Clinical trial NCT02625610: Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction
Keywords: Avelumab
Cancer
Unresectable
Locally advanced
Metastatic
Adenocarcinoma of the stomach
Gastro-esophageal junction
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2015-12-09
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
* 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
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization into maintenance phase up to 1276 days
Secondary outcomes:
measure: Progression Free Survival (PFS) by Independent Review Committee (IRC)
timeFrame: From randomization into maintenance phase up to 1276 days
measure: Best Overall Response (BOR) by Investigator Assessment
timeFrame: From randomization into maintenance phase up to 1276 days
measure: Objective Response Rate (ORR) by Investigator Assessment
timeFrame: From randomization into maintenance phase up to 1276 days
measure: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks)
timeFrame: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
measure: Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks)
timeFrame: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
measure: Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks)
timeFrame: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
measure: Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks)
timeFrame: Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks)
measure: Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
timeFrame: From randomization into maintenance phase up to 1276 days
measure: Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values
timeFrame: From baseline up to 1276 days
measure: Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
timeFrame: From randomization into maintenance phase up to 1276 days
measure: Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: From randomization into maintenance phase up to 1276 days
measure: Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1
timeFrame: From randomization into maintenance phase up to 1276 days
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Comprehensive Blood & Cancer Center
state: California
city: Fullerton
country: United States
facility: Virginia Crosson Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Inc.
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Santa Maria
country: United States
facility: Trio - Central Coast Medical Oncology Corporation
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Orlando
country: United States
facility: UF Health Cancer Center Orlando
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial West Cancer Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida - Parent
state: Florida
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health Cancer Center
state: Indiana
city: Cedar Rapids
country: United States
facility: Cedar Rapids Oncology Project
state: Iowa
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Hematology and Oncology
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute
state: Minnesota
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation
state: Nevada
city: Jamaica
country: United States
facility: Mount Sinai - PRIME
state: New York
city: New York
country: United States
facility: Clinical Research Alliance, Inc
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cincinnati
country: United States
facility: UC Health Clinical Trials Office
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Hatton Institute
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Hospital System University Medical Center (ITOR)
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Oncology Consultants, P.A.
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Health
state: Texas
city: East Seattle
country: United States
facility: University of Washington - Seattle Cancer Care Alliance
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics
state: Washington
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
state: Victoria
city: Bendigo
country: Australia
facility: Bendigo Hospital
state: Victoria
city: Bentleigh
country: Australia
facility: Monash Medical Centre Clayton
state: Victoria
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Salvador
country: Brazil
facility: NOB - Núcleo de Oncologia da Bahia
state: Bahia
city: Ijuí
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: Rio Grande Do Sul
city: Novo Hamburgo
country: Brazil
facility: Oncosinos - Clínica de Oncologia - Hospital Regina
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital de Câncer de Barretos-Fundação Pio XII
state: Sao Paulo
city: Porto Alegre
country: Brazil
facility: IMV - Instituto De Medicina Vascular Hospital Mae de Deus
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: Sao Paulo
city: São Paulo
country: Brazil
facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
state: Sao Paulo
city: Badajoz
country: Brazil
facility: Hospital Infanta Cristina
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: The Royal Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Laval
country: Canada
facility: Cité de la Santé de Laval
state: Quebec
city: Montréal
country: Canada
facility: McGill University - Dept. Oncology Clinical Research Program
state: Quebec
city: Nice cedex 02
country: France
facility: Centre Antoine Lacassagne
state: Alpes Maritimes
city: Marseille cedex 5
country: France
facility: Hôpital de la Timone
state: Bouches Du Rhone
city: Brest
country: France
facility: Hôpital Morvan
state: Brittany
city: Dijon cedex
country: France
facility: Centre Georges François Leclerc
state: Côte-d'Or
city: Besancon
country: France
facility: CHU Besancon - Hopital Jean Minjoz
state: Doubs
city: Bordeaux Cedex
country: France
facility: CHU Bordeaux
state: Gironde
city: Toulouse Cedex 9
country: France
facility: CHU de Toulouse - Hôpital Rangueil
state: Haute Garonne
city: Rennes cedex
country: France
facility: CRLCC Eugene Marquis
state: Ille Et Vilaine
city: Chambray les Tours
country: France
facility: CHU Tours - Hôpital Trousseau
state: Indre Et Loire
city: Angers Cedex 9
country: France
facility: ICO - Site René Gauducheau
state: Maine Et Loire
city: Paris cedex 14
country: France
facility: Hôpital Cochin
state: Paris
city: Paris Cedex 15
country: France
facility: Hôpital Européen Georges Pompidou
state: Paris
city: Clermont Ferrand cedex 1
country: France
facility: CHU Clermont Ferrand
state: Puy De Dome
city: Le Mans Cedex 02
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard
state: Sarthe
city: Esslingen A. N.
country: Germany
facility: Klinikum Esslingen GmbH
state: Baden Wuerttemberg
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
state: Baden Wuerttemberg
city: Muenchen
country: Germany
facility: Klinikum Bogenhausen
state: Bayern
city: Schweinfurt
country: Germany
facility: Leopoldina Krankenhaus Schweinfurt
state: Bayern
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest GmbH
state: Hessen
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
state: Rheinland Pfalz
city: Hamburg
country: Germany
facility: Onkologische Schwerpunktpraxis Eppendorf
city: Hamburg
country: Germany
facility: Marienkrankenhaus Hamburg
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
state: Baranya
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
state: Győr-Moson-Sopron
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
state: Hajdú-Bihar
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi
city: Nyiregyhaza
country: Hungary
facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz
city: Catania
country: Italy
facility: Presidio Ospedaliero Garibaldi Nesima
city: Cremona
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
city: Napoli
country: Italy
facility: Seconda Università degli Studi di Napoli
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto IRCCS
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Roma
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria Di Terni
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
city: Chiba-shi
country: Japan
facility: Chiba Cancer Center
state: Chiba-Ken
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa-Ken
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa-Ken
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto-Ken
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi-Ken
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata-Ken
city: Yufu-shi
country: Japan
facility: Oita University Hospital
state: Oita-ken
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka-Fu
city: Izumi-shi
country: Japan
facility: Izumi Municipal Hospital
state: Osaka
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama-Ken
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
state: Saitama-Ken
city: Utsunomiya-shi
country: Japan
facility: Tochigi Cancer Center
state: Tochigi-Ken
city: Chuo-ku
country: Japan
facility: Nat Cancer Ctr Hosp
state: Tokyo-To
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo-To
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Medical And Dental Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Jung-gu
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
state: Cluj
city: Comuna Floresti
country: Romania
facility: S.C Radiotherapy Center Cluj S.R.L
state: Cluj
city: Craiova
country: Romania
facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L
state: Dolj
city: Ploiesti
country: Romania
facility: Spital Lotus SRL
state: Prahova
city: Timisoara
country: Romania
facility: S.C Oncocenter Oncologie Clinica S.R.L
state: Timis
city: Timisoara
country: Romania
facility: S.C Oncomed S.R.L
state: Timis
city: Baia Mare
country: Romania
facility: S.C Oncopremium Team S.R.L
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea
city: Bucuresti
country: Romania
facility: Hifu Terramed Conformal SRL
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Saint-Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
state: Leningrado
city: Saint-Petersburg
country: Russian Federation
facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
state: Leningrado
city: Arkhangelsk
country: Russian Federation
facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
city: Chelyabinsk
country: Russian Federation
facility: LLC Evimed
city: Ivanovo
country: Russian Federation
facility: RBIH "Ivanovo Regional Oncological Dispensary"
city: Krasnodar
country: Russian Federation
facility: SBIH " Clinical Oncological Dispensary # 1"
city: Moscow
country: Russian Federation
facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
city: Omsk
country: Russian Federation
facility: BHI of Omsk region "Clinical Oncology Dispensary"
city: Pyatigorsk
country: Russian Federation
facility: SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"
city: Saint-Petersburg
country: Russian Federation
facility: SPb SBIH "City Clinical Oncological Dispensary"
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO l´Hospitalet - Hospital Duran i Reynals
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario HM Madrid Sanchinarro
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Patumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
state: Chiang Mai
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Adana
country: Turkey
facility: Acibadem Adana Hospital
city: Adana
country: Turkey
facility: Adana Numune Training and Research Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Diyarbakir
country: Turkey
facility: Dicle University, Medical faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Marmara University Pendik Research and Training Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Konya
country: Turkey
facility: Konya Necmettin Erbakan University Meram Medical Faculty
city: Malatya
country: Turkey
facility: Inonu Uni. Med. Fac.
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Torquay
country: United Kingdom
facility: Derriford Hospital
state: Devon
city: London
country: United Kingdom
facility: Barts Hospital
state: Greater London
city: London
country: United Kingdom
facility: University College London Hospitals
state: Greater London
city: Manchester
country: United Kingdom
facility: The Christie
state: Greater Manchester
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre
state: Merseyside
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
state: Middlesex
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Tayside Region
city: Leeds
country: United Kingdom
facility: St James's University Hospital
state: West Yorkshire
Study officials:
affiliation: EMD Serono Research & Development Institute, Inc. a business of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.