Back to resultsPembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)
Primary Purpose
Gastric Neoplasms, Gastroesophageal Junction Adenocarcinoma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Placebo
Cisplatin
5-FU
Oxaliplatin
Capecitabine
S-1
Trastuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Neoplasms focused on measuring programmed cell death receptor 1 (PD-1), programmed cell death ligand 1 (PD-L1), anti-PD-1, anti PD-1, GEJ, Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma
- HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor
- Has measurable disease as defined by RECIST 1.1 as determined by the site investigator
- Male participants must agree to use approved contraception
- Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of trial treatment
- Has a life expectancy of greater than 6 months
- Has adequate organ function
Exclusion Criteria:
- Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer
- Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment
- Has had radiotherapy within 14 days of randomization
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis)
- Has an active infection requiring systemic therapy
- Has poorly controlled diarrhea
- Accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. If the participant is receiving diuretic drugs for other reasons, it is acceptable
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Has peripheral neuropathy > Grade 1
- Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
- A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation
- Has active or clinically significant cardiac disease
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab, trastuzumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum-containing products
- Has had an allogeneic tissue/solid organ transplant
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, Cluster of Differentiation 137 [CD137])
Sites / Locations
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045)
- Pacific Cancer Care ( Site 0063)
- UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050)
- University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026)
- Southeastern Regional Medical Center, Inc. ( Site 0058)
- Midwestern Regional Medical Center, Inc. ( Site 0059)
- Beth Israel Deaconess Medical Center ( Site 0070)
- Dana-Farber Cancer Institute [Boston, MA] ( Site 0010)
- Minnesota Oncology Hematology, PA ( Site 8001)
- Washington University School of Medicine ( Site 0040)
- Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071)
- Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065)
- Memorial Sloan-Kettering Cancer Center ( Site 0017)
- University of Rochester ( Site 0041)
- Levine Cancer Institute ( Site 0015)
- Duke Cancer Institute ( Site 0042)
- CTCA Southwestern ( Site 0060)
- Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025)
- Allegheny General Hospital ( Site 0053)
- Sanford Hematology Oncology-Sioux Falls SD ( Site 0004)
- University of Texas MD Anderson Cancer Center ( Site 0001)
- Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000)
- Seattle Cancer Care Alliance ( Site 0038)
- Liverpool Hospital ( Site 2206)
- Westmead Hospital ( Site 2200)
- Southern Medical Day Care Centre ( Site 2207)
- Monash Health ( Site 2202)
- Hospital Sao Rafael ( Site 0209)
- Instituto do Cancer do Ceara ( Site 0208)
- CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205)
- Hospital de Caridade de Ijui ( Site 0202)
- Hospital Nossa Senhora da Conceicao ( Site 0203)
- CEPON - Centro de Pesquisas Oncologicas ( Site 0200)
- Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201)
- IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204)
- Centro Investigación del Cáncer James Lind ( Site 0300)
- Clinica Universidad Catolica del Maule ( Site 0305)
- Fundacion Arturo Lopez Perez FALP ( Site 0302)
- Pontificia Universidad Catolica de Chile ( Site 0301)
- Instituto Nacional del Cancer ( Site 0303)
- Shanghai General Hospital ( Site 2404)
- Peking Union Medical College Hospital ( Site 2419)
- Fifth Medical Center of CPLA General Hospital ( Site 2415)
- Beijing Cancer Hospital ( Site 2413)
- Fujian Provincial Cancer Hospital ( Site 2418)
- 900 Hospital of the Joint ( Site 2420)
- The First Affiliated Hospital of Xiamen University ( Site 2431)
- Guangdong General Hospital ( Site 2433)
- Harbin Medical University Cancer Hospital ( Site 2407)
- Henan Cancer Hospital ( Site 2400)
- Xiangya Hospital Central-South University ( Site 2426)
- Jiangsu Cancer Hospital ( Site 2432)
- The First Hospital Of Jilin University ( Site 2402)
- Fudan University Shanghai Cancer Center ( Site 2424)
- Zhongshan Hospital affiliated to Fudan University ( Site 2401)
- Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430)
- The First Affiliated Hospital.Zhejiang University ( Site 2408)
- Sir Run Run Shaw Hospital ( Site 2412)
- Zhejiang Cancer Hospital ( Site 2409)
- CHU de Rouen ( Site 0912)
- HUS Hopital Hautepierre ( Site 0910)
- Hopital Jean Minjoz Besancon ( Site 0901)
- C.H.R.U. de Brest - Hopital Morvan ( Site 0913)
- Centre Oscar Lambret ( Site 0911)
- Centre Leon Berard ( Site 0904)
- Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902)
- Institut Gustave Roussy ( Site 0900)
- CHU Hopital Saint Antoine ( Site 0905)
- SLK-Kliniken Heilbronn ( Site 1015)
- Klinikum Ludwigsburg ( Site 1014)
- Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020)
- Klinikum rechts der Isar der Technischen Universitaet ( Site 1027)
- Medizinische Hochschule Hannover ( Site 1019)
- Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001)
- Universitaetsklinikum Leipzig AOeR ( Site 1007)
- Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 1026)
- Klinikum Bremen Nord ( Site 1017)
- Facharztzentrum Eppendorf ( Site 1025)
- Asklepios Klinik Altona ( Site 1000)
- Celan SA ( Site 0504)
- Oncomedica ( Site 0500)
- Grupo Angeles SA ( Site 0501)
- Nucare Center ( Site 0506)
- Medi-K Cayala ( Site 0505)
- Centro Regional de Sub Especialidades Medicas SA ( Site 0502)
- Saint James's Hospital ( Site 1505)
- Beaumont Hospital ( Site 1506)
- Tallaght University Hospital ( Site 1513)
- Soroka University Medical Center ( Site 1603)
- Rambam Health Care Campus ( Site 1606)
- Edith Wolfson Medical Center ( Site 1605)
- Hadassah Ein Kerem Medical Center ( Site 1604)
- Meir Medical Center ( Site 1609)
- Rabin Medical Center ( Site 1602)
- Chaim Sheba Medical Center. ( Site 1607)
- Sourasky Medical Center ( Site 1601)
- AUOP Ospedale Santa Chiara ( Site 1100)
- Humanitas Gavazzeni ( Site 1106)
- Universita Magna Graecia di Catanzaro ( Site 1107)
- IEO Istituto Europeo di Oncologia ( Site 1105)
- Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1102)
- A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1103)
- Istituto Oncologico Veneto ( Site 1101)
- Ospedale Civile Spirito Santo ( Site 1104)
- Aichi Cancer Center Hospital ( Site 2617)
- National Cancer Center Hospital East ( Site 2605)
- National Hospital Organization Shikoku Cancer Center ( Site 2615)
- Gunma Prefectural Cancer Center ( Site 2602)
- Hyogo Cancer Center ( Site 2619)
- Kobe City Medical Center General Hospital ( Site 2614)
- Ibaraki Prefectural Central Hospital ( Site 2611)
- Kagawa University Hospital ( Site 2604)
- Kanagawa Cancer Center ( Site 2603)
- Osaki Citizen Hospital ( Site 2626)
- Kansai Medical University Hospital ( Site 2618)
- Kindai University Hospital ( Site 2616)
- Osaka University Hospital ( Site 2600)
- Saitama Cancer Center ( Site 2620)
- Shizuoka Cancer Center Hospital and Research Institute ( Site 2607)
- Tochigi Cancer Center ( Site 2627)
- Kyorin University Hospital ( Site 2608)
- Chiba Cancer Center ( Site 2623)
- National Hospital Organization Kyushu Cancer Center ( Site 2609)
- Gifu University Hospital ( Site 2621)
- Hiroshima City Hiroshima Citizens Hospital ( Site 2625)
- Kumamoto University Hospital ( Site 2601)
- Niigata Cancer Center Hospital ( Site 2622)
- National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26
- Osaka International Cancer Institute ( Site 2613)
- Osaka General Medical Center ( Site 2624)
- National Cancer Center Hospital ( Site 2612)
- Toranomon Hospital ( Site 2628)
- Tokyo Metropolitan Komagome Hospital ( Site 2606)
- The Cancer Institute Hospital of JFCR ( Site 2610)
- Seoul National University Hospital ( Site 2703)
- Severance Hospital Yonsei University Health System ( Site 2700)
- Asan Medical Center ( Site 2702)
- Samsung Medical Center ( Site 2701)
- Auckland City Hospital ( Site 2300)
- Uniwersytecki Szpital Kliniczny im. J. M. Radeckiego we Wroclawiu ( Site 1705)
- Dolnoslaskie Centrum Onkologii. ( Site 1712)
- Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1709)
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
- Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1715)
- Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1708)
- Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1710)
- Przychodnia Lekarska Komed ( Site 1716)
- Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1807)
- Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1815)
- Podolsky City Clinical Hospital ( Site 1817)
- Blokhin National Medical Oncology ( Site 1805)
- Medical University REAVIZ ( Site 1816)
- Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1801)
- St Petersburg City Clinical Oncology Dispensary ( Site 1812)
- Leningrad Regional Oncology Center ( Site 1800)
- Hospital General Universitario de Elche ( Site 1404)
- Hospital Universitario Central de Asturias ( Site 1402)
- Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1410)
- Hospital Universitario Marques de Valdecilla ( Site 1405)
- Hospital Universitario Quiron Madrid ( Site 1407)
- Hospital General Universitari Vall d Hebron ( Site 1401)
- Hospital Universitario Ramon y Cajal ( Site 1400)
- Adana Sehir Hastanesi ( Site 2002)
- Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2017)
- Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)
- Trakya Universitesi Tip Fakultesi ( Site 2015)
- Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)
- Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)
- Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)
- Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)
- Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)
- City Clinical Hosp.4 of DCC ( Site 2102)
- MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2101)
- MI Precarpathian Clinical Oncology Center ( Site 2105)
- Communal non profit enterprise Regional Clinical Oncology Center ( Site 2112)
- Medical Center Asklepion LLC ( Site 2115)
- Clinic of National Cancer Institute ( Site 2104)
- Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2114)
- Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2106)
- MI Odessa Regional Oncological Centre ( Site 2108)
- Medical Centre LLC Oncolife ( Site 2103)
- Kyiv City Clinical Oncology Centre ( Site 2110)
- Royal Hospital in Derby ( Site 1514)
- Ninewells Hospital and Medical School ( Site 1504)
- Castle Hill Hospital ( Site 1501)
- University College London Hospital NHS Foundation Trust ( Site 1508)
- St Georges University Hospitals NHS Foundation Trust. ( Site 1500)
- Royal Marsden Hospital ( Site 1510)
- Royal Marsden NHS Foundation Trust ( Site 1512)
- The Christie Hospital NHS Foundation Trust ( Site 1503)
- Mount Vernon Cancer Centre ( Site 1507)
- Manor Hospital Walsall England ( Site 1515)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pembrolizumab +Trastuzumab + Chemotherapy
Placebo +Trastuzumab + Chemotherapy
Arm Description
Participants receive 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy (Global Cohort) or SOX chemotherapy (Japan cohort).
Participants receive matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy (Global Cohort) or SOX chemotherapy (Japan cohort).
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. PFS will be determined for each treatment arm.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.
Secondary Outcome Measures
Objective Response Rate (ORR) per RECIST 1.1 assessed by BICR
ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by BICR. ORR will be determined for each treatment arm.
Duration of Response (DOR) per RECIST 1.1 assessed by BICR
For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR will be determined for each treatment arm.
Adverse Events (AE)
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm.
Treatment Discontinuations Due to AEs
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinue study treatment due to an AE will be reported for each treatment arm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03615326
Brief Title
Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)
Official Title
A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 5, 2018 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 30, 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 study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).
Detailed Description
Pembrolizumab (200 mg) or placebo will be administered intravenously [IV] on day 1 of each 3-week cycle. Trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance dose) will be administered IV on day 1 of each 3-week cycle. SOC chemotherapy for the global cohort will either be FP (80 mg/m^2 cisplatin administered IV on Day 1 of each 3-week cycle and 800 mg/m^2 5-fluorouracil [5-FU] administered IV on Days 1-5 of each 3-week cycle) or CAPOX (1000 mg/m^2 capecitabine administered orally twice daily [BID] on days 1-14 of each 3-week cycle and 130 mg/m^2 oxaliplatin administered IV on Day 1 of each 3-week cycle). A Japan cohort will receive SOX chemotherapy consisting of S-1 (tegafur, 5-chloro-2,4-dihydroxypyridine [CDHP], and potassium oxonate [Oxo]) administered orally BID according to Body Surface Area (BSA) on Days 1-14 of each 3-week cycle and oxaliplatin (130 mg/m^2) administered IV on Day 1 each 3-week cycle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Neoplasms, Gastroesophageal Junction Adenocarcinoma
Keywords
programmed cell death receptor 1 (PD-1), programmed cell death ligand 1 (PD-L1), anti-PD-1, anti PD-1, GEJ, Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
732 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab +Trastuzumab + Chemotherapy
Arm Type
Experimental
Arm Description
Participants receive 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy (Global Cohort) or SOX chemotherapy (Japan cohort).
Arm Title
Placebo +Trastuzumab + Chemotherapy
Arm Type
Active Comparator
Arm Description
Participants receive matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy (Global Cohort) or SOX chemotherapy (Japan cohort).
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda®, MK-3475
Intervention Description
200 mg on Day 1 of each 3-week cycle as an IV infusion.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Solution for IV infusion on Day 1 of each 3-week cycle.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
80 mg/m^2 on Day 1 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen.
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
800 mg/m^2/day continuous on Days 1-5 of each 3-week cycle (120 hours or per local standard), administered as part of FP chemotherapy regimen.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg/m^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen and as part of SOX chemotherapy regimen.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1000 mg/m^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): <1.25 m^2 BSA =40 mg, 1.25 to <1.5 m^2 BSA=50 mg, ≥1.5 m^2 BSA=60 mg. Administered as part of SOX chemotherapy regimen.
Intervention Type
Biological
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin®
Intervention Description
8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR
Description
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. PFS will be determined for each treatment arm.
Time Frame
Up to approximately 4 years
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.
Time Frame
Up to approximately 5 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) per RECIST 1.1 assessed by BICR
Description
ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by BICR. ORR will be determined for each treatment arm.
Time Frame
Up to approximately 5 years
Title
Duration of Response (DOR) per RECIST 1.1 assessed by BICR
Description
For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR will be determined for each treatment arm.
Time Frame
Up to approximately 5 years
Title
Adverse Events (AE)
Description
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm.
Time Frame
Up to approximately 5 years
Title
Treatment Discontinuations Due to AEs
Description
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinue study treatment due to an AE will be reported for each treatment arm.
Time Frame
Up to approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma
HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor
Has measurable disease as defined by RECIST 1.1 as determined by the site investigator
Male participants must agree to use approved contraception
Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of trial treatment
Has a life expectancy of greater than 6 months
Has adequate organ function
Exclusion Criteria:
Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer
Has had major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment
Has had radiotherapy within 14 days of randomization
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis)
Has an active infection requiring systemic therapy
Has poorly controlled diarrhea
Accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. If the participant is receiving diuretic drugs for other reasons, it is acceptable
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has peripheral neuropathy > Grade 1
Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation
Has active or clinically significant cardiac disease
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
Has severe hypersensitivity (≥Grade 3) to pembrolizumab, trastuzumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum-containing products
Has had an allogeneic tissue/solid organ transplant
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, Cluster of Differentiation 137 [CD137])
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
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pacific Cancer Care ( Site 0063)
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Southeastern Regional Medical Center, Inc. ( Site 0058)
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Midwestern Regional Medical Center, Inc. ( Site 0059)
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Beth Israel Deaconess Medical Center ( Site 0070)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute [Boston, MA] ( Site 0010)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Minnesota Oncology Hematology, PA ( Site 8001)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Washington University School of Medicine ( Site 0040)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center ( Site 0017)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester ( Site 0041)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Levine Cancer Institute ( Site 0015)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke Cancer Institute ( Site 0042)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
CTCA Southwestern ( Site 0060)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Allegheny General Hospital ( Site 0053)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Sanford Hematology Oncology-Sioux Falls SD ( Site 0004)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center ( Site 0001)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000)
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Seattle Cancer Care Alliance ( Site 0038)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Liverpool Hospital ( Site 2206)
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Westmead Hospital ( Site 2200)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Southern Medical Day Care Centre ( Site 2207)
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Monash Health ( Site 2202)
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Hospital Sao Rafael ( Site 0209)
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Instituto do Cancer do Ceara ( Site 0208)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810-050
Country
Brazil
Facility Name
Hospital de Caridade de Ijui ( Site 0202)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700 000
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao ( Site 0203)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
CEPON - Centro de Pesquisas Oncologicas ( Site 0200)
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201)
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204)
City
Sao Paulo
ZIP/Postal Code
03102-002
Country
Brazil
Facility Name
Centro Investigación del Cáncer James Lind ( Site 0300)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Facility Name
Clinica Universidad Catolica del Maule ( Site 0305)
City
Talca
State/Province
Maule
ZIP/Postal Code
3460000
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez FALP ( Site 0302)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 0301)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7620002
Country
Chile
Facility Name
Instituto Nacional del Cancer ( Site 0303)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380455
Country
Chile
Facility Name
Shanghai General Hospital ( Site 2404)
City
Shanghai
State/Province
Anhui
ZIP/Postal Code
200080
Country
China
Facility Name
Peking Union Medical College Hospital ( Site 2419)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Fifth Medical Center of CPLA General Hospital ( Site 2415)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Beijing Cancer Hospital ( Site 2413)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Fujian Provincial Cancer Hospital ( Site 2418)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
900 Hospital of the Joint ( Site 2420)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University ( Site 2431)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Guangdong General Hospital ( Site 2433)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Harbin Medical University Cancer Hospital ( Site 2407)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital ( Site 2400)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Xiangya Hospital Central-South University ( Site 2426)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Jiangsu Cancer Hospital ( Site 2432)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
The First Hospital Of Jilin University ( Site 2402)
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Fudan University Shanghai Cancer Center ( Site 2424)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Zhongshan Hospital affiliated to Fudan University ( Site 2401)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430)
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Facility Name
The First Affiliated Hospital.Zhejiang University ( Site 2408)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Sir Run Run Shaw Hospital ( Site 2412)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital ( Site 2409)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
CHU de Rouen ( Site 0912)
City
Rouen
State/Province
Ain
ZIP/Postal Code
76000
Country
France
Facility Name
HUS Hopital Hautepierre ( Site 0910)
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67098
Country
France
Facility Name
Hopital Jean Minjoz Besancon ( Site 0901)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Facility Name
C.H.R.U. de Brest - Hopital Morvan ( Site 0913)
City
Brest
State/Province
Finistere
ZIP/Postal Code
29200
Country
France
Facility Name
Centre Oscar Lambret ( Site 0911)
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Leon Berard ( Site 0904)
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69008
Country
France
Facility Name
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902)
City
Saint-Herblain
State/Province
Val-de-Marne
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Gustave Roussy ( Site 0900)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Facility Name
CHU Hopital Saint Antoine ( Site 0905)
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
SLK-Kliniken Heilbronn ( Site 1015)
City
Heilbronn
State/Province
Baden-Wurttemberg
ZIP/Postal Code
74078
Country
Germany
Facility Name
Klinikum Ludwigsburg ( Site 1014)
City
Ludwigsburg
State/Province
Baden-Wurttemberg
Country
Germany
Facility Name
Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universitaet ( Site 1027)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Medizinische Hochschule Hannover ( Site 1019)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Leipzig AOeR ( Site 1007)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 1026)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Klinikum Bremen Nord ( Site 1017)
City
Bremen
ZIP/Postal Code
28211
Country
Germany
Facility Name
Facharztzentrum Eppendorf ( Site 1025)
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Asklepios Klinik Altona ( Site 1000)
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Celan SA ( Site 0504)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Oncomedica ( Site 0500)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Grupo Angeles SA ( Site 0501)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Nucare Center ( Site 0506)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Medi-K Cayala ( Site 0505)
City
Guatemala
ZIP/Postal Code
01016
Country
Guatemala
Facility Name
Centro Regional de Sub Especialidades Medicas SA ( Site 0502)
City
Quetzaltenango
ZIP/Postal Code
09001
Country
Guatemala
Facility Name
Saint James's Hospital ( Site 1505)
City
Dublin
ZIP/Postal Code
D08NHY1
Country
Ireland
Facility Name
Beaumont Hospital ( Site 1506)
City
Dublin
ZIP/Postal Code
D09 V2N0
Country
Ireland
Facility Name
Tallaght University Hospital ( Site 1513)
City
Dublin
ZIP/Postal Code
D24 NR0A
Country
Ireland
Facility Name
Soroka University Medical Center ( Site 1603)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Health Care Campus ( Site 1606)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Edith Wolfson Medical Center ( Site 1605)
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Hadassah Ein Kerem Medical Center ( Site 1604)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center ( Site 1609)
City
Kfar-Saba
ZIP/Postal Code
4428132
Country
Israel
Facility Name
Rabin Medical Center ( Site 1602)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center. ( Site 1607)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Sourasky Medical Center ( Site 1601)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
AUOP Ospedale Santa Chiara ( Site 1100)
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
Humanitas Gavazzeni ( Site 1106)
City
Bergamo
ZIP/Postal Code
24125
Country
Italy
Facility Name
Universita Magna Graecia di Catanzaro ( Site 1107)
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
IEO Istituto Europeo di Oncologia ( Site 1105)
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1102)
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1103)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto ( Site 1101)
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale Civile Spirito Santo ( Site 1104)
City
Pescara
ZIP/Postal Code
65100
Country
Italy
Facility Name
Aichi Cancer Center Hospital ( Site 2617)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 2605)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 2615)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Gunma Prefectural Cancer Center ( Site 2602)
City
Ohta
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
Hyogo Cancer Center ( Site 2619)
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kobe City Medical Center General Hospital ( Site 2614)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Ibaraki Prefectural Central Hospital ( Site 2611)
City
Kasama
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Kagawa University Hospital ( Site 2604)
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kanagawa Cancer Center ( Site 2603)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Osaki Citizen Hospital ( Site 2626)
City
Osaki
State/Province
Miyagi
ZIP/Postal Code
989-6183
Country
Japan
Facility Name
Kansai Medical University Hospital ( Site 2618)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Kindai University Hospital ( Site 2616)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital ( Site 2600)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Cancer Center ( Site 2620)
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center Hospital and Research Institute ( Site 2607)
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tochigi Cancer Center ( Site 2627)
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
Kyorin University Hospital ( Site 2608)
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Chiba Cancer Center ( Site 2623)
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 2609)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Gifu University Hospital ( Site 2621)
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital ( Site 2625)
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Kumamoto University Hospital ( Site 2601)
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Niigata Cancer Center Hospital ( Site 2622)
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 2613)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Osaka General Medical Center ( Site 2624)
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
National Cancer Center Hospital ( Site 2612)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Toranomon Hospital ( Site 2628)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital ( Site 2606)
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR ( Site 2610)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Seoul National University Hospital ( Site 2703)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 2700)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 2702)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 2701)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Auckland City Hospital ( Site 2300)
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Uniwersytecki Szpital Kliniczny im. J. M. Radeckiego we Wroclawiu ( Site 1705)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Dolnoslaskie Centrum Onkologii. ( Site 1712)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1709)
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-080
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1715)
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1708)
City
Koscierzyna
State/Province
Pomorskie
ZIP/Postal Code
83-400
Country
Poland
Facility Name
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1710)
City
Bielsko-Biala
State/Province
Slaskie
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Przychodnia Lekarska Komed ( Site 1716)
City
Konin
State/Province
Wielkopolskie
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1807)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1815)
City
Chelyabinsk
State/Province
Chelyabinskaya Oblast
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Podolsky City Clinical Hospital ( Site 1817)
City
Podolsk
State/Province
Moskovskaya Oblast
ZIP/Postal Code
142110
Country
Russian Federation
Facility Name
Blokhin National Medical Oncology ( Site 1805)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Medical University REAVIZ ( Site 1816)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1801)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
St Petersburg City Clinical Oncology Dispensary ( Site 1812)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Center ( Site 1800)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Hospital General Universitario de Elche ( Site 1404)
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitario Central de Asturias ( Site 1402)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1410)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla ( Site 1405)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Quiron Madrid ( Site 1407)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital General Universitari Vall d Hebron ( Site 1401)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal ( Site 1400)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Adana Sehir Hastanesi ( Site 2002)
City
Adana
ZIP/Postal Code
01370
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2017)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi ( Site 2015)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)
City
Sakarya
ZIP/Postal Code
54290
Country
Turkey
Facility Name
City Clinical Hosp.4 of DCC ( Site 2102)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2101)
City
Kryviy Rih
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
MI Precarpathian Clinical Oncology Center ( Site 2105)
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 2112)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Medical Center Asklepion LLC ( Site 2115)
City
Khodosivka
State/Province
Kyivska Oblast
ZIP/Postal Code
08173
Country
Ukraine
Facility Name
Clinic of National Cancer Institute ( Site 2104)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2114)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03126
Country
Ukraine
Facility Name
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2106)
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
MI Odessa Regional Oncological Centre ( Site 2108)
City
Odesa
State/Province
Odeska Oblast
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Medical Centre LLC Oncolife ( Site 2103)
City
Zaporizhzhya
State/Province
Zaporizka Oblast
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
Kyiv City Clinical Oncology Centre ( Site 2110)
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Royal Hospital in Derby ( Site 1514)
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School ( Site 1504)
City
Dundee
State/Province
Dundee City
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Castle Hill Hospital ( Site 1501)
City
Cottingham
State/Province
East Riding Of Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
University College London Hospital NHS Foundation Trust ( Site 1508)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
St Georges University Hospitals NHS Foundation Trust. ( Site 1500)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Royal Marsden Hospital ( Site 1510)
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust ( Site 1512)
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Christie Hospital NHS Foundation Trust ( Site 1503)
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre ( Site 1507)
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Manor Hospital Walsall England ( Site 1515)
City
Walsall
ZIP/Postal Code
WS2 9PS
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
34912120
Citation
Janjigian YY, Kawazoe A, Yanez P, Li N, Lonardi S, Kolesnik O, Barajas O, Bai Y, Shen L, Tang Y, Wyrwicz LS, Xu J, Shitara K, Qin S, Van Cutsem E, Tabernero J, Li L, Shah S, Bhagia P, Chung HC. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021 Dec;600(7890):727-730. doi: 10.1038/s41586-021-04161-3. Epub 2021 Dec 15.
Results Reference
derived
PubMed Identifier
33167735
Citation
Chung HC, Bang YJ, S Fuchs C, Qin SK, Satoh T, Shitara K, Tabernero J, Van Cutsem E, Alsina M, Cao ZA, Lu J, Bhagia P, Shih CS, Janjigian YY. First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811. Future Oncol. 2021 Feb;17(5):491-501. doi: 10.2217/fon-2020-0737. Epub 2020 Nov 10.
Results Reference
derived
Links:
URL
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trials Information
Learn more about this trial
Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)
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