Back to resultsPembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
Primary Purpose
Stomach Neoplasms
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Cisplatin
5-fluorouracil
oxaliplatin
capecitabine
Placebo for Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1), programmed cell death ligand 2 (PD-L2, PDL2)
Eligibility Criteria
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-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, CD137)
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization or has not recovered from all 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
Sites / Locations
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124)
- UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128)
- University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113)
- Greater Baltimore Medical Center ( Site 0102)
- Minnesota Oncology Hematology, PA ( Site 8000)
- University of Rochester ( Site 0122)
- Cancer Treatment Centers of America - Philadelphia ( Site 0112)
- Allegheny General Hospital ( Site 0118)
- Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001)
- Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116)
- Instituto Medico Alexander Fleming ( Site 0307)
- Instituto de Investigaciones Metabolicas ( Site 0312)
- Fundacion Favaloro - Hospital Universitario ( Site 0302)
- Centro Oncologico Riojano Integral ( Site 0313)
- Instituto San Marcos ( Site 0311)
- Liverpool Hospital ( Site 2301)
- Southern Medical Day Care Centre ( Site 2303)
- Box Hill Hospital ( Site 2300)
- Instituto do Cancer do Ceara ( Site 0407)
- CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405)
- Hospital de Caridade de Ijui ( Site 0402)
- Hospital Nossa Senhora da Conceicao ( Site 0403)
- CEPON - Centro de Pesquisas Oncologicas ( Site 0400)
- Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401)
- IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404)
- BC Cancer - Abbotsford ( Site 0206)
- Sunnybrook Research Institute ( Site 0202)
- Princess Margaret Cancer Centre ( Site 0203)
- McGill University Health Centre ( Site 0208)
- Instituto Clinico Oncologico del Sur ( Site 0500)
- Fundacion Arturo Lopez Perez FALP ( Site 0501)
- Sociedad Oncovida S.A. ( Site 0508)
- Pontificia Universidad Catolica de Chile ( Site 0502)
- Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)
- Peking Union Medical College Hospital ( Site 2425)
- Fujian Medical University Union Hospital ( Site 2410)
- Fujian Provincial Cancer Hospital ( Site 2414)
- 900 Hospital of the Joint ( Site 2418)
- The First Affiliated Hospital of Xiamen University ( Site 2430)
- Zhongshan Hospital Xiamen University ( Site 2447)
- Guangdong General Hospital ( Site 2431)
- Peking University Shenzhen Hospital ( Site 2442)
- Fourth Hospital Of Hebei Medical University ( Site 2436)
- Harbin Medical University Cancer Hospital ( Site 2401)
- Henan Cancer Hospital ( Site 2415)
- Hubei Cancer Hospital ( Site 2434)
- Xiangya Hospital Central-South University ( Site 2419)
- Hunan Cancer Hospital ( Site 2439)
- Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)
- The 81st Hospital of PLA ( Site 2413)
- Jiangsu Cancer Hospital ( Site 2432)
- Yancheng First People s Hospital ( Site 2426)
- The First Affiliated Hospital of Nanchang University ( Site 2440)
- The First Hospital of Jilin University ( Site 2416)
- The Affiliated Hospital of Qingdao University ( Site 2405)
- Shanghai East Hospital ( Site 2403)
- Zhongshan Hospital affiliated to Fudan University ( Site 2407)
- 1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)
- Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)
- Zhejiang Provincial People's Hospital ( Site 2446)
- Sir Run Run Show Hospital ( Site 2427)
- Zhejiang Cancer Hospital ( Site 2417)
- Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608)
- Oncomedica S.A. ( Site 0606)
- Instituto Nacional de Cancerologia E.S.E ( Site 0605)
- Centro Medico Imbanaco de Cali S.A ( Site 0604)
- CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001)
- Policlinico San Bosco ( Site 3002)
- ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000)
- Masarykuv onkologicky ustav ( Site 3103)
- FN Ostrava ( Site 3105)
- Fakultni nemocnice Plzen ( Site 3102)
- Nemocnice AGEL Novy Jicin a.s. ( Site 3104)
- Fakultni nemocnice Olomouc ( Site 3100)
- Fakultni Thomayerova nemocnice ( Site 3101)
- Rigshospitalet ( Site 3202)
- Aalborg University Hospital ( Site 3204)
- Odense Universitets Hospital ( Site 3201)
- CHU de Rouen ( Site 1006)
- CHU-Jean Minjoz ( Site 1002)
- C.H.R.U. de Brest - Hopital Morvan ( Site 1007)
- Centre Oscar Lambret ( Site 1003)
- Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004)
- Institut Gustave Roussy ( Site 1000)
- CHU Hopital Saint Antoine ( Site 1001)
- SLK-Kliniken Heilbronn ( Site 1104)
- Universitaetsklinikum Leipzig ( Site 1114)
- Charite Universitaetsmedizin Berlin ( Site 1101)
- Facharztzentrum Eppendorf ( Site 1121)
- Asklepios Klinik Altona ( Site 1100)
- Celan SA ( Site 0705)
- Oncomedica ( Site 0702)
- Grupo Angeles SA ( Site 0701)
- MEDI-K CAYALA ( Site 0704)
- Centro Regional de Sub Especialidades Medicas SA ( Site 0703)
- Prince of Wales Hospital ( Site 2503)
- Princess Margaret Hospital. ( Site 2502)
- Queen Mary Hospital ( Site 2501)
- Bacs-Kiskun Megyei Korhaz ( Site 3306)
- Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302)
- Semmelweis Egyetem.. ( Site 3305)
- Orszagos Onkologiai Intezet ( Site 3303)
- University of Debrecen Medical Center Clinic of Oncology ( Site 3300)
- St. James s Hospital ( Site 1200)
- Beaumont Hospital ( Site 2101)
- Tallaght University Hospital ( Site 1202)
- Chaim Sheba Medical Center ( Site 1304)
- Edith Wolfson Medical Center ( Site 1307)
- Sourasky Medical Center ( Site 1306)
- Hadassah Ein Karem Jerusalem ( Site 1301)
- Soroka University Medical Center ( Site 1305)
- Rambam Medical Center ( Site 1303)
- Meir Medical Center ( Site 1308)
- Rabin Medical Center ( Site 1302)
- Istituto Europeo di Oncologia ( Site 1411)
- Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402)
- Istituto Oncologico Veneto ( Site 1412)
- Azienda Ospedaliera San Camillo Forlanini ( Site 1413)
- Aichi Cancer Center Hospital ( Site 2619)
- National Cancer Center Hospital East ( Site 2617)
- Hyogo Cancer Center ( Site 2604)
- Kobe City Medical Center General Hospital ( Site 2603)
- Ibaraki Prefectural Central Hospital ( Site 2610)
- Kagawa University Hospital ( Site 2615)
- Kitasato University Hospital ( Site 2618)
- Kanagawa Cancer Center ( Site 2614)
- Kansai Medical University Hospital ( Site 2608)
- Kindai University Hospital ( Site 2616)
- Osaka University Hospital ( Site 2600)
- Saitama Cancer Center ( Site 2601)
- National Hospital Organization Kyushu Cancer Center ( Site 2612)
- Hiroshima City Hiroshima Citizens Hospital ( Site 2611)
- Kumamoto University Hospital ( Site 2602)
- Niigata Cancer Center Hospital ( Site 2613)
- Osaka International Cancer Institute ( Site 2607)
- National Cancer Center Hospital ( Site 2606)
- Tokyo Metropolitan Komagome Hospital ( Site 2605)
- The Cancer Institute Hospital of JFCR ( Site 2609)
- Seoul National University Hospital ( Site 2803)
- Severance Hospital Yonsei University Health System ( Site 2800)
- Asan Medical Center ( Site 2802)
- Samsung Medical Center ( Site 2801)
- Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808)
- Christus Muguerza Clinica Vidriera ( Site 0802)
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806)
- Medical Care and Research S.A. de C.V. ( Site 0809)
- Instituto Nacional de Cancerologia. ( Site 0804)
- Auckland City Hospital ( Site 2700)
- Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908)
- Instituto Nacional de Enfermedades Neoplasicas ( Site 0901)
- Hospital Nacional Arzobispo Loayza ( Site 0902)
- Clinica San Gabriel ( Site 0907)
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506)
- Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504)
- Szpital Uniwersytecki w Krakowie ( Site 1503)
- Magodent Szpital Elblaska ( Site 1509)
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
- Przychodnia Lekarska Komed ( Site 1514)
- Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505)
- Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608)
- SBHI Leningrad Regional Clinical Hospital ( Site 1616)
- Blokhin National Medical Oncology ( Site 1604)
- Central Clinical Hospital with Polyclinic ( Site 1614)
- SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609)
- City Clinical Oncology Center ( Site 1603)
- Cancer Care Langenhoven Drive Oncology Centre ( Site 1708)
- Universitas Annex National Hospital ( Site 1701)
- Sandton Oncology Medical Group PTY LTD ( Site 1700)
- Wits Clinical Research ( Site 1707)
- Tshwane District Hospital ( Site 1702)
- The Oncology Centre Overport and Umhlanga ( Site 1705)
- Cancercare Rondebosch Oncology ( Site 1709)
- Groote Schuur Hospital ( Site 1706)
- Outeniqua Cancercare Oncology Unit ( Site 1704)
- Cape Town Oncology Trials Pty Ltd ( Site 1703)
- Hospital General Universitario de Elche ( Site 1803)
- Hospital Universitario General de Asturias ( Site 1802)
- Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806)
- Hospital Universitario Marques de Valdecilla ( Site 1804)
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805)
- Hospital General Universitari Vall d Hebron ( Site 1801)
- Universitaetsspital Basel ( Site 1900)
- Hopitaux Universitaires de Geneve HUG ( Site 1907)
- Kantonsspital Graubuenden ( Site 1903)
- Kantonsspital St. Gallen ( Site 1901)
- Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905)
- Universitaetsspital Zuerich ( Site 1902)
- Luzern Kantonsspital ( Site 1904)
- Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902)
- National Cheng Kung University Hospital ( Site 2901)
- National Taiwan University Hospital ( Site 2900)
- Mackay Memorial Hospital ( Site 2903)
- Adana Sehir Hastanesi ( Site 2002)
- Hacettepe University Medical Faculty ( Site 2017)
- Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)
- Trakya Universitesi Tip Fakultesi ( Site 2015)
- Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)
- Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)
- Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)
- Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)
- Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)
- City Clinical Hosp.4 of DCC ( Site 2201)
- MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200)
- MI Precarpathian Clinical Oncology Center ( Site 2204)
- Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208)
- Clinic of National Cancer Institute ( Site 2203)
- Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205)
- Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210)
- MI Odessa Regional Oncological Centre ( Site 2212)
- Medical Centre LLC Oncolife ( Site 2202)
- Kyiv City Clinical Oncology Centre ( Site 2213)
- South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205)
- Castle Hill Hospital ( Site 1201)
- University College London Hospital ( Site 1211)
- St. Georges University Hospital NHS Foundation Trust ( Site 1204)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pembrolizumab + Chemotherapy (FP or CAPOX regimen)
Placebo + Chemotherapy (FP or CAPOX regimen)
Arm Description
Participants 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).
Participants 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).
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03675737
First Posted
September 17, 2018
Last Updated
September 20, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03675737
Brief Title
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
October 3, 2022 (Actual)
Study Completion Date
September 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1), programmed cell death ligand 2 (PD-L2, PDL2)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1579 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab + Chemotherapy (FP or CAPOX regimen)
Arm Type
Experimental
Arm Description
Participants 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).
Arm Title
Placebo + Chemotherapy (FP or CAPOX regimen)
Arm Type
Active Comparator
Arm Description
Participants 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).
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
Administered as an IV infusion on Day 1 Q3W
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
PLATINOL®
Intervention Description
Administered as an IV infusion on Day 1 Q3W
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
ADRUCIL®, 5FU
Intervention Description
Administered as a continuous IV infusion on Days 1-5 Q3W
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
ELOXATIN®
Intervention Description
Administered as an IV infusion on Day 1 Q3W
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
XELODA®
Intervention Description
Administered orally BID on Days 1 to 14 Q3W
Intervention Type
Drug
Intervention Name(s)
Placebo for Pembrolizumab
Intervention Description
Administered as an IV infusion on Day 1 Q3W
Primary Outcome Measure Information:
Title
Overall Survival (OS) in All Participants
Description
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.
Time Frame
Up to 45.9 months
Title
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
Description
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.
Time Frame
Up to 45.9 months
Title
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Description
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.
Time Frame
Up to 45.9 months
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 49.5 months
Title
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
Description
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.
Time Frame
Up to 49.5 months
Title
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
Description
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.
Time Frame
Up to 49.5 months
Title
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
Description
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.
Time Frame
Up to 49.5 months
Title
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
Description
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.
Time Frame
Up to 49.5 months
Title
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
Description
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.
Time Frame
Up to 49.5 months
Title
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
Description
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.
Time Frame
Up to 49.5 months
Title
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
Description
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.
Time Frame
Up to 49.5 months
Title
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
Description
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.
Time Frame
Up to 49.5 months
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
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.
Time Frame
Up to 36.7 months
Title
Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
Description
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.
Time Frame
Up to 33.7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Greater Baltimore Medical Center ( Site 0102)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Minnesota Oncology Hematology, PA ( Site 8000)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Rochester ( Site 0122)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Cancer Treatment Centers of America - Philadelphia ( Site 0112)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Allegheny General Hospital ( Site 0118)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001)
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116)
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Instituto Medico Alexander Fleming ( Site 0307)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Instituto de Investigaciones Metabolicas ( Site 0312)
City
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Fundacion Favaloro - Hospital Universitario ( Site 0302)
City
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Centro Oncologico Riojano Integral ( Site 0313)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Instituto San Marcos ( Site 0311)
City
San Juan
ZIP/Postal Code
J5400EBB
Country
Argentina
Facility Name
Liverpool Hospital ( Site 2301)
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Southern Medical Day Care Centre ( Site 2303)
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Box Hill Hospital ( Site 2300)
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Instituto do Cancer do Ceara ( Site 0407)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810-050
Country
Brazil
Facility Name
Hospital de Caridade de Ijui ( Site 0402)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700 000
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao ( Site 0403)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
CEPON - Centro de Pesquisas Oncologicas ( Site 0400)
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401)
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404)
City
Sao Paulo
ZIP/Postal Code
03102-002
Country
Brazil
Facility Name
BC Cancer - Abbotsford ( Site 0206)
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 0C2
Country
Canada
Facility Name
Sunnybrook Research Institute ( Site 0202)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre ( Site 0203)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Health Centre ( Site 0208)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Instituto Clinico Oncologico del Sur ( Site 0500)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez FALP ( Site 0501)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Sociedad Oncovida S.A. ( Site 0508)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7510032
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 0502)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7620002
Country
Chile
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Peking Union Medical College Hospital ( Site 2425)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Fujian Medical University Union Hospital ( Site 2410)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Fujian Provincial Cancer Hospital ( Site 2414)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
900 Hospital of the Joint ( Site 2418)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University ( Site 2430)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Zhongshan Hospital Xiamen University ( Site 2447)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
Guangdong General Hospital ( Site 2431)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Peking University Shenzhen Hospital ( Site 2442)
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Facility Name
Fourth Hospital Of Hebei Medical University ( Site 2436)
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Facility Name
Harbin Medical University Cancer Hospital ( Site 2401)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital ( Site 2415)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Hubei Cancer Hospital ( Site 2434)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Xiangya Hospital Central-South University ( Site 2419)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Hunan Cancer Hospital ( Site 2439)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213032
Country
China
Facility Name
The 81st Hospital of PLA ( Site 2413)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Jiangsu Cancer Hospital ( Site 2432)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Yancheng First People s Hospital ( Site 2426)
City
Yancheng
State/Province
Jiangsu
ZIP/Postal Code
224000
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University ( Site 2440)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Hospital of Jilin University ( Site 2416)
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The Affiliated Hospital of Qingdao University ( Site 2405)
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266061
Country
China
Facility Name
Shanghai East Hospital ( Site 2403)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Zhongshan Hospital affiliated to Fudan University ( Site 2407)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
210000
Country
China
Facility Name
1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)
City
XiAn
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Facility Name
Zhejiang Provincial People's Hospital ( Site 2446)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Sir Run Run Show Hospital ( Site 2427)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital ( Site 2417)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Facility Name
Oncomedica S.A. ( Site 0606)
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Instituto Nacional de Cancerologia E.S.E ( Site 0605)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110321
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A ( Site 0604)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001)
City
San Jose
ZIP/Postal Code
10103
Country
Costa Rica
Facility Name
Policlinico San Bosco ( Site 3002)
City
San Jose
ZIP/Postal Code
10103
Country
Costa Rica
Facility Name
ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000)
City
San Jose
ZIP/Postal Code
10108
Country
Costa Rica
Facility Name
Masarykuv onkologicky ustav ( Site 3103)
City
Brno
State/Province
Jihomoravsky Kraj
ZIP/Postal Code
65653
Country
Czechia
Facility Name
FN Ostrava ( Site 3105)
City
Ostrava
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice Plzen ( Site 3102)
City
Plzen
State/Province
Plzensky Kraj
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Nemocnice AGEL Novy Jicin a.s. ( Site 3104)
City
Novy Jicin
ZIP/Postal Code
74101
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc ( Site 3100)
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni Thomayerova nemocnice ( Site 3101)
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Rigshospitalet ( Site 3202)
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Aalborg University Hospital ( Site 3204)
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Odense Universitets Hospital ( Site 3201)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CHU de Rouen ( Site 1006)
City
Rouen
State/Province
Ain
ZIP/Postal Code
76000
Country
France
Facility Name
CHU-Jean Minjoz ( Site 1002)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Facility Name
C.H.R.U. de Brest - Hopital Morvan ( Site 1007)
City
Brest
State/Province
Finistere
ZIP/Postal Code
29200
Country
France
Facility Name
Centre Oscar Lambret ( Site 1003)
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Facility Name
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004)
City
Saint-Herblain
State/Province
Val-de-Marne
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Gustave Roussy ( Site 1000)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Facility Name
CHU Hopital Saint Antoine ( Site 1001)
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
SLK-Kliniken Heilbronn ( Site 1104)
City
Heilbronn
State/Province
Baden-Wurttemberg
ZIP/Postal Code
74078
Country
Germany
Facility Name
Universitaetsklinikum Leipzig ( Site 1114)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin ( Site 1101)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Facharztzentrum Eppendorf ( Site 1121)
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Asklepios Klinik Altona ( Site 1100)
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Celan SA ( Site 0705)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Oncomedica ( Site 0702)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Grupo Angeles SA ( Site 0701)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
MEDI-K CAYALA ( Site 0704)
City
Guatemala
ZIP/Postal Code
01016
Country
Guatemala
Facility Name
Centro Regional de Sub Especialidades Medicas SA ( Site 0703)
City
Quetzaltenango
ZIP/Postal Code
09001
Country
Guatemala
Facility Name
Prince of Wales Hospital ( Site 2503)
City
Hong Kong
Country
Hong Kong
Facility Name
Princess Margaret Hospital. ( Site 2502)
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital ( Site 2501)
City
Hong Kong
Country
Hong Kong
Facility Name
Bacs-Kiskun Megyei Korhaz ( Site 3306)
City
Kecskemet
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302)
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Semmelweis Egyetem.. ( Site 3305)
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet ( Site 3303)
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
University of Debrecen Medical Center Clinic of Oncology ( Site 3300)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
St. James s Hospital ( Site 1200)
City
Dublin
ZIP/Postal Code
D08 W9RT
Country
Ireland
Facility Name
Beaumont Hospital ( Site 2101)
City
Dublin
ZIP/Postal Code
D09V2N0
Country
Ireland
Facility Name
Tallaght University Hospital ( Site 1202)
City
Dublin
ZIP/Postal Code
D24 NR0A
Country
Ireland
Facility Name
Chaim Sheba Medical Center ( Site 1304)
City
Ramat Gan
State/Province
Tel Aviv
ZIP/Postal Code
5266202
Country
Israel
Facility Name
Edith Wolfson Medical Center ( Site 1307)
City
Holon
State/Province
Tell Abib
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Sourasky Medical Center ( Site 1306)
City
Tel Aviv
State/Province
Tell Abib
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Hadassah Ein Karem Jerusalem ( Site 1301)
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Soroka University Medical Center ( Site 1305)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Medical Center ( Site 1303)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Meir Medical Center ( Site 1308)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center ( Site 1302)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Istituto Europeo di Oncologia ( Site 1411)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Oncologico Veneto ( Site 1412)
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini ( Site 1413)
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Aichi Cancer Center Hospital ( Site 2619)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 2617)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Hyogo Cancer Center ( Site 2604)
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kobe City Medical Center General Hospital ( Site 2603)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Ibaraki Prefectural Central Hospital ( Site 2610)
City
Kasama
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Kagawa University Hospital ( Site 2615)
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kitasato University Hospital ( Site 2618)
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Kanagawa Cancer Center ( Site 2614)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Kansai Medical University Hospital ( Site 2608)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Kindai University Hospital ( Site 2616)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital ( Site 2600)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Cancer Center ( Site 2601)
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 2612)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital ( Site 2611)
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Kumamoto University Hospital ( Site 2602)
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Niigata Cancer Center Hospital ( Site 2613)
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 2607)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
National Cancer Center Hospital ( Site 2606)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital ( Site 2605)
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR ( Site 2609)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Seoul National University Hospital ( Site 2803)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 2800)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 2802)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 2801)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Christus Muguerza Clinica Vidriera ( Site 0802)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64570
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806)
City
Ciudad de Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Medical Care and Research S.A. de C.V. ( Site 0809)
City
Merida
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Instituto Nacional de Cancerologia. ( Site 0804)
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Auckland City Hospital ( Site 2700)
City
Auckland
State/Province
Northland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908)
City
Lima
ZIP/Postal Code
15036
Country
Peru
Facility Name
Instituto Nacional de Enfermedades Neoplasicas ( Site 0901)
City
Lima
ZIP/Postal Code
15038
Country
Peru
Facility Name
Hospital Nacional Arzobispo Loayza ( Site 0902)
City
Lima
ZIP/Postal Code
15082
Country
Peru
Facility Name
Clinica San Gabriel ( Site 0907)
City
Lima
ZIP/Postal Code
15088
Country
Peru
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie ( Site 1503)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Magodent Szpital Elblaska ( Site 1509)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-748
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Przychodnia Lekarska Komed ( Site 1514)
City
Konin
State/Province
Wielkopolskie
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505)
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608)
City
Chelyabinsk
State/Province
Chelyabinskaya Oblast
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
SBHI Leningrad Regional Clinical Hospital ( Site 1616)
City
Saint Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Blokhin National Medical Oncology ( Site 1604)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Central Clinical Hospital with Polyclinic ( Site 1614)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
City Clinical Oncology Center ( Site 1603)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Cancer Care Langenhoven Drive Oncology Centre ( Site 1708)
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Universitas Annex National Hospital ( Site 1701)
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Sandton Oncology Medical Group PTY LTD ( Site 1700)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Wits Clinical Research ( Site 1707)
City
Parktown-Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Tshwane District Hospital ( Site 1702)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
The Oncology Centre Overport and Umhlanga ( Site 1705)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Cancercare Rondebosch Oncology ( Site 1709)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Groote Schuur Hospital ( Site 1706)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Outeniqua Cancercare Oncology Unit ( Site 1704)
City
George
State/Province
Western Cape
ZIP/Postal Code
6530
Country
South Africa
Facility Name
Cape Town Oncology Trials Pty Ltd ( Site 1703)
City
Kraaifontein
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Hospital General Universitario de Elche ( Site 1803)
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitario General de Asturias ( Site 1802)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla ( Site 1804)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital General Universitari Vall d Hebron ( Site 1801)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Universitaetsspital Basel ( Site 1900)
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4056
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve HUG ( Site 1907)
City
Geneva
State/Province
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Kantonsspital Graubuenden ( Site 1903)
City
Chur
State/Province
Grisons
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Kantonsspital St. Gallen ( Site 1901)
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905)
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Universitaetsspital Zuerich ( Site 1902)
City
Zuerich
State/Province
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Luzern Kantonsspital ( Site 1904)
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902)
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 2901)
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 2900)
City
Taipei
ZIP/Postal Code
100225
Country
Taiwan
Facility Name
Mackay Memorial Hospital ( Site 2903)
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Adana Sehir Hastanesi ( Site 2002)
City
Adana
ZIP/Postal Code
01370
Country
Turkey
Facility Name
Hacettepe University Medical Faculty ( Site 2017)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi ( Site 2015)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)
City
Sakarya
ZIP/Postal Code
54000
Country
Turkey
Facility Name
City Clinical Hosp.4 of DCC ( Site 2201)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200)
City
Kryviy Rih
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
MI Precarpathian Clinical Oncology Center ( Site 2204)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Clinic of National Cancer Institute ( Site 2203)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03126
Country
Ukraine
Facility Name
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210)
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
MI Odessa Regional Oncological Centre ( Site 2212)
City
Odesa
State/Province
Odeska Oblast
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Medical Centre LLC Oncolife ( Site 2202)
City
Zaporizhzhya
State/Province
Zaporizka Oblast
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
Kyiv City Clinical Oncology Centre ( Site 2213)
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205)
City
Torquay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Castle Hill Hospital ( Site 1201)
City
Cottingham
State/Province
East Riding Of Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
University College London Hospital ( Site 1211)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
St. Georges University Hospital NHS Foundation Trust ( Site 1204)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
33975465
Citation
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. Erratum In: Future Oncol. 2023 Jun;19(17):1229.
Results Reference
derived
Links:
URL
https://www.merckclinicaltrials.com
Description
Merck Clinical Trials Information
Learn more about this trial
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
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