Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)

PHASE3CompletedINTERVENTIONAL
Enrollment

371

Participants

Timeline

Start Date

December 28, 2015

Primary Completion Date

September 14, 2017

Study Completion Date

November 13, 2019

Conditions
Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaGastric Cancer Third Line
Interventions
DRUG

Avelumab

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).

DRUG

Irinotecan

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.

DRUG

Paclitaxel

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.

OTHER

Best Supportive Care (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.

Trial Locations (75)

1070

ULB Hopital Erasme, Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

2300

AZ Turnhout - Campus Sint-Elisabeth, Turnhout

2650

UZ Antwerpen, Edegem

3021

Sunshine Hospital, St Albans

3080

Seoul National Univ Hospital, Seoul

3128

Box Hill Hospital, Box Hill

3690

Border Medical Oncology, Wodonga

4000

CHC Clinique StJospeh, Liège

CHU Sart Tilman, Liège

4102

Princess Alexandra Hospital, Woolloongabba

5011

The Queen Elizabeth Hospital, Woodville South

5042

Flinders Medical Centre, Bedford Park

6008

Fiona Stanley Hospital, Subiaco

7000

Royal Hobart Hospital, Hobart

8003

Hospital del Mar, Barcelona

8310

AZ Sint Lucas, Bruges

9300

OLV Ziekenhuis, Aalst

10060

Fondazione del Piemonte per l'Oncologia IRCC Candiolo, Candiolo

10408

National Cancer Center, Goyang-si

12206

New York Oncology Hematology, P.C. 400 Patroon Creek Blvd, Suite 1, Albany

13353

Charite Universitaetsmedizin, Berlin

13620

Seoul National University Bundang Hospital, Seongnam-si

17033

Penn State University Milton S. Hershey Medical Center 500 University Drive, Hershey

20132

Ospedale San Raffaele, Milan

20249

Schwerpunktpraxis für Haematologie und OnkologieOnkologische Schwerpunktpraxis Eppendorf, Hamburg

28007

Hospital General Universitario Gregorio Marañon, Madrid

28040

Clinico San Carlos Hospital, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario la Paz - site 546, Madrid

28050

Hosp Univer Madrid Sanchinarro, Madrid

29605

Hematology and Oncology Associates of SC, LLC 900 West Faris Rd, 3rd Floor, Greenville

29609

Service d'Oncologie Médicale, Brest

33176

Advanced Medical Specialties 8940 North Kendall Drive, Suite 300E, Miami

33705

Florida Cancer Specialists 560 Jackson Street, Suite 220, St. Petersburg

34471

Ocala Oncology Center, P.L. 433 S.W. 10th Street, Ocala

37203

Tennessee Oncology 250 20th Ave North, Nashville

39104

Schwerpunktpraxis für Haematologie und Onkologie, Magdeburg

41404

Kyungpook National University Medical Center, Daegu

48202

Henry Ford Health System 2799 West Grand Boulevard, Detroit

50937

Universitaetsklinikum Koeln, Cologne

55404

Minnesota Oncology Hematology, P.A. 910 East 26th Street, Suites 100 and 200, Minneapolis

58122

Sanford Roger Maris Cancer Center - Fargo 801 Broadway North Route 1058, Fargo

58128

Chonnam National University Hwasun Hospital, Hwasun-Gun

59020

Centre Oscar Lambret, Lille

60126

A.O.U. Ospedali Riuniti Ancona- Clinica Oncologica, Torrette Di Ancona

60426

Ingalls Memorial Hospital One Ingalls Drive, W741, Harvey

60714

Illinois Cancer Specialists 8915 W. Golf Rd., Niles

Oncology Specialists, S.C. 1700 Luther Ln, Ste 2200, Park Ridge, IL 60068 7900 Milwaukee Ave, Ste 16, Niles

61801

Carle Cancer Center 509 W. University Avenue, Urbana

66604

Cotton-O'Neil Clinical Research Center, Hematology and Oncology and Stormont Vail Cancer Center 1414 SW 8th St, Topeka

70006

Metairie Oncologist, LLC Office of Jayne Gurtler MD, Laura Brinz MD, Janet Burroff MD 3939 Houma Blvd, Suite 6, Metairie

75246

Texas Oncology, P.A. 3410 Worth Street, Suites 300 & 400, Dallas

75702

Texas Oncology, P.A. - Tyler 910 E. Houston St, Suite 100, Tyler

76022

Texas Oncology Bedford 1609 Hospital Parkway, Bedford

76210

Texas Oncology, P.A. - Denton 3720 South I-35 East, Denton

76508

Scott and White Memorial Hospital and Clinic 2401 South 31st Street, Temple

76712

Texas Oncology - Waco 1700 W. Hwy. 6, Waco

77030

Oncology Consultants, P.A. 2130 W. Holcombe Blvd. 10th Floor, Houston

80218

Rocky Mountain Cancer Centers 1800 Williams Street, Suite 100, Denver

81008

Rocky Mountain Cancer Centers, LLP 3676 Parker Blvd #350, Pueblo

85925

Service d'Hépato-Gastro-Entérologie, La Roche S/ Yon Cedex 9

89106

Southern Nevada Cancer Research Foundation 601 S Rancho Drive, Las Vegas

97227

Northwest Cancer Specialists, P.C. 265 N Broadway, Portland

97422

Leopoldina Krankenhaus, Schweinfurt

78503-1298

Texas Oncology, P.A. - McAllen 1901 South 2nd Street, McAllen

256 01

Nemocnice Rudolfa a Stefanie Benesov, a. s., Benešov

02-781

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie, Warsaw

02841

Korea University Anam Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

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

08035

Hospital Univ Vall dHebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT02625623 - Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300) | Biotech Hunter | Biotech Hunter