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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)

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ClinicalTrials.gov Identifier: NCT03221426
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : November 30, 2018
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 hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS), event-free survival (EFS) and pathological complete response (pathCR) rate.


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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 860 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 : July 26, 2023
Estimated Study Completion Date : July 26, 2023

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 Name: MK-3475

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
Normal saline solution 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 Safety 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 Name: MK-3475

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 Safety 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
Normal saline solution 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. Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
    OS is defined as the time from randomization to death due to any cause.

  2. Event-free Survival (EFS) [ Time Frame: Up to approximately 2 years ]
    EFS is defined as the time from randomization to the first of the following events: radiographic disease progression per Response Criteria in Solid Tumors version 1.1 (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); or death due to any cause. A second primary malignancy is not considered as an EFS event.

  3. Pathological Complete Response (pathCR) Rate [ 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 pathCR. pathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.

  4. Adverse Events (AEs) [ 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 number of participants who experience at least one AE will be presented.

  5. Study Treatment Discontinuations Due to AEs [ 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 number of participants who discontinue study treatment due to an AE will be presented.


Secondary Outcome Measures :
  1. Disease-free Survival (DFS) [ 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 blinded independent central review.



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.


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


Contacts
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

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Locations
United States, California
City of Hope ( Site 0005) Recruiting
Duarte, California, United States, 91010
Contact: Study Coordinator    626-471-9200      
United States, Connecticut
Yale Cancer Center ( Site 0016) Recruiting
New Haven, Connecticut, United States, 06520
Contact: Study Coordinator    203-785-6661      
United States, District of Columbia
Georgetown University ( Site 0015) Recruiting
Washington, District of Columbia, United States, 20007
Contact: Study Coordinator    801-585-0330      
United States, Illinois
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018) Recruiting
Chicago, Illinois, United States, 60611
Contact: Study Coordinator    312-695-6180      
The University of Chicago Medical Center ( Site 0004) Recruiting
Chicago, Illinois, United States, 60637
Contact: Study Coordinator    773-702-7596      
United States, New York
Roswell Park Cancer Institute ( Site 0001) Recruiting
Buffalo, New York, United States, 14263
Contact: Study Coordinator    877-275-7724      
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019) Recruiting
New York, New York, United States, 10016
Contact: Study Coordinator    202-444-1781      
Memorial Sloan Kettering ( Site 0024) Recruiting
New York, New York, United States, 10065
Contact: Study Coordinator    646-888-4183      
Weill Cornell Medical Center ( Site 0023) Recruiting
New York, New York, United States, 10065
Contact: Study Coordinator    646-962-6200      
University of Rochester ( Site 0011) Recruiting
Rochester, New York, United States, 14642
Contact: Study Coordinator    703-280-5390      
United States, Pennsylvania
Fox Chase Cancer Center ( Site 0006) Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Study Coordinator    215-214-4283      
Temple University Hospital ( Site 0026) Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Study Coordinator    215-214-4283      
United States, Utah
University of Utah, Huntsman Cancer Institute ( Site 0012) Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Study Coordinator    585-275-5823      
United States, Virginia
Virginia Cancer Specialists, PC ( Site 0010) Recruiting
Fairfax, Virginia, United States, 22031
Contact: Study Coordinator    703-280-5390      
Belgium
Institut Jules Bordet ( Site 0480) Recruiting
Brussels, Belgium, 1000
Contact: Study Coordinator    +3225417209      
Hopital Erasme ULB ( Site 0484) Recruiting
Brussels, Belgium, 1070
Contact: Study Coordinator    +3225553714      
UCL Saint Luc ( Site 0479) Recruiting
Bruxelles, Belgium, 1200
Contact: Study Coordinator    +3227641274      
Grand Hopital de Charleroi ( Site 0478) Recruiting
Charleroi, Belgium, 6000
Contact: Study Coordinator    +3271104730      
AZ Groeninge ( Site 0481) Recruiting
Kortrijk, Belgium, 8500
Contact: Study Coordinator    +3256633338      
UZ Leuven ( Site 0483) Recruiting
Leuven, Belgium, 3000
Contact: Study Coordinator    +3216344218      
CHU - Sart Tilman ( Site 0482) Recruiting
Liege, Belgium, 4000
Contact: Study Coordinator    +3243667256      
CHU UCL Namur Site de Godinne ( Site 0485) Recruiting
Yvoir, Belgium, 5530
Contact: Study Coordinator    +3281423858      
Brazil
Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307) Recruiting
Rio de Janeiro, RJ, Brazil, 20230-130
Contact: Study Coordinator    +552132076564      
Hospital Sao Lucas da PUCRS ( Site 0308) Recruiting
Porto Alegre, RS, Brazil, 90610-000
Contact: Study Coordinator    +555133203039      
CEPON - Centro de Pesquisas Oncologicas ( Site 0302) Recruiting
Florianopolis, Santa Catarina, Brazil, 88034-000
Contact: Study Coordinator    +554833311553      
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301) Recruiting
Barretos, SP, Brazil, 14784-400
Contact: Study Coordinator    +551733216637      
Instituto do Cancer de Sao Paulo - ICESP ( Site 0305) Recruiting
Sao Paulo, SP, Brazil, 01246-000
Contact: Study Coordinator    +551138932615      
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0304) Recruiting
Sao Jose Rio Preto, Brazil, 15090-000
Contact: Study Coordinator    +551732015054      
Canada, Alberta
Cross Cancer Institute ( Site 0033) Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Study Coordinator    7804328513      
Canada, New Brunswick
Moncton Hospital - Horizon Health Network ( Site 0038) Recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Contact: Study Coordinator    5068575669      
Canada, Ontario
Sunnybrook Research Institute ( Site 0032) Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Study Coordinator    4164804270      
Canada, Quebec
CISSS de la Monteregie-Centre ( Site 0039) Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Contact: Study Coordinator    4504665000x2696      
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040) Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Study Coordinator    51425234005853      
Jewish General Hospital ( Site 0034) Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Study Coordinator    5143408222      
CIUSSS de l'Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035) Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Study Coordinator    819346111016216      
Canada
CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042) Recruiting
Quebec, Canada, G1R 2J6
Contact: Study Coordinator    4185254444      
Chile
Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299) Recruiting
Rancagua, Chile, 2820000
Contact: Study Coordinator    +56998 9000000      
Fundacion Arturo Lopez Perez FALP ( Site 0286) Recruiting
Santiago, Chile, 7500921
Contact: Study Coordinator    +56224457254      
Pontificia Universidad Catolica de Chile ( Site 0285) Recruiting
Santiago, Chile, 8330032
Contact: Study Coordinator    +56222472327      
Hospital Clinico Universidad de Chile ( Site 0287) Completed
Santiago, Chile, 8380456
Instituto Clinico del Sur. ICOS ( Site 0290) Recruiting
Temuco, Chile, 4810469
Contact: Study Coordinator    +56994443272      
France
CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474) Recruiting
Brest, France, 29200
Contact: Study Coordinator    +33298223428      
CHRU Lille - Hopital Claude Huriez ( Site 0461) Recruiting
Lille, France, 59037
Contact: Study Coordinator    +33320444407      
Hopital Prive Jean Mermoz ( Site 0462) Recruiting
Lyon, France, 69008
Contact: Study Coordinator    +33437538764      
Institut Paoli Calmettes ( Site 0472) Recruiting
Marseille, France, 13009
Contact: Study Coordinator    +33491223537      
Institut du Cancer de Montpellier ( Site 0473) Recruiting
Montpellier, France, 34298
Contact: Study Coordinator    +33467613136      
CHU Hopital Saint Antoine ( Site 0471) Recruiting
Paris, France, 75012
Contact: Study Coordinator    +33171970401      
Institut Mutualiste Montsouris ( Site 0463) Recruiting
Paris, France, 75014
Contact: Study Coordinator    +33156616241      
CHU Poitiers - Pole Regional de Cancerologie ( Site 0467) Recruiting
Poitiers, France, 86021
Contact: Study Coordinator    +33549444951      
Centre Eugene Marquis ( Site 0466) Recruiting
Rennes, France, 35042
Contact: Study Coordinator    +33299253159      
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469) Recruiting
Saint Herblain, France, 44805
Contact: Study Coordinator    +33240679900      
CHU Toulouse - Hopital Rangueil ( Site 0470) Recruiting
Toulouse, France, 31059
Contact: Study Coordinator    +33561322142      
Germany
Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448) Recruiting
Dresden, Germany, 01307
Contact: Study Coordinator    +493514584794      
Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445) Recruiting
Essen, Germany, 45136
Contact: Study Coordinator    +4920117424524      
Klinikum Esslingen GmbH ( Site 0453) Recruiting
Esslingen, Germany, 73730
Contact: Study Coordinator    +4971131032451      
Universitaetsklinikum Freiburg ( Site 0450) Recruiting
Freiburg, Germany, 79106
Contact: Study Coordinator    +4976127028080      
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454) Recruiting
Hamburg, Germany, 20249
Contact: Study Coordinator    +49404602001      
Medizinische Hochschule Hannover ( Site 0449) Recruiting
Hannover, Germany, 30625
Contact: Study Coordinator    +495115326727      
Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455) Recruiting
Mainz, Germany, 55131
Contact: Study Coordinator    +496131176076      
Klinikum der Universitaet in Muenchen ( Site 0446) Recruiting
Muenchen, Germany, 81377
Contact: Study Coordinator    +498944000      
Israel
Soroka University M.C ( Site 0385) Recruiting
Beer Sheva, Israel, 8410101
Contact: Study Coordinator    +972864000798      
Rambam Health Care Campus ( Site 0381) Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator    +97247776731      
Hadassah Medical Center ( Site 0383) Recruiting
Jerusalem, Israel, 9112001
Contact: Study Coordinator    +97226777957      
Meir medical center ( Site 0386) Recruiting
Kfar Saba, Israel, 4428164
Contact: Study Coordinator    +97297472393      
Rabin-Medical Center ( Site 0384) Recruiting
Petah Tikva, Israel, 4963211
Contact: Study Coordinator    +97239378081      
Sheba Medical center ( Site 0387) Recruiting
Ramat Gan, Israel, 5265601
Contact: Study Coordinator    +97235307776      
Sourasky Medical Center. ( Site 0382) Recruiting
Tel-Aviv, Israel, 6423906
Contact: Study Coordinator    +97236973082      
Italy
Istituto Clinico Humanitas Research Hospital ( Site 0432) Recruiting
Rozzano, Milano, Italy, 20089
Contact: Study Coordinator    +390282244080      
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429) Recruiting
Modena, MO, Italy, 41125
Contact: Study Coordinator    +300594224383      
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0430) Recruiting
Milano, Italy, 20133
Contact: Study Coordinator    +390223903835      
Seconda Universita Napoli ( Site 0436) Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +390815666713      
IRCCS Istituto Oncologico Veneto ( Site 0431) Recruiting
Padova, Italy, 35128
Contact: Study Coordinator    +390498215910      
IRCCS Policlinico San Donato ( Site 0433) Recruiting
San Donato Milanese, Italy, 20097
Contact: Study Coordinator    +3902527741      
A.O.U. Santa Maria della Misericordia di Udine ( Site 0434) Recruiting
Udine, Italy, 33100
Contact: Study Coordinator    +390432559330      
Japan
Aichi Cancer Center Hospital ( Site 0165) Recruiting
Nagoya, Aichi, Japan, 464-8681
Contact: Study Coordinator    +81527626111      
National Cancer Center Hospital East ( Site 0178) Recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact: Study Coordinator    +81471331111      
National Hospital Organization Shikoku Cancer Center ( Site 0186) Recruiting
Matsuyama, Ehime, Japan, 791-0280
Contact: Study Coordinator    +81899991111      
Hokkaido University Hospital ( Site 0160) Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Contact: Study Coordinator    +81117161161      
Hyogo Cancer Center ( Site 0182) Recruiting
Akashi, Hyogo, Japan, 673-8558
Contact: Study Coordinator    +81789291151      
Kobe University Hospital ( Site 0188) Recruiting
Kobe, Hyogo, Japan, 650-0017
Contact: Study Coordinator    +81783825111      
Kobe City Medical Center General Hospital ( Site 0181) Recruiting
Kobe, Hyogo, Japan, 650-0047
Contact: Study Coordinator    +81783024321      
Ibaraki Prefectural Central Hospital ( Site 0177) Recruiting
Kasama, Ibaraki, Japan, 309-1793
Contact: Study Coordinator    +81296771121      
Iwate Medical University Hospital ( Site 0184) Recruiting
Morioka, Iwate, Japan, 020-8505
Contact: Study Coordinator    +81196515111      
St. Marianna University School of Medicine Hospital ( Site 0187) Recruiting
Kawasaki, Kanagawa, Japan, 216-8511
Contact: Study Coordinator    +81449778111      
Kanagawa Cancer Center ( Site 0167) Recruiting
Yokohama, Kanagawa, Japan, 241-8515
Contact: Study Coordinator    +81455202222      
Kansai Medical University Hospital ( Site 0190) Recruiting
Hirakata, Osaka, Japan, 573-1191
Contact: Study Coordinator    +81728040101      
Osaka University Hospital ( Site 0162) Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Study Coordinator    +81668795111      
Osaka Medical College Hospital ( Site 0168) Recruiting
Takatsuki, Osaka, Japan, 569-8686
Contact: Study Coordinator    +81726831221      
Saitama Cancer Center ( Site 0170) Recruiting
Kitaadachi-gun, Saitama, Japan, 362-0806
Contact: Study Coordinator    +81487221111      
Shizuoka Cancer Center Hospital and Research Institute ( Site 0176) Recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Contact: Study Coordinator    +81559895222      
Chiba Cancer Center ( Site 0180) Recruiting
Chiba, Japan, 260-8717
Contact: Study Coordinator    +81432645431      
National Hospital Organization Kyushu Cancer Center ( Site 0172) Recruiting
Fukuoka, Japan, 811-1395
Contact: Study Coordinator    +81925413231      
Kyushu University Hospital ( Site 0173) Recruiting
Fukuoka, Japan, 812-8582
Contact: Study Coordinator    +81926411151      
Gifu University Hospital ( Site 0166) Recruiting
Gifu, Japan, 501-1194
Contact: Study Coordinator    +81582306000      
Hiroshima City Hiroshima Citizens Hospital ( Site 0171) Recruiting
Hiroshima, Japan, 730-8518
Contact: Study Coordinator    +81822212291      
Kochi Health Sciences Center ( Site 0189) Recruiting
Kochi, Japan, 781-8555
Contact: Study Coordinator    +81888373000      
Kumamoto University Hospital ( Site 0164) Recruiting
Kumamoto, Japan, 860-8556
Contact: Study Coordinator    +81963442111      
Niigata Cancer Center Hospital ( Site 0169) Recruiting
Niigata, Japan, 951-8566
Contact: Study Coordinator    +81252665111      
Osaka International Cancer Institute ( Site 0161) Recruiting
Osaka, Japan, 541-8567
Contact: Study Coordinator    +81669451181      
Osaka General Medical Center ( Site 0159) Recruiting
Osaka, Japan, 558-8558
Contact: Study Coordinator    +81666921201      
National Cancer Center Hospital ( Site 0179) Recruiting
Tokyo, Japan, 104-0045
Contact: Study Coordinator    +81335422511      
Tokyo Metropolitan Komagome Hospital ( Site 0183) Recruiting
Tokyo, Japan, 113-8677
Contact: Study Coordinator    +81338232101      
The Cancer Institute Hospital of JFCR ( Site 0185) Recruiting
Tokyo, Japan, 135-8550
Contact: Study Coordinator    +81335200111      
Toyama Prefectural Central Hospital ( Site 0163) Recruiting
Toyama, Japan, 930-8550
Contact: Study Coordinator    +81764241531      
Korea, Republic of
Seoul National University Bundang Hospital ( Site 0085) Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Study Coordinator    +82317877037      
Chonnam National University Hwasun Hospital ( Site 0083) Recruiting
Hwasun Gun, Jeollanam Do, Korea, Republic of, 58128
Contact: Study Coordinator    +82613797623      
Korea University Anam Hospital ( Site 0084) Recruiting
Seoul, Korea, Republic of, 02841
Contact: Study Coordinator    +8229206082      
Seoul National University Hospital -SNUH- ( Site 0080) Recruiting
Seoul, Korea, Republic of, 03080
Contact: Study Coordinator    82220722236      
Severance Hospital Yonsei University Health System ( Site 0081) Recruiting
Seoul, Korea, Republic of, 03722
Contact: Study Coordinator    +82222288132      
Asan Medical Center ( Site 0082) Recruiting
Seoul, Korea, Republic of, 05505
Contact: Study Coordinator    +82230103230      
SMG-SNU BORAMAE Medical Center ( Site 0086) Recruiting
Seoul, Korea, Republic of, 07061
Contact: Study Coordinator    +8228702231      
Poland
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353) Recruiting
Koscierzyna, Pomorskie, Poland, 83-400
Contact: Study Coordinator    +48793929449      
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354) Completed
Bielsko-Biala, Poland, 43-300
Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 0361) Recruiting
Gliwice, Poland, 44-101
Contact: Study Coordinator    +48322788237      
Szpital Uniwersytecki w Krakowie ( Site 0352) Recruiting
Krakow, Poland, 31-531
Contact: Study Coordinator    +48124248912      
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351) Recruiting
Lublin, Poland, 20-081
Contact: Study Coordinator    +48815344313      
SPZOZ WSS nr 3 w Rybniku ( Site 0357) Recruiting
Rybnik, Poland, 44-200
Contact: Study Coordinator    +48603759221      
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0349) Recruiting
Warszawa, Poland, 02-034
Contact: Study Coordinator    +48225462328      
Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358) Recruiting
Wroclaw, Poland, 51-124
Contact: Study Coordinator    +48606753363      
Russian Federation
Kaluga Regional Clinical Oncology Center ( Site 0345) Recruiting
Kaluga, Russian Federation, 248007
Contact: Study Coordinator    +79200900576      
National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338) Recruiting
Moscow, Russian Federation, 105203
Contact: Study Coordinator    +74956037218      
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344) Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Study Coordinator    +79219462123      
Leningrad Regional Oncology Center ( Site 0335) Recruiting
Saint-Petersburg, Russian Federation, 188663
Contact: Study Coordinator    +79219650996      
City clinical oncological dispensary ( Site 0336) Recruiting
Sankt-Petersburg, Russian Federation, 198255
Contact: Study Coordinator    +78127569923      
Tomsk Scientific Research Institute of Oncology ( Site 0337) Recruiting
Tomsk, Russian Federation, 634028
Contact: Study Coordinator    +73822418091      
Singapore
National University Hospital ( Site 0095) Recruiting
Singapore, Singapore, 119074
Contact: Study Coordinator    +6567724670      
National Cancer Centre Singapore ( Site 0097) Recruiting
Singapore, Singapore, 169610
Contact: Study Coordinator    +6564368497      
Oncocare Cancer Centre ( Site 0096) Recruiting
Singapore, Singapore, 258499
Contact: Study Coordinator    +6567723905      
Taiwan
Taipei Medical University Shuang Ho Hospital ( Site 0068) Recruiting
New Taipei, Taiwan, 23561
Contact: Study Coordinator    886222490088      
National Cheng Kung University Hospital ( Site 0067) Recruiting
Tainan, Taiwan, 70403
Contact: Study Coordinator    +88662353535      
National Taiwan University Hospital ( Site 0063) Recruiting
Taipei, Taiwan, 100
Contact: Study Coordinator    +886223123456      
Mackay Memorial Hospital ( Site 0065) Recruiting
Taipei, Taiwan, 104
Contact: Study Coordinator    +886225433535      
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066) Recruiting
Taipei, Taiwan, 11259
Contact: Study Coordinator    +886228970011      
Chang Gung Medical Foundation. Linkou ( Site 0064) Recruiting
Taoyuan, Taiwan, 333
Contact: Study Coordinator    +88633281200      
United Kingdom
Royal Marsden NHS Foundation Trust ( Site 0400) Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Study Coordinator    +442089156196      
Imperial College Healthcare NHS Trust ( Site 0402) Recruiting
London, UK, United Kingdom, W2 1NY
Contact: Study Coordinator    +442033113311      
Ninewells Hospital and Medical School ( Site 0406) Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Study Coordinator    +441382496685      
Royal Free London NHS Foundation Trust ( Site 0403) Recruiting
London, United Kingdom, NW3 2QG
Contact: Study Coordinator    +44207794050032325      
The Royal Marsden Foundation Trust ( Site 0405) Recruiting
London, United Kingdom, SW3 6JJ
Contact: Study Coordinator    +442089156196      
The Christie NHS Foundation Trust ( Site 0397) Active, not recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03221426     History of Changes
Other Study ID Numbers: 3475-585
2016-004408-76 ( EudraCT Number )
MK-3475-585 ( Other Identifier: Merck Protocol Number )
173786 ( Registry Identifier: JAPIC )
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

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.:
PD1
PD-1
PDL1
PD-L1

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pharmaceutical Solutions
Docetaxel
Oxaliplatin
Pembrolizumab
Cisplatin
Capecitabine
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs