AzTrials
AzTrials

Stomach NeoplasmsPhase 3NCT03675737

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

A Phase 3 study testing Pembrolizumab, Cisplatin and 5-fluorouracil in people with Stomach Neoplasms, run by Merck Sharp & Dohme LLC at 215 sites in 33 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stomach Neoplasms
What is being tested?
Pembrolizumab, Cisplatin and 5-fluorouracil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,579 participants
Where
215 sitesin 33 countries
Study dates
8 Nov 2018to 3 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status
  • Has human epidermal growth factor receptor 2 (HER2) negative cancer
  • Male participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy, refrain from donating sperm, and be abstinent from heterosexual intercourse, as their preferred and usual lifestyle, and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period
  • Female participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse, as their preferred and usual lifestyle, during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period
  • Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment
  • Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
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  • Has provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis
  • Has provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention
  • Has adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment

Who cannot join

  • Has squamous cell or undifferentiated gastric cancer
  • Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of the need for major surgery during the course of study intervention, or has not recovered adequately from the toxicity and/or complications from previous surgery
  • Has preexisting peripheral neuropathy >Grade 1
  • Is a WOCBP who has a positive urine pregnancy test within 24 hours for urine or within 72 hours for serum prior to randomization or treatment allocation
  • Has had previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer. Participants may have received prior neoadjuvant and/or adjuvant therapy as long as it was completed ≥6 months prior to randomization
  • Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1 or anti-programmed cell death ligand 2 (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, CD137)
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  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization or has not recovered from all adverse events (AEs) due to any previous therapies to ≤Grade 1 or baseline
  • Has received prior radiotherapy within 2 weeks prior to study start or has not recovered from all previous radiation-related toxicities, required corticosteroids, and have not had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy
  • Has known active CNS metastases and/or carcinomatous meningitis
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as Hepatitis C virus [HCV] ribonucleic acid [RNA] detected qualitatively) infection
  • Has a known history of active tuberculosis
  • Has hypokalemia (serum potassium less than the lower limit of normal)
  • Has hypomagnesemia (serum magnesium less than the lower limit of normal)
  • Has hypocalcemia (serum calcium less than the lower limit of normal)
  • Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last
  • Has had an allogenic tissue/solid organ transplant
  • Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents (including, but not limited to, infusional 5-fluorouracil or oral capecitabine) and/or to any of their excipients
  • For participants taking cisplatin: has Grade ≥2 audiometric hearing loss

Trial locations and contacts

215 sites in 33 countries.

215 sites in 33 countries

China29 sites

  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)

    Beijing, Beijing Municipality, 100021

  • Peking Union Medical College Hospital ( Site 2425)

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University ( Site 2416)

    Changchun, Jilin, 130021

  • Xiangya Hospital Central-South University ( Site 2419)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 2439)

    Changsha, Hunan, 410013

  • Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)

    Changzhou, Jiangsu, 213032

  • Fujian Medical University Union Hospital ( Site 2410)

    Fuzhou, Fujian, 350001

  • Fujian Provincial Cancer Hospital ( Site 2414)

    Fuzhou, Fujian, 350014

  • 900 Hospital of the Joint ( Site 2418)

    Fuzhou, Fujian, 350025

  • Guangdong General Hospital ( Site 2431)

    Guangzhou, Guangdong, 510080

  • Zhejiang Provincial People's Hospital ( Site 2446)

    Hangzhou, Zhejiang, 310014

  • Sir Run Run Show Hospital ( Site 2427)

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital ( Site 2417)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital ( Site 2401)

    Harbin, Heilongjiang, 150081

  • The First Affiliated Hospital of Nanchang University ( Site 2440)

    Nanchang, Jiangxi, 330006

  • The 81st Hospital of PLA ( Site 2413)

    Nanjing, Jiangsu, 210002

  • Jiangsu Cancer Hospital ( Site 2432)

    Nanjing, Jiangsu, 210009

  • The Affiliated Hospital of Qingdao University ( Site 2405)

    Qingdao, Shandong, 266061

  • Shanghai East Hospital ( Site 2403)

    Shanghai, Shanghai Municipality, 200120

  • Zhongshan Hospital affiliated to Fudan University ( Site 2407)

    Shanghai, Shanghai Municipality, 210000

  • Peking University Shenzhen Hospital ( Site 2442)

    Shenzhen, Guangdong, 518036

  • Fourth Hospital Of Hebei Medical University ( Site 2436)

    Shijiazhuang, Hebei, 050011

  • Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)

    Ürümqi, Xinjiang, 830001

  • Hubei Cancer Hospital ( Site 2434)

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xiamen University ( Site 2430)

    Xiamen, Fujian, 361003

  • Zhongshan Hospital Xiamen University ( Site 2447)

    Xiamen, Fujian, 361004

  • 1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)

    XiAn, Shanxi, 710061

  • Yancheng First People s Hospital ( Site 2426)

    Yancheng, Jiangsu, 224000

  • Henan Cancer Hospital ( Site 2415)

    Zhengzhou, Henan, 450008

Other trials in China

Japan20 sites

  • Hyogo Cancer Center ( Site 2604)

    Akashi, Hyōgo, 673-8558

  • National Hospital Organization Kyushu Cancer Center ( Site 2612)

    Fukuoka, 811-1395

  • Kansai Medical University Hospital ( Site 2608)

    Hirakata, Osaka, 573-1191

  • Hiroshima City Hiroshima Citizens Hospital ( Site 2611)

    Hiroshima, 730-8518

  • Ibaraki Prefectural Central Hospital ( Site 2610)

    Kasama, Ibaraki, 309-1793

  • National Cancer Center Hospital East ( Site 2617)

    Kashiwa, Chiba, 277-8577

  • Kagawa University Hospital ( Site 2615)

    Kita-gun, Kagawa-ken, 761-0793

  • Saitama Cancer Center ( Site 2601)

    Kitaadachi-gun, Saitama, 362-0806

  • Kobe City Medical Center General Hospital ( Site 2603)

    Kobe, Hyōgo, 650-0047

  • Kumamoto University Hospital ( Site 2602)

    Kumamoto, 860-8556

  • Aichi Cancer Center Hospital ( Site 2619)

    Nagoya, Aichi-ken, 464-8681

  • Niigata Cancer Center Hospital ( Site 2613)

    Niigata, 951-8566

  • Osaka International Cancer Institute ( Site 2607)

    Osaka, 541-8567

  • Kitasato University Hospital ( Site 2618)

    Sagamihara, Kanagawa, 252-0375

  • Kindai University Hospital ( Site 2616)

    Sayama, Osaka, 589-8511

  • Osaka University Hospital ( Site 2600)

    Suita, Osaka, 565-0871

  • National Cancer Center Hospital ( Site 2606)

    Tokyo, 104-0045

  • Tokyo Metropolitan Komagome Hospital ( Site 2605)

    Tokyo, 113-8677

  • The Cancer Institute Hospital of JFCR ( Site 2609)

    Tokyo, 135-8550

  • Kanagawa Cancer Center ( Site 2614)

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United States10 sites

  • Greater Baltimore Medical Center ( Site 0102)

    Baltimore, Maryland, 21204

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124)

    Los Angeles, California, 90095

  • University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113)

    Miami, Florida, 33136

  • Minnesota Oncology Hematology, PA ( Site 8000)

    Minneapolis, Minnesota, 55404

  • UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128)

    Orange, California, 92868

  • Cancer Treatment Centers of America - Philadelphia ( Site 0112)

    Philadelphia, Pennsylvania, 19124

  • Allegheny General Hospital ( Site 0118)

    Pittsburgh, Pennsylvania, 15212

  • Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001)

    Roanoke, Virginia, 24014

  • University of Rochester ( Site 0122)

    Rochester, New York, 14642

  • Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116)

    Wenatchee, Washington, 98801

Other trials in United States

South Africa10 sites

  • Universitas Annex National Hospital ( Site 1701)

    Bloemfontein, Free State, 9301

  • Cancercare Rondebosch Oncology ( Site 1709)

    Cape Town, Western Cape, 7700

  • Groote Schuur Hospital ( Site 1706)

    Cape Town, Western Cape, 7925

  • The Oncology Centre Overport and Umhlanga ( Site 1705)

    Durban, KwaZulu-Natal, 4091

  • Outeniqua Cancercare Oncology Unit ( Site 1704)

    George, Western Cape, 6530

  • Sandton Oncology Medical Group PTY LTD ( Site 1700)

    Johannesburg, Gauteng, 2196

  • Cape Town Oncology Trials Pty Ltd ( Site 1703)

    Kraaifontein, Western Cape, 7570

  • Wits Clinical Research ( Site 1707)

    Parktown-Johannesburg, Gauteng, 2193

  • Cancer Care Langenhoven Drive Oncology Centre ( Site 1708)

    Port Elizabeth, Eastern Cape, 6045

  • Tshwane District Hospital ( Site 1702)

    Pretoria, Gauteng, 0002

Other trials in South Africa

Ukraine10 sites

  • City Clinical Hosp.4 of DCC ( Site 2201)

    Dnipro, Dnipropetrovsk Oblast, 49102

  • MI Precarpathian Clinical Oncology Center ( Site 2204)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208)

    Kharkiv, Kharkiv Oblast, 61070

  • MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200)

    Kryviy Rih, Dnipropetrovsk Oblast, 50048

  • Clinic of National Cancer Institute ( Site 2203)

    Kyiv, Kyivska Oblast, 03022

  • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205)

    Kyiv, Kyivska Oblast, 03126

  • Kyiv City Clinical Oncology Centre ( Site 2213)

    Kyiv, 03115

  • Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210)

    Lviv, Lviv Oblast, 79031

  • MI Odessa Regional Oncological Centre ( Site 2212)

    Odesa, Odesa Oblast, 65055

  • Medical Centre LLC Oncolife ( Site 2202)

    Zaporizhzhya, Zaporizhzhia Oblast, 69104

Other trials in Ukraine

Turkey (Türkiye)9 sites

  • Adana Sehir Hastanesi ( Site 2002)

    Adana, 01370

  • Hacettepe University Medical Faculty ( Site 2017)

    Ankara, 06100

  • Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)

    Ankara, 06200

  • Trakya Universitesi Tip Fakultesi ( Site 2015)

    Edirne, 22030

  • Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)

    Erzurum, 25240

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)

    Istanbul, 34098

  • Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)

    Izmir, 35340

  • Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)

    Malatya, 44280

  • Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)

    Sakarya, 54000

Other trials in Turkey (Türkiye)

Israel8 sites

  • Soroka University Medical Center ( Site 1305)

    Beersheba, 8410101

  • Rambam Medical Center ( Site 1303)

    Haifa, 3109601

  • Edith Wolfson Medical Center ( Site 1307)

    Holon, Tell Abib, 5822012

  • Hadassah Ein Karem Jerusalem ( Site 1301)

    Jerusalem, Jerusalem, 9112001

  • Meir Medical Center ( Site 1308)

    Kfar Saba, 4428164

  • Rabin Medical Center ( Site 1302)

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center ( Site 1304)

    Ramat Gan, Tel Aviv, 5266202

  • Sourasky Medical Center ( Site 1306)

    Tel Aviv, Tell Abib, 6423906

Other trials in Israel

Brazil7 sites

  • CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405)

    Curitiba, Paraná, 80810-050

  • CEPON - Centro de Pesquisas Oncologicas ( Site 0400)

    Florianópolis, Santa Catarina, 88034-000

  • Instituto do Cancer do Ceara ( Site 0407)

    Fortaleza, Ceará, 60430-230

  • Hospital de Caridade de Ijui ( Site 0402)

    Ijuí, Rio Grande do Sul, 98700 000

  • Hospital Nossa Senhora da Conceicao ( Site 0403)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401)

    Rio de Janeiro, 20231-050

  • IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404)

    São Paulo, 03102-002

Other trials in Brazil

France7 sites

  • CHU-Jean Minjoz ( Site 1002)

    Besançon, Doubs, 25030

  • C.H.R.U. de Brest - Hopital Morvan ( Site 1007)

    Brest, Finistere, 29200

  • Centre Oscar Lambret ( Site 1003)

    Lille, Nord, 59000

  • CHU Hopital Saint Antoine ( Site 1001)

    Paris, 75012

  • CHU de Rouen ( Site 1006)

    Rouen, Ain, 76000

  • Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004)

    Saint-Herblain, Val-de-Marne, 44805

  • Institut Gustave Roussy ( Site 1000)

    Villejuif, Val-de-Marne, 94805

Other trials in France

Poland7 sites

  • Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505)

    Grudziądz, 86-300

  • Przychodnia Lekarska Komed ( Site 1514)

    Konin, Greater Poland Voivodeship, 62-500

  • Szpital Uniwersytecki w Krakowie ( Site 1503)

    Krakow, Lesser Poland Voivodeship, 31-501

  • Magodent Szpital Elblaska ( Site 1509)

    Warsaw, Masovian Voivodeship, 01-748

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

    Warsaw, Masovian Voivodeship, 02-781

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506)

    Wroclaw, Lower Silesian Voivodeship, 50-556

  • Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504)

    Wroclaw, Lower Silesian Voivodeship, 53-413

Other trials in Poland

Switzerland7 sites

  • Universitaetsspital Basel ( Site 1900)

    Basel, Canton of Basel-City, 4056

  • Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905)

    Bellinzona, Canton Ticino, 6500

  • Kantonsspital Graubuenden ( Site 1903)

    Chur, Kanton Graubünden, 7000

  • Hopitaux Universitaires de Geneve HUG ( Site 1907)

    Geneva, Canton of Geneva, 1211

  • Luzern Kantonsspital ( Site 1904)

    Lucerne, 6000

  • Kantonsspital St. Gallen ( Site 1901)

    Sankt Gallen, Canton of St. Gallen, 9007

  • Universitaetsspital Zuerich ( Site 1902)

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Czechia6 sites

  • Masarykuv onkologicky ustav ( Site 3103)

    Brno, South Moravian, 65653

  • Nemocnice AGEL Novy Jicin a.s. ( Site 3104)

    Nový Jičín, 74101

  • Fakultni nemocnice Olomouc ( Site 3100)

    Olomouc, 779 00

  • FN Ostrava ( Site 3105)

    Ostrava, Moravian-Silesian Region, 708 52

  • Fakultni nemocnice Plzen ( Site 3102)

    Pilsen, Plzeň Region, 304 60

  • Fakultni Thomayerova nemocnice ( Site 3101)

    Prague, 140 59

Other trials in Czechia

Russia6 sites

  • Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608)

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Blokhin National Medical Oncology ( Site 1604)

    Moscow, Moscow, 115478

  • Central Clinical Hospital with Polyclinic ( Site 1614)

    Moscow, Moscow, 121359

  • SBHI Leningrad Regional Clinical Hospital ( Site 1616)

    Saint Petersburg, Leningradskaya Oblast', 194291

  • City Clinical Oncology Center ( Site 1603)

    Saint Petersburg, Sankt-Peterburg, 198255

  • SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609)

    Samara, Samara Oblast, 443031

Other trials in Russia

Spain6 sites

  • Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806)

    Badalona, Barcelona, 08916

  • Hospital General Universitari Vall d Hebron ( Site 1801)

    Barcelona, 08035

  • Hospital General Universitario de Elche ( Site 1803)

    Elche, Alicante, 03203

  • Hospital Universitario General de Asturias ( Site 1802)

    Oviedo, Principality of Asturias, 33011

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805)

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Marques de Valdecilla ( Site 1804)

    Santander, Cantabria, 39008

Other trials in Spain

Argentina5 sites

  • Instituto Medico Alexander Fleming ( Site 0307)

    Buenos Aires, Buenos Aires F.D., C1426ANZ

  • Instituto de Investigaciones Metabolicas ( Site 0312)

    Buenos Aires, C1012AAR

  • Fundacion Favaloro - Hospital Universitario ( Site 0302)

    Buenos Aires, C1093AAS

  • Centro Oncologico Riojano Integral ( Site 0313)

    La Rioja, F5300COE

  • Instituto San Marcos ( Site 0311)

    San Juan, J5400EBB

Other trials in Argentina

Germany5 sites

  • Charite Universitaetsmedizin Berlin ( Site 1101)

    Berlin, 13353

  • Facharztzentrum Eppendorf ( Site 1121)

    Hamburg, 20249

  • Asklepios Klinik Altona ( Site 1100)

    Hamburg, 22763

  • SLK-Kliniken Heilbronn ( Site 1104)

    Heilbronn, Baden-Wurttemberg, 74078

  • Universitaetsklinikum Leipzig ( Site 1114)

    Leipzig, Saxony, 04103

Other trials in Germany

Guatemala5 sites

  • Celan SA ( Site 0705)

    Guatemala City, 01010

  • Oncomedica ( Site 0702)

    Guatemala City, 01010

  • Grupo Angeles SA ( Site 0701)

    Guatemala City, 01015

  • MEDI-K CAYALA ( Site 0704)

    Guatemala City, 01016

  • Centro Regional de Sub Especialidades Medicas SA ( Site 0703)

    Quetzaltenango, 09001

Other trials in Guatemala

Hungary5 sites

  • Semmelweis Egyetem.. ( Site 3305)

    Budapest, 1083

  • Orszagos Onkologiai Intezet ( Site 3303)

    Budapest, 1122

  • University of Debrecen Medical Center Clinic of Oncology ( Site 3300)

    Debrecen, 4032

  • Bacs-Kiskun Megyei Korhaz ( Site 3306)

    Kecskemét, Bács-Kiskun county, 6000

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302)

    Szolnok, Jász-Nagykun-Szolnok, 5004

Other trials in Hungary

Mexico5 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808)

    Guadalajara, Jalisco, 44280

  • Medical Care and Research S.A. de C.V. ( Site 0809)

    Mérida, 97070

  • Instituto Nacional de Cancerologia. ( Site 0804)

    Mexico City, 14080

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806)

    Mexico City, 14080

  • Christus Muguerza Clinica Vidriera ( Site 0802)

    Monterrey, Nuevo León, 64570

Other trials in Mexico

Canada4 sites

  • BC Cancer - Abbotsford ( Site 0206)

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • McGill University Health Centre ( Site 0208)

    Montreal, Quebec, H4A 3J1

  • Sunnybrook Research Institute ( Site 0202)

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre ( Site 0203)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Chile4 sites

  • Fundacion Arturo Lopez Perez FALP ( Site 0501)

    Santiago, Region M. de Santiago, 7500921

  • Sociedad Oncovida S.A. ( Site 0508)

    Santiago, Region M. de Santiago, 7510032

  • Pontificia Universidad Catolica de Chile ( Site 0502)

    Santiago, Region M. de Santiago, 7620002

  • Instituto Clinico Oncologico del Sur ( Site 0500)

    Temuco, Araucania, 4810469

Other trials in Chile

Colombia4 sites

  • Instituto Nacional de Cancerologia E.S.E ( Site 0605)

    Bogotá, Bogota D.C., 110321

  • Centro Medico Imbanaco de Cali S.A ( Site 0604)

    Cali, Valle del Cauca Department, 760042

  • Oncomedica S.A. ( Site 0606)

    Montería, Departamento de Córdoba, 230002

  • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Italy4 sites

  • Istituto Europeo di Oncologia ( Site 1411)

    Milan, Lombardy, 20141

  • Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402)

    Milan, 20133

  • Istituto Oncologico Veneto ( Site 1412)

    Padova, 35128

  • Azienda Ospedaliera San Camillo Forlanini ( Site 1413)

    Roma, 00152

Other trials in Italy

Peru4 sites

  • Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908)

    Lima, 15036

  • Instituto Nacional de Enfermedades Neoplasicas ( Site 0901)

    Lima, 15038

  • Hospital Nacional Arzobispo Loayza ( Site 0902)

    Lima, 15082

  • Clinica San Gabriel ( Site 0907)

    Lima, 15088

Other trials in Peru

South Korea4 sites

  • Seoul National University Hospital ( Site 2803)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 2800)

    Seoul, 03722

  • Asan Medical Center ( Site 2802)

    Seoul, 05505

  • Samsung Medical Center ( Site 2801)

    Seoul, 06351

Other trials in South Korea

Taiwan4 sites

  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902)

    Kaohsiung City, 83301

  • National Cheng Kung University Hospital ( Site 2901)

    Tainan, 70457

  • National Taiwan University Hospital ( Site 2900)

    Taipei, 100225

  • Mackay Memorial Hospital ( Site 2903)

    Taipei, 104

Other trials in Taiwan

United Kingdom4 sites

  • Castle Hill Hospital ( Site 1201)

    Cottingham, East Riding Of Yorkshire, HU16 5JQ

  • University College London Hospital ( Site 1211)

    London, London, City of, NW1 2PG

  • St. Georges University Hospital NHS Foundation Trust ( Site 1204)

    London, London, City of, SW17 0QT

  • South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205)

    Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Australia3 sites

  • Box Hill Hospital ( Site 2300)

    Box Hill, Victoria, 3128

  • Liverpool Hospital ( Site 2301)

    Liverpool, New South Wales, 2170

  • Southern Medical Day Care Centre ( Site 2303)

    Wollongong, New South Wales, 2500

Other trials in Australia

Costa Rica3 sites

  • CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001)

    San José, 10103

  • Policlinico San Bosco ( Site 3002)

    San José, 10103

  • ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000)

    San José, 10108

Other trials in Costa Rica

Denmark3 sites

  • Aalborg University Hospital ( Site 3204)

    Aalborg, North Denmark, 9000

  • Rigshospitalet ( Site 3202)

    Copenhagen, Capital Region, 2100

  • Odense Universitets Hospital ( Site 3201)

    Odense, Region Syddanmark, 5000

Other trials in Denmark

Hong Kong3 sites

  • Prince of Wales Hospital ( Site 2503)

    Hong Kong

  • Princess Margaret Hospital. ( Site 2502)

    Hong Kong

  • Queen Mary Hospital ( Site 2501)

    Hong Kong

Other trials in Hong Kong

Ireland3 sites

  • St. James s Hospital ( Site 1200)

    Dublin, D08 W9RT

  • Beaumont Hospital ( Site 2101)

    Dublin, D09V2N0

  • Tallaght University Hospital ( Site 1202)

    Dublin, D24 NR0A

Other trials in Ireland

New Zealand1 site

  • Auckland City Hospital ( Site 2700)

    Auckland, Northland, 1023

Other trials in New Zealand

About this study

Official title: A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants.

The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

Once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and enrolled in an extension study (Keynote 587; NCT03486873) to continue protocol-defined assessments and treatment.

Keywords
programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1), programmed cell death ligand 2 (PD-L2, PDL2)
Medical subject headings
Stomach Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called KEYTRUDA®, MK-3475

    Administered as an IV infusion on Day 1 Q3W

  • CisplatinDrug

    Also called PLATINOL®

    Administered as an IV infusion on Day 1 Q3W

  • 5-fluorouracilDrug

    Also called ADRUCIL®, 5FU

    Administered as a continuous IV infusion on Days 1-5 Q3W

  • oxaliplatinDrug

    Also called ELOXATIN®

    Administered as an IV infusion on Day 1 Q3W

  • capecitabineDrug

    Also called XELODA®

    Administered orally BID on Days 1 to 14 Q3W

  • Placebo for PembrolizumabDrug

    Administered as an IV infusion on Day 1 Q3W

Study groups in NCT03675737
Study groupRoleWhat they receive
Pembrolizumab + Chemotherapy (FP or CAPOX regimen)ExperimentalParticipants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who complete up to 35 administrations of pembrolizumab (approximately 2 years) or achieve a complete response (CR) but experience progression of disease (PD), can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
Receives: Biological: Pembrolizumab; Drug: Cisplatin; Drug: 5-fluorouracil; Drug: oxaliplatin; Drug: capecitabine
Placebo + Chemotherapy (FP or CAPOX regimen)Active comparatorParticipants receive placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m^2 IV on Day 1 Q3W and 5FU 800 mg/m^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m^2 IV on Day 1 Q3W + capecitabine 1000 mg/m^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
Receives: Drug: Cisplatin; Drug: 5-fluorouracil; Drug: oxaliplatin; Drug: capecitabine; Drug: Placebo for Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) in All Participants

    OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to 45.9 months

  2. Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

    OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to 45.9 months

  3. Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10

    OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to 45.9 months

Secondary outcomes (11)

  1. Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to 49.5 months

  2. Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to 49.5 months

  3. Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to 49.5 months

  4. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants

    ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.

    Measured: Up to 49.5 months

  5. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

    ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.

    Measured: Up to 49.5 months

  6. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10

    ORR was defined as the percentage of the participants who had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 as assessed by BICR.

    Measured: Up to 49.5 months

  7. Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants

    DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to 49.5 months

  8. Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

    DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to 49.5 months

  9. Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10

    DOR was defined as the time from first documented evidence of a confirmed Complete Response (CR) or Partial Response (PR) until progressive disease (PD) or death, whichever occurred first. Per RECIST 1.1 as assessed by BICR, CR was the disappearance of all target lesions and PR was ≥30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. PD was defined as ≥20% increase in the SOD of target lesions according to RECIST 1.1. In addition to the relative increase of 20%, the SOD must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. DOR for participants who had not progressed or died at the time of analysis was censored at the date of the last tumor assessment. DOR was estimated using the product-limit (Kaplan-Meier) method for censored data.

    Measured: Up to 49.5 months

  10. Number of Participants Who Experienced an Adverse Event (AE)

    An AE was defined as any untoward medical occurrence, in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE is presented.

    Measured: Up to approximately 49.3 months

  11. Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.

    Measured: Up to approximately 46.3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2018
  2. Study start8 Nov 2018
  3. Primary completion3 Oct 2022
  4. Study completion3 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,579 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03675737
Sponsor's protocol ID
3475-859
Other IDs
MK-3475-859, KEYNOTE-859, JAPIC-CTI, 2023-508890-10-00, U1111-1299-1405, 2018-001757-27, 2018, 2023
Status last verified
Feb 2026
First submitted
17 Sep 2018
Last updated
27 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Rha SY, Oh DY, Yanez P, Bai Y, Ryu MH, Lee J, Rivera F, Alves GV, Garrido M, Shiu KK, Fernandez MG, Li J, Lowery MA, Cil T, Cruz FM, Qin S, Luo S, Pan H, Wainberg ZA, Yin L, Bordia S, Bhagia P, Wyrwicz LS; KEYNOTE-859 investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Nov;24(11):1181-1195. doi: 10.1016/S1470-2045(23)00515-6. Epub 2023 Oct 21.

    PubMed 37875143

  • Qin S, Bai Y, Li J, Pan H, Luo S, Qu Y, Ye F, Yang L, Liu T, Li W, Chen X, Yang J, Ying J, Lin X, Zhao L, Liang X, Mao Y, Guo R, Zuo Y, Bordia S, Li S. First-Line Pembrolizumab Plus Chemotherapy for HER2-Negative Advanced Gastric Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-859 Study. Adv Ther. 2025 Apr;42(4):1892-1906. doi: 10.1007/s12325-024-03069-4. Epub 2025 Mar 1.

    PubMed 40025394

  • Wyrwicz L, Kalampoki V, Valderrama A, Young K. Pembrolizumab plus chemotherapy for advanced HER2-negative gastric or gastroesophageal junction cancer: KEYNOTE-859 Q-TWiST analysis. Immunotherapy. 2026 Feb;18(3):161-167. doi: 10.1080/1750743X.2026.2647579. Epub 2026 Apr 11.

    PubMed 41964430

  • Yasui H, Aizawa M, Yamaguchi K, Kawazoe A, Hara H, Tsuda M, Shoji H, Sugimoto N, Shibata N, Amagai K, Choda Y, Iwagami S, Esaki T, Kadowaki S, Shiratori S, Han S, Bordia S, Shitara K. First-line pembrolizumab plus chemotherapy for participants in Japan with gastric or gastroesophageal junction adenocarcinoma: subgroup analysis of the phase 3 KEYNOTE-859 study. Int J Clin Oncol. 2025 Oct;30(10):2003-2011. doi: 10.1007/s10147-025-02847-6. Epub 2025 Aug 1.

    PubMed 40750941

  • Tabernero J, Bang YJ, Van Cutsem E, Fuchs CS, Janjigian YY, Bhagia P, Li K, Adelberg D, Qin SK. KEYNOTE-859: a Phase III study of pembrolizumab plus chemotherapy in gastric/gastroesophageal junction adenocarcinoma. Future Oncol. 2021 Aug;17(22):2847-2855. doi: 10.2217/fon-2021-0176. Epub 2021 May 12.

    PubMed 33975465

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Cisplatin and 5-fluorouracil in people with Stomach Neoplasms, run by Merck Sharp & Dohme LLC at 215 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 215 sites in China, Japan, United States, South Africa, Ukraine and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in All Participants (time frame: Up to 45.9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03675737, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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