AzTrials
AzTrials

Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal JunctionPhase 3NCT02625610

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

A Phase 3 study testing Avelumab, Oxaliplatin and 5-Fluorouracil in people with Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction, run by EMD Serono Research & Development Institute, Inc. at 200 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Avelumab, Oxaliplatin and 5-Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
499 participants
Where
200 sitesin 17 countries
Study dates
24 Dec 2015to 3 Jun 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

200 sites in 17 countries.

200 sites in 17 countries

United States35 sites

  • Comprehensive Blood & Cancer Center

    Bakersfield, California, 93309

  • St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403

  • UC Health Clinical Trials Office

    Cincinnati, Ohio, 45206

  • TriHealth Hatton Institute

    Cincinnati, Ohio, 45220

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

    Columbus, Ohio, 43219

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9179

  • University of Washington - Seattle Cancer Care Alliance

    East Seattle, Washington, 98109

  • Virginia Crosson Cancer Center

    Fullerton, California, 92835

  • Greenville Hospital System University Medical Center (ITOR)

    Greenville, South Carolina, 29605

  • Oncology Consultants, P.A.

    Houston, Texas, 77024

  • Franciscan St. Francis Health Cancer Center

    Indianapolis, Indiana, 46237

  • Mount Sinai - PRIME

    Jamaica, New York, 11432

  • Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Clinical Research Alliance, Inc

    New York, New York, 10021

  • Norwalk Hospital

    Norwalk, Connecticut, 6856

  • UF Health Cancer Center Orlando

    Orlando, Florida, 32806

  • Oncology Specialists, S.C.

    Park Ridge, Illinois, 60068

  • Memorial West Cancer Institute

    Pembroke Pines, Florida, 33028

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Desert Hematology Oncology Medical Group, Inc.

    Rancho Mirage, California, 92262

  • University of Rochester

    Rochester, New York, 14642

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Trio - Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • University of South Florida - Parent

    Tampa, Florida, 33606

  • Baylor Scott & White Health

    Temple, Texas, 76508

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

    Topeka, Kansas, 66604

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

  • University of Kansas Medical Center Research Institute, Inc.

    Westwood, Kansas, 66205

Other trials in United States

Japan15 sites

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • Nat Cancer Ctr Hosp

    Chūōku, Tokyo-To, 104-0045

  • Saitama Medical University International Medical Center

    Hidaka-shi, Saitama, 350-1298

  • Izumi Municipal Hospital

    Izumi-shi, Osaka, 594-0071

  • Kagoshima University Medical And Dental Hospital

    Kagoshima, 890-8520

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793

  • Saitama Cancer Center

    Kitaadachi-gun, Saitama, 362-0806

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • Toranomon Hospital

    Minatoku, Tokyo-To, 105-8470

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Kindai University Hospital

    Sayama, Osaka, 589-8511

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

  • Oita University Hospital

    Yufu-shi, Oita Prefecture, 879-5593

Other trials in Japan

Australia14 sites

  • Ballarat Base Hospital

    Ballarat, Victoria, 3350

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Bendigo Hospital

    Bendigo, Victoria, 3550

  • Monash Medical Centre Clayton

    Bentleigh, Victoria, 8120

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4006

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Border Medical Oncology

    Wodonga, Victoria, 3690

Other trials in Australia

France14 sites

  • ICO - Site René Gauducheau

    Angers, Maine Et Loire, 49933

  • CHU Besancon - Hopital Jean Minjoz

    Besançon, Doubs, 25030

  • CHU Bordeaux

    Bordeaux, Gironde, 33076

  • Hôpital Morvan

    Brest, Brittany Region, 29200

  • CHU Tours - Hôpital Trousseau

    Chambray-lès-Tours, Indre Et Loire, 37170

  • CHU Clermont Ferrand

    Clermont-Ferrand, Puy De Dome, 63003

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, Sarthe, 72015

  • Hôpital de la Timone

    Marseille, Bouches Du Rhone, 13385

  • Centre Antoine Lacassagne

    Nice, Alpes Maritimes, 06189

  • Hôpital Européen Georges Pompidou

    Paris, Paris, 75015

  • Hôpital Cochin

    Paris, Paris, 75679

  • CRLCC Eugene Marquis

    Rennes, Ille Et Vilaine, 35042

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, Haute Garonne, 31059

Other trials in France

Italy13 sites

  • Presidio Ospedaliero Garibaldi Nesima

    Catania, 95100

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

    Cremona, 26100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50141

  • Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

  • Seconda Università degli Studi di Napoli

    Naples, 80131

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Ospedale degli Infermi

    Rimini, 47923

  • Università Campus Bio-Medico di Roma

    Roma, 00128

  • Azienda Ospedaliera S. Maria Di Terni

    Terni, 5100

  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

    Udine, 33100

Other trials in Italy

Brazil12 sites

  • Hospital Infanta Cristina

    Badajós, Badajoz, 06080

  • Hospital de Câncer de Barretos-Fundação Pio XII

    Barretos, São Paulo, 14784-400

  • Hospital São Lucas da PUCRS

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-000

  • Oncosinos - Clínica de Oncologia - Hospital Regina

    Novo Hamburgo, Rio Grande do Sul, 93510-250

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • IMV - Instituto De Medicina Vascular Hospital Mae de Deus

    Porto Alegre, São Paulo, 90110-270

  • NOB - Núcleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-110

  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

    Santo André, São Paulo, 09060-650

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

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

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

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

South Korea12 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Keimyung University Dongsan Hospital

    Daegu, Jung-gu, 41931

  • Kyungpook National University Medical Center

    Daegu, 41404

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, 58128

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Asan Medical Center

    Seoul, 05505

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

    Seoul, 06591

  • Korea University Anam Hospital

    Seoul, 2841

  • Seoul National University Hospital

    Seoul, 3080

  • Yonsei University Health System

    Seoul, 3722

Other trials in South Korea

Romania11 sites

  • S.C Oncopremium Team S.R.L

    Baia Mare, 430291

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Clinic Coltea

    Bucharest, 030171

  • Hifu Terramed Conformal SRL

    Bucharest, 031864

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

    Cluj-Napoca, Cluj, 400015

  • S.C Radiotherapy Center Cluj S.R.L

    Comuna Floresti, Cluj, 407280

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

    Craiova, Dolj, 200347

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Spital Lotus SRL

    Ploieşti, Prahova, 100011

  • S.C Oncocenter Oncologie Clinica S.R.L

    Timișoara, Timiș County, 300210

  • S.C Oncomed S.R.L

    Timișoara, Timiș County, 300239

Other trials in Romania

Spain11 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8025

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • ICO l´Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Madrid Sanchinarro

    Madrid, 28050

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Turkey (Türkiye)11 sites

  • Acibadem Adana Hospital

    Adana, 01130

  • Adana Numune Training and Research Hospital

    Adana, 1240

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Akdeniz University Medical Faculty

    Antalya, 7058

  • Dicle University, Medical faculty

    Diyarbakır, 21080

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Marmara University Pendik Research and Training Hospital

    Istanbul, 34340

  • Kocaeli University Medical Faculty

    Kocaeli, 41380

  • Konya Necmettin Erbakan University Meram Medical Faculty

    Konya, 42100

  • Inonu Uni. Med. Fac.

    Malatya, 44280

  • Mersin University Medical Faculty

    Mersin, 33169

Other trials in Turkey (Türkiye)

Russia10 sites

  • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

    Arkhangelsk, 163045

  • LLC Evimed

    Chelyabinsk, 454048

  • RBIH "Ivanovo Regional Oncological Dispensary"

    Ivanovo, 153040

  • SBIH " Clinical Oncological Dispensary # 1"

    Krasnodar, 350040

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

    Moscow, 115478

  • BHI of Omsk region "Clinical Oncology Dispensary"

    Omsk, 644013

  • SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"

    Pyatigorsk, 357502

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, Leningrado, 197022

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

    Saint Petersburg, Leningrado, 197758

  • SPb SBIH "City Clinical Oncological Dispensary"

    Saint Petersburg, 197022

Other trials in Russia

United Kingdom9 sites

  • Ninewells Hospital

    Dundee, Tayside Region, DD1 9SY

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX

  • St James's University Hospital

    Leeds, West Yorkshire, LS9 7TF

  • Barts Hospital

    London, Greater London, EC1A 7BE

  • University College London Hospitals

    London, Greater London, WC1E 6AG

  • The Christie

    Manchester, Greater Manchester, M20 4BX

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, Merseyside, CH63 4JY

  • Mount Vernon Hospital

    Northwood, Middlesex, HA6 2RN

  • Derriford Hospital

    Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Germany8 sites

  • Klinikum Esslingen GmbH

    Esslingen A. N., Baden-Wurttemberg, 73730

  • Krankenhaus Nordwest GmbH

    Frankfurt am Main, Hesse, 60488

  • Onkologische Schwerpunktpraxis Eppendorf

    Hamburg, 20249

  • Marienkrankenhaus Hamburg

    Hamburg, 22087

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, Baden-Wurttemberg, 74078

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Klinikum Bogenhausen

    Munich, Bavaria, 81925

  • Leopoldina Krankenhaus Schweinfurt

    Schweinfurt, Bavaria, 97422

Other trials in Germany

Hungary8 sites

  • Magyar Honvedseg Egeszsegugyi

    Budapest, 1062

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hajdú-Bihar, 4032

  • Petz Aladar Megyei Oktato Korhaz

    Győr, Győr-Moson-Sopron, 9024

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • Pecsi Tudomanyegyetem

    Pécs, Baranya, 7624

  • Tolna Megyei Balassa Janos Korhaz

    Szekszárd, 7100

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 5000

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Taiwan8 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10048

  • Mackay Memorial Hospital

    Taipei, 104

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 33305

Other trials in Taiwan

Canada6 sites

  • The Royal Victoria Hospital

    Barrie, Ontario, L4M 6M2

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Cité de la Santé de Laval

    Laval, Quebec, H7M 3L9

  • McGill University - Dept. Oncology Clinical Research Program

    Montreal, Quebec, H2W 1S6

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

Other trials in Canada

Thailand3 sites

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Muang, Chiang Mai, 50200

  • King Chulalongkorn Memorial Hospital

    Patumwan, Bangkok, 10330

Other trials in Thailand

About this study

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

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

Keywords
Avelumab, Cancer, Unresectable, Locally advanced, Metastatic, Adenocarcinoma of the stomach, Gastro-esophageal junction
Medical subject headings
Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvelumabDrug

    Also called MSB0010718C, Anti PD-L1

    Maintenance Phase: Intravenous (IV) infusion (10 mg/kg over 1 hour) once every 2 weeks.

  • OxaliplatinDrug

    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-FluorouracilDrug

    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.

  • LeucovorinDrug

    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.

  • CapecitabineDrug

    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 careOther

    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.

  • OxaliplatinDrug

    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-FluorouracilDrug

    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.

  • LeucovorinDrug

    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.

  • CapecitabineDrug

    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.

Study groups in NCT02625610
Study groupRoleWhat they receive
Chemotherapy + Best Supportive Care (BSC)ExperimentalIn 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.
Receives: Drug: Oxaliplatin; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Capecitabine; Other: Best supportive care
AvelumabExperimentalIn 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.
Receives: Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall Survival was defined as the time from randomization to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates.

    Measured: From randomization into maintenance phase up to 1276 days

Secondary outcomes (12)

  1. Progression Free Survival (PFS) by Independent Review Committee (IRC)

    The PFS time was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurs first). PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as per IRC. PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

    Measured: From randomization into maintenance phase up to 1276 days

  2. Best Overall Response (BOR) by Investigator Assessment

    BOR was determined by RECIST v1.1 per Investigator assessment and defined as best-confirmed response of any of following: complete response (CR), partial response (PR), stable disease (SD) and PD recorded from date of randomization until disease progression or recurrence. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in SLD of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions. PR or CR confirmed at a subsequent tumor assessment, not sooner than 5 weeks after initial documentation or at an assessment later than the next assessment after the initial documentation of PR or CR. SD confirmed at least 6 weeks after randomization. Confirmed PD equal to progression <=2 weeks after date of randomization.

    Measured: From randomization into maintenance phase up to 1276 days

  3. Objective Response Rate (ORR) by Investigator Assessment

    The ORR defined as the percentage of all randomized participants with a confirmed best overall response (BOR) of partial response (PR),or complete response (CR) according to RECIST v1.1 and as per Investigator assessment. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.

    Measured: From randomization into maintenance phase up to 1276 days

  4. 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)

    EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall composite health state index score, with scores ranging from -0.594 to 1. A higher score indicates better health state.

    Measured: 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)

  5. 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)

    EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.

    Measured: 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)

  6. 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)

    European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

    Measured: 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)

  7. 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)

    European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.

    Measured: 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)

  8. 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)

    Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported.

    Measured: From randomization into maintenance phase up to 1276 days

  9. Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values

    Blood samples were collected for the analysis of following hematology parameters: lymphocyte count, neutrophil count, white blood cells, platelet count, lipase, serum amylase, creatinine phosphokinase and creatinine. The hematology parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case (Grade 4) post Baseline is presented. Only those participants with increase to grade 4 have been presented.

    Measured: From baseline up to 1276 days

  10. Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs

    Vital signs assessment included Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Pulse Rate (PR). Number of Participants with any potentially clinically significant abnormalities in vital signs were reported. Clinical significance was determined by the investigator.

    Measured: From randomization into maintenance phase up to 1276 days

  11. Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities

    ECG parameters included heart rate, pulse rate intervals, QRS interval, QT interval corrected based on Fridericia's formula (QTcF) intervals and QTcB intervals. Clinical significance was determined by the investigator. Number of participants with potentially clinically significant ECG abnormalities were reported.

    Measured: From randomization into maintenance phase up to 1276 days

  12. Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1

    ECOG PS score is widely used by doctors and researchers to assess how a participants' disease is progressing, and is used to assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 5, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair, Grade 5 = Death. Number of participants with shift in ECOG PS Score to 1 or Higher Than 1 were reported.

    Measured: From randomization into maintenance phase up to 1276 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2015 (estimated)
  2. Study start24 Dec 2015
  3. Primary completion13 Sep 2019
  4. Study completion3 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02625610
Sponsor's protocol ID
EMR 100070-007
Other IDs
2015-003300-23, 2015
Status last verified
May 2022
First submitted
4 Dec 2015
Last updated
9 Jun 2022
Data monitoring committee
Yes

Publications

  • Mukherjee A, Sverdlov O, Deng Y. Estimands for Randomized Discontinuation Designs in Oncology. Pharm Stat. 2026 Nov-Dec;25(6):e70141. doi: 10.1002/pst.70141.

    PubMed 42968527

  • 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.

    PubMed 35623069

  • 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.

    PubMed 33197226

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Avelumab, Oxaliplatin and 5-Fluorouracil in people with Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction, run by EMD Serono Research & Development Institute, Inc. at 200 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 200 sites in United States, Japan, Australia, France, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization into maintenance phase up to 1276 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02625610, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.

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