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Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)

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ClinicalTrials.gov Identifier: NCT03615326
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).

Condition or disease Intervention/treatment Phase
Gastric Neoplasms Gastroesophageal Junction Adenocarcinoma Biological: Pembrolizumab Biological: Placebo Drug: Cisplatin Drug: 5-FU Drug: Oxaliplatin Drug: Capecitabine Drug: S-1 Biological: Trastuzumab Phase 3

Detailed Description:
Pembrolizumab (200 mg) or placebo will be administered intravenously [IV] on day 1 of each 3-week cycle. Trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance dose) will be administered IV on day 1 of each 3-week cycle. SOC chemotherapy for the global cohort will either be FP (80 mg/m^2 cisplatin administered IV on Day 1 of each 3-week cycle and 800 mg/m^2 5-fluorouracil [5-FU] administered IV on Days 1-5 of each 3-week cycle) or CAPOX (1000 mg/m^2 capecitabine administered orally twice daily [BID] on days 1-14 of each 3-week cycle and 130 mg/m^2 oxaliplatin administered IV on Day 1 of each 3-week cycle). A Japan cohort will receive SOX chemotherapy consisting of S-1 (tegafur, 5-chloro-2,4-dihydroxypyridine [CDHP], and potassium oxonate [Oxo]) administered orally BID according to Body Surface Area (BSA) on Days 1-14 of each 3-week cycle and oxaliplatin (130 mg/m^2) administered IV on Day 1 each 3-week cycle.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 732 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)
Actual Study Start Date : October 5, 2018
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : March 20, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab +Trastuzumab + Chemotherapy
Participants receive 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy (Global Cohort) or SOX chemotherapy (Japan cohort).
Biological: Pembrolizumab
200 mg on Day 1 of each 3-week cycle as an IV infusion.
Other Names:
  • Keytruda®
  • MK-3475

Drug: Cisplatin
80 mg/m^2 on Day 1 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen.

Drug: 5-FU
800 mg/m^2/day continuous on Days 1-5 of each 3-week cycle (120 hours or per local standard), administered as part of FP chemotherapy regimen.

Drug: Oxaliplatin
130 mg/m^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen and as part of SOX chemotherapy regimen.

Drug: Capecitabine
1000 mg/m^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.

Drug: S-1
Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): <1.25 m^2 BSA =40 mg, 1.25 to <1.5 m^2 BSA=50 mg, ≥1.5 m^2 BSA=60 mg. Administered as part of SOX chemotherapy regimen.

Biological: Trastuzumab
8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.
Other Name: Herceptin®

Active Comparator: Placebo +Trastuzumab + Chemotherapy
Participants receive matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy (Global Cohort) or SOX chemotherapy (Japan cohort).
Biological: Placebo
Solution for IV infusion on Day 1 of each 3-week cycle.

Drug: Cisplatin
80 mg/m^2 on Day 1 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen.

Drug: 5-FU
800 mg/m^2/day continuous on Days 1-5 of each 3-week cycle (120 hours or per local standard), administered as part of FP chemotherapy regimen.

Drug: Oxaliplatin
130 mg/m^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen and as part of SOX chemotherapy regimen.

Drug: Capecitabine
1000 mg/m^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.

Drug: S-1
Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): <1.25 m^2 BSA =40 mg, 1.25 to <1.5 m^2 BSA=50 mg, ≥1.5 m^2 BSA=60 mg. Administered as part of SOX chemotherapy regimen.

Biological: Trastuzumab
8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.
Other Name: Herceptin®




Primary Outcome Measures :
  1. Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR [ Time Frame: Up to 4 years ]
    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. PFS will be determined for each treatment arm.

  2. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) per RECIST 1.1 assessed by BICR [ Time Frame: Up to 5 years ]
    ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by BICR. ORR will be determined for each treatment arm.

  2. Duration of Response (DOR) per RECIST 1.1 assessed by BICR [ Time Frame: Up to 5 years ]
    For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR will be determined for each treatment arm.

  3. Adverse Events (AE) [ Time Frame: Up to 5 years ]
    An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm.

  4. Treatment Discontinuations Due to AEs [ Time Frame: Up to 5 years ]
    An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinue study treatment due to an AE will be reported for each treatment arm.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma
  • HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor
  • Has measurable disease as defined by RECIST 1.1 as determined by the site investigator
  • Male participants must agree to use approved contraception
  • Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of trial treatment
  • Has a life expectancy of greater than 6 months
  • Has adequate organ function

Exclusion Criteria:

  • Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer
  • Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment
  • Has had radiotherapy within 14 days of randomization
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis)
  • Has an active infection requiring systemic therapy
  • Has poorly controlled diarrhea
  • Accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. If the participant is receiving diuretic drugs for other reasons, it is acceptable
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has peripheral neuropathy > Grade 1
  • Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
  • A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization or treatment allocation
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 7 months after the last dose of trial treatment
  • Has active or clinically significant cardiac disease
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab, trastuzumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum-containing products
  • Has had an allogeneic tissue/solid organ transplant
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, Cluster of Differentiation 137 [CD137])

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): NCT03615326


Contacts
Layout table for location contacts
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

  Hide Study Locations
Locations
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United States, California
Pacific Cancer Care ( Site 0063) Recruiting
Monterey, California, United States, 93940
Contact: Study Coordinator    831-375-4105      
UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050) Completed
Orange, California, United States, 92868
University of California Los Angeles ( Site 0045) Recruiting
Santa Monica, California, United States, 90404
Contact: Study Coordinator    310-829-5471      
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026) Recruiting
Miami, Florida, United States, 33136
Contact: Study Coordinator    305-243-0116      
United States, Georgia
Southeastern Regional Medical Center, Inc. ( Site 0058) Recruiting
Newnan, Georgia, United States, 30265
Contact: Study Coordinator    770-400-6036      
United States, Illinois
Midwestern Regional Medical Center, Inc. ( Site 0059) Recruiting
Zion, Illinois, United States, 60099
Contact: Study Coordinator    310-829-5471      
United States, Minnesota
Minnesota Oncology Hematology, PA ( Site 8001) Completed
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Washington University School of Medicine ( Site 0040) Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Study Coordinator    314-747-6268      
United States, New York
Memorial Sloan-Kettering Cancer Center ( Site 0017) Recruiting
New York, New York, United States, 10065
Contact: Study Coordinator    646-888-4186      
University of Rochester ( Site 0041) Completed
Rochester, New York, United States, 14642
United States, North Carolina
Levine Cancer Institute ( Site 0015) Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Study Coordinator    980-442-2157      
Duke Cancer Institute ( Site 0042) Recruiting
Durham, North Carolina, United States, 27710
Contact: Study Coordinator    919-668-7222      
United States, Oklahoma
CTCA Southwestern ( Site 0060) Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Study Coordinator    918-286-5448      
United States, Pennsylvania
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025) Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Study Coordinator    215-537-4555      
Allegheny General Hospital ( Site 0053) Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Study Coordinator    412-389-3059      
United States, South Dakota
Sanford Hematology Oncology-Sioux Falls SD ( Site 0004) Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Study Coordinator    605-328-8000      
United States, Texas
University of Texas MD Anderson Cancer Center ( Site 0001) Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator    713-792-2828      
United States, Virginia
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000) Recruiting
Roanoke, Virginia, United States, 24014
Contact: Study Coordinator    281-863-6662      
United States, Washington
Seattle Cancer Care Alliance ( Site 0038) Recruiting
Seattle, Washington, United States, 98109
Contact: Study Coordinator    206-606-6439      
Australia, New South Wales
Liverpool Hospital ( Site 2206) Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Study Coordinator    +61287389156      
Westmead Hospital ( Site 2200) Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Study Coordinator    +61288907031      
Southern Medical Day Care Centre ( Site 2207) Recruiting
Wollongong, New South Wales, Australia, 2500
Contact: Study Coordinator    +61242851222      
Australia
Monash Health ( Site 2202) Recruiting
Clayton, Australia, 3168
Contact: Study Coordinator    +61385722392      
Brazil
Hospital Sao Rafael ( Site 0209) Recruiting
Salvador, BA, Brazil, 41253-190
Contact: Study Coordinator    +557132816964      
Instituto do Cancer do Ceara ( Site 0208) Recruiting
Fortaleza, Ceara, Brazil, 60430-230
Contact: Study Coordinator    +558532884576      
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201) Recruiting
Rio de Janeiro, RJ, Brazil, 20231-050
Contact: Study Coordinator    +552132076585      
Hospital de Caridade de Ijui ( Site 0202) Recruiting
Ijui, RS, Brazil, 98700-000
Contact: Study Coordinator    +5555991592101      
Hospital Nossa Senhora da Conceicao ( Site 0203) Recruiting
Porto Alegre, RS, Brazil, 91350-200
Contact: Study Coordinator    +5551993590437      
CEPON - Centro de Pesquisas Oncologicas ( Site 0200) Recruiting
Florianopolis, Santa Catarina, Brazil, 88034-000
Contact: Study Coordinator    +554891252255      
CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205) Recruiting
Curitiba, Brazil, 80810-050
Contact: Study Coordinator    +554130242421      
IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204) Recruiting
Sao Paulo, Brazil, 03102-002
Contact: Study Coordinator    +551134744249      
Chile
Fundacion Arturo Lopez Perez FALP ( Site 0302) Recruiting
Santiago, Chile, 7500921
Contact: Study Coordinator    +56998954525      
Pontificia Universidad Catolica de Chile ( Site 0301) Recruiting
Santiago, Chile, 8330024
Contact: Study Coordinator    +56991612199      
Instituto Nacional del Cancer ( Site 0303) Recruiting
Santiago, Chile, 8380455
Contact: Study Coordinator    +56222357923      
Clinica Universidad Catolica del Maule ( Site 0305) Recruiting
Talca, Chile, 3460000
Contact: Study Coordinator    +569811340385      
Instituto Clinico Oncologico del Sur ( Site 0300) Recruiting
Temuco, Chile, 4810469
Contact: Study Coordinator    +56994443272      
China, Fujian
Fujian Provincial Cancer Hospital ( Site 2418) Recruiting
Fuzhou, Fujian, China, 350014
Contact: Study Coordinator    +86059183660611      
900 Hospital of the Joint ( Site 2420) Recruiting
Fuzhou, Fujian, China, 350025
Contact: Study Coordinator    +8659122859888      
The First Affiliated Hospital of Xiamen University ( Site 2431) Recruiting
Xiamen, Fujian, China, 361003
Contact: Study Coordinator    +865922137327      
China, Guangdong
Guangdong General Hospital ( Site 2433) Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Study Coordinator    +8613332888281      
China, Heilongjiang
Harbin Medical University Cancer Hospital ( Site 2407) Recruiting
Harbin, Heilongjiang, China, 150081
Contact: Study Coordinator    +8613945095085      
China, Henan
Henan Cancer Hospital ( Site 2400) Recruiting
Zhengzhou, Henan, China, 450008
Contact: Study Coordinator    +8637165587009      
China, Hunan
Xiangya Hospital Central-South University ( Site 2426) Recruiting
Changsha, Hunan, China, 410008
Contact: Study Coordinator    1357483861      
China, Jiangsu
Jiangsu Cancer Hospital ( Site 2432) Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Study Coordinator    +8615380882716      
China, Jilin
The First Hospital Of Jilin University ( Site 2402) Recruiting
Chang chun, Jilin, China, 130021
Contact: Study Coordinator    +8615843073215      
China, Xinjiang
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430) Recruiting
Urumqi, Xinjiang, China, 830001
Contact: Study Coordinator    13899880718      
China, Zheijiang
The First Affiliated Hospital.Zhejiang University ( Site 2408) Recruiting
Hangzhou, Zheijiang, China, 310009
Contact: Study Coordinator    +86057156731277      
China, Zhejiang
Sir Run Run Shaw Hospital ( Site 2412) Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Study Coordinator    +86057186044817      
Zhejiang Cancer Hospital ( Site 2409) Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Study Coordinator    +8657188122167      
China
Fifth Medical Center of CPLA General Hospital ( Site 2415) Recruiting
Beijing, China, 100071
Contact: Study Coordinator    +8601066947967      
Beijing Cancer Hospital ( Site 2413) Recruiting
Beijing, China, 100142
Contact: Study Coordinator    +861088196869      
Fudan University Shanghai Cancer Center ( Site 2424) Recruiting
Shanghai, China, 200032
Contact: Study Coordinator    +8613816066360      
Zhongshan Hospital affiliated to Fudan University ( Site 2401) Recruiting
Shanghai, China, 200032
Contact: Study Coordinator    +862160267662      
Shanghai General Hospital ( Site 2404) Recruiting
Shanghai, China, 200080
Contact: Study Coordinator    +862136126309      
France
Hopital Jean Minjoz Besancon ( Site 0901) Recruiting
Besancon, France, 25030
Contact: Study Coordinator    +33381218454      
C.H.R.U. de Brest - Hopital Morvan ( Site 0913) Recruiting
Brest, France, 29200
Contact: Study Coordinator    +33298223428      
Centre Oscar Lambret ( Site 0911) Recruiting
Lille, France, 59000
Contact: Study Coordinator    +33320295942      
Centre Leon Berard ( Site 0904) Recruiting
Lyon, France, 69008
Contact: Study Coordinator    +33478785136      
CHU Hopital Saint Antoine ( Site 0905) Recruiting
Paris, France, 75012
Contact: Study Coordinator    33171970401      
CHU de Rouen ( Site 0912) Recruiting
Rouen, France, 76000
Contact: Study Coordinator    +33232886456      
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902) Recruiting
Saint-Herblain, France, 44805
Contact: Study Coordinator    +33240679978      
HUS Hopital Hautepierre ( Site 0910) Recruiting
Strasbourg, France, 67098
Contact: Study Coordinator    +33388127441      
Institut Gustave Roussy ( Site 0900) Recruiting
Villejuif, France, 94805
Contact: Study Coordinator    +33142115375      
Germany
Klinikum Bremen Nord ( Site 1017) Recruiting
Bremen, Germany, 28211
Contact: Study Coordinator    +4942166061303      
Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001) Recruiting
Dresden, Germany, 01307
Contact: Study Coordinator    +493514584794      
Asklepios Klinik Altona ( Site 1000) Recruiting
Hamburg, Germany, 22763
Contact: Study Coordinator    +493419712560      
Medizinische Hochschule Hannover ( Site 1019) Recruiting
Hannover, Germany, 30625
Contact: Study Coordinator    +495115329590      
SLK-Kliniken Heilbronn GmbH ( Site 1015) Recruiting
Heilbronn, Germany, 74078
Contact: Study Coordinator    +4971314928001      
Universitaetsklinikum Leipzig AOeR ( Site 1007) Recruiting
Leipzig, Germany, 04103
Contact: Study Coordinator    +493419712560      
Klinikum Ludwigsburg ( Site 1014) Recruiting
Ludwigsburg, Germany, 71640
Contact: Study Coordinator    +4971419994467      
Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020) Recruiting
Tuebingen, Germany, 72076
Contact: Study Coordinator    +4970712984457      
Guatemala
Celan SA ( Site 0504) Recruiting
Guatemala, Guatemala, 01010
Contact: Study Coordinator    +50223857572      
Oncomedica ( Site 0500) Recruiting
Guatemala, Guatemala, 01010
Contact: Study Coordinator    +50222781269      
Grupo Angeles SA ( Site 0501) Recruiting
Guatemala, Guatemala, 01015
Contact: Study Coordinator    +50257042323      
Nucare Center ( Site 0506) Recruiting
Guatemala, Guatemala, 01015
Contact: Study Coordinator    +50253066852      
Medi-K Cayala ( Site 0505) Recruiting
Guatemala, Guatemala, 01016
Contact: Study Coordinator    +50255505555      
Centro Regional de Sub Especialidades Medicas SA ( Site 0502) Recruiting
Quetzaltenango, Guatemala, 09001
Contact: Study Coordinator    +50259450559      
Ireland
Saint James's Hospital ( Site 1505) Recruiting
Dublin, Ireland, D08 K0Y5
Contact: Study Coordinator    +35314284934      
Beaumont Hospital ( Site 1506) Recruiting
Dublin, Ireland, D09 V2N0
Contact: Study Coordinator    +35318092010      
Tallaght University Hospital ( Site 1513) Recruiting
Dublin, Ireland, D24 NR0A
Contact: Study Coordinator    +35314144299      
Israel
Soroka University Medical Center ( Site 1603) Recruiting
Beer Sheva, Israel, 8410101
Contact: Study Coordinator    +97286400798      
Rambam Health Care Campus ( Site 1606) Recruiting
Haifa, Israel, 3525408
Contact: Study Coordinator    +97247773811      
Edith Wolfson Medical Center ( Site 1605) Recruiting
Holon, Israel, 5822012
Contact: Study Coordinator    +97236726259      
Hadassah Ein Kerem Medical Center ( Site 1604) Recruiting
Jerusalem, Israel, 9112001
Contact: Study Coordinator    +97226777957      
Meir Medical Center ( Site 1609) Recruiting
Kfar-Saba, Israel, 4428164
Contact: Study Coordinator    +97297660407      
Rabin Medical Center ( Site 1602) Recruiting
Petah Tikva, Israel, 4941492
Contact: Study Coordinator    +97239377990      
Chaim Sheba Medical Center. ( Site 1607) Recruiting
Ramat Gan, Israel, 5265601
Contact: Study Coordinator    +97235307776      
Sourasky Medical Center ( Site 1601) Recruiting
Tel Aviv, Israel, 6423906
Contact: Study Coordinator    +97236947615      
Italy
Universita Magna Graecia di Catanzaro ( Site 1107) Recruiting
Catanzaro, CZ, Italy, 88100
Contact: Study Coordinator    +393382901571      
Humanitas Gavazzeni ( Site 1106) Recruiting
Bergamo, Italy, 24125
Contact: Study Coordinator    +39354204761      
IEO Istituto Europeo di Oncologia ( Site 1105) Recruiting
Milano, Italy, 20141
Contact: Study Coordinator    +390294372730      
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1102) Recruiting
Modena, Italy, 41100
Contact: Study Coordinator    +390594224383      
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1103) Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +390815666713      
Istituto Oncologico Veneto ( Site 1101) Recruiting
Padova, Italy, 35128
Contact: Study Coordinator    +390498215910      
Ospedale Civile Spirito Santo ( Site 1104) Recruiting
Pescara, Italy, 65100
Contact: Study Coordinator    +39335421534      
AUOP Ospedale Santa Chiara ( Site 1100) Recruiting
Pisa, Italy, 56126
Contact: Study Coordinator    +39050992852      
Japan
Aichi Cancer Center Hospital ( Site 2617) Recruiting
Nagoya, Aichi, Japan, 464-8681
Contact: Study Coordinator    +81527626111      
National Cancer Center Hospital East ( Site 2605) Recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact: Study Coordinator    +81471331111      
National Hospital Organization Shikoku Cancer Center ( Site 2615) Recruiting
Matsuyama, Ehime, Japan, 791-0280
Contact: Study Coordinator    +81899991111      
Gunma Prefectural Cancer Center ( Site 2602) Recruiting
Ohta, Gunma, Japan, 373-8550
Contact: Study Coordinator    +81276380771      
Hyogo Cancer Center ( Site 2619) Recruiting
Akashi, Hyogo, Japan, 673-8558
Contact: Study Coordinator    +81789291151      
Kobe City Medical Center General Hospital ( Site 2614) Recruiting
Kobe, Hyogo, Japan, 650-0047
Contact: Study Coordinator    +81783024321      
Ibaraki Prefectural Central Hospital ( Site 2611) Recruiting
Kasama, Ibaraki, Japan, 309-1793
Contact: Study Coordinator    +81296771121      
Kagawa University Hospital ( Site 2604) Recruiting
Kita-gun, Kagawa, Japan, 761-0793
Contact: Study Coordinator    +81878985111      
Kanagawa Cancer Center ( Site 2603) Recruiting
Yokohama, Kanagawa, Japan, 241-8515
Contact: Study Coordinator    +81455202222      
Osaki Citizen Hospital ( Site 2626) Recruiting
Osaki, Miyagi, Japan, 989-6183
Contact: Study Coordinator    +81229233311      
Kansai Medical University Hospital ( Site 2618) Recruiting
Hirakata, Osaka, Japan, 573-1191
Contact: Study Coordinator    +81728040101      
Kindai University Hospital ( Site 2616) Recruiting
Osakasayama, Osaka, Japan, 589-8511
Contact: Study Coordinator    +81723660221      
Osaka University Hospital ( Site 2600) Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Study Coordinator    +81668795111      
Saitama Cancer Center ( Site 2620) Recruiting
Kitaadachi-gun, Saitama, Japan, 362-0806
Contact: Study Coordinator    +81487221111      
Shizuoka Cancer Center Hospital and Research Institute ( Site 2607) Recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Contact: Study Coordinator    +81559895222      
Tochigi Cancer Center ( Site 2627) Recruiting
Utsunomiya, Tochigi, Japan, 320-0834
Contact: Study Coordinator    +81286585151      
Kyorin University Hospital ( Site 2608) Recruiting
Mitaka, Tokyo, Japan, 181-8611
Contact: Study Coordinator    +81422475511      
Chiba Cancer Center ( Site 2623) Recruiting
Chiba, Japan, 260-8717
Contact: Study Coordinator    +81432645431      
National Hospital Organization Kyushu Cancer Center ( Site 2609) Recruiting
Fukuoka, Japan, 811-1395
Contact: Study Coordinator    +81925413231      
Gifu University Hospital ( Site 2621) Recruiting
Gifu, Japan, 501-1194
Contact: Study Coordinator    +81582306000      
Hiroshima City Hiroshima Citizens Hospital ( Site 2625) Recruiting
Hiroshima, Japan, 730-8518
Contact: Study Coordinator    +81822212291      
Kumamoto University Hospital ( Site 2601) Recruiting
Kumamoto, Japan, 860-8556
Contact: Study Coordinator    +81963442111      
Niigata Cancer Center Hospital ( Site 2622) Recruiting
Niigata, Japan, 951-8566
Contact: Study Coordinator    +81252665111      
National Hospital Organization Osaka National Hospital ( Site 2629) Recruiting
Osaka, Japan, 540-0006
Contact: Study Coordinator    +81669421331      
Osaka International Cancer Institute ( Site 2613) Recruiting
Osaka, Japan, 541-8567
Contact: Study Coordinator    +81669451181      
Osaka General Medical Center ( Site 2624) Recruiting
Osaka, Japan, 558-8558
Contact: Study Coordinator    +81666921201      
National Cancer Center Hospital ( Site 2612) Recruiting
Tokyo, Japan, 104-0045
Contact: Study Coordinator    +81335422511      
Toranomon Hospital ( Site 2628) Recruiting
Tokyo, Japan, 105-8470
Contact: Study Coordinator    +81335881111      
Tokyo Metropolitan Komagome Hospital ( Site 2606) Recruiting
Tokyo, Japan, 113-8677
Contact: Study Coordinator    +81338232101      
The Cancer Institute Hospital of JFCR ( Site 2610) Recruiting
Tokyo, Japan, 135-8550
Contact: Study Coordinator    +81335200111      
Korea, Republic of
Seoul National University Hospital ( Site 2703) Recruiting
Seoul, Korea, Republic of, 03080
Contact: Study Coordinator    +82220722362      
Severance Hospital Yonsei University Health System ( Site 2700) Recruiting
Seoul, Korea, Republic of, 03722
Contact: Study Coordinator    +82222288132      
Asan Medical Center ( Site 2702) Recruiting
Seoul, Korea, Republic of, 05505
Contact: Study Coordinator    +82230103230      
Samsung Medical Center ( Site 2701) Recruiting
Seoul, Korea, Republic of, 06351
Contact: Study Coordinator    +82234101779      
New Zealand
Auckland City Hospital ( Site 2300) Recruiting
Auckland, New Zealand, 1023
Contact: Study Coordinator    +6493074949      
Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1710) Recruiting
Bielsko-Biala, Poland, 43-300
Contact: Study Coordinator    +48334984003      
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1715) Recruiting
Gdynia, Poland, 81-519
Contact: Study Coordinator    +48583419348      
Przychodnia Lekarska Komed ( Site 1716) Recruiting
Konin, Poland, 62-500
Contact: Study Coordinator    +48632406136      
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1708) Recruiting
Koscierzyna, Poland, 83-400
Contact: Study Coordinator    +48793929449      
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1709) Completed
Lublin, Poland, 20-080
Klinika Onkologiczna COI im. Marii Sklodowskiej-Curie ( Site 1703) Recruiting
Warszawa, Poland, 02-034
Contact: Study Coordinator    +48225462328      
Uniwersytecki Szpital Kliniczny im. J. M. Radeckiego we Wroclawiu ( Site 1705) Recruiting
Wroclaw, Poland, 50-556
Contact: Study Coordinator    +48501760099      
Dolnoslaskie Centrum Onkologii. ( Site 1712) Recruiting
Wroclaw, Poland, 53-413
Contact: Study Coordinator    +48605363024      
Russian Federation
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1815) Recruiting
Chelyabinsk, Chelyabinsk Region, Russian Federation, 454087
Contact: Study Coordinator    +79127949047      
Leningrad Regional Oncology Center ( Site 1800) Recruiting
Saint-Petersburg, Leningrad Region, Vsevolozhsky District, Russian Federation, 188663
Contact: Study Coordinator    +79219650996      
N.N. Blokhin National Medical Oncology Research Centre ( Site 1805) Recruiting
Moscow, Russian Federation, 115478
Contact: Study Coordinator    +79037103422      
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1801) Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Study Coordinator    +79219462123      
St Petersburg City Clinical Oncology Dispensary ( Site 1812) Recruiting
Saint Petersburg, Russian Federation, 198255
Contact: Study Coordinator    +79111019156      
Medical University REAVIZ ( Site 1816) Recruiting
Samara, Russian Federation, 443011
Contact: Study Coordinator    +79023785196      
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1807) Recruiting
Ufa, Russian Federation, 450054
Contact: Study Coordinator    +79373010101      
Spain
Hospital Universitario Central de Asturias ( Site 1402) Recruiting
Oviedo, Asturias, Spain, 33011
Contact: Study Coordinator    +3498510610036281      
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1410) Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Study Coordinator    +34934978924      
Hospital Universitario Quiron Madrid ( Site 1407) Recruiting
Pozuelo de Alarcon, Madrid, Spain, 28223
Contact: Study Coordinator    +34902151016      
Hospital General Universitari Vall d Hebron ( Site 1401) Recruiting
Barcelona, Spain, 08035
Contact: Study Coordinator    +34934894158      
Hospital General Universitario de Elche ( Site 1404) Recruiting
Elche, Spain, 03203
Contact: Study Coordinator    +34966616492      
Hospital Universitario Ramon y Cajal ( Site 1400) Recruiting
Madrid, Spain, 28034
Contact: Study Coordinator    +34913368263      
Hospital Universitario Marques de Valdecilla ( Site 1405) Recruiting
Santander, Spain, 39008
Contact: Study Coordinator    +34942202525      
Turkey
Adana Sehir Hastanesi ( Site 2002) Recruiting
Adana, Turkey, 01370
Contact: Study Coordinator    +905335186317      
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2017) Recruiting
Ankara, Turkey, 06100
Contact: Study Coordinator    +903123052910      
Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006) Recruiting
Ankara, Turkey, 06200
Contact: Study Coordinator    +905067521275      
Trakya Universitesi Tip Fakultesi ( Site 2015) Recruiting
Edirne, Turkey, 22030
Contact: Study Coordinator    +905052137335      
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000) Recruiting
Erzurum, Turkey, 25240
Contact: Study Coordinator    +905072864555      
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001) Recruiting
Istanbul, Turkey, 34098
Contact: Study Coordinator    +905324167355      
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011) Recruiting
Izmir, Turkey, 35340
Contact: Study Coordinator    +905327321693      
Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009) Recruiting
Malatya, Turkey, 44280
Contact: Study Coordinator    +905326441884      
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012) Recruiting
Sakarya, Turkey, 54290
Contact: Study Coordinator    +905052014666      
Ukraine
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2101) Recruiting
Kryviy Rih, Dnipropetrovsk Region, Ukraine, 50048
Contact: Study Coordinator    +380675393937      
City Clinical Hosp.4 of DCC ( Site 2102) Recruiting
Dnipropetrovsk, Ukraine, 49102
Contact: Study Coordinator    +380675625054      
MI Precarpathian Clinical Oncology Center ( Site 2105) Recruiting
Ivano-Frankivsk, Ukraine, 76018
Contact: Study Coordinator    +380675777609      
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2112) Recruiting
Kharkiv, Ukraine, 61070
Contact: Study Coordinator    +380503439026      
Clinic of National Cancer Institute ( Site 2104) Recruiting
Kyiv, Ukraine, 03022
Contact: Study Coordinator    +380503560549      
Kyiv City Clinical Oncology Centre ( Site 2110) Recruiting
Kyiv, Ukraine, 03115
Contact: Study Coordinator    +380503818536      
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2114) Recruiting
Kyiv, Ukraine, 03126
Contact: Study Coordinator    +380503481865      
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2106) Recruiting
Lviv, Ukraine, 79031
Contact: Study Coordinator    +380322230767      
MI Odessa Regional Oncological Centre ( Site 2108) Recruiting
Odesa, Ukraine, 65055
Contact: Study Coordinator    +380504261911      
Medical Centre LLC Oncolife ( Site 2103) Recruiting
Zaporizhzhya, Ukraine, 69104
Contact: Study Coordinator    +380973153178      
United Kingdom
Castle Hill Hospital ( Site 1501) Recruiting
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Contact: Study Coordinator    +4401482461299      
Royal Marsden Hospital ( Site 1510) Recruiting
Sutton, South London, United Kingdom, SM2 5PT
Contact: Study Coordinator    +4402086613582      
St Georges University Hospitals NHS Foundation Trust. ( Site 1500) Recruiting
London, Tooting, United Kingdom, SW17 0QT
Contact: Study Coordinator    +4402087253362      
Royal Hospital in Derby ( Site 1514) Recruiting
Derby, United Kingdom, DE22 3NE
Contact: Study Coordinator    +441332787429      
Ninewells Hospital and Medical School ( Site 1504) Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Study Coordinator    +441382496685      
University College London Hospital NHS Foundation Trust ( Site 1508) Recruiting
London, United Kingdom, NW1 2PG
Contact: Study Coordinator    +442034475103      
Royal Marsden NHS Foundation Trust ( Site 1512) Recruiting
London, United Kingdom, SW3 6JJ
Contact: Study Coordinator    +4402086613582      
The Christie Hospital NHS Foundation Trust ( Site 1503) Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Study Coordinator    +441614463461      
Mount Vernon Cancer Centre ( Site 1507) Recruiting
Northwood, United Kingdom, HA6 2RN
Contact: Study Coordinator    +442038262106      
Manor Hospital Walsall England ( Site 1515) Recruiting
Walsall, United Kingdom, WS2 9PS
Contact: Study Coordinator    +4419227211727167      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03615326     History of Changes
Other Study ID Numbers: 3475-811
2018-000224-34 ( EudraCT Number )
MK-3475-811 ( Other Identifier: Merck Protocol Number )
184142 ( Registry Identifier: JAPAC-CTI )
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
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

Layout table for additional information
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 receptor 1 (PD-1)
programmed cell death ligand 1 (PD-L1)
anti-PD-1
anti PD-1
GEJ
Gastric Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Esophageal Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Pembrolizumab
Oxaliplatin
Trastuzumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological