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)

• ClinicalTrials.gov Identifier: NCT03221426
• Recruitment Status: Active, not recruiting
• First Posted: July 18, 2017
• Last Update Posted: May 24, 2021
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer; Gastroesophageal Junction Cancer	Biological: Pembrolizumab; Drug: Placebo; Drug: Cisplatin; Drug: Capecitabine; Drug: 5-fluorouracil; Drug: Docetaxel; Drug: Oxaliplatin; Drug: Leucovorin	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1007 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-blind study
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
• Actual Study Start Date: October 9, 2017
• Estimated Primary Completion Date: June 28, 2024
• Estimated Study Completion Date: June 28, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pembrolizumab+Chemotherapy; 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 via IV infusion on Day 1 Q3W and 5-fluorouracil (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 pembrolizumab 200 mg 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 pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.	Biological: Pembrolizumab; IV infusion; Other Names: MK-3475; KEYTRUDA®; Drug: Cisplatin; IV infusion; Other Name: PLATINOL®; Drug: Capecitabine; Oral tablets; Other Name: XELODA®; Drug: 5-fluorouracil; IV infusion; Other Names: ADRUCIL®; 5FU
Placebo Comparator: Placebo+Chemotherapy; 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.	Drug: Placebo; IV infusion; Other Name: Normal saline solution; Drug: Cisplatin; IV infusion; Other Name: PLATINOL®; Drug: Capecitabine; Oral tablets; Other Name: XELODA®; Drug: 5-fluorouracil; IV infusion; Other Names: ADRUCIL®; 5FU
Experimental: 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.	Biological: Pembrolizumab; IV infusion; Other Names: MK-3475; KEYTRUDA®; Drug: 5-fluorouracil; IV infusion; Other Names: ADRUCIL®; 5FU; Drug: Docetaxel; IV infusion; Other Name: TAXOTERE®; Drug: Oxaliplatin; IV infusion; Other Name: ELOXATIN®; Drug: Leucovorin; IV infusion; Other Name: WELLCOVORIN®
Placebo Comparator: 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.	Drug: Placebo; IV infusion; Other Name: Normal saline solution; Drug: 5-fluorouracil; IV infusion; Other Names: ADRUCIL®; 5FU; Drug: Docetaxel; IV infusion; Other Name: TAXOTERE®; Drug: Oxaliplatin; IV infusion; Other Name: ELOXATIN®; Drug: Leucovorin; IV infusion; Other Name: WELLCOVORIN®

Outcome Measures

Primary Outcome Measures :

1. Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms [ Time Frame: Up to approximately 2 years ]
   EFS is based on RECIST 1.1 as assessed by the investigator and is defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by computer tomography (CT) scan or biopsy if indicated (for participants who are disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who are confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), are not considered EFS events.
2. Pathological Complete Response (pathCR) Rate - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms [ Time Frame: Up to approximately 15 weeks ]
   PathCR rate is defined as the percentage of participants having a pathCR. pathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.
3. Overall Survival (OS) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms [ Time Frame: Up to approximately 2 years ]
   OS is defined as the time from randomization to death due to any cause.
4. Percentage of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 27 months ]
   An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience at least one AE will be presented.
5. Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 2 years ]
   An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinue study treatment due to an AE will be presented.

Secondary Outcome Measures :

1. Percentage of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms Separately and in Combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 27 months ]
   An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience at least one AE will be presented.
2. Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms Separately and in Combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 2 years ]
   An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinue study treatment due to an AE will be presented.
3. Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms [ Time Frame: Up to approximately 2 years ]
   DFS is defined as the time from post-surgery baseline scan until the first occurrence of local/distant recurrence or death from any cause and is based on RECIST 1.1 as assessed by the investigator.
4. Overall Survival (OS) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms and Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 2 years ]
   OS is defined as the time from randomization to death due to any cause.
5. Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms and Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 2 years ]
   EFS is based on RECIST 1.1 as assessed by the investigator and is defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by CT scan or biopsy if indicated (for participants who are disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who are confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), are not considered EFS events.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

City of Hope ( Site 0005)

Duarte, California, United States, 91010

United States, Connecticut

Yale Cancer Center ( Site 0016)

New Haven, Connecticut, United States, 06520

United States, District of Columbia

Georgetown University ( Site 0015)

Washington, District of Columbia, United States, 20007

United States, Illinois

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

Chicago, Illinois, United States, 60611

The University of Chicago Medical Center ( Site 0004)

Chicago, Illinois, United States, 60637

United States, New York

Roswell Park Cancer Institute ( Site 0001)

Buffalo, New York, United States, 14263

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

New York, New York, United States, 10016

Memorial Sloan Kettering ( Site 0024)

New York, New York, United States, 10065

Weill Cornell Medical Center ( Site 0023)

New York, New York, United States, 10065

University of Rochester ( Site 0011)

Rochester, New York, United States, 14642

United States, Pennsylvania

Fox Chase Cancer Center ( Site 0006)

Philadelphia, Pennsylvania, United States, 19111

Temple University Hospital ( Site 0026)

Philadelphia, Pennsylvania, United States, 19140

United States, Utah

University of Utah, Huntsman Cancer Institute ( Site 0012)

Salt Lake City, Utah, United States, 84112

United States, Virginia

Virginia Cancer Specialists, PC ( Site 0010)

Fairfax, Virginia, United States, 22031

Belgium

Institut Jules Bordet ( Site 0480)

Brussels, Bruxelles-Capitale, Region De, Belgium, 1000

Hopital Erasme ULB ( Site 0484)

Brussels, Bruxelles-Capitale, Region De, Belgium, 1070

UCL Saint Luc ( Site 0479)

Bruxelles, Bruxelles-Capitale, Region De, Belgium, 1200

Grand Hopital de Charleroi ( Site 0478)

Charleroi, Hainaut, Belgium, 6000

CHU de Liege ( Site 0482)

Liège, Liege, Belgium, 4000

CHU UCL Namur Site de Godinne ( Site 0485)

Yvoir, Namur, Belgium, 5530

UZ Gent ( Site 0486)

Gent, Oost-Vlaanderen, Belgium, 9000

UZ Leuven ( Site 0483)

Leuven, Vlaams-Brabant, Belgium, 3000

AZ Groeninge ( Site 0481)

Kortrijk, West-Vlaanderen, Belgium, 8500

Brazil

Instituto do Cancer do Ceara ( Site 0311)

Fortaleza, Ceara, Brazil, 60430-230

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

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

CEPON - Centro de Pesquisas Oncologicas ( Site 0302)

Florianopolis, Santa Catarina, Brazil, 88034-000

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

Barretos, Sao Paulo, Brazil, 14784-400

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

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

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

Rio de Janeiro, Brazil, 20230-130

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

Sao Paulo, Brazil, 01246-000

Hospital Israelita Albert Einstein ( Site 0309)

Sao Paulo, Brazil, 05652-900

Canada, Alberta

Cross Cancer Institute ( Site 0033)

Edmonton, Alberta, Canada, T6G 1Z2

Canada, New Brunswick

Moncton Hospital - Horizon Health Network ( Site 0038)

Moncton, New Brunswick, Canada, E1C 6Z8

Canada, Ontario

Sunnybrook Research Institute ( Site 0032)

Toronto, Ontario, Canada, M4N 3M5

Canada, Quebec

CISSS de la Monteregie-Centre ( Site 0039)

Greenfield Park, Quebec, Canada, J4V 2H1

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

Montreal, Quebec, Canada, H1T 2M4

Jewish General Hospital ( Site 0034)

Montreal, Quebec, Canada, H3T 1E2

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

Sherbrooke, Quebec, Canada, J1H 5N4

Canada

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

Quebec, Canada, G1R 2J6

Chile

Instituto Clinico del Sur. ICOS ( Site 0290)

Temuco, Araucania, Chile, 4810469

Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)

Rancagua, Lbtdr Gen Bernardo O Higgins, Chile, 2820000

Fundacion Arturo Lopez Perez FALP ( Site 0286)

Santiago, Region M. De Santiago, Chile, 7500921

Pontificia Universidad Catolica de Chile ( Site 0285)

Santiago, Region M. De Santiago, Chile, 8330032

Hospital Clinico Universidad de Chile ( Site 0287)

Santiago, Region M. De Santiago, Chile, 8380456

China, Beijing

Beijing Cancer Hospital ( Site 0221)

Beijing, Beijing, China, 100142

China, Zhejiang

Zhejiang Cancer Hospital ( Site 0231)

Hangzhou, Zhejiang, China, 310022

Sir Run Run Shaw Hospital ( Site 0233)

Hangzhou, Zhejiang, China, 430030

Estonia

SA Pohja-Eesti Regionaalhaigla ( Site 0526)

Tallinn, Harjumaa, Estonia, 13419

France

Hopital Prive Jean Mermoz ( Site 0462)

Lyon, Auvergne, France, 69008

Institut Paoli Calmettes ( Site 0472)

Marseille, Bouches-du-Rhone, France, 13009

CHU Reims - Hopital Robert Debre ( Site 0465)

Reims, Champagne-Ardenne, France, 51092

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

Brest, Finistere, France, 29200

CHU Toulouse - Hopital Rangueil ( Site 0470)

Toulouse, Haute-Garonne, France, 31059

Institut du Cancer de Montpellier ( Site 0473)

Montpellier, Herault, France, 34298

Centre Eugene Marquis ( Site 0466)

Rennes, Ille-et-Vilaine, France, 35042

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

Saint Herblain, Loire-Atlantique, France, 44805

CHRU Lille - Hopital Claude Huriez ( Site 0461)

Lille, Nord, France, 59037

CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)

Poitiers, Vienne, France, 86021

CHU Hopital Saint Antoine ( Site 0471)

Paris, France, 75012

Institut Mutualiste Montsouris ( Site 0463)

Paris, France, 75014

Germany

Klinikum Esslingen GmbH ( Site 0453)

Esslingen, Baden-Wurttemberg, Germany, 73730

Universitaetsklinikum Freiburg ( Site 0450)

Freiburg, Baden-Wurttemberg, Germany, 79106

Klinikum der Universitaet in Muenchen ( Site 0446)

Muenchen, Bayern, Germany, 81377

Medizinische Hochschule Hannover ( Site 0449)

Hannover, Niedersachsen, Germany, 30625

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

Essen, Nordrhein-Westfalen, Germany, 45136

Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)

Mainz, Rheinland-Pfalz, Germany, 55131

Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)

Dresden, Sachsen, Germany, 01307

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

Hamburg, Germany, 20249

Guatemala

Integra Cancer Institute ( Site 0262)

Guatemala, Guatemala, 01010

Grupo Medico Angeles ( Site 0261)

Guatemala, Guatemala, 01015

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

Quetzaltenango, Guatemala, 09002

Israel

Soroka University M.C ( Site 0385)

Beer Sheva, HaDarom, Israel, 8410101

Meir medical center ( Site 0386)

Kfar Saba, HaMerkaz, Israel, 4428164

Sourasky Medical Center. ( Site 0382)

Tel-Aviv, Tell Abib, Israel, 6423906

Rambam Health Care Campus ( Site 0381)

Haifa, Israel, 31096

Hadassah Medical Center. Ein Kerem ( Site 0383)

Jerusalem, Israel, 9112001

Rabin-Medical Center ( Site 0384)

Petah Tikva, Israel, 4941492

Sheba Medical center ( Site 0387)

Ramat Gan, Israel, 5265601

Italy

IRCCS Istituto Oncologico Veneto ( Site 0431)

Padova, Abruzzo, Italy, 35128

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

Milano, Lombardia, Italy, 20133

Istituto Clinico Humanitas Research Hospital ( Site 0432)

Rozzano, Milano, Italy, 20089

IRCCS Policlinico San Donato ( Site 0433)

San Donato Milanese, Milano, Italy, 20097

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)

Modena, Italy, 41125

Seconda Universita Napoli ( Site 0436)

Napoli, Italy, 80131

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

Udine, Italy, 33100

Japan

Aichi Cancer Center Hospital ( Site 0165)

Nagoya, Aichi, Japan, 464-8681

National Cancer Center Hospital East ( Site 0178)

Kashiwa, Chiba, Japan, 277-8577

National Hospital Organization Shikoku Cancer Center ( Site 0186)

Matsuyama, Ehime, Japan, 791-0280

Hokkaido University Hospital ( Site 0160)

Sapporo, Hokkaido, Japan, 060-8648

Hyogo Cancer Center ( Site 0182)

Akashi, Hyogo, Japan, 673-8558

Kobe University Hospital ( Site 0188)

Kobe, Hyogo, Japan, 650-0017

Kobe City Medical Center General Hospital ( Site 0181)

Kobe, Hyogo, Japan, 650-0047

Ibaraki Prefectural Central Hospital ( Site 0177)

Kasama, Ibaraki, Japan, 309-1793

Iwate Medical University Hospital ( Site 0184)

Shiwa-gun, Iwate, Japan, 028-3695

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

Kawasaki, Kanagawa, Japan, 216-8511

Kanagawa Cancer Center ( Site 0167)

Yokohama, Kanagawa, Japan, 241-8515

Kansai Medical University Hospital ( Site 0190)

Hirakata, Osaka, Japan, 573-1191

Osaka University Hospital ( Site 0162)

Suita, Osaka, Japan, 565-0871

Osaka Medical College Hospital ( Site 0168)

Takatsuki, Osaka, Japan, 569-8686

Saitama Cancer Center ( Site 0170)

Kitaadachi-gun, Saitama, Japan, 362-0806

Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)

Sunto-gun, Shizuoka, Japan, 411-8777

Chiba Cancer Center ( Site 0180)

Chiba, Japan, 260-8717

National Hospital Organization Kyushu Cancer Center ( Site 0172)

Fukuoka, Japan, 811-1395

Kyushu University Hospital ( Site 0173)

Fukuoka, Japan, 812-8582

Gifu University Hospital ( Site 0166)

Gifu, Japan, 501-1194

Hiroshima City Hiroshima Citizens Hospital ( Site 0171)

Hiroshima, Japan, 730-8518

Kochi Health Sciences Center ( Site 0189)

Kochi, Japan, 781-8555

Kumamoto University Hospital ( Site 0164)

Kumamoto, Japan, 860-8556

Niigata Cancer Center Hospital ( Site 0169)

Niigata, Japan, 951-8566

Osaka International Cancer Institute ( Site 0161)

Osaka, Japan, 541-8567

Osaka General Medical Center ( Site 0159)

Osaka, Japan, 558-8558

National Cancer Center Hospital ( Site 0179)

Tokyo, Japan, 104-0045

Tokyo Metropolitan Komagome Hospital ( Site 0183)

Tokyo, Japan, 113-8677

The Cancer Institute Hospital of JFCR ( Site 0185)

Tokyo, Japan, 135-8550

Toyama Prefectural Central Hospital ( Site 0163)

Toyama, Japan, 930-8550

Korea, Republic of

Chonnam National University Hwasun Hospital ( Site 0083)

Hwasun Gun, Jeonranamdo, Korea, Republic of, 58128

Seoul National University Bundang Hospital ( Site 0085)

Seongnam-si, Kyonggi-do, Korea, Republic of, 13620

Kyungpook National University Chilgok Hospital ( Site 0089)

Daegu, Taegu-Kwangyokshi, Korea, Republic of, 41404

Gachon University Gil Medical Center ( Site 0087)

Incheon, Korea, Republic of, 21565

Korea University Anam Hospital ( Site 0084)

Seoul, Korea, Republic of, 02841

Seoul National University Hospital -SNUH- ( Site 0080)

Seoul, Korea, Republic of, 03080

Severance Hospital Yonsei University Health System ( Site 0081)

Seoul, Korea, Republic of, 03722

Asan Medical Center ( Site 0082)

Seoul, Korea, Republic of, 05505

Gangnam Severance Hospital ( Site 0088)

Seoul, Korea, Republic of, 06273

SMG-SNU BORAMAE Medical Center ( Site 0086)

Seoul, Korea, Republic of, 07061

Latvia

Riga East Clinical University Hospital ( Site 0550)

Riga, Latvia, 1079

Lithuania

LSMUL Kauno Klinikos ( Site 0570)

Kaunas, Lithuania, 50161

Nacionalinis Vezio Institutas ( Site 0569)

Vilnius, Lithuania, 08406

Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)

Vilnius, Lithuania, 08460

Malaysia

Hospital Kuala Lumpur ( Site 0146)

Kuala Lumpur, Malaysia, 50586

University Malaya Medical Centre ( Site 0143)

Kuala Lumpur, Malaysia, 59100

Philippines

St. Luke s Medical Center ( Site 0622)

Quezon City, National Capital Region, Philippines, 1102

Poland

Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)

Wroclaw, Dolnoslaskie, Poland, 51-124

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

Lublin, Lubelskie, Poland, 20-080

Szpital Uniwersytecki w Krakowie ( Site 0352)

Krakow, Malopolskie, Poland, 31-501

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

Warszawa, Mazowieckie, Poland, 02-034

Mazowiecki Szpital Onkologiczny ( Site 0363)

Wieliszew, Mazowieckie, Poland, 05-135

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

Koscierzyna, Pomorskie, Poland, 83-400

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

Bielsko-Biala, Slaskie, Poland, 43-300

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

Gliwice, Slaskie, Poland, 44-101

SPZOZ WSS nr 3 w Rybniku ( Site 0357)

Rybnik, Slaskie, Poland, 44-200

Russian Federation

Kaluga Regional Clinical Oncology Center ( Site 0345)

Kaluga, Kaluzskaja Oblast, Russian Federation, 248007

SBHI Leningrad Regional Clinical Hospital ( Site 0496)

Saint Petersburg, Leningradskaya Oblast, Russian Federation, 194291

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

Moscow, Moskva, Russian Federation, 105203

Blokhin National Medical Oncology ( Site 0494)

Moscow, Moskva, Russian Federation, 115478

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

Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758

Leningrad Regional Oncology Center ( Site 0335)

Saint-Petersburg, Sankt-Peterburg, Russian Federation, 188663

City clinical oncological dispensary ( Site 0336)

Sankt-Petersburg, Sankt-Peterburg, Russian Federation, 198255

Tomsk Scientific Research Institute of Oncology ( Site 0337)

Tomsk, Tomskaya Oblast, Russian Federation, 634028

Singapore

National University Hospital ( Site 0095)

Singapore, Central Singapore, Singapore, 119074

National Cancer Centre Singapore ( Site 0097)

Singapore, Central Singapore, Singapore, 169610

Oncocare Cancer Centre ( Site 0096)

Singapore, Central Singapore, Singapore, 258499

Taiwan

Taipei Medical University Shuang Ho Hospital ( Site 0068)

New Taipei, Taiwan, 235

National Cheng Kung University Hospital ( Site 0067)

Tainan, Taiwan, 704

National Taiwan University Hospital ( Site 0063)

Taipei, Taiwan, 10002

Mackay Memorial Hospital ( Site 0065)

Taipei, Taiwan, 104

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

Taipei, Taiwan, 11259

Chang Gung Medical Foundation. Linkou ( Site 0064)

Taoyuan, Taiwan, 333

Ukraine

City Clinical Hosp.4 of DCC ( Site 0325)

Dnipro, Dnipropetrovska Oblast, Ukraine, 49102

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

Kryviy Rih, Dnipropetrovska Oblast, Ukraine, 50048

Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)

Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76018

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

Kharkiv, Kharkivska Oblast, Ukraine, 61070

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

Kyiv, Kyivska Oblast, Ukraine, 03022

Kyiv City Clinical Oncology Center ( Site 0590)

Kyiv, Kyivska Oblast, Ukraine, 03115

United Kingdom

University Hospitals Bristol NHS Foundation Trust ( Site 0407)

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

Ninewells Hospital and Medical School ( Site 0406)

Dundee, Dundee City, United Kingdom, DD1 9SY

Royal Free London NHS Foundation Trust ( Site 0403)

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

The Royal Marsden Foundation Trust ( Site 0405)

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

Imperial College Healthcare NHS Trust ( Site 0402)

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

Royal Marsden NHS Foundation Trust ( Site 0400)

Sutton, Surrey, United Kingdom, SM2 5PT

The Christie NHS Foundation Trust ( Site 0397)

Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

More Information

Additional Information:

Merck Oncology Clinical Trials Information 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT03221426
• Other Study ID Numbers: 3475-585; 2016-004408-76 ( EudraCT Number ); MK-3475-585 ( Other Identifier: Merck Protocol Number ); 173786 ( Registry Identifier: JAPIC ); KEYNOTE-585 ( Other Identifier: Merck ); PHRR200226-002534 ( Registry Identifier: PHRR Research Registration )
• First Posted: July 18, 2017
• Last Update Posted: May 24, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck Sharp & Dohme LLC:

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

Additional relevant MeSH terms:

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Leucovorin; Docetaxel; Pembrolizumab; Fluorouracil; Capecitabine; Oxaliplatin; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological; Antimetabolites; Antimetabolites, Antineoplastic; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antidotes; Protective Agents; Vitamin B Complex; Vitamins; Micronutrients