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

May 11, 2022 updated by: EMD Serono Research & Development Institute, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

499

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Greenslopes Private Hospital
      • Herston, Queensland, Australia, 4006
        • Royal Brisbane and Women's Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
      • Elizabeth Vale, South Australia, Australia, 5112
        • Lyell McEwin Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Ballarat Base Hospital
      • Bendigo, Victoria, Australia, 3550
        • Bendigo Hospital
      • Bentleigh, Victoria, Australia, 8120
        • Monash Medical Centre Clayton
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Wodonga, Victoria, Australia, 3690
        • Border Medical Oncology
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Brazil
      • Badajoz, Brazil, 06080
        • Hospital Infanta Cristina
    • Bahia
      • Salvador, Bahia, Brazil, 40170-110
        • Nob - Nucleo de Oncologia Da Bahia
    • Rio Grande Do Sul
      • Ijuí, Rio Grande Do Sul, Brazil, 98700-000
        • Hospital Sao Lucas da PUCRS
      • Lajeado, Rio Grande Do Sul, Brazil, 95900-000
        • Hospital Bruno Born
      • Novo Hamburgo, Rio Grande Do Sul, Brazil, 93510-250
        • Oncosinos - Clínica de Oncologia - Hospital Regina
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Hospital Sao Lucas da PUCRS
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Hospital de Câncer de Barretos-Fundação Pio XII
      • Porto Alegre, Sao Paulo, Brazil, 90110-270
        • IMV - Instituto De Medicina Vascular Hospital Mae de Deus
      • Santo Andre, Sao Paulo, Brazil, 09060-650
        • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
      • São José do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
      • São Paulo, Sao Paulo, Brazil, 01246-000
        • ICESP - Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • The Royal Victoria Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M3M 0B2
        • Humber River Hospital
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Cité de la santé de Laval
      • Montréal, Quebec, Canada, H2W 1S6
        • McGill University - Dept. Oncology Clinical Research Program
  • France
    • Alpes Maritimes
      • Nice cedex 02, Alpes Maritimes, France, 06189
        • Centre Antoine Lacassagne
    • Bouches Du Rhone
      • Marseille cedex 5, Bouches Du Rhone, France, 13385
        • Hopital de la Timone
    • Brittany
      • Brest, Brittany, France, 29200
        • Hopital Morvan
    • Côte-d'Or
      • Dijon cedex, Côte-d'Or, France, 21079
        • Centre Georges François Leclerc
    • Doubs
      • Besancon, Doubs, France, 25030
        • CHU Besançon - Hôpital Jean Minjoz
    • Gironde
      • Bordeaux Cedex, Gironde, France, 33076
        • CHU Bordeaux
    • Haute Garonne
      • Toulouse Cedex 9, Haute Garonne, France, 31059
        • CHU de Toulouse - Hôpital Rangueil
    • Ille Et Vilaine
      • Rennes cedex, Ille Et Vilaine, France, 35042
        • CRLCC Eugene Marquis
    • Indre Et Loire
      • Chambray les Tours, Indre Et Loire, France, 37170
        • CHU Tours - Hôpital Trousseau
    • Maine Et Loire
      • Angers Cedex 9, Maine Et Loire, France, 49933
        • ICO - Site René Gauducheau
    • Paris
      • Paris Cedex 15, Paris, France, 75015
        • Hopital Europeen Georges Pompidou
      • Paris cedex 14, Paris, France, 75679
        • Hopital Cochin
    • Puy De Dome
      • Clermont Ferrand cedex 1, Puy De Dome, France, 63003
        • CHU Clermont Ferrand
    • Sarthe
      • Le Mans Cedex 02, Sarthe, France, 72015
        • Clinique Victor Hugo - Centre Jean Bernard
  • Germany
      • Hamburg, Germany, 20249
        • Onkologische Schwerpunktpraxis Eppendorf
      • Hamburg, Germany, 22087
        • Marienkrankenhaus Hamburg
    • Baden Wuerttemberg
      • Esslingen A. N., Baden Wuerttemberg, Germany, 73730
        • Klinikum Esslingen GmbH
      • Heilbronn, Baden Wuerttemberg, Germany, 74078
        • SLK-Kliniken Heilbronn GmbH
    • Bayern
      • Muenchen, Bayern, Germany, 81925
        • Klinikum Bogenhausen
      • Schweinfurt, Bayern, Germany, 97422
        • Leopoldina Krankenhaus Schweinfurt
    • Hessen
      • Frankfurt, Hessen, Germany, 60488
        • Krankenhaus Nordwest Gmbh
    • Rheinland Pfalz
      • Mainz, Rheinland Pfalz, Germany, 55131
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Hungary
      • Budapest, Hungary, 1062
        • Magyar Honvedseg Egeszsegugyi
      • Nyiregyhaza, Hungary, 4400
        • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
      • Szekszard, Hungary, 7100
        • Tolna Megyei Balassa Janos Korhaz
      • Szolnok, Hungary, 5000
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet
      • Zalaegerszeg, Hungary, 8900
        • Zala Megyei Szent Rafael Kórház
    • Baranya
      • Pecs, Baranya, Hungary, 7624
        • Pecsi Tudomanyegyetem
    • Győr-Moson-Sopron
      • Gyor, Győr-Moson-Sopron, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
  • Italy
      • Catania, Italy, 95100
        • Presidio Ospedaliero Garibaldi Nesima
      • Cremona, Italy, 26100
        • Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)
      • Firenze, Italy, 50141
        • Azienda Ospedaliera Universitaria Careggi
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Italy, 20141
        • Ieo Istituto Europeo Di Oncologia
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione G. Pascale
      • Napoli, Italy, 80131
        • Seconda Università degli Studi di Napoli
      • Padova, Italy, 35128
        • IOV - Istituto Oncologico Veneto IRCCS
      • Rimini, Italy, 47923
        • Ospedale Degli Infermi
      • Roma, Italy, 00128
        • Università Campus Bio-Medico di Roma
      • Terni, Italy, 5100
        • Azienda Ospedaliera S. Maria di Terni
      • Udine, Italy, 33100
        • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
  • Japan
      • Kagoshima-shi, Japan, 890-8520
        • Kagoshima University Medical and Dental Hospital
    • Chiba-Ken
      • Chiba-shi, Chiba-Ken, Japan, 260-8717
        • Chiba Cancer Center
    • Kagawa-Ken
      • Kita-gun, Kagawa-Ken, Japan, 761-0793
        • Kagawa University Hospital
    • Kanagawa-Ken
      • Yokohama-shi, Kanagawa-Ken, Japan, 241-8515
        • Kanagawa Cancer Center
    • Kumamoto-Ken
      • Kumamoto-shi, Kumamoto-Ken, Japan, 860-8556
        • Kumamoto University Hospital
    • Miyagi-Ken
      • Sendai-shi, Miyagi-Ken, Japan, 980-8574
        • Tohoku University Hospital
    • Niigata-Ken
      • Niigata-shi, Niigata-Ken, Japan, 951-8566
        • Niigata Cancer Center Hospital
    • Oita-ken
      • Yufu-shi, Oita-ken, Japan, 879-5593
        • Oita University Hospital
    • Osaka
      • Izumi-shi, Osaka, Japan, 594-0071
        • Izumi Municipal Hospital
    • Osaka-Fu
      • Osakasayama, Osaka-Fu, Japan, 589-8511
        • Kindai University Hospital
    • Saitama-Ken
      • Hidaka-shi, Saitama-Ken, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Kitaadachi-gun, Saitama-Ken, Japan, 362-0806
        • Saitama Cancer Center
    • Tochigi-Ken
      • Utsunomiya-shi, Tochigi-Ken, Japan, 320-0834
        • Tochigi Cancer Center
    • Tokyo-To
      • Chuo-ku, Tokyo-To, Japan, 104-0045
        • Nat Cancer Ctr Hosp
      • Minato-ku, Tokyo-To, Japan, 105-8470
        • Toranomon Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Medical Center
      • Seoul, Korea, Republic of, 3080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 2841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 3722
        • Yonsei University Health System
    • Chungcheongbuk-do
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
        • Chungbuk National University Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Jeollanam-do
      • Hwasun-gun, Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
    • Jung-gu
      • Daegu, Jung-gu, Korea, Republic of, 41931
        • Keimyung University Dongsan Hospital
  • Romania
      • Baia Mare, Romania, 430291
        • S.C Oncopremium Team S.R.L
      • Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni
      • Bucuresti, Romania, 030171
        • Spitalul Clinic Coltea
      • Bucuresti, Romania, 031864
        • Hifu Terramed Conformal SRL
      • Iasi, Romania, 700483
        • Institutul Regional de Oncologie Iasi
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400015
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
      • Comuna Floresti, Cluj, Romania, 407280
        • S.C Radiotherapy Center Cluj S.R.L
    • Dolj
      • Craiova, Dolj, Romania, 200347
        • S.C Centrul de Oncologie Sf. Nectarie S.R.L
    • Prahova
      • Ploiesti, Prahova, Romania, 100011
        • Spital Lotus SRL
    • Timis
      • Timisoara, Timis, Romania, 300210
        • S.C Oncocenter Oncologie Clinica S.R.L
      • Timisoara, Timis, Romania, 300239
        • S.C Oncomed S.R.L
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
      • Chelyabinsk, Russian Federation, 454048
        • LLC Evimed
      • Ivanovo, Russian Federation, 153040
        • RBIH "Ivanovo Regional Oncological Dispensary"
      • Krasnodar, Russian Federation, 350040
        • SBIH " Clinical Oncological Dispensary # 1"
      • Moscow, Russian Federation, 115478
        • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
      • Omsk, Russian Federation, 644013
        • BHI of Omsk region "Clinical oncology dispensary"
      • Pyatigorsk, Russian Federation, 357502
        • SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"
      • Saint-Petersburg, Russian Federation, 197022
        • SPb SBIH "City Clinical Oncological Dispensary"
    • Leningrado
      • Saint-Petersburg, Leningrado, Russian Federation, 197022
        • Pavlov First Saint Petersburg State Medical University
      • Saint-Petersburg, Leningrado, Russian Federation, 197758
        • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 8025
        • Hospital de La Santa Creu I Sant Pau
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28050
        • Hospital Universitario HM Madrid Sanchinarro
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • ICO l´Hospitalet - Hospital Duran i Reynals
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 33305
        • Chang Gung Memorial Hospital, Linkou
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
    • Bangkok
      • Patumwan, Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
  • Turkey
      • Adana, Turkey, 01130
        • Acibadem Adana Hospital
      • Adana, Turkey, 1240
        • Adana Numune Training and Research Hospital
      • Ankara, Turkey, 06100
        • Hacettepe University Medical Faculty
      • Antalya, Turkey, 7058
        • Akdeniz University Medical Faculty
      • Diyarbakir, Turkey, 21080
        • Dicle University, Medical Faculty
      • Istanbul, Turkey, 34098
        • Istanbul University Cerrahpasa Medical Faculty
      • Istanbul, Turkey, 34340
        • Marmara University Pendik Research and Training Hospital
      • Kocaeli, Turkey, 41380
        • Kocaeli University Medical Faculty
      • Konya, Turkey, 42100
        • Konya Necmettin Erbakan University Meram Medical Faculty
      • Malatya, Turkey, 44280
        • Inonu Uni. Med. Fac.
      • Mersin, Turkey, 33169
        • Mersin University Medical Faculty
  • United Kingdom
    • Devon
      • Torquay, Devon, United Kingdom, TQ2 7AA
        • Derriford Hospital
    • Greater London
      • London, Greater London, United Kingdom, EC1A 7BE
        • Barts Hospital
      • London, Greater London, United Kingdom, WC1E 6AG
        • University College London Hospitals
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • The Christie
    • Merseyside
      • Wirral, Merseyside, United Kingdom, CH63 4JY
        • The Clatterbridge Cancer Centre
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
    • Tayside Region
      • Dundee, Tayside Region, United Kingdom, DD1 9SY
        • Ninewells Hospital
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • St James's University Hospital
  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood & Cancer Center
      • Fullerton, California, United States, 92835
        • Virginia Crosson Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Rancho Mirage, California, United States, 92262
        • Desert Hematology Oncology Medical Group, Inc.
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic
      • Santa Maria, California, United States, 93454
        • Trio - Central Coast Medical Oncology Corporation
    • Connecticut
      • Norwalk, Connecticut, United States, 6856
        • Norwalk Hospital
    • Florida
      • Orlando, Florida, United States, 32806
        • UF Health Cancer Center Orlando
      • Pembroke Pines, Florida, United States, 33028
        • Memorial West Cancer Institute
      • Tampa, Florida, United States, 33606
        • University of South Florida - PARENT
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C.
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan St. Francis Health Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Cedar Rapids Oncology Project
    • Kansas
      • Topeka, Kansas, United States, 66604
        • Cotton-O'Neil Clinical Research Center, Hematology and Oncology
      • Westwood, Kansas, United States, 66205
        • University of Kansas Medical Center Research Institute, Inc.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Nevada Cancer Research Foundation
    • New York
      • Jamaica, New York, United States, 11432
        • Mount Sinai - PRIME
      • New York, New York, United States, 10021
        • Clinical Research Alliance, Inc
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • UC Health Clinical Trials Office
      • Cincinnati, Ohio, United States, 45220
        • TriHealth Hatton Institute
      • Columbus, Ohio, United States, 43219
        • Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System University Medical Center (ITOR)
    • Texas
      • Dallas, Texas, United States, 75390-9179
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77024
        • Oncology Consultants, P.A.
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Health
    • Washington
      • East Seattle, Washington, United States, 98109
        • University of Washington - Seattle Cancer Care Alliance
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.

Drug: 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.
Drug: 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.

Drug: 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.

Other: 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.
Drug: 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.
Drug: 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.
Drug: 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.
Drug: 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.
Experimental: 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.
Drug: Avelumab
Maintenance Phase: Intravenous (IV) infusion (10 mg/kg over 1 hour) once every 2 weeks.
Other Names:
  • MSB0010718C
  • Anti PD-L1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization into maintenance phase up to 1276 days
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.
From randomization into maintenance phase up to 1276 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) by Independent Review Committee (IRC)
Time Frame: From randomization into maintenance phase up to 1276 days
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.
From randomization into maintenance phase up to 1276 days
Best Overall Response (BOR) by Investigator Assessment
Time Frame: From randomization into maintenance phase up to 1276 days
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.
From randomization into maintenance phase up to 1276 days
Objective Response Rate (ORR) by Investigator Assessment
Time Frame: From randomization into maintenance phase up to 1276 days
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.
From randomization into maintenance phase up to 1276 days
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)
Time Frame: 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)
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.
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)
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)
Time Frame: 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)
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.
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)
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)
Time Frame: 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)
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.
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)
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)
Time Frame: 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)
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.
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)
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)
Time Frame: From randomization into maintenance phase up to 1276 days
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.
From randomization into maintenance phase up to 1276 days
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values
Time Frame: From baseline up to 1276 days
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.
From baseline up to 1276 days
Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
Time Frame: From randomization into maintenance phase up to 1276 days
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.
From randomization into maintenance phase up to 1276 days
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Time Frame: From randomization into maintenance phase up to 1276 days
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.
From randomization into maintenance phase up to 1276 days
Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1
Time Frame: From randomization into maintenance phase up to 1276 days
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.
From randomization into maintenance phase up to 1276 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Medical Responsible, EMD Serono Research & Development Institute, Inc. a business of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2015

Primary Completion (Actual)

September 13, 2019

Study Completion (Actual)

June 3, 2021

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 100070-007
  • 2015-003300-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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