Gastric CancerPhase 3NCT03221426
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)
A Phase 3 study testing Pembrolizumab, Cisplatin and Capecitabine in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Merck Sharp & Dohme LLC at 171 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- Pembrolizumab, Cisplatin and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,007 participants
- Where
- 171 sitesin 24 countries
- Study dates
- 9 Oct 2017to 23 Apr 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 MSD pembrolizumab (MK-3475) clinical study.
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
171 sites in 24 countries.
171 sites in 24 countries
Japan30 sites
Hyogo Cancer Center ( Site 0182)
Akashi, Hyōgo, 673-8558
Chiba Cancer Center ( Site 0180)
Chiba, 260-8717
National Hospital Organization Kyushu Cancer Center ( Site 0172)
Fukuoka, 811-1395
Kyushu University Hospital ( Site 0173)
Fukuoka, 812-8582
Gifu University Hospital ( Site 0166)
Gifu, 501-1194
Kansai Medical University Hospital ( Site 0190)
Hirakata, Osaka, 573-1191
Hiroshima City Hiroshima Citizens Hospital ( Site 0171)
Hiroshima, 730-8518
Ibaraki Prefectural Central Hospital ( Site 0177)
Kasama, Ibaraki, 309-1793
National Cancer Center Hospital East ( Site 0178)
Kashiwa, Chiba, 277-8577
St. Marianna University School of Medicine Hospital ( Site 0187)
Kawasaki, Kanagawa, 216-8511
Saitama Cancer Center ( Site 0170)
Kitaadachi-gun, Saitama, 362-0806
Kobe University Hospital ( Site 0188)
Kobe, Hyōgo, 650-0017
Kobe City Medical Center General Hospital ( Site 0181)
Kobe, Hyōgo, 650-0047
Kochi Health Sciences Center ( Site 0189)
Kochi, 781-8555
Kumamoto University Hospital ( Site 0164)
Kumamoto, 860-8556
National Hospital Organization Shikoku Cancer Center ( Site 0186)
Matsuyama, Ehime, 791-0280
Aichi Cancer Center Hospital ( Site 0165)
Nagoya, Aichi-ken, 464-8681
Niigata Cancer Center Hospital ( Site 0169)
Niigata, 951-8566
Osaka International Cancer Institute ( Site 0161)
Osaka, 541-8567
Osaka General Medical Center ( Site 0159)
Osaka, 558-8558
Hokkaido University Hospital ( Site 0160)
Sapporo, Hokkaido, 060-8648
Iwate Medical University Hospital ( Site 0184)
Shiwa-gun, Iwate, 028-3695
Osaka University Hospital ( Site 0162)
Suita, Osaka, 565-0871
Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)
Sunto-gun, Shizuoka, 411-8777
Osaka Medical College Hospital ( Site 0168)
Takatsuki, Osaka, 569-8686
National Cancer Center Hospital ( Site 0179)
Tokyo, 104-0045
Tokyo Metropolitan Komagome Hospital ( Site 0183)
Tokyo, 113-8677
The Cancer Institute Hospital of JFCR ( Site 0185)
Tokyo, 135-8550
Toyama Prefectural Central Hospital ( Site 0163)
Toyama, 930-8550
Kanagawa Cancer Center ( Site 0167)
Yokohama, Kanagawa, 241-8515
United States14 sites
Roswell Park Cancer Institute ( Site 0001)
Buffalo, New York, 14263
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018)
Chicago, Illinois, 60611
The University of Chicago Medical Center ( Site 0004)
Chicago, Illinois, 60637
City of Hope ( Site 0005)
Duarte, California, 91010
Virginia Cancer Specialists, PC ( Site 0010)
Fairfax, Virginia, 22031
Yale Cancer Center ( Site 0016)
New Haven, Connecticut, 06520
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019)
New York, New York, 10016
Memorial Sloan Kettering ( Site 0024)
New York, New York, 10065
Weill Cornell Medical Center ( Site 0023)
New York, New York, 10065
Fox Chase Cancer Center ( Site 0006)
Philadelphia, Pennsylvania, 19111
Temple University Hospital ( Site 0026)
Philadelphia, Pennsylvania, 19140
University of Rochester ( Site 0011)
Rochester, New York, 14642
University of Utah, Huntsman Cancer Institute ( Site 0012)
Salt Lake City, Utah, 84112
Georgetown University ( Site 0015)
Washington D.C., District of Columbia, 20007
France12 sites
CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474)
Brest, Finistere, 29200
CHRU Lille - Hopital Claude Huriez ( Site 0461)
Lille, Nord, 59037
Hopital Prive Jean Mermoz ( Site 0462)
Lyon, Auvergne, 69008
Institut Paoli Calmettes ( Site 0472)
Marseille, Bouches-du-Rhone, 13009
Institut du Cancer de Montpellier ( Site 0473)
Montpellier, Herault, 34298
CHU Hopital Saint Antoine ( Site 0471)
Paris, 75012
Institut Mutualiste Montsouris ( Site 0463)
Paris, 75014
CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)
Poitiers, Vienne, 86021
CHU Reims - Hopital Robert Debre ( Site 0465)
Reims, Champagne-Ardenne, 51092
Centre Eugene Marquis ( Site 0466)
Rennes, Ille-et-Vilaine, 35042
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469)
Saint-Herblain, Loire-Atlantique, 44805
CHU Toulouse - Hopital Rangueil ( Site 0470)
Toulouse, Haute-Garonne, 31059
South Korea10 sites
Kyungpook National University Chilgok Hospital ( Site 0089)
Daegu, Taegu-Kwangyokshi, 41404
Chonnam National University Hwasun Hospital ( Site 0083)
Hwasun Gun, Jeonranamdo, 58128
Gachon University Gil Medical Center ( Site 0087)
Incheon, 21565
Seoul National University Bundang Hospital ( Site 0085)
Seongnam-si, Kyonggi-do, 13620
Korea University Anam Hospital ( Site 0084)
Seoul, 02841
Seoul National University Hospital -SNUH- ( Site 0080)
Seoul, 03080
Severance Hospital Yonsei University Health System ( Site 0081)
Seoul, 03722
Asan Medical Center ( Site 0082)
Seoul, 05505
Gangnam Severance Hospital ( Site 0088)
Seoul, 06273
SMG-SNU BORAMAE Medical Center ( Site 0086)
Seoul, 07061
Belgium9 sites
Institut Jules Bordet ( Site 0480)
Brussels, Bruxelles-Capitale, Region de, 1000
Hopital Erasme ULB ( Site 0484)
Brussels, Bruxelles-Capitale, Region de, 1070
UCL Saint Luc ( Site 0479)
Brussels, Bruxelles-Capitale, Region de, 1200
Grand Hopital de Charleroi ( Site 0478)
Charleroi, Hainaut, 6000
UZ Gent ( Site 0486)
Ghent, Oost-Vlaanderen, 9000
AZ Groeninge ( Site 0481)
Kortrijk, West-Vlaanderen, 8500
UZ Leuven ( Site 0483)
Leuven, Vlaams-Brabant, 3000
CHU de Liege ( Site 0482)
Liège, Liege, 4000
CHU UCL Namur Site de Godinne ( Site 0485)
Yvoir, Namur, 5530
Poland9 sites
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354)
Bielsko-Biala, Silesian Voivodeship, 43-300
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361)
Gliwice, Silesian Voivodeship, 44-101
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353)
Kościerzyna, Pomeranian Voivodeship, 83-400
Szpital Uniwersytecki w Krakowie ( Site 0352)
Krakow, Lesser Poland Voivodeship, 31-501
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351)
Lublin, Lublin Voivodeship, 20-080
SPZOZ WSS nr 3 w Rybniku ( Site 0357)
Rybnik, Silesian Voivodeship, 44-200
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349)
Warsaw, Masovian Voivodeship, 02-034
Mazowiecki Szpital Onkologiczny ( Site 0363)
Wieliszew, Masovian Voivodeship, 05-135
Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)
Wroclaw, Lower Silesian Voivodeship, 51-124
Brazil8 sites
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301)
Barretos, São Paulo, 14784-400
CEPON - Centro de Pesquisas Oncologicas ( Site 0302)
Florianópolis, Santa Catarina, 88034-000
Instituto do Cancer do Ceara ( Site 0311)
Fortaleza, Ceará, 60430-230
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308)
Porto Alegre, Rio Grande do Sul, 90610-000
Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307)
Rio de Janeiro, 20230-130
Hospital de Base de Sao Jose de Rio Preto ( Site 0304)
Sao Jose Rio Preto, São Paulo, 15090-000
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305)
São Paulo, 01246-000
Hospital Israelita Albert Einstein ( Site 0309)
São Paulo, 05652-900
Canada8 sites
Cross Cancer Institute ( Site 0033)
Edmonton, Alberta, T6G 1Z2
CISSS de la Monteregie-Centre ( Site 0039)
Greenfield Park, Quebec, J4V 2H1
Moncton Hospital - Horizon Health Network ( Site 0038)
Moncton, New Brunswick, E1C 6Z8
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040)
Montreal, Quebec, H1T 2M4
Jewish General Hospital ( Site 0034)
Montreal, Quebec, H3T 1E2
CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042)
Québec, Quebec, G1R 2J6
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035)
Sherbrooke, Quebec, J1H 5N4
Sunnybrook Research Institute ( Site 0032)
Toronto, Ontario, M4N 3M5
Germany8 sites
Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)
Dresden, Saxony, 01307
Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445)
Essen, North Rhine-Westphalia, 45136
Klinikum Esslingen GmbH ( Site 0453)
Esslingen am Neckar, Baden-Wurttemberg, 73730
Universitaetsklinikum Freiburg ( Site 0450)
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454)
Hamburg, 20249
Medizinische Hochschule Hannover ( Site 0449)
Hanover, Lower Saxony, 30625
Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)
Mainz, Rhineland-Palatinate, 55131
Klinikum der Universitaet in Muenchen ( Site 0446)
Munich, Bavaria, 81377
Russia8 sites
Kaluga Regional Clinical Oncology Center ( Site 0345)
Kaluga, Kaluzskaja Oblast, 248007
National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338)
Moscow, Moscow, 105203
Blokhin National Medical Oncology ( Site 0494)
Moscow, Moscow, 115478
SBHI Leningrad Regional Clinical Hospital ( Site 0496)
Saint Petersburg, Leningradskaya Oblast', 194291
Leningrad Regional Oncology Center ( Site 0335)
Saint Petersburg, Sankt-Peterburg, 188663
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344)
Saint Petersburg, Sankt-Peterburg, 197758
City clinical oncological dispensary ( Site 0336)
Saint Petersburg, Sankt-Peterburg, 198255
Tomsk Scientific Research Institute of Oncology ( Site 0337)
Tomsk, Tomsk Oblast, 634028
Israel7 sites
Soroka University M.C ( Site 0385)
Beersheba, Southern District, 8410101
Rambam Health Care Campus ( Site 0381)
Haifa, 31096
Hadassah Medical Center. Ein Kerem ( Site 0383)
Jerusalem, 9112001
Meir medical center ( Site 0386)
Kfar Saba, Central District, 4428164
Rabin-Medical Center ( Site 0384)
Petah Tikva, 4941492
Sheba Medical center ( Site 0387)
Ramat Gan, 5265601
Sourasky Medical Center. ( Site 0382)
Tel Aviv, Tell Abib, 6423906
Italy7 sites
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430)
Milan, Lombardy, 20133
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)
Modena, 41125
Seconda Universita Napoli ( Site 0436)
Naples, 80131
IRCCS Istituto Oncologico Veneto ( Site 0431)
Padova, Abruzzo, 35128
Istituto Clinico Humanitas Research Hospital ( Site 0432)
Rozzano, Milano, 20089
IRCCS Policlinico San Donato ( Site 0433)
San Donato Milanese, Milano, 20097
A.O.U. Santa Maria della Misericordia di Udine ( Site 0434)
Udine, 33100
United Kingdom7 sites
University Hospitals Bristol NHS Foundation Trust ( Site 0407)
Bristol, Bristol, City of, BS2 8ED
Ninewells Hospital and Medical School ( Site 0406)
Dundee, Dundee City, DD1 9SY
Royal Free London NHS Foundation Trust ( Site 0403)
London, London, City of, NW3 2QG
The Royal Marsden Foundation Trust ( Site 0405)
London, London, City of, SW3 6JJ
Imperial College Healthcare NHS Trust ( Site 0402)
London, London, City of, W2 1NY
The Christie NHS Foundation Trust ( Site 0397)
Manchester, M20 4BX
Royal Marsden NHS Foundation Trust ( Site 0400)
Sutton, Surrey, SM2 5PT
Taiwan6 sites
Taipei Medical University Shuang Ho Hospital ( Site 0068)
New Taipei City, 235
National Cheng Kung University Hospital ( Site 0067)
Tainan, 704
National Taiwan University Hospital ( Site 0063)
Taipei, 10002
Mackay Memorial Hospital ( Site 0065)
Taipei, 104
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066)
Taipei, 11259
Chang Gung Medical Foundation. Linkou ( Site 0064)
Taoyuan, 333
Ukraine6 sites
City Clinical Hosp.4 of DCC ( Site 0325)
Dnipro, Dnipropetrovsk Oblast, 49102
Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591)
Kharkiv, Kharkiv Oblast, 61070
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589)
Kryviy Rih, Dnipropetrovsk Oblast, 50048
National Cancer Institute of the MoH of Ukraine ( Site 0319)
Kyiv, Kyivska Oblast, 03022
Kyiv City Clinical Oncology Center ( Site 0590)
Kyiv, Kyivska Oblast, 03115
Chile5 sites
Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)
Rancagua, Lbtdr Gen Bernardo O Higgins, 2820000
Fundacion Arturo Lopez Perez FALP ( Site 0286)
Santiago, Region M. de Santiago, 7500921
Pontificia Universidad Catolica de Chile ( Site 0285)
Santiago, Region M. de Santiago, 8330032
Hospital Clinico Universidad de Chile ( Site 0287)
Santiago, Region M. de Santiago, 8380456
Instituto Clinico del Sur. ICOS ( Site 0290)
Temuco, Araucania, 4810469
China3 sites
Beijing Cancer Hospital ( Site 0221)
Beijing, Beijing Municipality, 100142
Zhejiang Cancer Hospital ( Site 0231)
Hangzhou, Zhejiang, 310022
Sir Run Run Shaw Hospital ( Site 0233)
Hangzhou, Zhejiang, 430030
Guatemala3 sites
Integra Cancer Institute ( Site 0262)
Guatemala City, 01010
Grupo Medico Angeles ( Site 0261)
Guatemala City, 01015
Centro Medico Integral De Cancerología (CEMIC) ( Site 0260)
Quetzaltenango, 09002
Lithuania3 sites
LSMUL Kauno Klinikos ( Site 0570)
Kaunas, 50161
Nacionalinis Vezio Institutas ( Site 0569)
Vilnius, 08406
Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)
Vilnius, 08460
Singapore3 sites
National University Hospital ( Site 0095)
Singapore, Central Singapore, 119074
National Cancer Centre Singapore ( Site 0097)
Singapore, Central Singapore, 169610
Oncocare Cancer Centre ( Site 0096)
Singapore, Central Singapore, 258499
Malaysia2 sites
Hospital Kuala Lumpur ( Site 0146)
Kuala Lumpur, 50586
University Malaya Medical Centre ( Site 0143)
Kuala Lumpur, 59100
Estonia1 site
SA Pohja-Eesti Regionaalhaigla ( Site 0526)
Tallinn, Harju, 13419
Philippines1 site
St. Luke s Medical Center ( Site 0622)
Quezon City, National Capital Region, 1102
About this study
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)
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:
Read more
- 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.
With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Being tested
- Pembrolizumab, Placebo, Cisplatin, Capecitabine, 5-fluorouracil
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
- Medical subject headings
- Stomach Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called MK-3475, KEYTRUDA®
IV infusion
PlaceboDrug
Also called Normal saline solution
IV infusion
CisplatinDrug
Also called PLATINOL®
IV infusion
CapecitabineDrug
Also called XELODA®
Oral tablets
5-fluorouracilDrug
Also called ADRUCIL®, 5FU
IV infusion
DocetaxelDrug
Also called TAXOTERE®
IV infusion
OxaliplatinDrug
Also called ELOXATIN®
IV infusion
LeucovorinDrug
Also called WELLCOVORIN®
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + XP/FP | Experimental | XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. 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 IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 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 IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 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 IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg IV infusion on Day 1 Q3W for up to 11 additional cycles. Receives: Biological: Pembrolizumab; Drug: Cisplatin; Drug: Capecitabine; Drug: 5-fluorouracil |
| Placebo + XP/FP | Placebo comparator | 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. Receives: Drug: Placebo; Drug: Cisplatin; Drug: Capecitabine; Drug: 5-fluorouracil |
| Pembrolizumab+FLOT Cohort | Experimental | 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. Receives: Biological: Pembrolizumab; Drug: 5-fluorouracil; Drug: Docetaxel; Drug: Oxaliplatin; Drug: Leucovorin |
| Placebo+FLOT Cohort | Placebo comparator | 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. Receives: Drug: Placebo; Drug: 5-fluorouracil; Drug: Docetaxel; Drug: Oxaliplatin; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
EFS was based on RECIST 1.1 as assessed by the investigator and was 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 were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were 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), were not considered EFS events.
Measured: Up to approximately 75 months
Pathological Complete Response (pathCR) Rate - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
PathCR rate was defined as the percentage of participants having a pathCR based on central review. pathCR was defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes. The percentage of participants having pathCR was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.
Measured: Up to approximately 9 weeks following completion of neoadjuvant treatment (up to Study Week 18)
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
OS was defined as the time from randomization to death due to any cause. OS was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.
Measured: Up to approximately 75 months
Number of Participants Who Experienced One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE was presented for the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Measured: Up to approximately 70 months
Number of Participants Who Discontinued Study Treatment Due to an AE - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE was presented for the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Measured: Up to approximately 17 months
Secondary outcomes (5)
Number of Participants Who Experienced One or More Adverse Events (AEs) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced at least one AE was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Measured: Up to approximately 89 months
Number of Participants Who Discontinued Study Treatment Due to an AE - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Measured: Up to approximately 17 months
Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
DFS was defined as the time from post-surgery baseline scan until the first occurrence of local or distant recurrence or death from any cause and was based on RECIST 1.1 as assessed by the investigator.
Measured: Up to approximately 75 months
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
OS was defined as the time from randomization to death due to any cause. OS was presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Measured: Up to approximately 75 months
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
EFS was based on RECIST 1.1 as assessed by the investigator and was 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 were disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who were 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), were not considered EFS events.
Measured: Up to approximately 75 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start9 Oct 2017
- Primary completion16 Feb 2024
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221426
- Sponsor's protocol ID
- 3475-585
- Other IDs
- MK-3475-585, 173786, KEYNOTE-585, PHRR200226-002534, 2023-509595-42-00, 2023-509595-42, 2023
- Status last verified
- Feb 2026
- First submitted
- 17 Jul 2017
- Last updated
- 9 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Shitara K, Rha SY, Wyrwicz LS, Oshima T, Karaseva N, Osipov M, Yasui H, Yabusaki H, Afanasyev S, Park YK, Al-Batran SE, Yoshikawa T, Yanez P, Dib Bartolomeo M, Lonardi S, Tabernero J, Van Cutsem E, Janjigian YY, Oh DY, Xu J, Fang X, Shih CS, Bhagia P, Bang YJ; KEYNOTE-585 investigators. Neoadjuvant and adjuvant pembrolizumab plus chemotherapy in locally advanced gastric or gastro-oesophageal cancer (KEYNOTE-585): an interim analysis of the multicentre, double-blind, randomised phase 3 study. Lancet Oncol. 2024 Feb;25(2):212-224. doi: 10.1016/S1470-2045(23)00541-7. Epub 2023 Dec 19.
PubMed 38134948Shitara K, Rha SY, Wyrwicz L, Oshima T, Karaseva N, Osipov M, Yasui H, Yabusaki H, Afanasyev S, Park YK, Al-Batran SE, Yoshikawa T, Yanez P, Pietrantonio F, Lonardi S, Fang X, Guan Y, Valderrama A, Leconte P, Bhagia P, Bang YJ; KEYNOTE-585 Investigators. Pembrolizumab Plus Chemotherapy Versus Chemotherapy as Perioperative Therapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer: Final Analysis of the Randomized, Phase III KEYNOTE-585 Study. J Clin Oncol. 2025 Oct 10;43(29):3152-3159. doi: 10.1200/JCO-25-00486. Epub 2025 Aug 19.
PubMed 40829093Chang 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.
PubMed 35623069Bang 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.
PubMed 30777447