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
Status: Completed
Location: See all (74) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
⁃ Other protocol defined inclusion criteria could apply
Locations
United States
Colorado
Rocky Mountain Cancer Centers 1800 Williams Street, Suite 100
Denver
Rocky Mountain Cancer Centers, LLP 3676 Parker Blvd #350
Pueblo
Florida
Advanced Medical Specialties 8940 North Kendall Drive, Suite 300E
Miami
Ocala Oncology Center, P.L. 433 S.W. 10th Street
Ocala
Florida Cancer Specialists 560 Jackson Street, Suite 220
Saint Petersburg
Illinois
Ingalls Memorial Hospital One Ingalls Drive, W741
Harvey
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
Carle Cancer Center 509 W. University Avenue
Urbana
Kansas
Cotton-O'Neil Clinical Research Center, Hematology and Oncology and Stormont Vail Cancer Center 1414 SW 8th St
Topeka
Louisiana
Metairie Oncologist, LLC Office of Jayne Gurtler MD, Laura Brinz MD, Janet Burroff MD 3939 Houma Blvd, Suite 6
Metairie
Michigan
Henry Ford Health System 2799 West Grand Boulevard
Detroit
Minnesota
Minnesota Oncology Hematology, P.A. 910 East 26th Street, Suites 100 and 200
Minneapolis
North Dakota
Sanford Roger Maris Cancer Center - Fargo 801 Broadway North Route 1058
Fargo
Nevada
Southern Nevada Cancer Research Foundation 601 S Rancho Drive
Las Vegas
New York
New York Oncology Hematology, P.C. 400 Patroon Creek Blvd, Suite 1
Albany
Oregon
Northwest Cancer Specialists, P.C. 265 N Broadway
Portland
Pennsylvania
Penn State University Milton S. Hershey Medical Center 500 University Drive
Hershey
South Carolina
Hematology and Oncology Associates of SC, LLC 900 West Faris Rd, 3rd Floor
Greenville
Tennessee
Tennessee Oncology 250 20th Ave North
Nashville
Texas
Texas Oncology Bedford 1609 Hospital Parkway
Bedford
Texas Oncology, P.A. 3410 Worth Street, Suites 300 & 400
Dallas
Texas Oncology, P.A. - Denton 3720 South I-35 East
Denton
Oncology Consultants, P.A. 2130 W. Holcombe Blvd. 10th Floor
Houston
Texas Oncology, P.A. - McAllen 1901 South 2nd Street
Mcallen
Scott and White Memorial Hospital and Clinic 2401 South 31st Street
Temple
Texas Oncology, P.A. - Tyler 910 E. Houston St, Suite 100
Tyler
Texas Oncology - Waco 1700 W. Hwy. 6
Waco
Other Locations
Australia
Flinders Medical Centre
Bedford Park
Box Hill Hospital
Box Hill
Royal Hobart Hospital
Hobart
Sunshine Hospital
St. Albans
Fiona Stanley Hospital
Subiaco
Border Medical Oncology
Wodonga
The Queen Elizabeth Hospital
Woodville South
Princess Alexandra Hospital
Woolloongabba
Belgium
OLV Ziekenhuis
Aalst
AZ Sint Lucas
Brugge
Cliniques Universitaires Saint-Luc
Bruxelles
ULB Hopital Erasme
Bruxelles
UZ Antwerpen
Edegem
CHC Clinique StJospeh
Liege
CHU Sart Tilman
Liège
AZ Turnhout - Campus Sint-Elisabeth
Turnhout
France
Service d'Oncologie Médicale
Brest Cedex
Service d'Hépato-Gastro-Entérologie
La Roche S/ Yon Cedex 9
Centre Oscar Lambret
Lille
Germany
Charite Universitaetsmedizin
Berlin
Schwerpunktpraxis für Haematologie und OnkologieOnkologische Schwerpunktpraxis Eppendorf
Hamburg
Universitaetsklinikum Koeln
Koeln
Schwerpunktpraxis für Haematologie und Onkologie
Magdeburg
Leopoldina Krankenhaus
Schweinfurt
Italy
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo
Ospedale San Raffaele
Milano
A.O.U. Ospedali Riuniti Ancona- Clinica Oncologica
Torrette Di Ancona
Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warszawa
Republic of Korea
Kyungpook National University Medical Center
Daegu
National Cancer Center
Goyang-si
Chonnam National University Hwasun Hospital
Hwasun-gun
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National Univ Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Spain
Hospital del Mar
Barcelona
Hospital Univ Vall dHebron
Barcelona
Hospital Clinic de Barcelona
Barselona
Clinico San Carlos Hospital
Madrid
Hosp Univer Madrid Sanchinarro
Madrid
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario la Paz - site 546
Madrid
Time Frame
Start Date: 2015-12-28
Completion Date: 2019-11-13
Participants
Target number of participants: 371
Treatments
Experimental: Physician choice chemotherapy+Best Supportive Care (BSC)
Participants 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.
Active_comparator: Avelumab+BSC
Participants 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.
Authors
Jos Janssens, Antonio Ucar, Sharad Jain, Spencer Shao, Richard Siegel, Suresh Ratnam, Dr. John Ellerton, Thomas Anderson, Jennifer Cultrera, Johanna Bendell, Donald Richards, Ki Chung, Amit Panwalkar, Jayne Gurtler, Yvonne Coyle, Linda DeMarco, Dr. Nelson Yee, David Einspahr, Allen Cohn, Dr. Lucas Wong, Mark Kozloff, Peter Thuss-Patience, Christopher Steer, Stephan Kanzler, Antoine Adenis, Julio A. Peguero, Ira Wollner, Chris Karapetis, Martin Smakal, Lara Lipton, Rosemary Young, Javier Sastre, Jong Gwang Kim, Luca Gianni, Yung-Jue Bang, Marc Van den Eynde, Hyun Cheol Chung, Antonio Cubillo, Rachel Wong, Euan Walpole, Marc Peeters, Yeul Hong Kim, Timothy Price, Gauthier Demolin, Min-Hee Ryu, Daniel Van Daele, Jean-Luc Van Laethem, Keun-wook Lee, Lucjan Wyrwicz, Joris Arts, Se Hoon Park
Related Therapeutic Areas
Sponsors
Collaborators: Merck KGaA, Darmstadt, Germany
Leads: EMD Serono Research & Development Institute, Inc.