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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03221426
Recruitment Status : Active, not recruiting
First Posted : July 18, 2017
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 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

Resource links provided by the National Library of Medicine


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) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.

Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 14 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.

Adjuvant: 4 to 10 weeks post-surgery, participants receive 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 via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 14 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 pembrolizumab 200 mg via IV infusion Day 1 Q3W for up to 11 cycles 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.

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 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.

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®




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 6 weeks after completion of 3 cycles of neoadjuvant treatment (Up to 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. 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.

  4. 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. 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. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221426


Locations
Hide Hide 171 study locations
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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 Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
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    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Leucovorin
Docetaxel
Fluorouracil
Capecitabine
Oxaliplatin
Pembrolizumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances