Esophageal Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

499

Study ID:

NCT02625610

Recruitment Status:

Completed

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 198 Locations for this study

See Locations Near You

Comprehensive Blood & Cancer Center
Bakersfield California, 93309, United States
Virginia Crosson Cancer Center
Fullerton California, 92835, United States
UCLA Medical Center
Los Angeles California, 90095, United States
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage California, 92262, United States
Sansum Clinic
Santa Barbara California, 93105, United States
Trio - Central Coast Medical Oncology Corporation
Santa Maria California, 93454, United States
Norwalk Hospital
Norwalk Connecticut, 6856, United States
UF Health Cancer Center Orlando
Orlando Florida, 32806, United States
Memorial West Cancer Institute
Pembroke Pines Florida, 33028, United States
University of South Florida - Parent
Tampa Florida, 33606, United States
Oncology Specialists, S.C.
Park Ridge Illinois, 60068, United States
Franciscan St. Francis Health Cancer Center
Indianapolis Indiana, 46237, United States
Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
Cotton-O'Neil Clinical Research Center, Hematology and Oncology
Topeka Kansas, 66604, United States
University of Kansas Medical Center Research Institute, Inc.
Westwood Kansas, 66205, United States
Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Mount Sinai - PRIME
Jamaica New York, 11432, United States
Clinical Research Alliance, Inc
New York New York, 10021, United States
University of Rochester
Rochester New York, 14642, United States
UC Health Clinical Trials Office
Cincinnati Ohio, 45206, United States
TriHealth Hatton Institute
Cincinnati Ohio, 45220, United States
Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
Columbus Ohio, 43219, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
St. Luke's Hospital
Bethlehem Pennsylvania, 18015, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Greenville Hospital System University Medical Center (ITOR)
Greenville South Carolina, 29605, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Oncology Consultants, P.A.
Houston Texas, 77024, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Baylor Scott & White Health
Temple Texas, 76508, United States
University of Washington - Seattle Cancer Care Alliance
East Seattle Washington, 98109, United States
Northwest Medical Specialties, PLLC
Tacoma Washington, 98405, United States
Wenatchee Valley Hospital & Clinics
Wenatchee Washington, 98801, United States
St George Hospital
Kogarah New South Wales, 2217, Australia
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia
Greenslopes Private Hospital
Greenslopes Queensland, 4120, Australia
Royal Brisbane and Women's Hospital
Herston Queensland, 4006, Australia
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia
Lyell McEwin Hospital
Elizabeth Vale South Australia, 5112, Australia
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia
Ballarat Base Hospital
Ballarat Victoria, 3350, Australia
Bendigo Hospital
Bendigo Victoria, 3550, Australia
Monash Medical Centre Clayton
Bentleigh Victoria, 8120, Australia
Box Hill Hospital
Box Hill Victoria, 3128, Australia
Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
Border Medical Oncology
Wodonga Victoria, 3690, Australia
Fiona Stanley Hospital
Murdoch Western Australia, 6150, Australia
NOB - Núcleo de Oncologia da Bahia
Salvador Bahia, 40170, Brazil
Hospital São Lucas da PUCRS
Ijuí Rio Grande Do Sul, 98700, Brazil
Hospital Bruno Born
Lajeado Rio Grande Do Sul, 95900, Brazil
Oncosinos - Clínica de Oncologia - Hospital Regina
Novo Hamburgo Rio Grande Do Sul, 93510, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Hospital São Lucas da PUCRS
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Hospital de Câncer de Barretos-Fundação Pio XII
Barretos Sao Paulo, 14784, Brazil
IMV - Instituto De Medicina Vascular Hospital Mae de Deus
Porto Alegre Sao Paulo, 90110, Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo Andre Sao Paulo, 09060, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto Sao Paulo, 15090, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo Sao Paulo, 01246, Brazil
Hospital Infanta Cristina
Badajoz , 06080, Brazil
Queen Elizabeth II Health Sciences Centre
Halifax Nova Scotia, B3H 2, Canada
The Royal Victoria Hospital
Barrie Ontario, L4M 6, Canada
Humber River Hospital
Toronto Ontario, M3M 0, Canada
Mount Sinai Hospital
Toronto Ontario, M5G 1, Canada
Cité de la Santé de Laval
Laval Quebec, H7M 3, Canada
McGill University - Dept. Oncology Clinical Research Program
Montréal Quebec, H2W 1, Canada
Centre Antoine Lacassagne
Nice cedex 02 Alpes Maritimes, 06189, France
Hôpital de la Timone
Marseille cedex 5 Bouches Du Rhone, 13385, France
Hôpital Morvan
Brest Brittany, 29200, France
Centre Georges François Leclerc
Dijon cedex Côte-d'Or, 21079, France
CHU Besancon - Hopital Jean Minjoz
Besancon Doubs, 25030, France
CHU Bordeaux
Bordeaux Cedex Gironde, 33076, France
CHU de Toulouse - Hôpital Rangueil
Toulouse Cedex 9 Haute Garonne, 31059, France
CRLCC Eugene Marquis
Rennes cedex Ille Et Vilaine, 35042, France
CHU Tours - Hôpital Trousseau
Chambray les Tours Indre Et Loire, 37170, France
ICO - Site René Gauducheau
Angers Cedex 9 Maine Et Loire, 49933, France
Hôpital Cochin
Paris cedex 14 Paris, 75679, France
Hôpital Européen Georges Pompidou
Paris Cedex 15 Paris, 75015, France
CHU Clermont Ferrand
Clermont Ferrand cedex 1 Puy De Dome, 63003, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans Cedex 02 Sarthe, 72015, France
Klinikum Esslingen GmbH
Esslingen A. N. Baden Wuerttemberg, 73730, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn Baden Wuerttemberg, 74078, Germany
Klinikum Bogenhausen
Muenchen Bayern, 81925, Germany
Leopoldina Krankenhaus Schweinfurt
Schweinfurt Bayern, 97422, Germany
Krankenhaus Nordwest GmbH
Frankfurt Hessen, 60488, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz Rheinland Pfalz, 55131, Germany
Onkologische Schwerpunktpraxis Eppendorf
Hamburg , 20249, Germany
Marienkrankenhaus Hamburg
Hamburg , 22087, Germany
Pecsi Tudomanyegyetem
Pecs Baranya, 7624, Hungary
Petz Aladar Megyei Oktato Korhaz
Gyor Győr-Moson-Sopron, 9024, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen Hajdú-Bihar, 4032, Hungary
Magyar Honvedseg Egeszsegugyi
Budapest , 1062, Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza , 4400, Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszard , 7100, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok , 5000, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg , 8900, Hungary
Presidio Ospedaliero Garibaldi Nesima
Catania , 95100, Italy
Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)
Cremona , 26100, Italy
Azienda Ospedaliera Universitaria Careggi
Firenze , 50141, Italy
Ospedale San Raffaele
Milano , 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
IEO Istituto Europeo di Oncologia
Milano , 20141, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli , 80131, Italy
Seconda Università degli Studi di Napoli
Napoli , 80131, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padova , 35128, Italy
Ospedale degli Infermi
Rimini , 47923, Italy
Università Campus Bio-Medico di Roma
Roma , 00128, Italy
Azienda Ospedaliera S. Maria Di Terni
Terni , 5100, Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
Udine , 33100, Italy
Chiba Cancer Center
Chiba-shi Chiba-Ken, 260-8, Japan
Kagawa University Hospital
Kita-gun Kagawa-Ken, 761-0, Japan
Kanagawa Cancer Center
Yokohama-shi Kanagawa-Ken, 241-8, Japan
Kumamoto University Hospital
Kumamoto-shi Kumamoto-Ken, 860-8, Japan
Tohoku University Hospital
Sendai-shi Miyagi-Ken, 980-8, Japan
Niigata Cancer Center Hospital
Niigata-shi Niigata-Ken, 951-8, Japan
Oita University Hospital
Yufu-shi Oita-ken, 879-5, Japan
Kindai University Hospital
Osakasayama Osaka-Fu, 589-8, Japan
Izumi Municipal Hospital
Izumi-shi Osaka, 594-0, Japan
Saitama Medical University International Medical Center
Hidaka-shi Saitama-Ken, 350-1, Japan
Saitama Cancer Center
Kitaadachi-gun Saitama-Ken, 362-0, Japan
Tochigi Cancer Center
Utsunomiya-shi Tochigi-Ken, 320-0, Japan
Nat Cancer Ctr Hosp
Chuo-ku Tokyo-To, 104-0, Japan
Toranomon Hospital
Minato-ku Tokyo-To, 105-8, Japan
Kagoshima University Medical And Dental Hospital
Kagoshima-shi , 890-8, Japan
Chungbuk National University Hospital
Cheongju-si Chungcheongbuk-do, 28644, Korea, Republic of
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun-gun Jeollanam-do, 58128, Korea, Republic of
Keimyung University Dongsan Hospital
Daegu Jung-gu, 41931, Korea, Republic of
Inje University Haeundae Paik Hospital
Busan , 48108, Korea, Republic of
Kyungpook National University Medical Center
Daegu , 41404, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Korea University Anam Hospital
Seoul , 2841, Korea, Republic of
Seoul National University Hospital
Seoul , 3080, Korea, Republic of
Yonsei University Health System
Seoul , 3722, Korea, Republic of
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
Cluj Napoca Cluj, 40001, Romania
S.C Radiotherapy Center Cluj S.R.L
Comuna Floresti Cluj, 40728, Romania
S.C Centrul de Oncologie Sf. Nectarie S.R.L
Craiova Dolj, 20034, Romania
Spital Lotus SRL
Ploiesti Prahova, 10001, Romania
S.C Oncocenter Oncologie Clinica S.R.L
Timisoara Timis, 30021, Romania
S.C Oncomed S.R.L
Timisoara Timis, 30023, Romania
S.C Oncopremium Team S.R.L
Baia Mare , 43029, Romania
Institutul Clinic Fundeni
Bucuresti , 02232, Romania
Spitalul Clinic Coltea
Bucuresti , 03017, Romania
Hifu Terramed Conformal SRL
Bucuresti , 03186, Romania
Institutul Regional de Oncologie Iasi
Iasi , 70048, Romania
Pavlov First Saint Petersburg State Medical University
Saint-Petersburg Leningrado, 19702, Russian Federation
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint-Petersburg Leningrado, 19775, Russian Federation
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
Arkhangelsk , 16304, Russian Federation
LLC Evimed
Chelyabinsk , 45404, Russian Federation
RBIH "Ivanovo Regional Oncological Dispensary"
Ivanovo , 15304, Russian Federation
SBIH " Clinical Oncological Dispensary # 1"
Krasnodar , 35004, Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow , 11547, Russian Federation
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk , 64401, Russian Federation
SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"
Pyatigorsk , 35750, Russian Federation
SPb SBIH "City Clinical Oncological Dispensary"
Saint-Petersburg , 19702, Russian Federation
Hospital General Universitario de Elche
Elche Alicante, 03203, Spain
ICO l´Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Corporacio Sanitaria Parc Tauli
Sabadell Barcelona, 08208, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona , 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 8025, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario HM Madrid Sanchinarro
Madrid , 28050, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , 83301, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
National Taiwan University Hospital
Taipei , 10048, Taiwan
Mackay Memorial Hospital
Taipei , 104, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan , 33305, Taiwan
King Chulalongkorn Memorial Hospital
Patumwan Bangkok, 10330, Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang Chiang Mai, 50200, Thailand
Siriraj Hospital
Bangkok , 10700, Thailand
Acibadem Adana Hospital
Adana , 01130, Turkey
Adana Numune Training and Research Hospital
Adana , 1240, Turkey
Hacettepe University Medical Faculty
Ankara , 06100, Turkey
Akdeniz University Medical Faculty
Antalya , 7058, Turkey
Dicle University, Medical faculty
Diyarbakir , 21080, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34098, Turkey
Marmara University Pendik Research and Training Hospital
Istanbul , 34340, Turkey
Kocaeli University Medical Faculty
Kocaeli , 41380, Turkey
Konya Necmettin Erbakan University Meram Medical Faculty
Konya , 42100, Turkey
Inonu Uni. Med. Fac.
Malatya , 44280, Turkey
Mersin University Medical Faculty
Mersin , 33169, Turkey
Derriford Hospital
Torquay Devon, TQ2 7, United Kingdom
Barts Hospital
London Greater London, EC1A , United Kingdom
University College London Hospitals
London Greater London, WC1E , United Kingdom
The Christie
Manchester Greater Manchester, M20 4, United Kingdom
The Clatterbridge Cancer Centre
Wirral Merseyside, CH63 , United Kingdom
Mount Vernon Hospital
Northwood Middlesex, HA6 2, United Kingdom
Royal Surrey County Hospital
Guildford Surrey, GU2 7, United Kingdom
Ninewells Hospital
Dundee Tayside Region, DD1 9, United Kingdom
St James's University Hospital
Leeds West Yorkshire, LS9 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

499

Study ID:

NCT02625610

Recruitment Status:

Completed

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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