Stomach Neoplasms Clinical Trial
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)
| Verified date | January 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Active, not recruiting |
| Enrollment | 1579 |
| Est. completion date | September 28, 2024 |
| Est. primary completion date | October 3, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria - 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 - 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 Exclusion Criteria - 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) - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Fundacion Favaloro - Hospital Universitario ( Site 0302) | Buenos Aires | |
| Argentina | Instituto de Investigaciones Metabolicas ( Site 0312) | Buenos Aires | |
| Argentina | Instituto Medico Alexander Fleming ( Site 0307) | Buenos Aires | Caba |
| Argentina | Centro Oncologico Riojano Integral ( Site 0313) | La Rioja | |
| Argentina | Instituto San Marcos ( Site 0311) | San Juan | |
| Australia | Box Hill Hospital ( Site 2300) | Box Hill | Victoria |
| Australia | Liverpool Hospital ( Site 2301) | Liverpool | New South Wales |
| Australia | Southern Medical Day Care Centre ( Site 2303) | Wollongong | New South Wales |
| Brazil | CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405) | Curitiba | Parana |
| Brazil | CEPON - Centro de Pesquisas Oncologicas ( Site 0400) | Florianopolis | Santa Catarina |
| Brazil | Instituto do Cancer do Ceara ( Site 0407) | Fortaleza | Ceara |
| Brazil | Hospital de Caridade de Ijui ( Site 0402) | Ijui | Rio Grande Do Sul |
| Brazil | Hospital Nossa Senhora da Conceicao ( Site 0403) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401) | Rio de Janeiro | |
| Brazil | IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404) | Sao Paulo | |
| Canada | BC Cancer - Abbotsford ( Site 0206) | Abbotsford | British Columbia |
| Canada | McGill University Health Centre ( Site 0208) | Montreal | Quebec |
| Canada | Princess Margaret Cancer Centre ( Site 0203) | Toronto | Ontario |
| Canada | Sunnybrook Research Institute ( Site 0202) | Toronto | Ontario |
| Chile | Fundacion Arturo Lopez Perez FALP ( Site 0501) | Santiago | Region M. De Santiago |
| Chile | Pontificia Universidad Catolica de Chile ( Site 0502) | Santiago | Region M. De Santiago |
| Chile | Sociedad Oncovida S.A. ( Site 0508) | Santiago | Region M. De Santiago |
| Chile | Instituto Clinico Oncologico del Sur ( Site 0500) | Temuco | Araucania |
| China | Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421) | Beijing | Beijing |
| China | Peking Union Medical College Hospital ( Site 2425) | Beijing | Beijing |
| China | The First Hospital of Jilin University ( Site 2416) | Chang chun | Jilin |
| China | Hunan Cancer Hospital ( Site 2439) | Changsha | Hunan |
| China | Xiangya Hospital Central-South University ( Site 2419) | Changsha | Hunan |
| China | Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441) | Changzhou | Jiangsu |
| China | 900 Hospital of the Joint ( Site 2418) | Fuzhou | Fujian |
| China | Fujian Medical University Union Hospital ( Site 2410) | Fuzhou | Fujian |
| China | Fujian Provincial Cancer Hospital ( Site 2414) | Fuzhou | Fujian |
| China | Guangdong General Hospital ( Site 2431) | Guangzhou | Guangdong |
| China | Sir Run Run Show Hospital ( Site 2427) | Hangzhou | Zhejiang |
| China | Zhejiang Cancer Hospital ( Site 2417) | Hangzhou | Zhejiang |
| China | Zhejiang Provincial People's Hospital ( Site 2446) | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital ( Site 2401) | Harbin | Heilongjiang |
| China | The First Affiliated Hospital of Nanchang University ( Site 2440) | Nanchang | Jiangxi |
| China | Jiangsu Cancer Hospital ( Site 2432) | Nanjing | Jiangsu |
| China | The 81st Hospital of PLA ( Site 2413) | Nanjing | Jiangsu |
| China | The Affiliated Hospital of Qingdao University ( Site 2405) | Qingdao | Shandong |
| China | Shanghai East Hospital ( Site 2403) | Shanghai | Shanghai |
| China | Zhongshan Hospital affiliated to Fudan University ( Site 2407) | Shanghai | Shanghai |
| China | Peking University Shenzhen Hospital ( Site 2442) | Shenzhen | Guangdong |
| China | Fourth Hospital Of Hebei Medical University ( Site 2436) | Shijiazhuang | Hebei |
| China | Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420) | Urumqi | Xinjiang |
| China | Hubei Cancer Hospital ( Site 2434) | Wuhan | Hubei |
| China | The First Affiliated Hospital of Xiamen University ( Site 2430) | Xiamen | Fujian |
| China | Zhongshan Hospital Xiamen University ( Site 2447) | Xiamen | Fujian |
| China | 1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428) | XiAn | Shanxi |
| China | Yancheng First People s Hospital ( Site 2426) | Yancheng | Jiangsu |
| China | Henan Cancer Hospital ( Site 2415) | Zhengzhou | Henan |
| Colombia | Instituto Nacional de Cancerologia E.S.E ( Site 0605) | Bogota | Distrito Capital De Bogota |
| Colombia | Centro Medico Imbanaco de Cali S.A ( Site 0604) | Cali | Valle Del Cauca |
| Colombia | Oncomedica S.A. ( Site 0606) | Monteria | Cordoba |
| Colombia | Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608) | Valledupar | Cesar |
| Costa Rica | CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001) | San Jose | |
| Costa Rica | ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000) | San Jose | |
| Costa Rica | Policlinico San Bosco ( Site 3002) | San Jose | |
| Czechia | Masarykuv onkologicky ustav ( Site 3103) | Brno | Jihomoravsky Kraj |
| Czechia | Nemocnice AGEL Novy Jicin a.s. ( Site 3104) | Novy Jicin | |
| Czechia | Fakultni nemocnice Olomouc ( Site 3100) | Olomouc | |
| Czechia | FN Ostrava ( Site 3105) | Ostrava | Moravskoslezsky Kraj |
| Czechia | Fakultni nemocnice Plzen ( Site 3102) | Plzen | Plzensky Kraj |
| Czechia | Fakultni Thomayerova nemocnice ( Site 3101) | Praha 4 | |
| Denmark | Aalborg University Hospital ( Site 3204) | Aalborg | Nordjylland |
| Denmark | Rigshospitalet ( Site 3202) | Copenhagen | Hovedstaden |
| Denmark | Odense Universitets Hospital ( Site 3201) | Odense | Syddanmark |
| France | CHU-Jean Minjoz ( Site 1002) | Besancon | Doubs |
| France | C.H.R.U. de Brest - Hopital Morvan ( Site 1007) | Brest | Finistere |
| France | Centre Oscar Lambret ( Site 1003) | Lille | Nord |
| France | CHU Hopital Saint Antoine ( Site 1001) | Paris | |
| France | CHU de Rouen ( Site 1006) | Rouen | Ain |
| France | Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004) | Saint-Herblain | Val-de-Marne |
| France | Institut Gustave Roussy ( Site 1000) | Villejuif | Val-de-Marne |
| Germany | Charite Universitaetsmedizin Berlin ( Site 1101) | Berlin | |
| Germany | Asklepios Klinik Altona ( Site 1100) | Hamburg | |
| Germany | Facharztzentrum Eppendorf ( Site 1121) | Hamburg | |
| Germany | SLK-Kliniken Heilbronn ( Site 1104) | Heilbronn | Baden-Wurttemberg |
| Germany | Universitaetsklinikum Leipzig ( Site 1114) | Leipzig | Sachsen |
| Guatemala | Celan SA ( Site 0705) | Guatemala | |
| Guatemala | Grupo Angeles SA ( Site 0701) | Guatemala | |
| Guatemala | MEDI-K CAYALA ( Site 0704) | Guatemala | |
| Guatemala | Oncomedica ( Site 0702) | Guatemala | |
| Guatemala | Centro Regional de Sub Especialidades Medicas SA ( Site 0703) | Quetzaltenango | |
| Hong Kong | Prince of Wales Hospital ( Site 2503) | Hong Kong | |
| Hong Kong | Princess Margaret Hospital. ( Site 2502) | Hong Kong | |
| Hong Kong | Queen Mary Hospital ( Site 2501) | Hong Kong | |
| Hungary | Orszagos Onkologiai Intezet ( Site 3303) | Budapest | |
| Hungary | Semmelweis Egyetem.. ( Site 3305) | Budapest | |
| Hungary | University of Debrecen Medical Center Clinic of Oncology ( Site 3300) | Debrecen | |
| Hungary | Bacs-Kiskun Megyei Korhaz ( Site 3306) | Kecskemet | Bacs-Kiskun |
| Hungary | Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302) | Szolnok | Jasz-Nagykun-Szolnok |
| Ireland | Beaumont Hospital ( Site 2101) | Dublin | |
| Ireland | St. James s Hospital ( Site 1200) | Dublin | |
| Ireland | Tallaght University Hospital ( Site 1202) | Dublin | |
| Israel | Soroka University Medical Center ( Site 1305) | Beer Sheva | |
| Israel | Rambam Medical Center ( Site 1303) | Haifa | |
| Israel | Edith Wolfson Medical Center ( Site 1307) | Holon | Tell Abib |
| Israel | Hadassah Ein Karem Jerusalem ( Site 1301) | Jerusalem | Yerushalayim |
| Israel | Meir Medical Center ( Site 1308) | Kfar Saba | |
| Israel | Rabin Medical Center ( Site 1302) | Petah Tikva | |
| Israel | Chaim Sheba Medical Center ( Site 1304) | Ramat Gan | Tel Aviv |
| Israel | Sourasky Medical Center ( Site 1306) | Tel Aviv | Tell Abib |
| Italy | Istituto Europeo di Oncologia ( Site 1411) | Milano | Lombardia |
| Italy | Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402) | Milano | |
| Italy | Istituto Oncologico Veneto ( Site 1412) | Padova | |
| Italy | Azienda Ospedaliera San Camillo Forlanini ( Site 1413) | Roma | |
| Japan | Hyogo Cancer Center ( Site 2604) | Akashi | Hyogo |
| Japan | National Hospital Organization Kyushu Cancer Center ( Site 2612) | Fukuoka | |
| Japan | Kansai Medical University Hospital ( Site 2608) | Hirakata | Osaka |
| Japan | Hiroshima City Hiroshima Citizens Hospital ( Site 2611) | Hiroshima | |
| Japan | Ibaraki Prefectural Central Hospital ( Site 2610) | Kasama | Ibaraki |
| Japan | National Cancer Center Hospital East ( Site 2617) | Kashiwa | Chiba |
| Japan | Kagawa University Hospital ( Site 2615) | Kita-gun | Kagawa |
| Japan | Saitama Cancer Center ( Site 2601) | Kitaadachi-gun | Saitama |
| Japan | Kobe City Medical Center General Hospital ( Site 2603) | Kobe | Hyogo |
| Japan | Kumamoto University Hospital ( Site 2602) | Kumamoto | |
| Japan | Aichi Cancer Center Hospital ( Site 2619) | Nagoya | Aichi |
| Japan | Niigata Cancer Center Hospital ( Site 2613) | Niigata | |
| Japan | Osaka International Cancer Institute ( Site 2607) | Osaka | |
| Japan | Kindai University Hospital ( Site 2616) | Osakasayama | Osaka |
| Japan | Kitasato University Hospital ( Site 2618) | Sagamihara | Kanagawa |
| Japan | Osaka University Hospital ( Site 2600) | Suita | Osaka |
| Japan | National Cancer Center Hospital ( Site 2606) | Tokyo | |
| Japan | The Cancer Institute Hospital of JFCR ( Site 2609) | Tokyo | |
| Japan | Tokyo Metropolitan Komagome Hospital ( Site 2605) | Tokyo | |
| Japan | Kanagawa Cancer Center ( Site 2614) | Yokohama | Kanagawa |
| Korea, Republic of | Asan Medical Center ( Site 2802) | Seoul | |
| Korea, Republic of | Samsung Medical Center ( Site 2801) | Seoul | |
| Korea, Republic of | Seoul National University Hospital ( Site 2803) | Seoul | |
| Korea, Republic of | Severance Hospital Yonsei University Health System ( Site 2800) | Seoul | |
| Mexico | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806) | Ciudad de Mexico | |
| Mexico | Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808) | Guadalajara | Jalisco |
| Mexico | Medical Care and Research S.A. de C.V. ( Site 0809) | Merida | |
| Mexico | Instituto Nacional de Cancerologia. ( Site 0804) | Mexico City | |
| Mexico | Christus Muguerza Clinica Vidriera ( Site 0802) | Monterrey | Nuevo Leon |
| New Zealand | Auckland City Hospital ( Site 2700) | Auckland | Northland |
| Peru | Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908) | Lima | |
| Peru | Clinica San Gabriel ( Site 0907) | Lima | |
| Peru | Hospital Nacional Arzobispo Loayza ( Site 0902) | Lima | |
| Peru | Instituto Nacional de Enfermedades Neoplasicas ( Site 0901) | Lima | |
| Poland | Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505) | Grudziadz | |
| Poland | Przychodnia Lekarska Komed ( Site 1514) | Konin | Wielkopolskie |
| Poland | Szpital Uniwersytecki w Krakowie ( Site 1503) | Krakow | Malopolskie |
| Poland | Magodent Szpital Elblaska ( Site 1509) | Warszawa | Mazowieckie |
| Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( | Warszawa | Mazowieckie |
| Poland | Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504) | Wroclaw | Dolnoslaskie |
| Poland | Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506) | Wroclaw | Dolnoslaskie |
| Russian Federation | Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608) | Chelyabinsk | Chelyabinskaya Oblast |
| Russian Federation | Blokhin National Medical Oncology ( Site 1604) | Moscow | Moskva |
| Russian Federation | Central Clinical Hospital with Polyclinic ( Site 1614) | Moscow | Moskva |
| Russian Federation | City Clinical Oncology Center ( Site 1603) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | SBHI Leningrad Regional Clinical Hospital ( Site 1616) | Saint Petersburg | Leningradskaya Oblast |
| Russian Federation | SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609) | Samara | Samarskaya Oblast |
| South Africa | Universitas Annex National Hospital ( Site 1701) | Bloemfontein | Free State |
| South Africa | Cancercare Rondebosch Oncology ( Site 1709) | Cape Town | Western Cape |
| South Africa | Groote Schuur Hospital ( Site 1706) | Cape Town | Western Cape |
| South Africa | The Oncology Centre Overport and Umhlanga ( Site 1705) | Durban | Kwazulu-Natal |
| South Africa | Outeniqua Cancercare Oncology Unit ( Site 1704) | George | Western Cape |
| South Africa | Sandton Oncology Medical Group PTY LTD ( Site 1700) | Johannesburg | Gauteng |
| South Africa | Cape Town Oncology Trials Pty Ltd ( Site 1703) | Kraaifontein | Western Cape |
| South Africa | Wits Clinical Research ( Site 1707) | Parktown-Johannesburg | Gauteng |
| South Africa | Cancer Care Langenhoven Drive Oncology Centre ( Site 1708) | Port Elizabeth | Eastern Cape |
| South Africa | Tshwane District Hospital ( Site 1702) | Pretoria | Gauteng |
| Spain | Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806) | Badalona | Barcelona |
| Spain | Hospital General Universitari Vall d Hebron ( Site 1801) | Barcelona | |
| Spain | Hospital General Universitario de Elche ( Site 1803) | Elche | Alicante |
| Spain | Hospital Universitario General de Asturias ( Site 1802) | Oviedo | Asturias |
| Spain | HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805) | Pozuelo de Alarcon | Madrid |
| Spain | Hospital Universitario Marques de Valdecilla ( Site 1804) | Santander | Cantabria |
| Switzerland | Universitaetsspital Basel ( Site 1900) | Basel | Basel-Stadt |
| Switzerland | Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905) | Bellinzona | Ticino |
| Switzerland | Kantonsspital Graubuenden ( Site 1903) | Chur | Grisons |
| Switzerland | Hopitaux Universitaires de Geneve HUG ( Site 1907) | Geneva | Geneve |
| Switzerland | Luzern Kantonsspital ( Site 1904) | Luzern | |
| Switzerland | Kantonsspital St. Gallen ( Site 1901) | St. Gallen | Sankt Gallen |
| Switzerland | Universitaetsspital Zuerich ( Site 1902) | Zuerich | Zurich |
| Taiwan | Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902) | Kaohsiung | |
| Taiwan | National Cheng Kung University Hospital ( Site 2901) | Tainan | |
| Taiwan | Mackay Memorial Hospital ( Site 2903) | Taipei | |
| Taiwan | National Taiwan University Hospital ( Site 2900) | Taipei | |
| Turkey | Adana Sehir Hastanesi ( Site 2002) | Adana | |
| Turkey | Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006) | Ankara | |
| Turkey | Hacettepe University Medical Faculty ( Site 2017) | Ankara | |
| Turkey | Trakya Universitesi Tip Fakultesi ( Site 2015) | Edirne | |
| Turkey | Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000) | Erzurum | |
| Turkey | Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001) | Istanbul | |
| Turkey | Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011) | Izmir | |
| Turkey | Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009) | Malatya | |
| Turkey | Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012) | Sakarya | |
| Ukraine | City Clinical Hosp.4 of DCC ( Site 2201) | Dnipro | Dnipropetrovska Oblast |
| Ukraine | MI Precarpathian Clinical Oncology Center ( Site 2204) | Ivano-Frankivsk | Ivano-Frankivska Oblast |
| Ukraine | Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208) | Kharkiv | Kharkivska Oblast |
| Ukraine | MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200) | Kryviy Rih | Dnipropetrovska Oblast |
| Ukraine | Clinic of National Cancer Institute ( Site 2203) | Kyiv | Kyivska Oblast |
| Ukraine | Kyiv City Clinical Oncology Centre ( Site 2213) | Kyiv | |
| Ukraine | Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205) | Kyiv | Kyivska Oblast |
| Ukraine | Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210) | Lviv | Lvivska Oblast |
| Ukraine | MI Odessa Regional Oncological Centre ( Site 2212) | Odesa | Odeska Oblast |
| Ukraine | Medical Centre LLC Oncolife ( Site 2202) | Zaporizhzhya | Zaporizka Oblast |
| United Kingdom | Castle Hill Hospital ( Site 1201) | Cottingham | East Riding Of Yorkshire |
| United Kingdom | St. Georges University Hospital NHS Foundation Trust ( Site 1204) | London | London, City Of |
| United Kingdom | University College London Hospital ( Site 1211) | London | London, City Of |
| United Kingdom | South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205) | Torquay | Devon |
| United States | Greater Baltimore Medical Center ( Site 0102) | Baltimore | Maryland |
| United States | UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124) | Los Angeles | California |
| United States | University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113) | Miami | Florida |
| United States | Minnesota Oncology Hematology, PA ( Site 8000) | Minneapolis | Minnesota |
| United States | UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128) | Orange | California |
| United States | Cancer Treatment Centers of America - Philadelphia ( Site 0112) | Philadelphia | Pennsylvania |
| United States | Allegheny General Hospital ( Site 0118) | Pittsburgh | Pennsylvania |
| United States | Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001) | Roanoke | Virginia |
| United States | University of Rochester ( Site 0122) | Rochester | New York |
| United States | Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116) | Wenatchee | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czechia, Denmark, France, Germany, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Peru, Poland, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom,
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 che — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to 45.9 months | |
| Primary | 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. | Up to 45.9 months | |
| Primary | 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. | Up to 45.9 months | |
| Secondary | 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. | Up to 49.5 months | |
| Secondary | 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. | Up to 49.5 months | |
| Secondary | 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. | Up to 49.5 months | |
| Secondary | 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. | Up to 49.5 months | |
| Secondary | 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. | Up to 49.5 months | |
| Secondary | 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. | Up to 49.5 months | |
| Secondary | 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. | Up to 49.5 months | |
| Secondary | 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. | Up to 49.5 months | |
| Secondary | 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. | Up to 49.5 months | |
| Secondary | 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. | Up to 36.7 months | |
| Secondary | 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. | Up to 33.7 months |
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