Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)
A Phase III Open-label, Multicenter Trial of Avelumab (MSB0010718C) as a Third-line Treatment of Unresectable, Recurrent, or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
2 other identifiers
interventional
371
10 countries
75
Brief Summary
The purpose of this study was to demonstrate superiority of treatment with avelumab plus best supportive care (BSC) versus physician's choice (chosen from a pre-specified list of therapeutic options) plus BSC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2015
Typical duration for phase_3
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2015
CompletedFirst Posted
Study publicly available on registry
December 9, 2015
CompletedStudy Start
First participant enrolled
December 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2017
CompletedResults Posted
Study results publicly available
October 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2019
CompletedNovember 24, 2020
October 1, 2020
1.7 years
December 4, 2015
September 10, 2018
November 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS 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 up to 627 days
Secondary Outcomes (7)
Progression Free Survival (PFS)
From randomization up to 627 days
Best Overall Response (BOR)
From randomization up to 627 days
Objective Response Rate (ORR)
From randomization up to 627 days
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)
Baseline, EOT (up to Week 66)
Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)
Baseline, EOT (up to Week 66)
- +2 more secondary outcomes
Study Arms (2)
Physician choice chemotherapy+Best Supportive Care (BSC)
EXPERIMENTALParticipants received BSC plus physician's choice chemotherapy. Chemotherapy comprises of one of the following: paclitaxel at a dose of 80 milligram per meter square (mg/m\^2) on Days 1, 8, and 15 of a 4-week treatment cycle until confirmed progressive disease or unacceptable toxicity OR irinotecan at a dose of 150 mg/m\^2 on Days 1 and 15 of a 4-week treatment cycle until confirmed progressive disease or unacceptable toxicity. Participants who are not deemed eligible to receive paclitaxel or irinotecan at the dose and schedule specified above receive BSC alone once every 3 weeks. BSC is defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and is based on investigator's discretion.
Avelumab+BSC
ACTIVE COMPARATORParticipants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2-week treatment cycle until confirmed progressive disease or unacceptable toxicity along with BSC. BSC is defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and is based on investigator's discretion.
Interventions
Avelumab was administered as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2-week treatment cycle until confirmed progressive disease or unacceptable toxicity along with best supportive care (BSC).
Irinotecan was administered at a dose of 150 mg/m \^2 on Day 1 and 15 of a 4-week treatment cycle until disease progression or unacceptable toxicities along with BSC.
Paclitaxel was administered at a dose of 80 mg/m\^2 on Day 1, 8, and 15 of a 4-week treatment cycle until disease progression or unacceptable toxicities along with BSC.
BSC is defined as treatment administered with the intent to maximize Quality of life without a specific antineoplastic regimen and is based on investigator's discretion. BSC was administered once every 3 weeks.
Eligibility Criteria
You may qualify if:
- Male or female subjects aged greater than or equal to (\>=) 18 years
- Subjects with histologically confirmed recurrent unresectable, recurrent locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ)
- Availability of a formalin-fixed, paraffin-embedded (FFPE) block containing tumor tissue
- Subjects must have received 2 prior courses of systemic treatment for unresectable, recurrent, locally advanced or metastatic gastric cancer, and must have progressed after the second line
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at trial entry
- Adequate hematological, 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 subjects if the risk of conception exists
You may not qualify if:
- Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
- Concurrent anticancer treatment
- Major surgery
- Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to less than \[\<\] 10 mg prednisone daily).
- All subjects with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, 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 of grade \>2 related to prior therapy except neuropathy and alopecia
- Neuropathy Grade greater than or equal (\>=) 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
Rocky Mountain Cancer Centers 1800 Williams Street, Suite 100
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers, LLP 3676 Parker Blvd #350
Pueblo, Colorado, 81008, United States
Advanced Medical Specialties 8940 North Kendall Drive, Suite 300E
Miami, Florida, 33176, United States
Ocala Oncology Center, P.L. 433 S.W. 10th Street
Ocala, Florida, 34471, United States
Florida Cancer Specialists 560 Jackson Street, Suite 220
St. Petersburg, Florida, 33705, United States
Ingalls Memorial Hospital One Ingalls Drive, W741
Harvey, Illinois, 60426, United States
Illinois Cancer Specialists 8915 W. Golf Rd.
Niles, Illinois, 60714, United States
Oncology Specialists, S.C. 1700 Luther Ln, Ste 2200, Park Ridge, IL 60068 7900 Milwaukee Ave, Ste 16
Niles, Illinois, 60714, United States
Carle Cancer Center 509 W. University Avenue
Urbana, Illinois, 61801, United States
Cotton-O'Neil Clinical Research Center, Hematology and Oncology and Stormont Vail Cancer Center 1414 SW 8th St
Topeka, Kansas, 66604, United States
Metairie Oncologist, LLC Office of Jayne Gurtler MD, Laura Brinz MD, Janet Burroff MD 3939 Houma Blvd, Suite 6
Metairie, Louisiana, 70006, United States
Henry Ford Health System 2799 West Grand Boulevard
Detroit, Michigan, 48202, United States
Minnesota Oncology Hematology, P.A. 910 East 26th Street, Suites 100 and 200
Minneapolis, Minnesota, 55404, United States
Southern Nevada Cancer Research Foundation 601 S Rancho Drive
Las Vegas, Nevada, 89106, United States
New York Oncology Hematology, P.C. 400 Patroon Creek Blvd, Suite 1
Albany, New York, 12206, United States
Sanford Roger Maris Cancer Center - Fargo 801 Broadway North Route 1058
Fargo, North Dakota, 58122, United States
Northwest Cancer Specialists, P.C. 265 N Broadway
Portland, Oregon, 97227, United States
Penn State University Milton S. Hershey Medical Center 500 University Drive
Hershey, Pennsylvania, 17033, United States
Hematology and Oncology Associates of SC, LLC 900 West Faris Rd, 3rd Floor
Greenville, South Carolina, 29605, United States
Tennessee Oncology 250 20th Ave North
Nashville, Tennessee, 37203, United States
Texas Oncology Bedford 1609 Hospital Parkway
Bedford, Texas, 76022, United States
Texas Oncology, P.A. 3410 Worth Street, Suites 300 & 400
Dallas, Texas, 75246, United States
Texas Oncology, P.A. - Denton 3720 South I-35 East
Denton, Texas, 76210, United States
Oncology Consultants, P.A. 2130 W. Holcombe Blvd. 10th Floor
Houston, Texas, 77030, United States
Texas Oncology, P.A. - McAllen 1901 South 2nd Street
McAllen, Texas, 78503-1298, United States
Scott and White Memorial Hospital and Clinic 2401 South 31st Street
Temple, Texas, 76508, United States
Texas Oncology, P.A. - Tyler 910 E. Houston St, Suite 100
Tyler, Texas, 75702, United States
Texas Oncology - Waco 1700 W. Hwy. 6
Waco, Texas, 76712, United States
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
Border Medical Oncology
Wodonga, Victoria, 3690, Australia
Fiona Stanley Hospital
Subiaco, Western Australia, 6008, Australia
OLV Ziekenhuis
Aalst, 9300, Belgium
AZ Sint Lucas
Bruges, 8310, Belgium
ULB Hopital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
CHC Clinique StJospeh
Liège, 4000, Belgium
CHU Sart Tilman
Liège, 4000, Belgium
AZ Turnhout - Campus Sint-Elisabeth
Turnhout, 2300, Belgium
Nemocnice Rudolfa a Stefanie Benesov, a. s.
Benešov, 256 01, Czechia
Service d'Oncologie Médicale
Brest, Finistere, 29609, France
Service d'Hépato-Gastro-Entérologie
La Roche S/ Yon Cedex 9, Vendee, 85925, France
Centre Oscar Lambret
Lille, 59020, France
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50937, Germany
Schwerpunktpraxis für Haematologie und Onkologie
Magdeburg, Saxony-Anhalt, 39104, Germany
Charite Universitaetsmedizin
Berlin, 13353, Germany
Schwerpunktpraxis für Haematologie und OnkologieOnkologische Schwerpunktpraxis Eppendorf
Hamburg, 20249, Germany
Leopoldina Krankenhaus
Schweinfurt, 97422, Germany
A.O.U. Ospedali Riuniti Ancona- Clinica Oncologica
Torrette Di Ancona, Ancona, 60126, Italy
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, 10060, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, 02-781, Poland
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Chonnam National University Hwasun Hospital
Hwasun-Gun, Jeollanam-do, 58128, South Korea
Kyungpook National University Medical Center
Daegu, 41404, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Seoul National Univ Hospital
Seoul, 3080, South Korea
Hospital Univ Vall dHebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital del Mar
Barcelona, 8003, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Clinico San Carlos Hospital
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario la Paz - site 546
Madrid, 28046, Spain
Hosp Univer Madrid Sanchinarro
Madrid, 28050, Spain
Related Publications (1)
Bang YJ, Ruiz EY, Van Cutsem E, Lee KW, Wyrwicz L, Schenker M, Alsina M, Ryu MH, Chung HC, Evesque L, Al-Batran SE, Park SH, Lichinitser M, Boku N, Moehler MH, Hong J, Xiong H, Hallwachs R, Conti I, Taieb J. Phase III, randomised trial of avelumab versus physician's choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300. Ann Oncol. 2018 Oct 1;29(10):2052-2060. doi: 10.1093/annonc/mdy264.
PMID: 30052729RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Communication Center
- Organization
- Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2015
First Posted
December 9, 2015
Study Start
December 28, 2015
Primary Completion
September 14, 2017
Study Completion
November 13, 2019
Last Updated
November 24, 2020
Results First Posted
October 15, 2018
Record last verified: 2020-10