Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)
NCT ID: NCT02625610
Last Updated: 2022-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
499 participants
INTERVENTIONAL
2015-12-24
2021-06-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
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.
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.
Avelumab
Maintenance Phase: Intravenous (IV) infusion (10 mg/kg over 1 hour) once every 2 weeks.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Concurrent anticancer treatment or immunosuppressive agents
* Prior chemotherapy for unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ)
* Tumor shown to be human epidermal growth factor 2 plus (HER2+)
* Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment and/or if the participant has not fully recovered from the surgery within 4 weeks of enrolment
* Participants receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the study treatment (with the exception of participants with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to \<= 10 mg prednisone daily)
* All participants with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, have not been progressing at least 2 months after completion of therapy, and no steroid maintenance therapy is required, and b. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
* Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)
* Prior organ transplantation, including allogeneic stem-cell transplantation
* Significant acute or chronic infections
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
* Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
* Persisting toxicity related to prior therapy except alopecia
* Neuropathy Grade \> 3
* Pregnancy or lactation
* Known alcohol or drug abuse
* History of uncontrolled intercurrent illness including hypertension, active infection, diabetes
* Clinically significant (i.e., active) cardiovascular disease
* All other significant diseases might impair the participant's tolerance of study treatment
* Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with study requirements
* Vaccination with live or live/attenuated viruses within 55 days of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
* Legal incapacity or limited legal capacity
* Participants will be excluded from the Induction Phase and the Maintenance Phase if administration of their chemotherapy would be inconsistent with the current local labelling (SmPC) (e.g., in regard to contraindications, warnings/precautions or special provisions) for that chemotherapy. Investigators should check updated labelling via relevant websites at the time of entry into the Induction Phase and the Maintenance Phase
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Research & Development Institute, Inc. a business of Merck KGaA, Darmstadt, Germany
Locations
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Comprehensive Blood & Cancer Center
Bakersfield, California, United States
Virginia Crosson Cancer Center
Fullerton, California, United States
UCLA Medical Center
Los Angeles, California, United States
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States
Sansum Clinic
Santa Barbara, California, United States
Trio - Central Coast Medical Oncology Corporation
Santa Maria, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
UF Health Cancer Center Orlando
Orlando, Florida, United States
Memorial West Cancer Institute
Pembroke Pines, Florida, United States
University of South Florida - Parent
Tampa, Florida, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, United States
Franciscan St. Francis Health Cancer Center
Indianapolis, Indiana, United States
Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
Cotton-O'Neil Clinical Research Center, Hematology and Oncology
Topeka, Kansas, United States
University of Kansas Medical Center Research Institute, Inc.
Westwood, Kansas, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Mount Sinai - PRIME
Jamaica, New York, United States
Clinical Research Alliance, Inc
New York, New York, United States
University of Rochester
Rochester, New York, United States
UC Health Clinical Trials Office
Cincinnati, Ohio, United States
TriHealth Hatton Institute
Cincinnati, Ohio, United States
Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Oncology Consultants, P.A.
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Baylor Scott & White Health
Temple, Texas, United States
University of Washington - Seattle Cancer Care Alliance
East Seattle, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States
St George Hospital
Kogarah, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Ballarat Base Hospital
Ballarat, Victoria, Australia
Bendigo Hospital
Bendigo, Victoria, Australia
Monash Medical Centre Clayton
Bentleigh, Victoria, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Border Medical Oncology
Wodonga, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Hospital Infanta Cristina
Badajós, Badajoz, Brazil
NOB - Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, Brazil
Hospital São Lucas da PUCRS
Ijuí, Rio Grande do Sul, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Oncosinos - Clínica de Oncologia - Hospital Regina
Novo Hamburgo, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Câncer de Barretos-Fundação Pio XII
Barretos, São Paulo, Brazil
IMV - Instituto De Medicina Vascular Hospital Mae de Deus
Porto Alegre, São Paulo, Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, São Paulo, Brazil
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
The Royal Victoria Hospital
Barrie, Ontario, Canada
Humber River Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Cité de la Santé de Laval
Laval, Quebec, Canada
McGill University - Dept. Oncology Clinical Research Program
Montreal, Quebec, Canada
Centre Antoine Lacassagne
Nice, Alpes Maritimes, France
Hôpital de la Timone
Marseille, Bouches Du Rhone, France
Hôpital Morvan
Brest, Brittany Region, France
Centre Georges François Leclerc
Dijon, Côte-d'Or, France
CHU Besancon - Hopital Jean Minjoz
Besançon, Doubs, France
CHU Bordeaux
Bordeaux, Gironde, France
CHU de Toulouse - Hôpital Rangueil
Toulouse, Haute Garonne, France
CRLCC Eugene Marquis
Rennes, Ille Et Vilaine, France
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, Indre Et Loire, France
ICO - Site René Gauducheau
Angers, Maine Et Loire, France
Hôpital Européen Georges Pompidou
Paris, Paris, France
Hôpital Cochin
Paris, Paris, France
CHU Clermont Ferrand
Clermont-Ferrand, Puy De Dome, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, Sarthe, France
Klinikum Esslingen GmbH
Esslingen A. N., Baden-Wurttemberg, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, Baden-Wurttemberg, Germany
Klinikum Bogenhausen
Munich, Bavaria, Germany
Leopoldina Krankenhaus Schweinfurt
Schweinfurt, Bavaria, Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, Hesse, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Rhineland-Palatinate, Germany
Onkologische Schwerpunktpraxis Eppendorf
Hamburg, , Germany
Marienkrankenhaus Hamburg
Hamburg, , Germany
Pecsi Tudomanyegyetem
Pécs, Baranya, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, Győr-Moson-Sopron, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, Hungary
Magyar Honvedseg Egeszsegugyi
Budapest, , Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, , Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, , Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, , Hungary
Presidio Ospedaliero Garibaldi Nesima
Catania, , Italy
Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)
Cremona, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
IEO Istituto Europeo di Oncologia
Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
Seconda Università degli Studi di Napoli
Napoli, , Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, , Italy
Ospedale degli Infermi
Rimini, , Italy
Università Campus Bio-Medico di Roma
Roma, , Italy
Azienda Ospedaliera S. Maria Di Terni
Terni, , Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
Udine, , Italy
Chiba Cancer Center
Chiba, Chiba, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Oita University Hospital
Yufu-shi, Oita Prefecture, Japan
Izumi Municipal Hospital
Izumi-shi, Osaka, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan
Saitama Cancer Center
Kitaadachi-gun, Saitama, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
Nat Cancer Ctr Hosp
Chūōku, Tokyo-To, Japan
Toranomon Hospital
Minatoku, Tokyo-To, Japan
Kagoshima University Medical And Dental Hospital
Kagoshima, , Japan
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
Cluj-Napoca, Cluj, Romania
S.C Radiotherapy Center Cluj S.R.L
Comuna Floresti, Cluj, Romania
S.C Centrul de Oncologie Sf. Nectarie S.R.L
Craiova, Dolj, Romania
Spital Lotus SRL
Ploieşti, Prahova, Romania
S.C Oncocenter Oncologie Clinica S.R.L
Timișoara, Timiș County, Romania
S.C Oncomed S.R.L
Timișoara, Timiș County, Romania
S.C Oncopremium Team S.R.L
Baia Mare, , Romania
Institutul Clinic Fundeni
Bucharest, , Romania
Spitalul Clinic Coltea
Bucharest, , Romania
Hifu Terramed Conformal SRL
Bucharest, , Romania
Institutul Regional de Oncologie Iasi
Iași, , Romania
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, Leningrado, Russia
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint Petersburg, Leningrado, Russia
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
Arkhangelsk, , Russia
LLC Evimed
Chelyabinsk, , Russia
RBIH "Ivanovo Regional Oncological Dispensary"
Ivanovo, , Russia
SBIH " Clinical Oncological Dispensary # 1"
Krasnodar, , Russia
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow, , Russia
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, , Russia
SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"
Pyatigorsk, , Russia
SPb SBIH "City Clinical Oncological Dispensary"
Saint Petersburg, , Russia
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, South Korea
Keimyung University Dongsan Hospital
Daegu, Jung-gu, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Kyungpook National University Medical Center
Daegu, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Health System
Seoul, , South Korea
Hospital General Universitario de Elche
Elche, Alicante, Spain
ICO l´Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario HM Madrid Sanchinarro
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, Thailand
Siriraj Hospital
Bangkok, , Thailand
Acibadem Adana Hospital
Adana, , Turkey (Türkiye)
Adana Numune Training and Research Hospital
Adana, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, , Turkey (Türkiye)
Dicle University, Medical faculty
Diyarbakır, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Marmara University Pendik Research and Training Hospital
Istanbul, , Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, , Turkey (Türkiye)
Konya Necmettin Erbakan University Meram Medical Faculty
Konya, , Turkey (Türkiye)
Inonu Uni. Med. Fac.
Malatya, , Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, , Turkey (Türkiye)
Derriford Hospital
Torquay, Devon, United Kingdom
Barts Hospital
London, Greater London, United Kingdom
University College London Hospitals
London, Greater London, United Kingdom
The Christie
Manchester, Greater Manchester, United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, Merseyside, United Kingdom
Mount Vernon Hospital
Northwood, Middlesex, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Ninewells Hospital
Dundee, Tayside Region, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, United Kingdom
Countries
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References
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Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
Moehler M, Dvorkin M, Boku N, Ozguroglu M, Ryu MH, Muntean AS, Lonardi S, Nechaeva M, Bragagnoli AC, Coskun HS, Cubillo Gracian A, Takano T, Wong R, Safran H, Vaccaro GM, Wainberg ZA, Silver MR, Xiong H, Hong J, Taieb J, Bang YJ. Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100. J Clin Oncol. 2021 Mar 20;39(9):966-977. doi: 10.1200/JCO.20.00892. Epub 2020 Nov 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2015-003300-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EMR 100070-007
Identifier Type: -
Identifier Source: org_study_id
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