Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)

NCT ID: NCT03221426

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1007 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2025-04-23

Brief Summary

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

The primary study hypotheses are that:

• Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
• Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.

With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.

Conditions

Gastric Cancer; Gastroesophageal Junction Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pembrolizumab + XP/FP

XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle.

Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of pembrolizumab 200 mg IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg IV infusion on Day 1 Q3W for up to 11 additional cycles.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion

Cisplatin

Intervention Type: DRUG

IV infusion

Capecitabine

Intervention Type: DRUG

Oral tablets

5-fluorouracil

Intervention Type: DRUG

IV infusion

Placebo + XP/FP

Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.

Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV infusion

Cisplatin

Intervention Type: DRUG

IV infusion

Capecitabine

Intervention Type: DRUG

Oral tablets

5-fluorouracil

Intervention Type: DRUG

IV infusion

Pembrolizumab+FLOT Cohort

FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).

Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m^2, oxaliplatin 85 mg/m^2, 5FU 2600 mg/m^2, and leucovorin 200 mg/m^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion

5-fluorouracil

Intervention Type: DRUG

IV infusion

Docetaxel

Intervention Type: DRUG

IV infusion

Oxaliplatin

Intervention Type: DRUG

IV infusion

Leucovorin

Intervention Type: DRUG

IV infusion

Placebo+FLOT Cohort

Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).

Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV infusion

5-fluorouracil

Intervention Type: DRUG

IV infusion

Docetaxel

Intervention Type: DRUG

IV infusion

Oxaliplatin

Intervention Type: DRUG

IV infusion

Leucovorin

Intervention Type: DRUG

IV infusion

Interventions

Pembrolizumab

IV infusion

Intervention Type: BIOLOGICAL

Placebo

IV infusion

Intervention Type: DRUG

Cisplatin

IV infusion

Intervention Type: DRUG

Capecitabine

Oral tablets

Intervention Type: DRUG

5-fluorouracil

IV infusion

Intervention Type: DRUG

Docetaxel

IV infusion

Intervention Type: DRUG

Oxaliplatin

IV infusion

Intervention Type: DRUG

Leucovorin

IV infusion

Intervention Type: DRUG

Other Intervention Names

MK-3475; KEYTRUDA®; Normal saline solution; PLATINOL®; XELODA®; ADRUCIL®; 5FU; TAXOTERE®; ELOXATIN®; WELLCOVORIN®

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 Merck pembrolizumab (MK-3475) clinical trial.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

City of Hope ( Site 0005)

Duarte, California, United States

Yale Cancer Center ( Site 0016)

New Haven, Connecticut, United States

Georgetown University ( Site 0015)

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

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

Chicago, Illinois, United States

The University of Chicago Medical Center ( Site 0004)

Chicago, Illinois, United States

Roswell Park Cancer Institute ( Site 0001)

Buffalo, New York, United States

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

New York, New York, United States

Memorial Sloan Kettering ( Site 0024)

New York, New York, United States

Weill Cornell Medical Center ( Site 0023)

New York, New York, United States

University of Rochester ( Site 0011)

Rochester, New York, United States

Fox Chase Cancer Center ( Site 0006)

Philadelphia, Pennsylvania, United States

Temple University Hospital ( Site 0026)

Philadelphia, Pennsylvania, United States

University of Utah, Huntsman Cancer Institute ( Site 0012)

Salt Lake City, Utah, United States

Virginia Cancer Specialists, PC ( Site 0010)

Fairfax, Virginia, United States

Institut Jules Bordet ( Site 0480)

Brussels, Bruxelles-Capitale, Region de, Belgium

Hopital Erasme ULB ( Site 0484)

Brussels, Bruxelles-Capitale, Region de, Belgium

UCL Saint Luc ( Site 0479)

Brussels, Bruxelles-Capitale, Region de, Belgium

Grand Hopital de Charleroi ( Site 0478)

Charleroi, Hainaut, Belgium

CHU de Liege ( Site 0482)

Liège, Liege, Belgium

CHU UCL Namur Site de Godinne ( Site 0485)

Yvoir, Namur, Belgium

UZ Gent ( Site 0486)

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven ( Site 0483)

Leuven, Vlaams-Brabant, Belgium

AZ Groeninge ( Site 0481)

Kortrijk, West-Vlaanderen, Belgium

Instituto do Cancer do Ceara ( Site 0311)

Fortaleza, Ceará, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

CEPON - Centro de Pesquisas Oncologicas ( Site 0302)

Florianópolis, Santa Catarina, Brazil

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

Barretos, São Paulo, Brazil

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

Sao Jose Rio Preto, São Paulo, Brazil

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

Rio de Janeiro, , Brazil

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

São Paulo, , Brazil

Hospital Israelita Albert Einstein ( Site 0309)

São Paulo, , Brazil

Cross Cancer Institute ( Site 0033)

Edmonton, Alberta, Canada

Moncton Hospital - Horizon Health Network ( Site 0038)

Moncton, New Brunswick, Canada

Sunnybrook Research Institute ( Site 0032)

Toronto, Ontario, Canada

CISSS de la Monteregie-Centre ( Site 0039)

Greenfield Park, Quebec, Canada

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

Montreal, Quebec, Canada

Jewish General Hospital ( Site 0034)

Montreal, Quebec, Canada

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

Québec, Quebec, Canada

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

Sherbrooke, Quebec, Canada

Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)

Rancagua, Lbtdr Gen Bernardo O Higgins, Chile

Fundacion Arturo Lopez Perez FALP ( Site 0286)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 0285)

Santiago, Region M. de Santiago, Chile

Hospital Clinico Universidad de Chile ( Site 0287)

Santiago, Region M. de Santiago, Chile

Instituto Clinico del Sur. ICOS ( Site 0290)

Temuco, Región de la Araucanía, Chile

Beijing Cancer Hospital ( Site 0221)

Beijing, Beijing Municipality, China

Zhejiang Cancer Hospital ( Site 0231)

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital ( Site 0233)

Hangzhou, Zhejiang, China

SA Pohja-Eesti Regionaalhaigla ( Site 0526)

Tallinn, Harju, Estonia

Hopital Prive Jean Mermoz ( Site 0462)

Lyon, Auvergne, France

Institut Paoli Calmettes ( Site 0472)

Marseille, Bouches-du-Rhone, France

CHU Reims - Hopital Robert Debre ( Site 0465)

Reims, Champagne-Ardenne, France

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

Brest, Finistere, France

CHU Toulouse - Hopital Rangueil ( Site 0470)

Toulouse, Haute-Garonne, France

Institut du Cancer de Montpellier ( Site 0473)

Montpellier, Herault, France

Centre Eugene Marquis ( Site 0466)

Rennes, Ille-et-Vilaine, France

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

Saint-Herblain, Loire-Atlantique, France

CHRU Lille - Hopital Claude Huriez ( Site 0461)

Lille, Nord, France

CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)

Poitiers, Vienne, France

CHU Hopital Saint Antoine ( Site 0471)

Paris, , France

Institut Mutualiste Montsouris ( Site 0463)

Paris, , France

Klinikum Esslingen GmbH ( Site 0453)

Esslingen am Neckar, Baden-Wurttemberg, Germany

Universitaetsklinikum Freiburg ( Site 0450)

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Klinikum der Universitaet in Muenchen ( Site 0446)

Munich, Bavaria, Germany

Medizinische Hochschule Hannover ( Site 0449)

Hanover, Lower Saxony, Germany

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

Essen, North Rhine-Westphalia, Germany

Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)

Mainz, Rhineland-Palatinate, Germany

Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)

Dresden, Saxony, Germany

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

Hamburg, , Germany

Integra Cancer Institute ( Site 0262)

Guatemala City, , Guatemala

Grupo Medico Angeles ( Site 0261)

Guatemala City, , Guatemala

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

Quetzaltenango, , Guatemala

Meir medical center ( Site 0386)

Kfar Saba, Central District, Israel

Soroka University M.C ( Site 0385)

Beersheba, Southern District, Israel

Sourasky Medical Center. ( Site 0382)

Tel Aviv, Tell Abib, Israel

Rambam Health Care Campus ( Site 0381)

Haifa, , Israel

Hadassah Medical Center. Ein Kerem ( Site 0383)

Jerusalem, , Israel

Rabin-Medical Center ( Site 0384)

Petah Tikva, , Israel

Sheba Medical center ( Site 0387)

Ramat Gan, , Israel

IRCCS Istituto Oncologico Veneto ( Site 0431)

Padova, Abruzzo, Italy

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

Milan, Lombardy, Italy

Istituto Clinico Humanitas Research Hospital ( Site 0432)

Rozzano, Milano, Italy

IRCCS Policlinico San Donato ( Site 0433)

San Donato Milanese, Milano, Italy

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)

Modena, , Italy

Seconda Universita Napoli ( Site 0436)

Napoli, , Italy

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

Udine, , Italy

Aichi Cancer Center Hospital ( Site 0165)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 0178)

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center ( Site 0186)

Matsuyama, Ehime, Japan

Hokkaido University Hospital ( Site 0160)

Sapporo, Hokkaido, Japan

Hyogo Cancer Center ( Site 0182)

Akashi, Hyōgo, Japan

Kobe University Hospital ( Site 0188)

Kobe, Hyōgo, Japan

Kobe City Medical Center General Hospital ( Site 0181)

Kobe, Hyōgo, Japan

Ibaraki Prefectural Central Hospital ( Site 0177)

Kasama, Ibaraki, Japan

Iwate Medical University Hospital ( Site 0184)

Shiwa-gun, Iwate, Japan

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

Kawasaki, Kanagawa, Japan

Kanagawa Cancer Center ( Site 0167)

Yokohama, Kanagawa, Japan

Kansai Medical University Hospital ( Site 0190)

Hirakata, Osaka, Japan

Osaka University Hospital ( Site 0162)

Suita, Osaka, Japan

Osaka Medical College Hospital ( Site 0168)

Takatsuki, Osaka, Japan

Saitama Cancer Center ( Site 0170)

Kitaadachi-gun, Saitama, Japan

Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)

Sunto-gun, Shizuoka, Japan

Chiba Cancer Center ( Site 0180)

Chiba, , Japan

National Hospital Organization Kyushu Cancer Center ( Site 0172)

Fukuoka, , Japan

Kyushu University Hospital ( Site 0173)

Fukuoka, , Japan

Gifu University Hospital ( Site 0166)

Gifu, , Japan

Hiroshima City Hiroshima Citizens Hospital ( Site 0171)

Hiroshima, , Japan

Kochi Health Sciences Center ( Site 0189)

Kochi, , Japan

Kumamoto University Hospital ( Site 0164)

Kumamoto, , Japan

Niigata Cancer Center Hospital ( Site 0169)

Niigata, , Japan

Osaka International Cancer Institute ( Site 0161)

Osaka, , Japan

Osaka General Medical Center ( Site 0159)

Osaka, , Japan

National Cancer Center Hospital ( Site 0179)

Tokyo, , Japan

Tokyo Metropolitan Komagome Hospital ( Site 0183)

Tokyo, , Japan

The Cancer Institute Hospital of JFCR ( Site 0185)

Tokyo, , Japan

Toyama Prefectural Central Hospital ( Site 0163)

Toyama, , Japan

Riga East Clinical University Hospital ( Site 0550)

Riga, , Latvia

LSMUL Kauno Klinikos ( Site 0570)

Kaunas, , Lithuania

Nacionalinis Vezio Institutas ( Site 0569)

Vilnius, , Lithuania

Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)

Vilnius, , Lithuania

Hospital Kuala Lumpur ( Site 0146)

Kuala Lumpur, , Malaysia

University Malaya Medical Centre ( Site 0143)

Kuala Lumpur, , Malaysia

St. Luke s Medical Center ( Site 0622)

Quezon City, National Capital Region, Philippines

Szpital Uniwersytecki w Krakowie ( Site 0352)

Krakow, Lesser Poland Voivodeship, Poland

Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)

Wroclaw, Lower Silesian Voivodeship, Poland

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

Lublin, Lublin Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Mazowiecki Szpital Onkologiczny ( Site 0363)

Wieliszew, Masovian Voivodeship, Poland

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

Kościerzyna, Pomeranian Voivodeship, Poland

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

Bielsko-Biala, Silesian Voivodeship, Poland

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

Gliwice, Silesian Voivodeship, Poland

SPZOZ WSS nr 3 w Rybniku ( Site 0357)

Rybnik, Silesian Voivodeship, Poland

Kaluga Regional Clinical Oncology Center ( Site 0345)

Kaluga, Kaluzskaja Oblast, Russia

SBHI Leningrad Regional Clinical Hospital ( Site 0496)

Saint Petersburg, Leningradskaya Oblast', Russia

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

Moscow, Moscow, Russia

Blokhin National Medical Oncology ( Site 0494)

Moscow, Moscow, Russia

Leningrad Regional Oncology Center ( Site 0335)

Saint Petersburg, Sankt-Peterburg, Russia

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

Saint Petersburg, Sankt-Peterburg, Russia

City clinical oncological dispensary ( Site 0336)

Saint Petersburg, Sankt-Peterburg, Russia

Tomsk Scientific Research Institute of Oncology ( Site 0337)

Tomsk, Tomsk Oblast, Russia

National University Hospital ( Site 0095)

Singapore, Central Singapore, Singapore

National Cancer Centre Singapore ( Site 0097)

Singapore, Central Singapore, Singapore

Oncocare Cancer Centre ( Site 0096)

Singapore, Central Singapore, Singapore

Chonnam National University Hwasun Hospital ( Site 0083)

Hwasun Gun, Jeonranamdo, South Korea

Seoul National University Bundang Hospital ( Site 0085)

Seongnam-si, Kyonggi-do, South Korea

Kyungpook National University Chilgok Hospital ( Site 0089)

Daegu, Taegu-Kwangyokshi, South Korea

Gachon University Gil Medical Center ( Site 0087)

Incheon, , South Korea

Korea University Anam Hospital ( Site 0084)

Seoul, , South Korea

Seoul National University Hospital -SNUH- ( Site 0080)

Seoul, , South Korea

Severance Hospital Yonsei University Health System ( Site 0081)

Seoul, , South Korea

Asan Medical Center ( Site 0082)

Seoul, , South Korea

Gangnam Severance Hospital ( Site 0088)

Seoul, , South Korea

SMG-SNU BORAMAE Medical Center ( Site 0086)

Seoul, , South Korea

Taipei Medical University Shuang Ho Hospital ( Site 0068)

New Taipei City, , Taiwan

National Cheng Kung University Hospital ( Site 0067)

Tainan City, , Taiwan

National Taiwan University Hospital ( Site 0063)

Taipei, , Taiwan

Mackay Memorial Hospital ( Site 0065)

Taipei, , Taiwan

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

Taipei, , Taiwan

Chang Gung Medical Foundation. Linkou ( Site 0064)

Taoyuan District, , Taiwan

City Clinical Hosp.4 of DCC ( Site 0325)

Dnipro, Dnipropetrovsk Oblast, Ukraine

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

Kryviy Rih, Dnipropetrovsk Oblast, Ukraine

Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

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

Kyiv, Kyivska Oblast, Ukraine

Kyiv City Clinical Oncology Center ( Site 0590)

Kyiv, Kyivska Oblast, Ukraine

University Hospitals Bristol NHS Foundation Trust ( Site 0407)

Bristol, Bristol, City of, United Kingdom

Ninewells Hospital and Medical School ( Site 0406)

Dundee, Dundee City, United Kingdom

Royal Free London NHS Foundation Trust ( Site 0403)

London, London, City of, United Kingdom

The Royal Marsden Foundation Trust ( Site 0405)

London, London, City of, United Kingdom

Imperial College Healthcare NHS Trust ( Site 0402)

London, London, City of, United Kingdom

Royal Marsden NHS Foundation Trust ( Site 0400)

Sutton, Surrey, United Kingdom

The Christie NHS Foundation Trust ( Site 0397)

Manchester, , United Kingdom

Countries

United States; Belgium; Brazil; Canada; Chile; China; Estonia; France; Germany; Guatemala; Israel; Italy; Japan; Latvia; Lithuania; Malaysia; Philippines; Poland; Russia; Singapore; South Korea; Taiwan; Ukraine; United Kingdom

References

Shitara K, Rha SY, Wyrwicz LS, Oshima T, Karaseva N, Osipov M, Yasui H, Yabusaki H, Afanasyev S, Park YK, Al-Batran SE, Yoshikawa T, Yanez P, Dib Bartolomeo M, Lonardi S, Tabernero J, Van Cutsem E, Janjigian YY, Oh DY, Xu J, Fang X, Shih CS, Bhagia P, Bang YJ; KEYNOTE-585 investigators. Neoadjuvant and adjuvant pembrolizumab plus chemotherapy in locally advanced gastric or gastro-oesophageal cancer (KEYNOTE-585): an interim analysis of the multicentre, double-blind, randomised phase 3 study. Lancet Oncol. 2024 Feb;25(2):212-224. doi: 10.1016/S1470-2045(23)00541-7. Epub 2023 Dec 19.

Reference Type: RESULT

PMID: 38134948 (View on PubMed)

Shitara K, Rha SY, Wyrwicz L, Oshima T, Karaseva N, Osipov M, Yasui H, Yabusaki H, Afanasyev S, Park YK, Al-Batran SE, Yoshikawa T, Yanez P, Pietrantonio F, Lonardi S, Fang X, Guan Y, Valderrama A, Leconte P, Bhagia P, Bang YJ; KEYNOTE-585 Investigators. Pembrolizumab Plus Chemotherapy Versus Chemotherapy as Perioperative Therapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer: Final Analysis of the Randomized, Phase III KEYNOTE-585 Study. J Clin Oncol. 2025 Oct 10;43(29):3152-3159. doi: 10.1200/JCO-25-00486. Epub 2025 Aug 19.

Reference Type: DERIVED

PMID: 40829093 (View on PubMed)

Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

Reference Type: DERIVED

PMID: 35623069 (View on PubMed)

Bang YJ, Van Cutsem E, Fuchs CS, Ohtsu A, Tabernero J, Ilson DH, Hyung WJ, Strong VE, Goetze TO, Yoshikawa T, Tang LH, Hwang PMT, Webb N, Adelberg D, Shitara K. KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer. Future Oncol. 2019 Mar;15(9):943-952. doi: 10.2217/fon-2018-0581. Epub 2019 Feb 19.

Reference Type: DERIVED

PMID: 30777447 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26112&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-3475-585

Identifier Type: OTHER

Identifier Source: secondary_id

173786

Identifier Type: REGISTRY

Identifier Source: secondary_id

KEYNOTE-585

Identifier Type: OTHER

Identifier Source: secondary_id

PHRR200226-002534

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-509595-42-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2016-004408-76

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3475-585

Identifier Type: -

Identifier Source: org_study_id