Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100) | NCT02625610 | Trialant

Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100) | NCT02625610 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Comprehensive Blood & Cancer Center

Bakersfield, California 93309, United States

Virginia Crosson Cancer Center

Fullerton, California 92835, United States

UCLA Medical Center

Los Angeles, California 90095, United States

Desert Hematology Oncology Medical Group, Inc.

Rancho Mirage, California 92262, United States

Sansum Clinic

Santa Barbara, California 93105, United States

Trio - Central Coast Medical Oncology Corporation

Santa Maria, California 93454, United States

Norwalk Hospital

Norwalk, Connecticut 6856, United States

UF Health Cancer Center Orlando

Orlando, Florida 32806, United States

Memorial West Cancer Institute

Pembroke Pines, Florida 33028, United States

University of South Florida - Parent

Tampa, Florida 33606, United States

Oncology Specialists, S.C.

Park Ridge, Illinois 60068, United States

Franciscan St. Francis Health Cancer Center

Indianapolis, Indiana 46237, United States

Cedar Rapids Oncology Project

Cedar Rapids, Iowa 52403, United States

Cotton-O'Neil Clinical Research Center, Hematology and Oncology

Topeka, Kansas 66604, United States

University of Kansas Medical Center Research Institute, Inc.

Westwood, Kansas 66205, United States

Virginia Piper Cancer Institute

Minneapolis, Minnesota 55407, United States

Nevada Cancer Research Foundation

Las Vegas, Nevada 89106, United States

Mount Sinai - PRIME

Jamaica, New York 11432, United States

Clinical Research Alliance, Inc

New York, New York 10021, United States

University of Rochester

Rochester, New York 14642, United States

UC Health Clinical Trials Office

Cincinnati, Ohio 45206, United States

TriHealth Hatton Institute

Cincinnati, Ohio 45220, United States

Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center

Columbus, Ohio 43219, United States

Oregon Health & Science University

Portland, Oregon 97239, United States

St. Luke's Hospital

Bethlehem, Pennsylvania 18015, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107, United States

Rhode Island Hospital

Providence, Rhode Island 02903, United States

Greenville Hospital System University Medical Center (ITOR)

Greenville, South Carolina 29605, United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390-9179, United States

Oncology Consultants, P.A.

Houston, Texas 77024, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas 78229, United States

Baylor Scott & White Health

Temple, Texas 76508, United States

University of Washington - Seattle Cancer Care Alliance

East Seattle, Washington 98109, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington 98405, United States

Wenatchee Valley Hospital & Clinics

Wenatchee, Washington 98801, United States

St George Hospital

Kogarah, New South Wales 2217, Australia

Royal North Shore Hospital

St Leonards, New South Wales 2065, Australia

Greenslopes Private Hospital

Greenslopes, Queensland 4120, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland 4006, Australia

Flinders Medical Centre

Bedford Park, South Australia 5042, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia 5112, Australia

Royal Hobart Hospital

Hobart, Tasmania 7000, Australia

Ballarat Base Hospital

Ballarat, Victoria 3350, Australia

Bendigo Hospital

Bendigo, Victoria 3550, Australia

Monash Medical Centre Clayton

Bentleigh, Victoria 8120, Australia

Box Hill Hospital

Box Hill, Victoria 3128, Australia

Royal Melbourne Hospital

Parkville, Victoria 3050, Australia

Border Medical Oncology

Wodonga, Victoria 3690, Australia

Fiona Stanley Hospital

Murdoch, Western Australia 6150, Australia

Hospital Infanta Cristina

Badajós, Badajoz 06080, Brazil

NOB - Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia 40170-110, Brazil

Hospital São Lucas da PUCRS

Ijuí, Rio Grande do Sul 98700-000, Brazil

Hospital Bruno Born

Lajeado, Rio Grande do Sul 95900-000, Brazil

Oncosinos - Clínica de Oncologia - Hospital Regina

Novo Hamburgo, Rio Grande do Sul 93510-250, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul 90035-903, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul 90610-000, Brazil

Hospital de Câncer de Barretos-Fundação Pio XII

Barretos, São Paulo 14784-400, Brazil

IMV - Instituto De Medicina Vascular Hospital Mae de Deus

Porto Alegre, São Paulo 90110-270, Brazil

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

Santo André, São Paulo 09060-650, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo 15090-000, Brazil

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

São Paulo, São Paulo 01246-000, Brazil

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia B3H 2Y9, Canada

The Royal Victoria Hospital

Barrie, Ontario L4M 6M2, Canada

Humber River Hospital

Toronto, Ontario M3M 0B2, Canada

Mount Sinai Hospital

Toronto, Ontario M5G 1X5, Canada

Cité de la Santé de Laval

Laval, Quebec H7M 3L9, Canada

McGill University - Dept. Oncology Clinical Research Program

Montreal, Quebec H2W 1S6, Canada

Centre Antoine Lacassagne

Nice, Alpes Maritimes 06189, France

Hôpital de la Timone

Marseille, Bouches Du Rhone 13385, France

Hôpital Morvan

Brest, Brittany Region 29200, France

Centre Georges François Leclerc

Dijon, Côte-d'Or 21079, France

CHU Besancon - Hopital Jean Minjoz

Besançon, Doubs 25030, France

CHU Bordeaux

Bordeaux, Gironde 33076, France

CHU de Toulouse - Hôpital Rangueil

Toulouse, Haute Garonne 31059, France

CRLCC Eugene Marquis

Rennes, Ille Et Vilaine 35042, France

CHU Tours - Hôpital Trousseau

Chambray-lès-Tours, Indre Et Loire 37170, France

ICO - Site René Gauducheau

Angers, Maine Et Loire 49933, France

Hôpital Européen Georges Pompidou

Paris, Paris 75015, France

Hôpital Cochin

Paris, Paris 75679, France

CHU Clermont Ferrand

Clermont-Ferrand, Puy De Dome 63003, France

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, Sarthe 72015, France

Klinikum Esslingen GmbH

Esslingen A. N., Baden-Wurttemberg 73730, Germany

SLK-Kliniken Heilbronn GmbH

Heilbronn, Baden-Wurttemberg 74078, Germany

Klinikum Bogenhausen

Munich, Bavaria 81925, Germany

Leopoldina Krankenhaus Schweinfurt

Schweinfurt, Bavaria 97422, Germany

Krankenhaus Nordwest GmbH

Frankfurt am Main, Hesse 60488, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Rhineland-Palatinate 55131, Germany

Onkologische Schwerpunktpraxis Eppendorf

Hamburg, 20249, Germany

Marienkrankenhaus Hamburg

Hamburg, 22087, Germany

Pecsi Tudomanyegyetem

Pécs, Baranya 7624, Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, Győr-Moson-Sopron 9024, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hajdú-Bihar 4032, Hungary

Magyar Honvedseg Egeszsegugyi

Budapest, 1062, Hungary

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, 4400, Hungary

Tolna Megyei Balassa Janos Korhaz

Szekszárd, 7100, Hungary

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, 5000, Hungary

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, 8900, Hungary

Presidio Ospedaliero Garibaldi Nesima

Catania, 95100, Italy

Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)

Cremona, 26100, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, 50141, Italy

Ospedale San Raffaele

Milan, 20132, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

IEO Istituto Europeo di Oncologia

Milan, 20141, Italy

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, 80131, Italy

Seconda Università degli Studi di Napoli

Naples, 80131, Italy

IOV - Istituto Oncologico Veneto IRCCS

Padova, 35128, Italy

Ospedale degli Infermi

Rimini, 47923, Italy

Università Campus Bio-Medico di Roma

Roma, 00128, Italy

Azienda Ospedaliera S. Maria Di Terni

Terni, 5100, Italy

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

Udine, 33100, Italy

Chiba Cancer Center

Chiba, Chiba 260-8717, Japan

Kagawa University Hospital

Kita-gun, Kagawa-ken 761-0793, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa 241-8515, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto 860-8556, Japan

Tohoku University Hospital

Sendai, Miyagi 980-8574, Japan

Niigata Cancer Center Hospital

Niigata, Niigata 951-8566, Japan

Oita University Hospital

Yufu-shi, Oita Prefecture 879-5593, Japan

Izumi Municipal Hospital

Izumi-shi, Osaka 594-0071, Japan

Kindai University Hospital

Sayama, Osaka 589-8511, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Saitama 350-1298, Japan

Saitama Cancer Center

Kitaadachi-gun, Saitama 362-0806, Japan

Tochigi Cancer Center

Utsunomiya, Tochigi 320-0834, Japan

Nat Cancer Ctr Hosp

Chūōku, Tokyo-To 104-0045, Japan

Toranomon Hospital

Minatoku, Tokyo-To 105-8470, Japan

Kagoshima University Medical And Dental Hospital

Kagoshima, 890-8520, Japan

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca

Cluj-Napoca, Cluj 400015, Romania

S.C Radiotherapy Center Cluj S.R.L

Comuna Floresti, Cluj 407280, Romania

S.C Centrul de Oncologie Sf. Nectarie S.R.L

Craiova, Dolj 200347, Romania

Spital Lotus SRL

Ploieşti, Prahova 100011, Romania

S.C Oncocenter Oncologie Clinica S.R.L

Timișoara, Timiș County 300210, Romania

S.C Oncomed S.R.L

Timișoara, Timiș County 300239, Romania

S.C Oncopremium Team S.R.L

Baia Mare, 430291, Romania

Institutul Clinic Fundeni

Bucharest, 022328, Romania

Spitalul Clinic Coltea

Bucharest, 030171, Romania

Hifu Terramed Conformal SRL

Bucharest, 031864, Romania

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, Leningrado 197022, Russia

FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

Saint Petersburg, Leningrado 197758, Russia

SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

Arkhangelsk, 163045, Russia

LLC Evimed

Chelyabinsk, 454048, Russia

RBIH "Ivanovo Regional Oncological Dispensary"

Ivanovo, 153040, Russia

SBIH " Clinical Oncological Dispensary # 1"

Krasnodar, 350040, Russia

FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

Moscow, 115478, Russia

BHI of Omsk region "Clinical Oncology Dispensary"

Omsk, 644013, Russia

SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"

Pyatigorsk, 357502, Russia

SPb SBIH "City Clinical Oncological Dispensary"

Saint Petersburg, 197022, Russia

National Cancer Center

Goyang-si, Gyeonggi-do 10408, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620, South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do 58128, South Korea

Keimyung University Dongsan Hospital

Daegu, Jung-gu 41931, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong 28644, South Korea

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Kyungpook National University Medical Center

Daegu, 41404, South Korea

Asan Medical Center

Seoul, 05505, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Korea University Anam Hospital

Seoul, 2841, South Korea

Seoul National University Hospital

Seoul, 3080, South Korea

Yonsei University Health System

Seoul, 3722, South Korea

Hospital General Universitario de Elche

Elche, Alicante 03203, Spain

ICO l´Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona 08908, Spain

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona 08208, Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 8025, Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Hospital Universitario La Paz

Madrid, 28046, Spain

Hospital Universitario HM Madrid Sanchinarro

Madrid, 28050, Spain

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

China Medical University Hospital

Taichung, 40447, Taiwan

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

National Cheng Kung University Hospital

Tainan, 704, Taiwan

National Taiwan University Hospital

Taipei, 10048, Taiwan

Mackay Memorial Hospital

Taipei, 104, Taiwan

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, 33305, Taiwan

King Chulalongkorn Memorial Hospital

Patumwan, Bangkok 10330, Thailand

Maharaj Nakorn Chiang Mai Hospital

Muang, Chiang Mai 50200, Thailand

Siriraj Hospital

Bangkok, 10700, Thailand

Acibadem Adana Hospital

Adana, 01130, Turkey (Türkiye)

Adana Numune Training and Research Hospital

Adana, 1240, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Akdeniz University Medical Faculty

Antalya, 7058, Turkey (Türkiye)

Dicle University, Medical faculty

Diyarbakır, 21080, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Marmara University Pendik Research and Training Hospital

Istanbul, 34340, Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, 41380, Turkey (Türkiye)

Konya Necmettin Erbakan University Meram Medical Faculty

Konya, 42100, Turkey (Türkiye)

Inonu Uni. Med. Fac.

Malatya, 44280, Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, 33169, Turkey (Türkiye)

Derriford Hospital

Torquay, Devon TQ2 7AA, United Kingdom

Barts Hospital

London, Greater London EC1A 7BE, United Kingdom

University College London Hospitals

London, Greater London WC1E 6AG, United Kingdom

The Christie

Manchester, Greater Manchester M20 4BX, United Kingdom

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, Merseyside CH63 4JY, United Kingdom

Mount Vernon Hospital

Northwood, Middlesex HA6 2RN, United Kingdom

Royal Surrey County Hospital

Guildford, Surrey GU2 7XX, United Kingdom

Ninewells Hospital

Dundee, Tayside Region DD1 9SY, United Kingdom

St James's University Hospital

Leeds, West Yorkshire LS9 7TF, United Kingdom