Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction... | NCT03221426 | Trialant

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction... | NCT03221426 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.

Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.

Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.

Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment.

Has adequate organ function.

Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.

Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.

Has life expectancy of greater than 6 months.

Exclusion Criteria:

Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.

Has an active infection requiring systemic therapy.

Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.

Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], necrosis factor receptor superfamily member 9 [CD137]) or has previously participated in a MSD pembrolizumab (MK-3475) clinical study.

Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment.

Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.

Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients, or to any of the study chemotherapy agents and/or to any of their excipients.

Has an active autoimmune disease that has required systemic treatment in past 2 years.

Has a known history of human immunodeficiency virus (HIV) infection.

Has a known history of Hepatitis B or known active Hepatitis C virus infection.

Has a known history of active tuberculosis (TB).

Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.

Male participants who are expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy.

Has had an allogenic tissue/solid organ transplant.

Has received a live vaccine within 30 days prior to the first dose of study treatment.

City of Hope ( Site 0005)

Duarte, California 91010, United States

Yale Cancer Center ( Site 0016)

New Haven, Connecticut 06520, United States

Georgetown University ( Site 0015)

Washington D.C., District of Columbia 20007, United States

Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018)

Chicago, Illinois 60611, United States

The University of Chicago Medical Center ( Site 0004)

Chicago, Illinois 60637, United States

Roswell Park Cancer Institute ( Site 0001)

Buffalo, New York 14263, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019)

New York, New York 10016, United States

Memorial Sloan Kettering ( Site 0024)

New York, New York 10065, United States

Weill Cornell Medical Center ( Site 0023)

New York, New York 10065, United States

University of Rochester ( Site 0011)

Rochester, New York 14642, United States

Fox Chase Cancer Center ( Site 0006)

Philadelphia, Pennsylvania 19111, United States

Temple University Hospital ( Site 0026)

Philadelphia, Pennsylvania 19140, United States

University of Utah, Huntsman Cancer Institute ( Site 0012)

Salt Lake City, Utah 84112, United States

Virginia Cancer Specialists, PC ( Site 0010)

Fairfax, Virginia 22031, United States

Institut Jules Bordet ( Site 0480)

Brussels, Bruxelles-Capitale, Region de 1000, Belgium

Hopital Erasme ULB ( Site 0484)

Brussels, Bruxelles-Capitale, Region de 1070, Belgium

UCL Saint Luc ( Site 0479)

Brussels, Bruxelles-Capitale, Region de 1200, Belgium

Grand Hopital de Charleroi ( Site 0478)

Charleroi, Hainaut 6000, Belgium

CHU de Liege ( Site 0482)

Liège, Liege 4000, Belgium

CHU UCL Namur Site de Godinne ( Site 0485)

Yvoir, Namur 5530, Belgium

UZ Gent ( Site 0486)

Ghent, Oost-Vlaanderen 9000, Belgium

UZ Leuven ( Site 0483)

Leuven, Vlaams-Brabant 3000, Belgium

AZ Groeninge ( Site 0481)

Kortrijk, West-Vlaanderen 8500, Belgium

Instituto do Cancer do Ceara ( Site 0311)

Fortaleza, Ceará 60430-230, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308)

Porto Alegre, Rio Grande do Sul 90610-000, Brazil

CEPON - Centro de Pesquisas Oncologicas ( Site 0302)

Florianópolis, Santa Catarina 88034-000, Brazil

Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301)

Barretos, São Paulo 14784-400, Brazil

Hospital de Base de Sao Jose de Rio Preto ( Site 0304)

Sao Jose Rio Preto, São Paulo 15090-000, Brazil

Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307)

Rio de Janeiro, 20230-130, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305)

São Paulo, 01246-000, Brazil

Hospital Israelita Albert Einstein ( Site 0309)

São Paulo, 05652-900, Brazil

Cross Cancer Institute ( Site 0033)

Edmonton, Alberta T6G 1Z2, Canada

Moncton Hospital - Horizon Health Network ( Site 0038)

Moncton, New Brunswick E1C 6Z8, Canada

Sunnybrook Research Institute ( Site 0032)

Toronto, Ontario M4N 3M5, Canada

CISSS de la Monteregie-Centre ( Site 0039)

Greenfield Park, Quebec J4V 2H1, Canada

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040)

Montreal, Quebec H1T 2M4, Canada

Jewish General Hospital ( Site 0034)

Montreal, Quebec H3T 1E2, Canada

CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042)

Québec, Quebec G1R 2J6, Canada

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035)

Sherbrooke, Quebec J1H 5N4, Canada

Instituto Clinico del Sur. ICOS ( Site 0290)

Temuco, Araucania 4810469, Chile

Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)

Rancagua, Lbtdr Gen Bernardo O Higgins 2820000, Chile

Fundacion Arturo Lopez Perez FALP ( Site 0286)

Santiago, Region M. de Santiago 7500921, Chile

Pontificia Universidad Catolica de Chile ( Site 0285)

Santiago, Region M. de Santiago 8330032, Chile

Hospital Clinico Universidad de Chile ( Site 0287)

Santiago, Region M. de Santiago 8380456, Chile

Beijing Cancer Hospital ( Site 0221)

Beijing, Beijing Municipality 100142, China

Zhejiang Cancer Hospital ( Site 0231)

Hangzhou, Zhejiang 310022, China

Sir Run Run Shaw Hospital ( Site 0233)

Hangzhou, Zhejiang 430030, China

SA Pohja-Eesti Regionaalhaigla ( Site 0526)

Tallinn, Harju 13419, Estonia

Hopital Prive Jean Mermoz ( Site 0462)

Lyon, Auvergne 69008, France

Institut Paoli Calmettes ( Site 0472)

Marseille, Bouches-du-Rhone 13009, France

CHU Reims - Hopital Robert Debre ( Site 0465)

Reims, Champagne-Ardenne 51092, France

CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474)

Brest, Finistere 29200, France

CHU Toulouse - Hopital Rangueil ( Site 0470)

Toulouse, Haute-Garonne 31059, France

Institut du Cancer de Montpellier ( Site 0473)

Montpellier, Herault 34298, France

Centre Eugene Marquis ( Site 0466)

Rennes, Ille-et-Vilaine 35042, France

Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469)

Saint-Herblain, Loire-Atlantique 44805, France

CHRU Lille - Hopital Claude Huriez ( Site 0461)

Lille, Nord 59037, France

CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)

Poitiers, Vienne 86021, France

CHU Hopital Saint Antoine ( Site 0471)

Paris, 75012, France

Institut Mutualiste Montsouris ( Site 0463)

Paris, 75014, France

Klinikum Esslingen GmbH ( Site 0453)

Esslingen am Neckar, Baden-Wurttemberg 73730, Germany

Universitaetsklinikum Freiburg ( Site 0450)

Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany

Klinikum der Universitaet in Muenchen ( Site 0446)

Munich, Bavaria 81377, Germany

Medizinische Hochschule Hannover ( Site 0449)

Hanover, Lower Saxony 30625, Germany

Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445)

Essen, North Rhine-Westphalia 45136, Germany

Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)

Mainz, Rhineland-Palatinate 55131, Germany

Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)

Dresden, Saxony 01307, Germany

Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454)

Hamburg, 20249, Germany

Integra Cancer Institute ( Site 0262)

Guatemala City, 01010, Guatemala

Grupo Medico Angeles ( Site 0261)

Guatemala City, 01015, Guatemala

Centro Medico Integral De Cancerología (CEMIC) ( Site 0260)

Quetzaltenango, 09002, Guatemala

Meir medical center ( Site 0386)

Kfar Saba, Central District 4428164, Israel

Soroka University M.C ( Site 0385)

Beersheba, Southern District 8410101, Israel

Sourasky Medical Center. ( Site 0382)

Tel Aviv, Tell Abib 6423906, Israel

Rambam Health Care Campus ( Site 0381)

Haifa, 31096, Israel

Hadassah Medical Center. Ein Kerem ( Site 0383)

Jerusalem, 9112001, Israel

Rabin-Medical Center ( Site 0384)

Petah Tikva, 4941492, Israel

Sheba Medical center ( Site 0387)

Ramat Gan, 5265601, Israel

IRCCS Istituto Oncologico Veneto ( Site 0431)

Padova, Abruzzo 35128, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430)

Milan, Lombardy 20133, Italy

Istituto Clinico Humanitas Research Hospital ( Site 0432)

Rozzano, Milano 20089, Italy

IRCCS Policlinico San Donato ( Site 0433)

San Donato Milanese, Milano 20097, Italy

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)

Modena, 41125, Italy

Seconda Universita Napoli ( Site 0436)

Naples, 80131, Italy

A.O.U. Santa Maria della Misericordia di Udine ( Site 0434)

Udine, 33100, Italy

Aichi Cancer Center Hospital ( Site 0165)

Nagoya, Aichi-ken 464-8681, Japan

National Cancer Center Hospital East ( Site 0178)

Kashiwa, Chiba 277-8577, Japan

National Hospital Organization Shikoku Cancer Center ( Site 0186)

Matsuyama, Ehime 791-0280, Japan

Hokkaido University Hospital ( Site 0160)

Sapporo, Hokkaido 060-8648, Japan

Hyogo Cancer Center ( Site 0182)

Akashi, Hyōgo 673-8558, Japan

Kobe University Hospital ( Site 0188)

Kobe, Hyōgo 650-0017, Japan

Kobe City Medical Center General Hospital ( Site 0181)

Kobe, Hyōgo 650-0047, Japan

Ibaraki Prefectural Central Hospital ( Site 0177)

Kasama, Ibaraki 309-1793, Japan

Iwate Medical University Hospital ( Site 0184)

Shiwa-gun, Iwate 028-3695, Japan

St. Marianna University School of Medicine Hospital ( Site 0187)

Kawasaki, Kanagawa 216-8511, Japan

Kanagawa Cancer Center ( Site 0167)

Yokohama, Kanagawa 241-8515, Japan

Kansai Medical University Hospital ( Site 0190)

Hirakata, Osaka 573-1191, Japan

Osaka University Hospital ( Site 0162)

Suita, Osaka 565-0871, Japan

Osaka Medical College Hospital ( Site 0168)

Takatsuki, Osaka 569-8686, Japan

Saitama Cancer Center ( Site 0170)

Kitaadachi-gun, Saitama 362-0806, Japan

Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)

Sunto-gun, Shizuoka 411-8777, Japan

Chiba Cancer Center ( Site 0180)

Chiba, 260-8717, Japan

National Hospital Organization Kyushu Cancer Center ( Site 0172)

Fukuoka, 811-1395, Japan

Kyushu University Hospital ( Site 0173)

Fukuoka, 812-8582, Japan

Gifu University Hospital ( Site 0166)

Gifu, 501-1194, Japan

Hiroshima City Hiroshima Citizens Hospital ( Site 0171)

Hiroshima, 730-8518, Japan

Kochi Health Sciences Center ( Site 0189)

Kochi, 781-8555, Japan

Kumamoto University Hospital ( Site 0164)

Kumamoto, 860-8556, Japan

Niigata Cancer Center Hospital ( Site 0169)

Niigata, 951-8566, Japan

Osaka International Cancer Institute ( Site 0161)

Osaka, 541-8567, Japan

Osaka General Medical Center ( Site 0159)

Osaka, 558-8558, Japan

National Cancer Center Hospital ( Site 0179)

Tokyo, 104-0045, Japan

Tokyo Metropolitan Komagome Hospital ( Site 0183)

Tokyo, 113-8677, Japan

The Cancer Institute Hospital of JFCR ( Site 0185)

Tokyo, 135-8550, Japan

Toyama Prefectural Central Hospital ( Site 0163)

Toyama, 930-8550, Japan

Riga East Clinical University Hospital ( Site 0550)

Riga, 1079, Latvia

LSMUL Kauno Klinikos ( Site 0570)

Kaunas, 50161, Lithuania

Nacionalinis Vezio Institutas ( Site 0569)

Vilnius, 08406, Lithuania

Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)

Vilnius, 08460, Lithuania

Hospital Kuala Lumpur ( Site 0146)

Kuala Lumpur, 50586, Malaysia

University Malaya Medical Centre ( Site 0143)

Kuala Lumpur, 59100, Malaysia

St. Luke s Medical Center ( Site 0622)

Quezon City, National Capital Region 1102, Philippines

Szpital Uniwersytecki w Krakowie ( Site 0352)

Krakow, Lesser Poland Voivodeship 31-501, Poland

Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)

Wroclaw, Lower Silesian Voivodeship 51-124, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351)

Lublin, Lublin Voivodeship 20-080, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349)

Warsaw, Masovian Voivodeship 02-034, Poland

Mazowiecki Szpital Onkologiczny ( Site 0363)

Wieliszew, Masovian Voivodeship 05-135, Poland

Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353)

Kościerzyna, Pomeranian Voivodeship 83-400, Poland

Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354)

Bielsko-Biala, Silesian Voivodeship 43-300, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361)

Gliwice, Silesian Voivodeship 44-101, Poland

SPZOZ WSS nr 3 w Rybniku ( Site 0357)

Rybnik, Silesian Voivodeship 44-200, Poland

Kaluga Regional Clinical Oncology Center ( Site 0345)

Kaluga, Kaluzskaja Oblast 248007, Russia

SBHI Leningrad Regional Clinical Hospital ( Site 0496)

Saint Petersburg, Leningradskaya Oblast' 194291, Russia

National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338)

Moscow, Moscow 105203, Russia

Blokhin National Medical Oncology ( Site 0494)

Moscow, Moscow 115478, Russia

Leningrad Regional Oncology Center ( Site 0335)

Saint Petersburg, Sankt-Peterburg 188663, Russia

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344)

Saint Petersburg, Sankt-Peterburg 197758, Russia

City clinical oncological dispensary ( Site 0336)

Saint Petersburg, Sankt-Peterburg 198255, Russia

Tomsk Scientific Research Institute of Oncology ( Site 0337)

Tomsk, Tomsk Oblast 634028, Russia

National University Hospital ( Site 0095)

Singapore, Central Singapore 119074, Singapore

National Cancer Centre Singapore ( Site 0097)

Singapore, Central Singapore 169610, Singapore

Oncocare Cancer Centre ( Site 0096)

Singapore, Central Singapore 258499, Singapore

Chonnam National University Hwasun Hospital ( Site 0083)

Hwasun Gun, Jeonranamdo 58128, South Korea

Seoul National University Bundang Hospital ( Site 0085)

Seongnam-si, Kyonggi-do 13620, South Korea

Kyungpook National University Chilgok Hospital ( Site 0089)

Daegu, Taegu-Kwangyokshi 41404, South Korea

Gachon University Gil Medical Center ( Site 0087)

Incheon, 21565, South Korea

Korea University Anam Hospital ( Site 0084)

Seoul, 02841, South Korea

Seoul National University Hospital -SNUH- ( Site 0080)

Seoul, 03080, South Korea

Severance Hospital Yonsei University Health System ( Site 0081)

Seoul, 03722, South Korea

Asan Medical Center ( Site 0082)

Seoul, 05505, South Korea

Gangnam Severance Hospital ( Site 0088)

Seoul, 06273, South Korea

SMG-SNU BORAMAE Medical Center ( Site 0086)

Seoul, 07061, South Korea

Taipei Medical University Shuang Ho Hospital ( Site 0068)

New Taipei City, 235, Taiwan

National Cheng Kung University Hospital ( Site 0067)

Tainan, 704, Taiwan

National Taiwan University Hospital ( Site 0063)

Taipei, 10002, Taiwan

Mackay Memorial Hospital ( Site 0065)

Taipei, 104, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066)

Taipei, 11259, Taiwan

Chang Gung Medical Foundation. Linkou ( Site 0064)

Taoyuan, 333, Taiwan

City Clinical Hosp.4 of DCC ( Site 0325)

Dnipro, Dnipropetrovsk Oblast 49102, Ukraine

MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589)

Kryviy Rih, Dnipropetrovsk Oblast 50048, Ukraine

Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)

Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine

Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591)

Kharkiv, Kharkiv Oblast 61070, Ukraine

National Cancer Institute of the MoH of Ukraine ( Site 0319)

Kyiv, Kyivska Oblast 03022, Ukraine

Kyiv City Clinical Oncology Center ( Site 0590)

Kyiv, Kyivska Oblast 03115, Ukraine

University Hospitals Bristol NHS Foundation Trust ( Site 0407)

Bristol, Bristol, City of BS2 8ED, United Kingdom

Ninewells Hospital and Medical School ( Site 0406)

Dundee, Dundee City DD1 9SY, United Kingdom

Royal Free London NHS Foundation Trust ( Site 0403)

London, London, City of NW3 2QG, United Kingdom

The Royal Marsden Foundation Trust ( Site 0405)

London, London, City of SW3 6JJ, United Kingdom

Imperial College Healthcare NHS Trust ( Site 0402)

London, London, City of W2 1NY, United Kingdom

Royal Marsden NHS Foundation Trust ( Site 0400)

Sutton, Surrey SM2 5PT, United Kingdom

The Christie NHS Foundation Trust ( Site 0397)

Manchester, M20 4BX, United Kingdom