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)

Gastric Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03221426
• Other study ID #: 3475-585
• Secondary ID: MK-3475-58517378
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 9, 2017
• Est. completion date: June 28, 2024

Study information

• Verified date: February 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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. With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1007
• Est. completion date: June 28, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer
• Gastroesophageal Junction Cancer

Intervention

Biological:
• Pembrolizumab
IV infusion

Drug:
• Placebo
IV infusion
• Cisplatin
IV infusion
• Capecitabine
Oral tablets
• 5-fluorouracil
IV infusion
• Docetaxel
IV infusion
• Oxaliplatin
IV infusion
• Leucovorin
IV infusion

Locations

Country	Name	City	State
Belgium	Hopital Erasme ULB ( Site 0484)	Brussels	Bruxelles-Capitale, Region De
Belgium	Institut Jules Bordet ( Site 0480)	Brussels	Bruxelles-Capitale, Region De
Belgium	UCL Saint Luc ( Site 0479)	Bruxelles	Bruxelles-Capitale, Region De
Belgium	Grand Hopital de Charleroi ( Site 0478)	Charleroi	Hainaut
Belgium	UZ Gent ( Site 0486)	Gent	Oost-Vlaanderen
Belgium	AZ Groeninge ( Site 0481)	Kortrijk	West-Vlaanderen
Belgium	UZ Leuven ( Site 0483)	Leuven	Vlaams-Brabant
Belgium	CHU de Liege ( Site 0482)	Liège	Liege
Belgium	CHU UCL Namur Site de Godinne ( Site 0485)	Yvoir	Namur
Brazil	Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301)	Barretos	Sao Paulo
Brazil	CEPON - Centro de Pesquisas Oncologicas ( Site 0302)	Florianopolis	Santa Catarina
Brazil	Instituto do Cancer do Ceara ( Site 0311)	Fortaleza	Ceara
Brazil	Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308)	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307)	Rio de Janeiro
Brazil	Hospital de Base de Sao Jose de Rio Preto ( Site 0304)	Sao Jose Rio Preto	Sao Paulo
Brazil	Hospital Israelita Albert Einstein ( Site 0309)	Sao Paulo
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305)	Sao Paulo
Canada	Cross Cancer Institute ( Site 0033)	Edmonton	Alberta
Canada	CISSS de la Monteregie-Centre ( Site 0039)	Greenfield Park	Quebec
Canada	Moncton Hospital - Horizon Health Network ( Site 0038)	Moncton	New Brunswick
Canada	CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040)	Montreal	Quebec
Canada	Jewish General Hospital ( Site 0034)	Montreal	Quebec
Canada	CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042)	Quebec
Canada	CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035)	Sherbrooke	Quebec
Canada	Sunnybrook Research Institute ( Site 0032)	Toronto	Ontario
Chile	Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)	Rancagua	Lbtdr Gen Bernardo O Higgins
Chile	Fundacion Arturo Lopez Perez FALP ( Site 0286)	Santiago	Region M. De Santiago
Chile	Hospital Clinico Universidad de Chile ( Site 0287)	Santiago	Region M. De Santiago
Chile	Pontificia Universidad Catolica de Chile ( Site 0285)	Santiago	Region M. De Santiago
Chile	Instituto Clinico del Sur. ICOS ( Site 0290)	Temuco	Araucania
China	Beijing Cancer Hospital ( Site 0221)	Beijing	Beijing
China	Sir Run Run Shaw Hospital ( Site 0233)	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital ( Site 0231)	Hangzhou	Zhejiang
Estonia	SA Pohja-Eesti Regionaalhaigla ( Site 0526)	Tallinn	Harjumaa
France	CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474)	Brest	Finistere
France	CHRU Lille - Hopital Claude Huriez ( Site 0461)	Lille	Nord
France	Hopital Prive Jean Mermoz ( Site 0462)	Lyon	Auvergne
France	Institut Paoli Calmettes ( Site 0472)	Marseille	Bouches-du-Rhone
France	Institut du Cancer de Montpellier ( Site 0473)	Montpellier	Herault
France	CHU Hopital Saint Antoine ( Site 0471)	Paris
France	Institut Mutualiste Montsouris ( Site 0463)	Paris
France	CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)	Poitiers	Vienne
France	CHU Reims - Hopital Robert Debre ( Site 0465)	Reims	Champagne-Ardenne
France	Centre Eugene Marquis ( Site 0466)	Rennes	Ille-et-Vilaine
France	Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469)	Saint Herblain	Loire-Atlantique
France	CHU Toulouse - Hopital Rangueil ( Site 0470)	Toulouse	Haute-Garonne
Germany	Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)	Dresden	Sachsen
Germany	Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445)	Essen	Nordrhein-Westfalen
Germany	Klinikum Esslingen GmbH ( Site 0453)	Esslingen	Baden-Wurttemberg
Germany	Universitaetsklinikum Freiburg ( Site 0450)	Freiburg	Baden-Wurttemberg
Germany	Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454)	Hamburg
Germany	Medizinische Hochschule Hannover ( Site 0449)	Hannover	Niedersachsen
Germany	Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)	Mainz	Rheinland-Pfalz
Germany	Klinikum der Universitaet in Muenchen ( Site 0446)	Muenchen	Bayern
Guatemala	Grupo Medico Angeles ( Site 0261)	Guatemala
Guatemala	Integra Cancer Institute ( Site 0262)	Guatemala
Guatemala	Centro Medico Integral De Cancerología (CEMIC) ( Site 0260)	Quetzaltenango
Israel	Soroka University M.C ( Site 0385)	Beer Sheva	HaDarom
Israel	Rambam Health Care Campus ( Site 0381)	Haifa
Israel	Hadassah Medical Center. Ein Kerem ( Site 0383)	Jerusalem
Israel	Meir medical center ( Site 0386)	Kfar Saba	HaMerkaz
Israel	Rabin-Medical Center ( Site 0384)	Petah Tikva
Israel	Sheba Medical center ( Site 0387)	Ramat Gan
Israel	Sourasky Medical Center. ( Site 0382)	Tel-Aviv	Tell Abib
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430)	Milano	Lombardia
Italy	Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)	Modena
Italy	Seconda Universita Napoli ( Site 0436)	Napoli
Italy	IRCCS Istituto Oncologico Veneto ( Site 0431)	Padova	Abruzzo
Italy	Istituto Clinico Humanitas Research Hospital ( Site 0432)	Rozzano	Milano
Italy	IRCCS Policlinico San Donato ( Site 0433)	San Donato Milanese	Milano
Italy	A.O.U. Santa Maria della Misericordia di Udine ( Site 0434)	Udine
Japan	Hyogo Cancer Center ( Site 0182)	Akashi	Hyogo
Japan	Chiba Cancer Center ( Site 0180)	Chiba
Japan	Kyushu University Hospital ( Site 0173)	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center ( Site 0172)	Fukuoka
Japan	Gifu University Hospital ( Site 0166)	Gifu
Japan	Kansai Medical University Hospital ( Site 0190)	Hirakata	Osaka
Japan	Hiroshima City Hiroshima Citizens Hospital ( Site 0171)	Hiroshima
Japan	Ibaraki Prefectural Central Hospital ( Site 0177)	Kasama	Ibaraki
Japan	National Cancer Center Hospital East ( Site 0178)	Kashiwa	Chiba
Japan	St. Marianna University School of Medicine Hospital ( Site 0187)	Kawasaki	Kanagawa
Japan	Saitama Cancer Center ( Site 0170)	Kitaadachi-gun	Saitama
Japan	Kobe City Medical Center General Hospital ( Site 0181)	Kobe	Hyogo
Japan	Kobe University Hospital ( Site 0188)	Kobe	Hyogo
Japan	Kochi Health Sciences Center ( Site 0189)	Kochi
Japan	Kumamoto University Hospital ( Site 0164)	Kumamoto
Japan	National Hospital Organization Shikoku Cancer Center ( Site 0186)	Matsuyama	Ehime
Japan	Aichi Cancer Center Hospital ( Site 0165)	Nagoya	Aichi
Japan	Niigata Cancer Center Hospital ( Site 0169)	Niigata
Japan	Osaka General Medical Center ( Site 0159)	Osaka
Japan	Osaka International Cancer Institute ( Site 0161)	Osaka
Japan	Hokkaido University Hospital ( Site 0160)	Sapporo	Hokkaido
Japan	Iwate Medical University Hospital ( Site 0184)	Shiwa-gun	Iwate
Japan	Osaka University Hospital ( Site 0162)	Suita	Osaka
Japan	Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)	Sunto-gun	Shizuoka
Japan	Osaka Medical College Hospital ( Site 0168)	Takatsuki	Osaka
Japan	National Cancer Center Hospital ( Site 0179)	Tokyo
Japan	The Cancer Institute Hospital of JFCR ( Site 0185)	Tokyo
Japan	Tokyo Metropolitan Komagome Hospital ( Site 0183)	Tokyo
Japan	Toyama Prefectural Central Hospital ( Site 0163)	Toyama
Japan	Kanagawa Cancer Center ( Site 0167)	Yokohama	Kanagawa
Korea, Republic of	Kyungpook National University Chilgok Hospital ( Site 0089)	Daegu	Taegu-Kwangyokshi
Korea, Republic of	Chonnam National University Hwasun Hospital ( Site 0083)	Hwasun Gun	Jeonranamdo
Korea, Republic of	Gachon University Gil Medical Center ( Site 0087)	Incheon
Korea, Republic of	Seoul National University Bundang Hospital ( Site 0085)	Seongnam-si	Kyonggi-do
Korea, Republic of	Asan Medical Center ( Site 0082)	Seoul
Korea, Republic of	Gangnam Severance Hospital ( Site 0088)	Seoul
Korea, Republic of	Korea University Anam Hospital ( Site 0084)	Seoul
Korea, Republic of	Seoul National University Hospital -SNUH- ( Site 0080)	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System ( Site 0081)	Seoul
Korea, Republic of	SMG-SNU BORAMAE Medical Center ( Site 0086)	Seoul
Latvia	Riga East Clinical University Hospital ( Site 0550)	Riga
Lithuania	LSMUL Kauno Klinikos ( Site 0570)	Kaunas
Lithuania	Nacionalinis Vezio Institutas ( Site 0569)	Vilnius
Lithuania	Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)	Vilnius
Malaysia	Hospital Kuala Lumpur ( Site 0146)	Kuala Lumpur
Malaysia	University Malaya Medical Centre ( Site 0143)	Kuala Lumpur
Philippines	St. Luke s Medical Center ( Site 0622)	Quezon City	National Capital Region
Poland	Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354)	Bielsko-Biala	Slaskie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361)	Gliwice	Slaskie
Poland	Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353)	Koscierzyna	Pomorskie
Poland	Szpital Uniwersytecki w Krakowie ( Site 0352)	Krakow	Malopolskie
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351)	Lublin	Lubelskie
Poland	SPZOZ WSS nr 3 w Rybniku ( Site 0357)	Rybnik	Slaskie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349)	Warszawa	Mazowieckie
Poland	Mazowiecki Szpital Onkologiczny ( Site 0363)	Wieliszew	Mazowieckie
Poland	Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)	Wroclaw	Dolnoslaskie
Russian Federation	Kaluga Regional Clinical Oncology Center ( Site 0345)	Kaluga	Kaluzskaja Oblast
Russian Federation	Blokhin National Medical Oncology ( Site 0494)	Moscow	Moskva
Russian Federation	National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338)	Moscow	Moskva
Russian Federation	SBHI Leningrad Regional Clinical Hospital ( Site 0496)	Saint Petersburg	Leningradskaya Oblast
Russian Federation	Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344)	Saint Petersburg	Sankt-Peterburg
Russian Federation	Leningrad Regional Oncology Center ( Site 0335)	Saint-Petersburg	Sankt-Peterburg
Russian Federation	City clinical oncological dispensary ( Site 0336)	Sankt-Petersburg	Sankt-Peterburg
Russian Federation	Tomsk Scientific Research Institute of Oncology ( Site 0337)	Tomsk	Tomskaya Oblast
Singapore	National Cancer Centre Singapore ( Site 0097)	Singapore	Central Singapore
Singapore	National University Hospital ( Site 0095)	Singapore	Central Singapore
Singapore	Oncocare Cancer Centre ( Site 0096)	Singapore	Central Singapore
Taiwan	Taipei Medical University Shuang Ho Hospital ( Site 0068)	New Taipei
Taiwan	National Cheng Kung University Hospital ( Site 0067)	Tainan
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066)	Taipei
Taiwan	Mackay Memorial Hospital ( Site 0065)	Taipei
Taiwan	National Taiwan University Hospital ( Site 0063)	Taipei
Taiwan	Chang Gung Medical Foundation. Linkou ( Site 0064)	Taoyuan
Ukraine	City Clinical Hosp.4 of DCC ( Site 0325)	Dnipro	Dnipropetrovska Oblast
Ukraine	Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)	Ivano-Frankivsk	Ivano-Frankivska Oblast
Ukraine	Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591)	Kharkiv	Kharkivska Oblast
Ukraine	MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589)	Kryviy Rih	Dnipropetrovska Oblast
Ukraine	Kyiv City Clinical Oncology Center ( Site 0590)	Kyiv	Kyivska Oblast
Ukraine	National Cancer Institute of the MoH of Ukraine ( Site 0319)	Kyiv	Kyivska Oblast
United Kingdom	University Hospitals Bristol NHS Foundation Trust ( Site 0407)	Bristol	Bristol, City Of
United Kingdom	Ninewells Hospital and Medical School ( Site 0406)	Dundee	Dundee City
United Kingdom	Imperial College Healthcare NHS Trust ( Site 0402)	London	London, City Of
United Kingdom	Royal Free London NHS Foundation Trust ( Site 0403)	London	London, City Of
United Kingdom	The Royal Marsden Foundation Trust ( Site 0405)	London	London, City Of
United Kingdom	The Christie NHS Foundation Trust ( Site 0397)	Manchester
United Kingdom	Royal Marsden NHS Foundation Trust ( Site 0400)	Sutton	Surrey
United States	Roswell Park Cancer Institute ( Site 0001)	Buffalo	New York
United States	Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018)	Chicago	Illinois
United States	The University of Chicago Medical Center ( Site 0004)	Chicago	Illinois
United States	City of Hope ( Site 0005)	Duarte	California
United States	Virginia Cancer Specialists, PC ( Site 0010)	Fairfax	Virginia
United States	Yale Cancer Center ( Site 0016)	New Haven	Connecticut
United States	Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019)	New York	New York
United States	Memorial Sloan Kettering ( Site 0024)	New York	New York
United States	Weill Cornell Medical Center ( Site 0023)	New York	New York
United States	Fox Chase Cancer Center ( Site 0006)	Philadelphia	Pennsylvania
United States	Temple University Hospital ( Site 0026)	Philadelphia	Pennsylvania
United States	University of Rochester ( Site 0011)	Rochester	New York
United States	University of Utah, Huntsman Cancer Institute ( Site 0012)	Salt Lake City	Utah
United States	Georgetown University ( Site 0015)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Chile,  China,  Estonia,  France,  Germany,  Guatemala,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Philippines,  Poland,  Russian Federation,  Singapore,  Taiwan,  Ukraine,  United Kingdom, 

References & Publications (1)

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, Ban — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 2 years
Primary	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.	Up to approximately 15 weeks
Primary	Overall Survival (OS) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms	OS is defined as the time from randomization to death due to any cause.	Up to approximately 2 years
Primary	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.	Up to approximately 27 months
Primary	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.	Up to approximately 2 years
Secondary	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.	Up to approximately 27 months
Secondary	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.	Up to approximately 2 years
Secondary	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.	Up to approximately 2 years
Secondary	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.	Up to approximately 2 years
Secondary	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.	Up to approximately 2 years

External Links

•   Merck Clinical Trials Information