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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)

Primary Purpose

Gastric Cancer, Gastroesophageal Junction Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Placebo
Cisplatin
Capecitabine
5-fluorouracil
Docetaxel
Oxaliplatin
Leucovorin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope ( Site 0005)
  • Yale Cancer Center ( Site 0016)
  • Georgetown University ( Site 0015)
  • Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018)
  • The University of Chicago Medical Center ( Site 0004)
  • Roswell Park Cancer Institute ( Site 0001)
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019)
  • Memorial Sloan Kettering ( Site 0024)
  • Weill Cornell Medical Center ( Site 0023)
  • University of Rochester ( Site 0011)
  • Fox Chase Cancer Center ( Site 0006)
  • Temple University Hospital ( Site 0026)
  • University of Utah, Huntsman Cancer Institute ( Site 0012)
  • Virginia Cancer Specialists, PC ( Site 0010)
  • Institut Jules Bordet ( Site 0480)
  • Hopital Erasme ULB ( Site 0484)
  • UCL Saint Luc ( Site 0479)
  • Grand Hopital de Charleroi ( Site 0478)
  • CHU de Liege ( Site 0482)
  • CHU UCL Namur Site de Godinne ( Site 0485)
  • UZ Gent ( Site 0486)
  • UZ Leuven ( Site 0483)
  • AZ Groeninge ( Site 0481)
  • Instituto do Cancer do Ceara ( Site 0311)
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308)
  • CEPON - Centro de Pesquisas Oncologicas ( Site 0302)
  • Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301)
  • Hospital de Base de Sao Jose de Rio Preto ( Site 0304)
  • Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307)
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305)
  • Hospital Israelita Albert Einstein ( Site 0309)
  • Cross Cancer Institute ( Site 0033)
  • Moncton Hospital - Horizon Health Network ( Site 0038)
  • Sunnybrook Research Institute ( Site 0032)
  • CISSS de la Monteregie-Centre ( Site 0039)
  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040)
  • Jewish General Hospital ( Site 0034)
  • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035)
  • CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042)
  • Instituto Clinico del Sur. ICOS ( Site 0290)
  • Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)
  • Fundacion Arturo Lopez Perez FALP ( Site 0286)
  • Pontificia Universidad Catolica de Chile ( Site 0285)
  • Hospital Clinico Universidad de Chile ( Site 0287)
  • Beijing Cancer Hospital ( Site 0221)
  • Zhejiang Cancer Hospital ( Site 0231)
  • Sir Run Run Shaw Hospital ( Site 0233)
  • SA Pohja-Eesti Regionaalhaigla ( Site 0526)
  • Hopital Prive Jean Mermoz ( Site 0462)
  • Institut Paoli Calmettes ( Site 0472)
  • CHU Reims - Hopital Robert Debre ( Site 0465)
  • CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474)
  • CHU Toulouse - Hopital Rangueil ( Site 0470)
  • Institut du Cancer de Montpellier ( Site 0473)
  • Centre Eugene Marquis ( Site 0466)
  • Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469)
  • CHRU Lille - Hopital Claude Huriez ( Site 0461)
  • CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)
  • CHU Hopital Saint Antoine ( Site 0471)
  • Institut Mutualiste Montsouris ( Site 0463)
  • Klinikum Esslingen GmbH ( Site 0453)
  • Universitaetsklinikum Freiburg ( Site 0450)
  • Klinikum der Universitaet in Muenchen ( Site 0446)
  • Medizinische Hochschule Hannover ( Site 0449)
  • Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445)
  • Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)
  • Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)
  • Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454)
  • Integra Cancer Institute ( Site 0262)
  • Grupo Medico Angeles ( Site 0261)
  • Centro Medico Integral De Cancerología (CEMIC) ( Site 0260)
  • Soroka University M.C ( Site 0385)
  • Meir medical center ( Site 0386)
  • Sourasky Medical Center. ( Site 0382)
  • Rambam Health Care Campus ( Site 0381)
  • Hadassah Medical Center. Ein Kerem ( Site 0383)
  • Rabin-Medical Center ( Site 0384)
  • Sheba Medical center ( Site 0387)
  • IRCCS Istituto Oncologico Veneto ( Site 0431)
  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430)
  • Istituto Clinico Humanitas Research Hospital ( Site 0432)
  • IRCCS Policlinico San Donato ( Site 0433)
  • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)
  • Seconda Universita Napoli ( Site 0436)
  • A.O.U. Santa Maria della Misericordia di Udine ( Site 0434)
  • Aichi Cancer Center Hospital ( Site 0165)
  • National Cancer Center Hospital East ( Site 0178)
  • National Hospital Organization Shikoku Cancer Center ( Site 0186)
  • Hokkaido University Hospital ( Site 0160)
  • Hyogo Cancer Center ( Site 0182)
  • Kobe University Hospital ( Site 0188)
  • Kobe City Medical Center General Hospital ( Site 0181)
  • Ibaraki Prefectural Central Hospital ( Site 0177)
  • Iwate Medical University Hospital ( Site 0184)
  • St. Marianna University School of Medicine Hospital ( Site 0187)
  • Kanagawa Cancer Center ( Site 0167)
  • Kansai Medical University Hospital ( Site 0190)
  • Osaka University Hospital ( Site 0162)
  • Osaka Medical College Hospital ( Site 0168)
  • Saitama Cancer Center ( Site 0170)
  • Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)
  • Chiba Cancer Center ( Site 0180)
  • National Hospital Organization Kyushu Cancer Center ( Site 0172)
  • Kyushu University Hospital ( Site 0173)
  • Gifu University Hospital ( Site 0166)
  • Hiroshima City Hiroshima Citizens Hospital ( Site 0171)
  • Kochi Health Sciences Center ( Site 0189)
  • Kumamoto University Hospital ( Site 0164)
  • Niigata Cancer Center Hospital ( Site 0169)
  • Osaka International Cancer Institute ( Site 0161)
  • Osaka General Medical Center ( Site 0159)
  • National Cancer Center Hospital ( Site 0179)
  • Tokyo Metropolitan Komagome Hospital ( Site 0183)
  • The Cancer Institute Hospital of JFCR ( Site 0185)
  • Toyama Prefectural Central Hospital ( Site 0163)
  • Chonnam National University Hwasun Hospital ( Site 0083)
  • Seoul National University Bundang Hospital ( Site 0085)
  • Kyungpook National University Chilgok Hospital ( Site 0089)
  • Gachon University Gil Medical Center ( Site 0087)
  • Korea University Anam Hospital ( Site 0084)
  • Seoul National University Hospital -SNUH- ( Site 0080)
  • Severance Hospital Yonsei University Health System ( Site 0081)
  • Asan Medical Center ( Site 0082)
  • Gangnam Severance Hospital ( Site 0088)
  • SMG-SNU BORAMAE Medical Center ( Site 0086)
  • Riga East Clinical University Hospital ( Site 0550)
  • LSMUL Kauno Klinikos ( Site 0570)
  • Nacionalinis Vezio Institutas ( Site 0569)
  • Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)
  • Hospital Kuala Lumpur ( Site 0146)
  • University Malaya Medical Centre ( Site 0143)
  • St. Luke s Medical Center ( Site 0622)
  • Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351)
  • Szpital Uniwersytecki w Krakowie ( Site 0352)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349)
  • Mazowiecki Szpital Onkologiczny ( Site 0363)
  • Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353)
  • Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361)
  • SPZOZ WSS nr 3 w Rybniku ( Site 0357)
  • Kaluga Regional Clinical Oncology Center ( Site 0345)
  • SBHI Leningrad Regional Clinical Hospital ( Site 0496)
  • National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338)
  • Blokhin National Medical Oncology ( Site 0494)
  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344)
  • Leningrad Regional Oncology Center ( Site 0335)
  • City clinical oncological dispensary ( Site 0336)
  • Tomsk Scientific Research Institute of Oncology ( Site 0337)
  • National University Hospital ( Site 0095)
  • National Cancer Centre Singapore ( Site 0097)
  • Oncocare Cancer Centre ( Site 0096)
  • Taipei Medical University Shuang Ho Hospital ( Site 0068)
  • National Cheng Kung University Hospital ( Site 0067)
  • National Taiwan University Hospital ( Site 0063)
  • Mackay Memorial Hospital ( Site 0065)
  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066)
  • Chang Gung Medical Foundation. Linkou ( Site 0064)
  • City Clinical Hosp.4 of DCC ( Site 0325)
  • MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589)
  • Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)
  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591)
  • National Cancer Institute of the MoH of Ukraine ( Site 0319)
  • Kyiv City Clinical Oncology Center ( Site 0590)
  • University Hospitals Bristol NHS Foundation Trust ( Site 0407)
  • Ninewells Hospital and Medical School ( Site 0406)
  • Royal Free London NHS Foundation Trust ( Site 0403)
  • The Royal Marsden Foundation Trust ( Site 0405)
  • Imperial College Healthcare NHS Trust ( Site 0402)
  • Royal Marsden NHS Foundation Trust ( Site 0400)
  • The Christie NHS Foundation Trust ( Site 0397)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Pembrolizumab+Chemotherapy

Placebo+Chemotherapy

Pembrolizumab+FLOT Cohort

Placebo+FLOT Cohort

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms
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.
Pathological Complete Response (pathCR) Rate - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms
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.
Overall Survival (OS) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms
OS is defined as the time from randomization to death due to any cause.
Percentage of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
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.
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
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

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
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.
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
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.
Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms
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.
Overall Survival (OS) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms and Pembrolizumab+FLOT and Placebo+FLOT Cohorts
OS is defined as the time from randomization to death due to any cause.
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
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.

Full Information

First Posted
July 17, 2017
Last Updated
September 21, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03221426
Brief Title
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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
June 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Cancer
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind study
Allocation
Randomized
Enrollment
1007 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab+Chemotherapy
Arm Type
Experimental
Arm Description
Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Arm Title
Placebo+Chemotherapy
Arm Type
Placebo Comparator
Arm Description
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Arm Title
Pembrolizumab+FLOT Cohort
Arm Type
Experimental
Arm Description
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m^2, oxaliplatin 85 mg/m^2, 5FU 2600 mg/m^2, and leucovorin 200 mg/m^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Arm Title
Placebo+FLOT Cohort
Arm Type
Placebo Comparator
Arm Description
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline solution
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
PLATINOL®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
XELODA®
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
ADRUCIL®, 5FU
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
TAXOTERE®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
ELOXATIN®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
WELLCOVORIN®
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms
Description
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.
Time Frame
Up to approximately 2 years
Title
Pathological Complete Response (pathCR) Rate - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms
Description
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.
Time Frame
Up to approximately 15 weeks
Title
Overall Survival (OS) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 2 years
Title
Percentage of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
Description
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.
Time Frame
Up to approximately 27 months
Title
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
Description
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.
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to approximately 27 months
Title
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
Description
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.
Time Frame
Up to approximately 2 years
Title
Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms
Description
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.
Time Frame
Up to approximately 2 years
Title
Overall Survival (OS) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms and Pembrolizumab+FLOT and Placebo+FLOT Cohorts
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 2 years
Title
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
Description
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.
Time Frame
Up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease. Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice. Is willing to provide tissue from a tumor lesion at baseline and at time of surgery. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment. Has adequate organ function. Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy. Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater. Has life expectancy of greater than 6 months. Exclusion Criteria: Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Has an active infection requiring systemic therapy. Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], necrosis factor receptor superfamily member 9 [CD137]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial. Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded. Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients, or to any of the study chemotherapy agents and/or to any of their excipients. Has an active autoimmune disease that has required systemic treatment in past 2 years. Has a known history of human immunodeficiency virus (HIV) infection. Has a known history of Hepatitis B or known active Hepatitis C virus infection. Has a known history of active tuberculosis (TB). Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater. Male participants who are expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy. Has had an allogenic tissue/solid organ transplant. Has received a live vaccine within 30 days prior to the first dose of study treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope ( Site 0005)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Yale Cancer Center ( Site 0016)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Georgetown University ( Site 0015)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago Medical Center ( Site 0004)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Roswell Park Cancer Institute ( Site 0001)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering ( Site 0024)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical Center ( Site 0023)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester ( Site 0011)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Fox Chase Cancer Center ( Site 0006)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Temple University Hospital ( Site 0026)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Utah, Huntsman Cancer Institute ( Site 0012)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Cancer Specialists, PC ( Site 0010)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Institut Jules Bordet ( Site 0480)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hopital Erasme ULB ( Site 0484)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UCL Saint Luc ( Site 0479)
City
Bruxelles
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hopital de Charleroi ( Site 0478)
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
CHU de Liege ( Site 0482)
City
Liège
State/Province
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU UCL Namur Site de Godinne ( Site 0485)
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
UZ Gent ( Site 0486)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven ( Site 0483)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Groeninge ( Site 0481)
City
Kortrijk
State/Province
West-Vlaanderen
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Instituto do Cancer do Ceara ( Site 0311)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
CEPON - Centro de Pesquisas Oncologicas ( Site 0302)
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301)
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital de Base de Sao Jose de Rio Preto ( Site 0304)
City
Sao Jose Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307)
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein ( Site 0309)
City
Sao Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Facility Name
Cross Cancer Institute ( Site 0033)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Moncton Hospital - Horizon Health Network ( Site 0038)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Sunnybrook Research Institute ( Site 0032)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
CISSS de la Monteregie-Centre ( Site 0039)
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Jewish General Hospital ( Site 0034)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042)
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Instituto Clinico del Sur. ICOS ( Site 0290)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)
City
Rancagua
State/Province
Lbtdr Gen Bernardo O Higgins
ZIP/Postal Code
2820000
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez FALP ( Site 0286)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 0285)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Hospital Clinico Universidad de Chile ( Site 0287)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Beijing Cancer Hospital ( Site 0221)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Zhejiang Cancer Hospital ( Site 0231)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Sir Run Run Shaw Hospital ( Site 0233)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
430030
Country
China
Facility Name
SA Pohja-Eesti Regionaalhaigla ( Site 0526)
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Hopital Prive Jean Mermoz ( Site 0462)
City
Lyon
State/Province
Auvergne
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Paoli Calmettes ( Site 0472)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13009
Country
France
Facility Name
CHU Reims - Hopital Robert Debre ( Site 0465)
City
Reims
State/Province
Champagne-Ardenne
ZIP/Postal Code
51092
Country
France
Facility Name
CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474)
City
Brest
State/Province
Finistere
ZIP/Postal Code
29200
Country
France
Facility Name
CHU Toulouse - Hopital Rangueil ( Site 0470)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Institut du Cancer de Montpellier ( Site 0473)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Eugene Marquis ( Site 0466)
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35042
Country
France
Facility Name
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469)
City
Saint Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez ( Site 0461)
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Facility Name
CHU Hopital Saint Antoine ( Site 0471)
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Institut Mutualiste Montsouris ( Site 0463)
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Klinikum Esslingen GmbH ( Site 0453)
City
Esslingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
73730
Country
Germany
Facility Name
Universitaetsklinikum Freiburg ( Site 0450)
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Klinikum der Universitaet in Muenchen ( Site 0446)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Medizinische Hochschule Hannover ( Site 0449)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454)
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Integra Cancer Institute ( Site 0262)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Grupo Medico Angeles ( Site 0261)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Centro Medico Integral De Cancerología (CEMIC) ( Site 0260)
City
Quetzaltenango
ZIP/Postal Code
09002
Country
Guatemala
Facility Name
Soroka University M.C ( Site 0385)
City
Beer Sheva
State/Province
HaDarom
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Meir medical center ( Site 0386)
City
Kfar Saba
State/Province
HaMerkaz
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Sourasky Medical Center. ( Site 0382)
City
Tel-Aviv
State/Province
Tell Abib
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Rambam Health Care Campus ( Site 0381)
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Center. Ein Kerem ( Site 0383)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin-Medical Center ( Site 0384)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical center ( Site 0387)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
IRCCS Istituto Oncologico Veneto ( Site 0431)
City
Padova
State/Province
Abruzzo
ZIP/Postal Code
35128
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Clinico Humanitas Research Hospital ( Site 0432)
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
IRCCS Policlinico San Donato ( Site 0433)
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)
City
Modena
ZIP/Postal Code
41125
Country
Italy
Facility Name
Seconda Universita Napoli ( Site 0436)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O.U. Santa Maria della Misericordia di Udine ( Site 0434)
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Aichi Cancer Center Hospital ( Site 0165)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 0178)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 0186)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Hokkaido University Hospital ( Site 0160)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Hyogo Cancer Center ( Site 0182)
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kobe University Hospital ( Site 0188)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Kobe City Medical Center General Hospital ( Site 0181)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Ibaraki Prefectural Central Hospital ( Site 0177)
City
Kasama
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Iwate Medical University Hospital ( Site 0184)
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital ( Site 0187)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kanagawa Cancer Center ( Site 0167)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Kansai Medical University Hospital ( Site 0190)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Osaka University Hospital ( Site 0162)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Osaka Medical College Hospital ( Site 0168)
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Saitama Cancer Center ( Site 0170)
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Chiba Cancer Center ( Site 0180)
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 0172)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kyushu University Hospital ( Site 0173)
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gifu University Hospital ( Site 0166)
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital ( Site 0171)
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Kochi Health Sciences Center ( Site 0189)
City
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
Kumamoto University Hospital ( Site 0164)
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Niigata Cancer Center Hospital ( Site 0169)
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 0161)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Osaka General Medical Center ( Site 0159)
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
National Cancer Center Hospital ( Site 0179)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital ( Site 0183)
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR ( Site 0185)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Toyama Prefectural Central Hospital ( Site 0163)
City
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital ( Site 0083)
City
Hwasun Gun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 0085)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital ( Site 0089)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center ( Site 0087)
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital ( Site 0084)
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital -SNUH- ( Site 0080)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 0081)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0082)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital ( Site 0088)
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
SMG-SNU BORAMAE Medical Center ( Site 0086)
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Riga East Clinical University Hospital ( Site 0550)
City
Riga
ZIP/Postal Code
1079
Country
Latvia
Facility Name
LSMUL Kauno Klinikos ( Site 0570)
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Nacionalinis Vezio Institutas ( Site 0569)
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)
City
Vilnius
ZIP/Postal Code
08460
Country
Lithuania
Facility Name
Hospital Kuala Lumpur ( Site 0146)
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
University Malaya Medical Centre ( Site 0143)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
St. Luke s Medical Center ( Site 0622)
City
Quezon City
State/Province
National Capital Region
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351)
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-080
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie ( Site 0352)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Mazowiecki Szpital Onkologiczny ( Site 0363)
City
Wieliszew
State/Province
Mazowieckie
ZIP/Postal Code
05-135
Country
Poland
Facility Name
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353)
City
Koscierzyna
State/Province
Pomorskie
ZIP/Postal Code
83-400
Country
Poland
Facility Name
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354)
City
Bielsko-Biala
State/Province
Slaskie
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361)
City
Gliwice
State/Province
Slaskie
ZIP/Postal Code
44-101
Country
Poland
Facility Name
SPZOZ WSS nr 3 w Rybniku ( Site 0357)
City
Rybnik
State/Province
Slaskie
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Kaluga Regional Clinical Oncology Center ( Site 0345)
City
Kaluga
State/Province
Kaluzskaja Oblast
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
SBHI Leningrad Regional Clinical Hospital ( Site 0496)
City
Saint Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
105203
Country
Russian Federation
Facility Name
Blokhin National Medical Oncology ( Site 0494)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Center ( Site 0335)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
City clinical oncological dispensary ( Site 0336)
City
Sankt-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Tomsk Scientific Research Institute of Oncology ( Site 0337)
City
Tomsk
State/Province
Tomskaya Oblast
ZIP/Postal Code
634028
Country
Russian Federation
Facility Name
National University Hospital ( Site 0095)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Centre Singapore ( Site 0097)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Oncocare Cancer Centre ( Site 0096)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
258499
Country
Singapore
Facility Name
Taipei Medical University Shuang Ho Hospital ( Site 0068)
City
New Taipei
ZIP/Postal Code
235
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 0067)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0063)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Mackay Memorial Hospital ( Site 0065)
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066)
City
Taipei
ZIP/Postal Code
11259
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Linkou ( Site 0064)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
City Clinical Hosp.4 of DCC ( Site 0325)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589)
City
Kryviy Rih
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
National Cancer Institute of the MoH of Ukraine ( Site 0319)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Kyiv City Clinical Oncology Center ( Site 0590)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
University Hospitals Bristol NHS Foundation Trust ( Site 0407)
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School ( Site 0406)
City
Dundee
State/Province
Dundee City
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust ( Site 0403)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
The Royal Marsden Foundation Trust ( Site 0405)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust ( Site 0402)
City
London
State/Province
London, City Of
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust ( Site 0400)
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust ( Site 0397)
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
35623069
Citation
Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
Results Reference
derived
PubMed Identifier
30777447
Citation
Bang YJ, Van Cutsem E, Fuchs CS, Ohtsu A, Tabernero J, Ilson DH, Hyung WJ, Strong VE, Goetze TO, Yoshikawa T, Tang LH, Hwang PMT, Webb N, Adelberg D, Shitara K. KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer. Future Oncol. 2019 Mar;15(9):943-952. doi: 10.2217/fon-2018-0581. Epub 2019 Feb 19.
Results Reference
derived
Links:
URL
http://merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

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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