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

Primary Purpose

Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Avelumab
Oxaliplatin
5-Fluorouracil
Leucovorin
Capecitabine
Best supportive care
Oxaliplatin
5-Fluorouracil
Leucovorin
Capecitabine
Sponsored by
EMD Serono Research & Development Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction focused on measuring Avelumab, Cancer, Unresectable, Locally advanced, Metastatic, Adenocarcinoma of the stomach, Gastro-esophageal junction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Blood & Cancer Center
  • Virginia Crosson Cancer Center
  • UCLA Medical Center
  • Desert Hematology Oncology Medical Group, Inc.
  • Sansum Clinic
  • Trio - Central Coast Medical Oncology Corporation
  • Norwalk Hospital
  • UF Health Cancer Center Orlando
  • Memorial West Cancer Institute
  • University of South Florida - Parent
  • Oncology Specialists, S.C.
  • Franciscan St. Francis Health Cancer Center
  • Cedar Rapids Oncology Project
  • Cotton-O'Neil Clinical Research Center, Hematology and Oncology
  • University of Kansas Medical Center Research Institute, Inc.
  • Virginia Piper Cancer Institute
  • Nevada Cancer Research Foundation
  • Mount Sinai - PRIME
  • Clinical Research Alliance, Inc
  • University of Rochester
  • UC Health Clinical Trials Office
  • TriHealth Hatton Institute
  • Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
  • Oregon Health & Science University
  • St. Luke's Hospital
  • Thomas Jefferson University Hospital
  • Rhode Island Hospital
  • Greenville Hospital System University Medical Center (ITOR)
  • University of Texas Southwestern Medical Center
  • Oncology Consultants, P.A.
  • University of Texas Health Science Center at San Antonio
  • Baylor Scott & White Health
  • University of Washington - Seattle Cancer Care Alliance
  • Northwest Medical Specialties, PLLC
  • Wenatchee Valley Hospital & Clinics
  • St George Hospital
  • Royal North Shore Hospital
  • Greenslopes Private Hospital
  • Royal Brisbane and Women's Hospital
  • Flinders Medical Centre
  • Lyell McEwin Hospital
  • Royal Hobart Hospital
  • Ballarat Base Hospital
  • Bendigo Hospital
  • Monash Medical Centre Clayton
  • Box Hill Hospital
  • Royal Melbourne Hospital
  • Border Medical Oncology
  • Fiona Stanley Hospital
  • NOB - Núcleo de Oncologia da Bahia
  • Hospital São Lucas da PUCRS
  • Hospital Bruno Born
  • Oncosinos - Clínica de Oncologia - Hospital Regina
  • Hospital de Clínicas de Porto Alegre
  • Hospital São Lucas da PUCRS
  • Hospital de Câncer de Barretos-Fundação Pio XII
  • IMV - Instituto De Medicina Vascular Hospital Mae de Deus
  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
  • Hospital Infanta Cristina
  • Queen Elizabeth II Health Sciences Centre
  • The Royal Victoria Hospital
  • Humber River Hospital
  • Mount Sinai Hospital
  • Cité de la Santé de Laval
  • McGill University - Dept. Oncology Clinical Research Program
  • Centre Antoine Lacassagne
  • Hôpital de la Timone
  • Hôpital Morvan
  • Centre Georges François Leclerc
  • CHU Besancon - Hopital Jean Minjoz
  • CHU Bordeaux
  • CHU de Toulouse - Hôpital Rangueil
  • CRLCC Eugene Marquis
  • CHU Tours - Hôpital Trousseau
  • ICO - Site René Gauducheau
  • Hôpital Cochin
  • Hôpital Européen Georges Pompidou
  • CHU Clermont Ferrand
  • Clinique Victor Hugo - Centre Jean Bernard
  • Klinikum Esslingen GmbH
  • SLK-Kliniken Heilbronn GmbH
  • Klinikum Bogenhausen
  • Leopoldina Krankenhaus Schweinfurt
  • Krankenhaus Nordwest GmbH
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Onkologische Schwerpunktpraxis Eppendorf
  • Marienkrankenhaus Hamburg
  • Pecsi Tudomanyegyetem
  • Petz Aladar Megyei Oktato Korhaz
  • Debreceni Egyetem Klinikai Kozpont
  • Magyar Honvedseg Egeszsegugyi
  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • Tolna Megyei Balassa Janos Korhaz
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
  • Zala Megyei Szent Rafael Korhaz
  • Presidio Ospedaliero Garibaldi Nesima
  • Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)
  • Azienda Ospedaliera Universitaria Careggi
  • Ospedale San Raffaele
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • IEO Istituto Europeo di Oncologia
  • Istituto Nazionale Tumori Fondazione G. Pascale
  • Seconda Università degli Studi di Napoli
  • IOV - Istituto Oncologico Veneto IRCCS
  • Ospedale degli Infermi
  • Università Campus Bio-Medico di Roma
  • Azienda Ospedaliera S. Maria Di Terni
  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
  • Chiba Cancer Center
  • Kagawa University Hospital
  • Kanagawa Cancer Center
  • Kumamoto University Hospital
  • Tohoku University Hospital
  • Niigata Cancer Center Hospital
  • Oita University Hospital
  • Kindai University Hospital
  • Izumi Municipal Hospital
  • Saitama Medical University International Medical Center
  • Saitama Cancer Center
  • Tochigi Cancer Center
  • Nat Cancer Ctr Hosp
  • Toranomon Hospital
  • Kagoshima University Medical And Dental Hospital
  • Chungbuk National University Hospital
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Chonnam National University Hwasun Hospital
  • Keimyung University Dongsan Hospital
  • Inje University Haeundae Paik Hospital
  • Kyungpook National University Medical Center
  • Asan Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Yonsei University Health System
  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
  • S.C Radiotherapy Center Cluj S.R.L
  • S.C Centrul de Oncologie Sf. Nectarie S.R.L
  • Spital Lotus SRL
  • S.C Oncocenter Oncologie Clinica S.R.L
  • S.C Oncomed S.R.L
  • S.C Oncopremium Team S.R.L
  • Institutul Clinic Fundeni
  • Spitalul Clinic Coltea
  • Hifu Terramed Conformal SRL
  • Institutul Regional de Oncologie Iasi
  • Pavlov First Saint Petersburg State Medical University
  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
  • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
  • LLC Evimed
  • RBIH "Ivanovo Regional Oncological Dispensary"
  • SBIH " Clinical Oncological Dispensary # 1"
  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  • BHI of Omsk region "Clinical Oncology Dispensary"
  • SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"
  • SPb SBIH "City Clinical Oncological Dispensary"
  • Hospital General Universitario de Elche
  • ICO l´Hospitalet - Hospital Duran i Reynals
  • Corporacio Sanitaria Parc Tauli
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic i Provincial de Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario HM Madrid Sanchinarro
  • Hospital Universitario Virgen del Rocio
  • Kaohsiung Chang Gung Memorial Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Mackay Memorial Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital, Linkou
  • King Chulalongkorn Memorial Hospital
  • Maharaj Nakorn Chiang Mai Hospital
  • Siriraj Hospital
  • Acibadem Adana Hospital
  • Adana Numune Training and Research Hospital
  • Hacettepe University Medical Faculty
  • Akdeniz University Medical Faculty
  • Dicle University, Medical faculty
  • Istanbul University Cerrahpasa Medical Faculty
  • Marmara University Pendik Research and Training Hospital
  • Kocaeli University Medical Faculty
  • Konya Necmettin Erbakan University Meram Medical Faculty
  • Inonu Uni. Med. Fac.
  • Mersin University Medical Faculty
  • Derriford Hospital
  • Barts Hospital
  • University College London Hospitals
  • The Christie
  • The Clatterbridge Cancer Centre
  • Mount Vernon Hospital
  • Royal Surrey County Hospital
  • Ninewells Hospital
  • St James's University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Chemotherapy + Best Supportive Care (BSC)

Avelumab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 4, 2015
Last Updated
May 11, 2022
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02625610
Brief Title
Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)
Official Title
A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 24, 2015 (Actual)
Primary Completion Date
September 13, 2019 (Actual)
Study Completion Date
June 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction
Keywords
Avelumab, Cancer, Unresectable, Locally advanced, Metastatic, Adenocarcinoma of the stomach, Gastro-esophageal junction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
499 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy + Best Supportive Care (BSC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Avelumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Avelumab
Other Intervention Name(s)
MSB0010718C, Anti PD-L1
Intervention Description
Maintenance Phase: Intravenous (IV) infusion (10 mg/kg over 1 hour) once every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Best supportive care
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
From randomization into maintenance phase up to 1276 days
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) by Independent Review Committee (IRC)
Description
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.
Time Frame
From randomization into maintenance phase up to 1276 days
Title
Best Overall Response (BOR) by Investigator Assessment
Description
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.
Time Frame
From randomization into maintenance phase up to 1276 days
Title
Objective Response Rate (ORR) by Investigator Assessment
Description
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.
Time Frame
From randomization into maintenance phase up to 1276 days
Title
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)
Description
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.
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)
Title
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)
Description
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.
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)
Title
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)
Description
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.
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)
Title
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)
Description
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.
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)
Title
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)
Description
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.
Time Frame
From randomization into maintenance phase up to 1276 days
Title
Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values
Description
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.
Time Frame
From baseline up to 1276 days
Title
Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
Description
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.
Time Frame
From randomization into maintenance phase up to 1276 days
Title
Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Description
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.
Time Frame
From randomization into maintenance phase up to 1276 days
Title
Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1
Description
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.
Time Frame
From randomization into maintenance phase up to 1276 days

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35623069
Citation
Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
Results Reference
derived
PubMed Identifier
33197226
Citation
Moehler M, Dvorkin M, Boku N, Ozguroglu M, Ryu MH, Muntean AS, Lonardi S, Nechaeva M, Bragagnoli AC, Coskun HS, Cubillo Gracian A, Takano T, Wong R, Safran H, Vaccaro GM, Wainberg ZA, Silver MR, Xiong H, Hong J, Taieb J, Bang YJ. Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100. J Clin Oncol. 2021 Mar 20;39(9):966-977. doi: 10.1200/JCO.20.00892. Epub 2020 Nov 16.
Results Reference
derived
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=EMR%20100070-007
Description
Trial Awareness and Transparency website
URL
https://medical.emdserono.com/en_US/home.html
Description
US Medical Information website, Medical Resources

Learn more about this trial

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

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