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.
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
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There are 198 Locations for this study
Bakersfield California, 93309, United States
Fullerton California, 92835, United States
Los Angeles California, 90095, United States
Rancho Mirage California, 92262, United States
Santa Barbara California, 93105, United States
Santa Maria California, 93454, United States
Norwalk Connecticut, 6856, United States
Orlando Florida, 32806, United States
Pembroke Pines Florida, 33028, United States
Tampa Florida, 33606, United States
Park Ridge Illinois, 60068, United States
Indianapolis Indiana, 46237, United States
Cedar Rapids Iowa, 52403, United States
Topeka Kansas, 66604, United States
Westwood Kansas, 66205, United States
Minneapolis Minnesota, 55407, United States
Las Vegas Nevada, 89106, United States
Jamaica New York, 11432, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Cincinnati Ohio, 45206, United States
Cincinnati Ohio, 45220, United States
Columbus Ohio, 43219, United States
Portland Oregon, 97239, United States
Bethlehem Pennsylvania, 18015, United States
Philadelphia Pennsylvania, 19107, United States
Providence Rhode Island, 02903, United States
Greenville South Carolina, 29605, United States
Dallas Texas, 75390, United States
Houston Texas, 77024, United States
San Antonio Texas, 78229, United States
Temple Texas, 76508, United States
East Seattle Washington, 98109, United States
Tacoma Washington, 98405, United States
Wenatchee Washington, 98801, United States
Kogarah New South Wales, 2217, Australia
St Leonards New South Wales, 2065, Australia
Greenslopes Queensland, 4120, Australia
Herston Queensland, 4006, Australia
Bedford Park South Australia, 5042, Australia
Elizabeth Vale South Australia, 5112, Australia
Hobart Tasmania, 7000, Australia
Ballarat Victoria, 3350, Australia
Bendigo Victoria, 3550, Australia
Bentleigh Victoria, 8120, Australia
Box Hill Victoria, 3128, Australia
Parkville Victoria, 3050, Australia
Wodonga Victoria, 3690, Australia
Murdoch Western Australia, 6150, Australia
Salvador Bahia, 40170, Brazil
Ijuà Rio Grande Do Sul, 98700, Brazil
Lajeado Rio Grande Do Sul, 95900, Brazil
Novo Hamburgo Rio Grande Do Sul, 93510, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Barretos Sao Paulo, 14784, Brazil
Porto Alegre Sao Paulo, 90110, Brazil
Santo Andre Sao Paulo, 09060, Brazil
São José do Rio Preto Sao Paulo, 15090, Brazil
São Paulo Sao Paulo, 01246, Brazil
Badajoz , 06080, Brazil
Halifax Nova Scotia, B3H 2, Canada
Barrie Ontario, L4M 6, Canada
Toronto Ontario, M3M 0, Canada
Toronto Ontario, M5G 1, Canada
Laval Quebec, H7M 3, Canada
Montréal Quebec, H2W 1, Canada
Nice cedex 02 Alpes Maritimes, 06189, France
Marseille cedex 5 Bouches Du Rhone, 13385, France
Brest Brittany, 29200, France
Dijon cedex Côte-d'Or, 21079, France
Besancon Doubs, 25030, France
Bordeaux Cedex Gironde, 33076, France
Toulouse Cedex 9 Haute Garonne, 31059, France
Rennes cedex Ille Et Vilaine, 35042, France
Chambray les Tours Indre Et Loire, 37170, France
Angers Cedex 9 Maine Et Loire, 49933, France
Paris cedex 14 Paris, 75679, France
Paris Cedex 15 Paris, 75015, France
Clermont Ferrand cedex 1 Puy De Dome, 63003, France
Le Mans Cedex 02 Sarthe, 72015, France
Esslingen A. N. Baden Wuerttemberg, 73730, Germany
Heilbronn Baden Wuerttemberg, 74078, Germany
Muenchen Bayern, 81925, Germany
Schweinfurt Bayern, 97422, Germany
Frankfurt Hessen, 60488, Germany
Mainz Rheinland Pfalz, 55131, Germany
Hamburg , 20249, Germany
Hamburg , 22087, Germany
Pecs Baranya, 7624, Hungary
Gyor Győr-Moson-Sopron, 9024, Hungary
Debrecen Hajdú-Bihar, 4032, Hungary
Budapest , 1062, Hungary
Nyiregyhaza , 4400, Hungary
Szekszard , 7100, Hungary
Szolnok , 5000, Hungary
Zalaegerszeg , 8900, Hungary
Catania , 95100, Italy
Cremona , 26100, Italy
Firenze , 50141, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Napoli , 80131, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Rimini , 47923, Italy
Roma , 00128, Italy
Terni , 5100, Italy
Udine , 33100, Italy
Chiba-shi Chiba-Ken, 260-8, Japan
Kita-gun Kagawa-Ken, 761-0, Japan
Yokohama-shi Kanagawa-Ken, 241-8, Japan
Kumamoto-shi Kumamoto-Ken, 860-8, Japan
Sendai-shi Miyagi-Ken, 980-8, Japan
Niigata-shi Niigata-Ken, 951-8, Japan
Yufu-shi Oita-ken, 879-5, Japan
Osakasayama Osaka-Fu, 589-8, Japan
Izumi-shi Osaka, 594-0, Japan
Hidaka-shi Saitama-Ken, 350-1, Japan
Kitaadachi-gun Saitama-Ken, 362-0, Japan
Utsunomiya-shi Tochigi-Ken, 320-0, Japan
Chuo-ku Tokyo-To, 104-0, Japan
Minato-ku Tokyo-To, 105-8, Japan
Kagoshima-shi , 890-8, Japan
Cheongju-si Chungcheongbuk-do, 28644, Korea, Republic of
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Hwasun-gun Jeollanam-do, 58128, Korea, Republic of
Daegu Jung-gu, 41931, Korea, Republic of
Busan , 48108, Korea, Republic of
Daegu , 41404, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 2841, Korea, Republic of
Seoul , 3080, Korea, Republic of
Seoul , 3722, Korea, Republic of
Cluj Napoca Cluj, 40001, Romania
Comuna Floresti Cluj, 40728, Romania
Craiova Dolj, 20034, Romania
Ploiesti Prahova, 10001, Romania
Timisoara Timis, 30021, Romania
Timisoara Timis, 30023, Romania
Baia Mare , 43029, Romania
Bucuresti , 02232, Romania
Bucuresti , 03017, Romania
Bucuresti , 03186, Romania
Iasi , 70048, Romania
Saint-Petersburg Leningrado, 19702, Russian Federation
Saint-Petersburg Leningrado, 19775, Russian Federation
Arkhangelsk , 16304, Russian Federation
Chelyabinsk , 45404, Russian Federation
Ivanovo , 15304, Russian Federation
Krasnodar , 35004, Russian Federation
Moscow , 11547, Russian Federation
Omsk , 64401, Russian Federation
Pyatigorsk , 35750, Russian Federation
Saint-Petersburg , 19702, Russian Federation
Elche Alicante, 03203, Spain
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Sabadell Barcelona, 08208, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 8025, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Sevilla , 41013, Spain
Kaohsiung , 83301, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Taipei , 10048, Taiwan
Taipei , 104, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 33305, Taiwan
Patumwan Bangkok, 10330, Thailand
Muang Chiang Mai, 50200, Thailand
Bangkok , 10700, Thailand
Adana , 01130, Turkey
Adana , 1240, Turkey
Ankara , 06100, Turkey
Antalya , 7058, Turkey
Diyarbakir , 21080, Turkey
Istanbul , 34098, Turkey
Istanbul , 34340, Turkey
Kocaeli , 41380, Turkey
Konya , 42100, Turkey
Malatya , 44280, Turkey
Mersin , 33169, Turkey
Torquay Devon, TQ2 7, United Kingdom
London Greater London, EC1A , United Kingdom
London Greater London, WC1E , United Kingdom
Manchester Greater Manchester, M20 4, United Kingdom
Wirral Merseyside, CH63 , United Kingdom
Northwood Middlesex, HA6 2, United Kingdom
Guildford Surrey, GU2 7, United Kingdom
Dundee Tayside Region, DD1 9, United Kingdom
Leeds West Yorkshire, LS9 7, United Kingdom
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