Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT03615326

PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

738

Start Date

2018-10-05

Completion Date

2025-11-12

Last Updated

2026-08-26

Healthy Volunteers

Conditions

Gastric Neoplasms Gastroesophageal Junction Adenocarcinoma

Interventions

BIOLOGICAL

Pembrolizumab

200 mg on Day 1 of each 3-week cycle as an IV infusion.

BIOLOGICAL

Placebo

Solution for IV infusion on Day 1 of each 3-week cycle.

DRUG

Cisplatin

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

DRUG

5-FU

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

DRUG

Oxaliplatin

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

DRUG

Capecitabine

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

DRUG

S-1

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

BIOLOGICAL

Trastuzumab

8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.

Inclusion Criteria: Inclusion criteria include, but are not limited to: * Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive gastric or gastroesophageal junction (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 Response Evaluation Criteria in Solid Tumors version 1.1 (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: Exclusion criteria include, but are not limited to: * 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 \[CD137\])

Locations (192)

UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045)

Los Angeles, California, United States

Pacific Cancer Care ( Site 0063)

Monterey, California, United States

UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050)

Orange, California, United States

University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026)

Miami, Florida, United States

Southeastern Regional Medical Center, Inc. ( Site 0058)

Newnan, Georgia, United States

Midwestern Regional Medical Center, Inc. ( Site 0059)

Zion, Illinois, United States

Beth Israel Deaconess Medical Center ( Site 0070)

Boston, Massachusetts, United States

Dana-Farber Cancer Institute [Boston, MA] ( Site 0010)

Boston, Massachusetts, United States

Minnesota Oncology Hematology, PA ( Site 8001)

Minneapolis, Minnesota, United States

Washington University School of Medicine ( Site 0040)

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071)

Middletown, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065)

Harrison, New York, United States

Memorial Sloan-Kettering Cancer Center ( Site 0017)

New York, New York, United States

University of Rochester ( Site 0041)

Rochester, New York, United States

Levine Cancer Institute ( Site 0015)

Charlotte, North Carolina, United States

Duke Cancer Institute ( Site 0042)

Durham, North Carolina, United States

CTCA Southwestern ( Site 0060)

Tulsa, Oklahoma, United States

Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025)

Philadelphia, Pennsylvania, United States

Allegheny General Hospital ( Site 0053)

Pittsburgh, Pennsylvania, United States

Sanford Hematology Oncology-Sioux Falls SD ( Site 0004)

Sioux Falls, South Dakota, United States

University of Texas MD Anderson Cancer Center ( Site 0001)

Houston, Texas, United States

Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000)

Roanoke, Virginia, United States

Seattle Cancer Care Alliance ( Site 0038)

Seattle, Washington, United States

Liverpool Hospital ( Site 2206)

Liverpool, New South Wales, Australia

Westmead Hospital ( Site 2200)

Westmead, New South Wales, Australia

Southern Medical Day Care Centre ( Site 2207)

Wollongong, New South Wales, Australia

Monash Health ( Site 2202)

Clayton, Victoria, Australia

Instituto do Cancer do Ceara ( Site 0208)

Fortaleza, Ceará, Brazil

Hospital Sao Rafael ( Site 0209)

Salvador, Estado de Bahia, Brazil

CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205)

Curitiba, Paraná, Brazil

Hospital de Caridade de Ijui ( Site 0202)

Ijuí, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao ( Site 0203)

Porto Alegre, Rio Grande do Sul, Brazil

CEPON - Centro de Pesquisas Oncologicas ( Site 0200)

Florianópolis, Santa Catarina, Brazil

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201)

Rio de Janeiro, Brazil

IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204)

São Paulo, Brazil

Centro Investigación del Cáncer James Lind ( Site 0300)

Temuco, Araucania, Chile

Clinica Universidad Catolica del Maule ( Site 0305)

Talca, Maule Region, Chile

Fundacion Arturo Lopez Perez FALP ( Site 0302)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 0301)

Santiago, Region M. de Santiago, Chile

Instituto Nacional del Cancer ( Site 0303)

Santiago, Region M. de Santiago, Chile

Shanghai General Hospital ( Site 2404)

Shanghai, Anhui, China

Peking Union Medical College Hospital ( Site 2419)

Beijing, Beijing Municipality, China

Fifth Medical Center of CPLA General Hospital ( Site 2415)

Beijing, Beijing Municipality, China

Beijing Cancer Hospital ( Site 2413)

Beijing, Beijing Municipality, China

Fujian Provincial Cancer Hospital ( Site 2418)

Fuzhou, Fujian, China

900 Hospital of the Joint ( Site 2420)

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University ( Site 2431)

Xiamen, Fujian, China

Guangdong General Hospital ( Site 2433)

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital ( Site 2407)

Harbin, Heilongjiang, China

Henan Cancer Hospital ( Site 2400)

Zhengzhou, Henan, China

Xiangya Hospital Central-South University ( Site 2426)

Changsha, Hunan, China

Jiangsu Cancer Hospital ( Site 2432)

Nanjing, Jiangsu, China

The First Hospital Of Jilin University ( Site 2402)

Changchun, Jilin, China

Fudan University Shanghai Cancer Center ( Site 2424)

Shanghai, Shanghai Municipality, China

Zhongshan Hospital affiliated to Fudan University ( Site 2401)

Shanghai, Shanghai Municipality, China

Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430)

Ürümqi, Xinjiang, China

The First Affiliated Hospital.Zhejiang University ( Site 2408)

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital ( Site 2412)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 2409)

Hangzhou, Zhejiang, China

CHU de Rouen ( Site 0912)

Rouen, Ain, France

HUS Hopital Hautepierre ( Site 0910)

Strasbourg, Bas-Rhin, France

Hopital Jean Minjoz Besancon ( Site 0901)

Besançon, Doubs, France

C.H.R.U. de Brest - Hopital Morvan ( Site 0913)

Brest, Finistere, France

Centre Oscar Lambret ( Site 0911)

Lille, Nord, France

Centre Leon Berard ( Site 0904)

Lyon, Rhone, France

Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902)

Saint-Herblain, Val-de-Marne, France

Institut Gustave Roussy ( Site 0900)

Villejuif, Val-de-Marne, France

CHU Hopital Saint Antoine ( Site 0905)

Paris, France

SLK-Kliniken Heilbronn ( Site 1015)

Heilbronn, Baden-Wurttemberg, Germany

Klinikum Ludwigsburg ( Site 1014)

Ludwigsburg, Baden-Wurttemberg, Germany

Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020)

Tübingen, Baden-Wurttemberg, Germany

Klinikum rechts der Isar der Technischen Universitaet ( Site 1027)

Munich, Bavaria, Germany

Medizinische Hochschule Hannover ( Site 1019)

Hanover, Lower Saxony, Germany

Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001)

Dresden, Saxony, Germany

Universitaetsklinikum Leipzig AOeR ( Site 1007)

Leipzig, Saxony, Germany

Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 1026)

Berlin, Germany

Klinikum Bremen Nord ( Site 1017)

Bremen, Germany

Facharztzentrum Eppendorf ( Site 1025)

Hamburg, Germany

Asklepios Klinik Altona ( Site 1000)

Hamburg, Germany

Celan SA ( Site 0504)

Guatemala City, Guatemala

Oncomedica ( Site 0500)

Guatemala City, Guatemala

Grupo Angeles SA ( Site 0501)

Guatemala City, Guatemala

Nucare Center ( Site 0506)

Guatemala City, Guatemala

Medi-K Cayala ( Site 0505)

Guatemala City, Guatemala

Centro Regional de Sub Especialidades Medicas SA ( Site 0502)

Quetzaltenango, Guatemala

Saint James's Hospital ( Site 1505)

Dublin, Ireland

Beaumont Hospital ( Site 1506)

Dublin, Ireland

Tallaght University Hospital ( Site 1513)

Dublin, Ireland

Soroka University Medical Center ( Site 1603)

Beersheba, Israel

Rambam Health Care Campus ( Site 1606)

Haifa, Israel

Edith Wolfson Medical Center ( Site 1605)

Holon, Israel

Hadassah Ein Kerem Medical Center ( Site 1604)

Jerusalem, Israel

Meir Medical Center ( Site 1609)

Kfar Saba, Israel

Rabin Medical Center ( Site 1602)

Petah Tikva, Israel

Chaim Sheba Medical Center. ( Site 1607)

Ramat Gan, Israel

Sourasky Medical Center ( Site 1601)

Tel Aviv, Israel

AUOP Ospedale Santa Chiara ( Site 1100)

Pisa, Tuscany, Italy

Humanitas Gavazzeni ( Site 1106)

Bergamo, Italy

Universita Magna Graecia di Catanzaro ( Site 1107)

Catanzaro, Italy

IEO Istituto Europeo di Oncologia ( Site 1105)

Milan, Italy

And 92 more locations on ClinicalTrials.gov

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (192)