regional de Oncologie Iasi, Iași
Rhode Island Hospital, Providence
University of Texas Southwestern Medical Center, Dallas
Hospital Infanta Cristina, Badajós
NOB - Núcleo de Oncologia da Bahia, Salvador
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
Hospital de Câncer de Barretos-Fundação Pio XII, Barretos
IMV - Instituto De Medicina Vascular Hospital Mae de Deus, Porto Alegre
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia, Santo André
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
Queen Elizabeth II Health Sciences Centre, Halifax
The Royal Victoria Hospital, Barrie
Humber River Hospital, Toronto
Mount Sinai Hospital, Toronto
Cité de la Santé de Laval, Laval
McGill University - Dept. Oncology Clinical Research Program, Montreal
Centre Antoine Lacassagne, Nice
Università Campus Bio-Medico di Roma, Roma
Chiba Cancer Center, Chiba
Kagawa University Hospital, Kita-gun
Kanagawa Cancer Center, Yokohama
Kumamoto University Hospital, Kumamoto
Tohoku University Hospital, Sendai
Niigata Cancer Center Hospital, Niigata
Oita University Hospital, Yufu-shi
Izumi Municipal Hospital, Izumi-shi
Kindai University Hospital, Sayama
Saitama Medical University International Medical Center, Hidaka-shi
Saitama Cancer Center, Kitaadachi-gun
Tochigi Cancer Center, Utsunomiya
Nat Cancer Ctr Hosp, Chūōku
Toranomon Hospital, Minatoku
Kagoshima University Medical And Dental Hospital, Kagoshima
Institutul Clinic Fundeni, Bucharest
Spitalul Clinic Coltea, Bucharest
Hifu Terramed Conformal SRL, Bucharest
Asan Medical Center, Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul
Hospital General Universitario de Elche, Elche
ICO l´Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat
Corporacio Sanitaria Parc Tauli, Sabadell
Hospital Universitari Vall d'Hebron, Barcelona
Hospital Clinic i Provincial de Barcelona, Barcelona
Acibadem Adana Hospital, Adana
Hacettepe University Medical Faculty, Ankara
Derriford Hospital, Torquay
Barts Hospital, London
University College London Hospitals, London
The Christie, Manchester
The Clatterbridge Cancer Centre, Metropolitan Borough of Wirral
Mount Vernon Hospital, Northwood
Royal Surrey County Hospital, Guildford
Ninewells Hospital, Dundee
St James's University Hospital, Leeds
Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY