Back to resultsEfficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
Primary Purpose
Metastatic Esophageal Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Lenvatinib
Cisplatin
5-FU
Oxaliplatin
Leucovorin
Levoleucovorin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Esophageal Squamous Cell Carcinoma focused on measuring programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1)
Eligibility Criteria
Inclusion Criteria:
- Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus
- Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or 90 days after the last dose of chemotherapy, whichever comes last; 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only and is greater than 90 days post chemotherapy, no male contraception is needed
- Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days after the last dose of pembrolizumab, 30 days after the last dose of lenvatinib, or 180 days after the last dose of chemotherapy, whichever occurs last, and agrees not to donate eggs during this period
- Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week prior to randomization
- Has adequate organ function
Exclusion Criteria:
- Has had previous therapy for locally advanced unresectable or metastatic esophageal cancer
- Has locally advanced esophageal carcinoma
- Has metastatic adenocarcinoma of the esophagus
- Has direct invasion into adjacent organs such as the aorta or trachea
- Has radiographic evidence of encasement of a major blood vessel, or of intratumoral cavitation
- Has perforation risks or significant gastrointestinal (GI) bleeding
- Has had clinically significant hemoptysis within 3 weeks prior to the first dose of study drug or tumor bleeding within 2 weeks prior to the first dose of study intervention
- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
- Has GI obstruction, poor oral intake, difficulty in taking oral medication, or existing esophageal stent
- Has had major surgery, open biopsy, or significant traumatic injury within 3 weeks prior to first dose of study interventions
- Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis
- Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention, or has a history of organ transplant, including allogeneic stem cell transplant
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment and is allowed
- Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
- Has poorly controlled diarrhea
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
- Has peripheral neuropathy ≥Grade 2
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B or know active Hepatitis C virus infection
- Has a weight loss of >20% within the last 3 months
Sites / Locations
- City of Hope ( Site 0102)
- MedStar Washington Hospital Center ( Site 0186)Recruiting
- James Graham Brown Cancer Center ( Site 0117)Recruiting
- Norton Cancer Institute ( Site 0116)Recruiting
- Johns Hopkins Bayview Medical Center ( Site 0152)Recruiting
- UMASS Memorial Medical Center ( Site 0120)Recruiting
- Hematology-Oncology Associates of CNY ( Site 0173)Recruiting
- Memorial Sloan Kettering Cancer Center ( Site 0132)Recruiting
- Weill Cornell Medical College ( Site 0133)Recruiting
- AHN Allegheny General Hospital ( Site 0164)Recruiting
- VCU Health Adult Outpatient Pavillion ( Site 0160)Recruiting
- Seattle Cancer Care Alliance ( Site 0145)Recruiting
- Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203)Recruiting
- IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)Recruiting
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205)Recruiting
- Fundacion Estudios Clinicos-Oncology ( Site 0215)Recruiting
- Sanatorio Parque ( Site 0206)Recruiting
- Hospital Provincial del Centenario ( Site 0217)Recruiting
- Fundacion Favaloro ( Site 0201)Recruiting
- Fundación Respirar ( Site 0216)Recruiting
- Hospital Italiano de Córdoba ( Site 0218)Recruiting
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221)Recruiting
- Instituto San Marcos ( Site 0213)Recruiting
- Princess Margaret Cancer Centre ( Site 0004)Recruiting
- Hotel-Dieu de Levis ( Site 0013)Recruiting
- James Lind Centro de Investigación del Cáncer ( Site 0412)Recruiting
- Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401)Recruiting
- Fundacion Arturo Lopez Perez FALP ( Site 0403)Recruiting
- Oncovida ( Site 0413)Recruiting
- Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)Recruiting
- Bradford Hill Centro de Investigaciones Clinicas ( Site 0404)Recruiting
- Anhui Cancer Hospital ( Site 8058)Recruiting
- The Second Affiliated Hospital of Anhui Medical University ( Site 8026)Recruiting
- Beijing Cancer Hospital ( Site 8001)Recruiting
- Fujian Provincial Cancer Hospital ( Site 8029)Recruiting
- The First Affiliated Hospital of Xiamen University ( Site 8003)Recruiting
- Zhongshan Hospital Affiliated to Xiamen University ( Site 8055)Recruiting
- The First Affiliated Hospital.Sun Yat-sen University ( Site 8047)Recruiting
- Southern Medical University Nanfang Hospital ( Site 8031)Recruiting
- The Third Xiangya Hospital of Central South University ( Site 8046)Recruiting
- The First Affiliated Hospital of Hainan Medical University ( Site 8042)Recruiting
- Affiliated Hospital of Chengde Medical Univeristy ( Site 8053)Recruiting
- Harbin Medical University Cancer Hospital ( Site 8009)Recruiting
- Anyang Cancer Hospital ( Site 8006)Recruiting
- The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036)Recruiting
- The First Affiliated Hospital of Xinxiang Medical University ( Site 8018)Recruiting
- Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025)Recruiting
- Hubei Cancer Hospital ( Site 8014)Recruiting
- Affiliated hospital of Jiangnan university ( Site 8049)Recruiting
- The Affiliated Hospital of Xuzhou Medical University ( Site 8015)Recruiting
- Jilin Cancer Hospital ( Site 8016)Recruiting
- Jinan Central Hospital ( Site 8052)Recruiting
- Shandong Cancer Hospital ( Site 8060)Recruiting
- Affiliated Hospital of Jining Medical University ( Site 8017)Recruiting
- Linyi Cancer Hospital- Medical Oncology Department ( Site 8051)Recruiting
- Shanxi Provincial Cancer Hospital ( Site 8019)Recruiting
- West China Hospital of Sichuan University ( Site 8048)Recruiting
- Tianjin Medical University Cancer Institute & Hospital ( Site 8035)Recruiting
- Cancer Hospital Affiliated to Xinjiang Medical University ( Site 8041)Recruiting
- Sir Run Run Shaw Hospital ( Site 8021)Recruiting
- ICIMED-Oncology Research Unit ( Site 0903)Recruiting
- PROCLINICAL Pharma ( Site 0904)Recruiting
- CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902)Recruiting
- Onco Tech S A ( Site 0901)Recruiting
- Rigshospitalet ( Site 2102)Recruiting
- Odense University Hospital ( Site 2101)Recruiting
- Institut De Cancerologie De Lorraine ( Site 1010)Recruiting
- Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1014)Recruiting
- Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologiRecruiting
- Centre François Baclesse ( Site 1009)Recruiting
- Centre Georges Francois Leclerc ( Site 1008)Recruiting
- CHU Besançon ( Site 1015)Recruiting
- CHU Bordeaux Haut-Leveque ( Site 1012)Recruiting
- Institut du Cancer de Montpellier ( Site 1002)Recruiting
- CHRU de Tours - Hopital Bretonneau ( Site 1018)Recruiting
- Institut De Cancerologie De L Ouest ( Site 1003)Recruiting
- Hôpital Claude Huriez ( Site 1030)Recruiting
- Hopital Henri Mondor ( Site 1007)Recruiting
- Hopital Saint Louis ( Site 1029)Recruiting
- Centro Regional de Sub Especialidades Medicas SA ( Site 0604)Recruiting
- Oncomedica ( Site 0602)Recruiting
- Soluciones Gastrointestinales S.A. ( Site 0607)
- Medi-K Cayala ( Site 0601)Recruiting
- Queen Mary Hospital ( Site 4001)Recruiting
- Queen Elizabeth Hospital. ( Site 4004)Recruiting
- Pecsi Tudomanyegyetem AOK ( Site 1204)Recruiting
- Petz Aladar Egyetemi Oktato Korhaz ( Site 1210)Recruiting
- Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1203)Recruiting
- Orszagos Onkologiai Intezet ( Site 1207)Recruiting
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1313)Recruiting
- A.O.U. Santa Maria della Misericordia di Udine ( Site 1302)Recruiting
- IRCCS Ospedale San Raffaele di Milano ( Site 1304)Recruiting
- Humanitas Research Hospital ( Site 1309)Recruiting
- Azienda Ospedaliera Universitaria Pisana ( Site 1312)Recruiting
- Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1314)Recruiting
- Azienda Ospedaliero Universitaria Careggi ( Site 1301)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306)Recruiting
- A.O. Universitaria di Modena ( Site 1307)Recruiting
- A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305)Recruiting
- Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310)Recruiting
- Aichi Cancer Center Hospital ( Site 9006)Recruiting
- Chiba cancer center ( Site 9023)Recruiting
- National Cancer Center Hospital East ( Site 9002)Recruiting
- National Hospital Organization Shikoku Cancer Center ( Site 9019)Recruiting
- Hyogo Cancer Center ( Site 9014)Recruiting
- Ibaraki Prefectural Central Hospital ( Site 9007)Recruiting
- Kagawa University Hospital ( Site 9015)Recruiting
- Kanagawa Cancer Center ( Site 9004)Recruiting
- Tohoku University Hospital ( Site 9013)Recruiting
- Kindai University Hospital- Osakasayama Campus ( Site 9017)Recruiting
- Osaka University Hospital ( Site 9021)Recruiting
- Osaka Medical and Pharmaceutical University Hospital ( Site 9008)Recruiting
- Saitama Cancer Center ( Site 9003)Recruiting
- Shizuoka Cancer Center ( Site 9016)Recruiting
- Showa University Hospital ( Site 9025)Recruiting
- National Hospital Organization Kyushu Cancer Center ( Site 9010)Recruiting
- Kyoto University Hospital ( Site 9011)Recruiting
- Okayama University Hospital ( Site 9024)Recruiting
- Osaka International Cancer Institute ( Site 9009)Recruiting
- Osaka General Medical Center ( Site 9018)Recruiting
- National Cancer Center Hospital ( Site 9001)Recruiting
- The Cancer Institute Hospital of JFCR ( Site 9005)Recruiting
- Keio university hospital ( Site 9020)Recruiting
- Seoul National University Bundang Hospital ( Site 5006)Recruiting
- Asan Medical Center ( Site 5002)Recruiting
- Severance Hospital ( Site 5003)Recruiting
- Samsung Medical Center ( Site 5005)Recruiting
- Korea University Guro Hospital ( Site 5001)Recruiting
- University Malaya Medical Centre ( Site 9101)Recruiting
- SC Radiotherapy Center Cluj SRL ( Site 2202)Recruiting
- Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 2203)Recruiting
- S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2204)Recruiting
- Policlinica Oncomed SRL ( Site 2206)Recruiting
- S.C.Focus Lab Plus S.R.L ( Site 2201)Recruiting
- Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)
- FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510)
- SBHI Leningrad Regional Oncology Dispensary ( Site 1502)
- Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503)
- Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519)
- Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)
- SAIH of Tyumen reg "Multifield clinical medical center "Medical city" ( Site 1520)
- National Cancer Centre Singapore ( Site 9201)Recruiting
- The Oncology Centre ( Site 9505)Recruiting
- Hospital Universitario General de Asturias ( Site 1601)Recruiting
- Hospital Universitario Marques de Valdecilla ( Site 1602)Recruiting
- Complexo Hospitalario Universitario de Ourense-MEDICAL ONCOLOGY ( Site 1609)Recruiting
- Hospital General Universitari Vall d Hebron ( Site 1607)Recruiting
- Hospital General Universitario Gregorio Maranon ( Site 1604)Recruiting
- Hospital Virgen del Rocio ( Site 1606)Recruiting
- Chi Mei Hospital - Liouying Branch-Clinical Trial Center ( Site 6007)Recruiting
- Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005)Recruiting
- China Medical University Hospital ( Site 6003)Recruiting
- National Cheng Kung University Hospital ( Site 6004)Recruiting
- National Taiwan University Hospital ( Site 6001)Recruiting
- Taipei Veterans General Hospital ( Site 6006)Recruiting
- Medeniyet Universitesi Tip Fakultesi ( Site 1703)Recruiting
- Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701)Recruiting
- Memorial Ankara Hastanesi ( Site 1702)Recruiting
- Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 1712)Recruiting
- Istanbul Okmeydanı Egitim ve Arastirma Hastanesi ( Site 1711)
- Chernihiv Medical Center of Modern Oncology ( Site 1811)
- MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804)
- Kharkiv Regional Clinical Oncology Center ( Site 1812)
- Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813)
- Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
- National Cancer Institute of the MoH of Ukraine ( Site 1806)
- Podillya Regional Center of Oncology ( Site 1809)
- Volyn Regional Oncological Dispensary ( Site 1816)
- Cambridge University Hospitals NHSFT ( Site 1908)Recruiting
- Ninewells Hospital and Medical School ( Site 1907)Recruiting
- Nottingham University Hospital NHS Trust ( Site 1910)Recruiting
- St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915)Recruiting
- University College London Hospitals NHS Foundation Trust ( Site 1901)Recruiting
- Royal Marsden NHS Foundation Trust ( Site 1905)Recruiting
- Royal Marsden NHS Trust. ( Site 1906)Recruiting
- Western General Hospital ( Site 1912)Recruiting
- The Christie NHS Foundation Trust ( Site 1909)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pembrolizumab + Lenvatinib + Chemotherapy
Pembrolizumab + Chemotherapy
Arm Description
Participants receive pembrolizumab intravenously (IV) plus lenvatinib orally in combination with FP or TP in Part 1, or in combination with investigator's choice of chemotherapy with FP IV or TP IV or oxaliplatin, 5-FU and leucovorin (mFOLFOX6) IV in Part 2. Induction consists of pembrolizumab 400 mg once every 6-weeks (Q6W) for up to ~12 weeks plus lenvatinib 8 mg once daily (QD) for up to ~12 weeks plus chemotherapy with FP (cisplatin 80 mg/m^2 and 5-FU 4000 mg/m^2) or TP (paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2) once every 3 weeks (Q3W) for up to ~12 weeks or mFOLFOX6 (oxaliplatin 85 mg/m^2, 5-FU 400 mg/m^2 followed by 2400 mg/m^2, and leucovorin 400 mg/m^2 [or levoleucovorin 200 mg/m^2] once every 2 weeks [Q2W] for up to ~12 weeks). This is followed by consolidation with pembrolizumab 400 mg Q6W for up to 16 cycles (each cycle = 6 weeks; total pembrolizumab treatment duration is ~2 years) plus lenvatinib 20 mg QD until progressive disease or discontinuation.
Participants receive pembrolizumab 400 mg IV Q6W for up to 18 cycles (each cycle = 6 weeks; total pembrolizumab treatment duration is ~2 years) in combination with investigator's choice of chemotherapy with FP (cisplatin 80 mg/m^2 IV Q3W for up to 6 administrations [up to ~18 weeks] and 5-FU 4000 mg/m^2 IV Q3W for up to 35 administrations [up to ~2 years]) or TP (paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 Q3W for up 6 administrations [up to ~18 weeks]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2, 5-FU 400 mg/m^2 followed by 2400 mg/m^2 and leucovorin 400 mg/m^2 [or levoleucovorin 200 mg/m^2] IV Q2W for up to 52 administrations [approximately 2 years]), during Part 2.
Outcomes
Primary Outcome Measures
Part 1 (FP and TP Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs)
Hematologic DLTs are defined as Grade 4 neutropenia lasting for ≥7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia. Other nonhematologic toxicities considered a DLT include any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting >3 days (excluding nausea, vomiting, and diarrhea controlled by medical intervention within 72 hours, and Grade 3 rash in the absence of desquamation with no mucosal involvement), Grade 3 hypertension not able to be controlled by medication, ≥Grade 3 gastrointestinal perforation, ≥Grade 3 wound dehiscence requiring medical or surgical intervention, any grade thromboembolic event or any Grade 3 nonhematologic laboratory value requiring medical intervention or hospitalization. The number of participants in Part 1 with DLTs will be presented.
Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs)
An AE is 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. The number of participants in Part 1 with AEs will be presented.
Part 1 (FP and TP Safety Run-in): Number of Participants who Discontinued Study Treatment Due to an AE
An AE is 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. The number of participants in Part 1 who discontinue study treatment due to an AE will be presented.
Part 2 (Main Study): Overall Survival (OS) in all Participants
OS is defined as the time from randomization to death due to any cause. OS in Part 2 for all randomized participants will be presented.
Part 2 (Main Study): Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in all Participants
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for all randomized participants will be presented.
Secondary Outcome Measures
Part 2 (Main Study): Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR in all Participants
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for all randomized participants will be presented.
Part 2 (Main Study): Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR in all Participants
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for all randomized participants will be presented.
Part 2 (Main Study): OS in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
OS is defined as the time from randomization to death due to any cause. OS in Part 2 for randomized participants with PD-L1 CPS ≥10 will be presented.
Part 2 (Main Study): PFS per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for randomized participants with PD-L1 CPS ≥10 will be presented.
Part 2 (Main Study): ORR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
ORR is defined as the percentage of participants with CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for randomized participants with PD-L1 CPS ≥10 will be presented.
Part 2 (Main Study): DOR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for randomized participants with PD-L1 CPS ≥10 will be presented.
Part 2 (Main Study): Number of Participants With AEs
An AE is 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. The number of participants in Part 2 with AEs will be presented.
Part 2 (Main Study): Number of Participants who Discontinued Study Treatment Due to an AE
An AE is 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. The number of participants in Part 2 who discontinue study treatment due to an AE will be presented.
Part 2 (Main Study): Change From Baseline in Health-related Quality of life (HRQoL) Score Using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
The EORTC QLQ-C30 is a questionnaire to assess the overall HRQoL. Participant responses to the question " How would you rate your overall quality of life (QoL) during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall QoL. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in HRQoL EORTC QLQ-C30 score in participants in Part 2 will be presented.
Part 2 (Main Study): Change From Baseline in HRQoL Score Using EORTC Quality of Life Questionnaire-Oesophageal Module (QLQ-OES18)
The EORTC QLQ-OES18 is a disease-specific questionnaire to assess measurements specific to esophageal cancer. It contains 18 items and is based on four subscales-dysphagia, eating, reflux and pain. All items are scored using a four-point scale that offers these response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. A higher score indicates worse level of symptoms. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in HRQoL QLQ-OES18 score in participants in Part 2 will be presented.
Part 2 (Main Study): Time to Deterioration (TTD) in HRQoL Score Using EORTC QLQ-C30
TTD is defined as the time from baseline to the first onset of a ≥10-point change from baseline in the HRQoL EORTC QLQ-C30 score. The EORTC QLQ-C30 is a questionnaire to assess the overall HRQoL. Participant responses to the question " How would you rate your overall QoL during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall QoL. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A longer TTD indicates a better outcome. The TTD in HRQoL EORTC QLQ-C30 score in participants in Part 2 will be presented.
Part 2 (Main Study): TTD in HRQoL Score Using EORTC QLQ-OES18
TTD is defined as the time from baseline to the first onset of a ≥10-point change from baseline in the HRQoL EORTC QLQ-OES18 score. The EORTC QLQ-OES18 is a disease-specific questionnaire to assess measurements specific to esophageal cancer. It contains 18 items and is based on four subscales-dysphagia, eating, reflux and pain. All items are scored using a four-point scale that offers these response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. A higher score indicates worse level of symptoms. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A longer TTD indicates a better outcome. The TTD in HRQoL QLQ-OES18 score in participants in Part 2 will be presented.
Full Information
NCT ID
NCT04949256
First Posted
June 29, 2021
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04949256
Brief Title
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
Official Title
A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
December 29, 2025 (Anticipated)
Study Completion Date
December 29, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
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 assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma
The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Detailed Description
There will be 2 parts to the study: the cisplatin and 5-fluorouracil (5-FU) (FP) and paclitaxel and cisplatin (TP) Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (FP and TP Safety Run-in), participants will be treated with pembrolizumab plus lenvatinib plus FP or TP. Dose-limiting toxicities, safety, and tolerability will be assessed.
In Part 2 (Main Study), participants (not including those participating in Part 1) will be treated with pembrolizumab plus lenvatinib plus chemotherapy or pembrolizumab plus chemotherapy. Efficacy, safety, and tolerability will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Esophageal Squamous Cell Carcinoma
Keywords
programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
862 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab + Lenvatinib + Chemotherapy
Arm Type
Experimental
Arm Description
Participants receive pembrolizumab intravenously (IV) plus lenvatinib orally in combination with FP or TP in Part 1, or in combination with investigator's choice of chemotherapy with FP IV or TP IV or oxaliplatin, 5-FU and leucovorin (mFOLFOX6) IV in Part 2. Induction consists of pembrolizumab 400 mg once every 6-weeks (Q6W) for up to ~12 weeks plus lenvatinib 8 mg once daily (QD) for up to ~12 weeks plus chemotherapy with FP (cisplatin 80 mg/m^2 and 5-FU 4000 mg/m^2) or TP (paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2) once every 3 weeks (Q3W) for up to ~12 weeks or mFOLFOX6 (oxaliplatin 85 mg/m^2, 5-FU 400 mg/m^2 followed by 2400 mg/m^2, and leucovorin 400 mg/m^2 [or levoleucovorin 200 mg/m^2] once every 2 weeks [Q2W] for up to ~12 weeks). This is followed by consolidation with pembrolizumab 400 mg Q6W for up to 16 cycles (each cycle = 6 weeks; total pembrolizumab treatment duration is ~2 years) plus lenvatinib 20 mg QD until progressive disease or discontinuation.
Arm Title
Pembrolizumab + Chemotherapy
Arm Type
Active Comparator
Arm Description
Participants receive pembrolizumab 400 mg IV Q6W for up to 18 cycles (each cycle = 6 weeks; total pembrolizumab treatment duration is ~2 years) in combination with investigator's choice of chemotherapy with FP (cisplatin 80 mg/m^2 IV Q3W for up to 6 administrations [up to ~18 weeks] and 5-FU 4000 mg/m^2 IV Q3W for up to 35 administrations [up to ~2 years]) or TP (paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 Q3W for up 6 administrations [up to ~18 weeks]) or in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2, 5-FU 400 mg/m^2 followed by 2400 mg/m^2 and leucovorin 400 mg/m^2 [or levoleucovorin 200 mg/m^2] IV Q2W for up to 52 administrations [approximately 2 years]), during Part 2.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
400 mg once every 6-week-cycle, via IV infusion.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
MK-7902, E7080, LENVIMA®
Intervention Description
8 mg QD (induction) or 20 mg QD (consolidation) via oral capsule.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
PLATINOL®
Intervention Description
80 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 75 mg/m^2 Q3W via infusion, as part of investigator's choice TP chemotherapy.
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
ADRUCIL®
Intervention Description
4000 mg/m^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m^2 Q2W via bolus IV infusion followed by 2400 mg/m^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
ELOXATIN®
Intervention Description
85 mg/m^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
calcium folinate, folinic acid, WELLCOVORIN®
Intervention Description
400 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Levoleucovorin
Other Intervention Name(s)
calcium levofolinate, levofolinic acid, FUSILEV®
Intervention Description
200 mg/m^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TAXOL®, ONXAL®
Intervention Description
175 mg/m^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.
Primary Outcome Measure Information:
Title
Part 1 (FP and TP Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs)
Description
Hematologic DLTs are defined as Grade 4 neutropenia lasting for ≥7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia. Other nonhematologic toxicities considered a DLT include any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting >3 days (excluding nausea, vomiting, and diarrhea controlled by medical intervention within 72 hours, and Grade 3 rash in the absence of desquamation with no mucosal involvement), Grade 3 hypertension not able to be controlled by medication, ≥Grade 3 gastrointestinal perforation, ≥Grade 3 wound dehiscence requiring medical or surgical intervention, any grade thromboembolic event or any Grade 3 nonhematologic laboratory value requiring medical intervention or hospitalization. The number of participants in Part 1 with DLTs will be presented.
Time Frame
Up to ~21 days
Title
Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs)
Description
An AE is 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. The number of participants in Part 1 with AEs will be presented.
Time Frame
Up to ~51 months
Title
Part 1 (FP and TP Safety Run-in): Number of Participants who Discontinued Study Treatment Due to an AE
Description
An AE is 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. The number of participants in Part 1 who discontinue study treatment due to an AE will be presented.
Time Frame
Up to ~51 months
Title
Part 2 (Main Study): Overall Survival (OS) in all Participants
Description
OS is defined as the time from randomization to death due to any cause. OS in Part 2 for all randomized participants will be presented.
Time Frame
Up to ~49 months
Title
Part 2 (Main Study): Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in all Participants
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for all randomized participants will be presented.
Time Frame
Up to ~41 months
Secondary Outcome Measure Information:
Title
Part 2 (Main Study): Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR in all Participants
Description
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for all randomized participants will be presented.
Time Frame
Up to ~34 months
Title
Part 2 (Main Study): Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR in all Participants
Description
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for all randomized participants will be presented.
Time Frame
Up to ~34 months
Title
Part 2 (Main Study): OS in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Description
OS is defined as the time from randomization to death due to any cause. OS in Part 2 for randomized participants with PD-L1 CPS ≥10 will be presented.
Time Frame
Up to ~49 months
Title
Part 2 (Main Study): PFS per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
Description
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS in Part 2 for randomized participants with PD-L1 CPS ≥10 will be presented.
Time Frame
Up to ~41 months
Title
Part 2 (Main Study): ORR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
Description
ORR is defined as the percentage of participants with CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 adjusted to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, as assessed by BICR. ORR in Part 2 for randomized participants with PD-L1 CPS ≥10 will be presented.
Time Frame
Up to ~34 months
Title
Part 2 (Main Study): DOR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
Description
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), per RECIST 1.1 by BICR, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been adjusted to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR in Part 2 for randomized participants with PD-L1 CPS ≥10 will be presented.
Time Frame
Up to ~34 months
Title
Part 2 (Main Study): Number of Participants With AEs
Description
An AE is 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. The number of participants in Part 2 with AEs will be presented.
Time Frame
Up to ~49 months
Title
Part 2 (Main Study): Number of Participants who Discontinued Study Treatment Due to an AE
Description
An AE is 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. The number of participants in Part 2 who discontinue study treatment due to an AE will be presented.
Time Frame
Up to ~49 months
Title
Part 2 (Main Study): Change From Baseline in Health-related Quality of life (HRQoL) Score Using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall HRQoL. Participant responses to the question " How would you rate your overall quality of life (QoL) during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall QoL. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in HRQoL EORTC QLQ-C30 score in participants in Part 2 will be presented.
Time Frame
Baseline and ~24 months
Title
Part 2 (Main Study): Change From Baseline in HRQoL Score Using EORTC Quality of Life Questionnaire-Oesophageal Module (QLQ-OES18)
Description
The EORTC QLQ-OES18 is a disease-specific questionnaire to assess measurements specific to esophageal cancer. It contains 18 items and is based on four subscales-dysphagia, eating, reflux and pain. All items are scored using a four-point scale that offers these response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. A higher score indicates worse level of symptoms. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in HRQoL QLQ-OES18 score in participants in Part 2 will be presented.
Time Frame
Baseline and ~24 months
Title
Part 2 (Main Study): Time to Deterioration (TTD) in HRQoL Score Using EORTC QLQ-C30
Description
TTD is defined as the time from baseline to the first onset of a ≥10-point change from baseline in the HRQoL EORTC QLQ-C30 score. The EORTC QLQ-C30 is a questionnaire to assess the overall HRQoL. Participant responses to the question " How would you rate your overall QoL during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall QoL. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A longer TTD indicates a better outcome. The TTD in HRQoL EORTC QLQ-C30 score in participants in Part 2 will be presented.
Time Frame
Up to ~ 24 months
Title
Part 2 (Main Study): TTD in HRQoL Score Using EORTC QLQ-OES18
Description
TTD is defined as the time from baseline to the first onset of a ≥10-point change from baseline in the HRQoL EORTC QLQ-OES18 score. The EORTC QLQ-OES18 is a disease-specific questionnaire to assess measurements specific to esophageal cancer. It contains 18 items and is based on four subscales-dysphagia, eating, reflux and pain. All items are scored using a four-point scale that offers these response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. A higher score indicates worse level of symptoms. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A longer TTD indicates a better outcome. The TTD in HRQoL QLQ-OES18 score in participants in Part 2 will be presented.
Time Frame
Up to ~ 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus
Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or 90 days after the last dose of chemotherapy, whichever comes last; 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only and is greater than 90 days post chemotherapy, no male contraception is needed
Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days after the last dose of pembrolizumab, 30 days after the last dose of lenvatinib, or 180 days after the last dose of chemotherapy, whichever occurs last, and agrees not to donate eggs during this period
Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week prior to randomization
Has adequate organ function
Exclusion Criteria:
Has had previous therapy for locally advanced unresectable or metastatic esophageal cancer
Has locally advanced esophageal carcinoma
Has metastatic adenocarcinoma of the esophagus
Has direct invasion into adjacent organs such as the aorta or trachea
Has radiographic evidence of encasement of a major blood vessel, or of intratumoral cavitation
Has perforation risks or significant gastrointestinal (GI) bleeding
Has had clinically significant hemoptysis within 3 weeks prior to the first dose of study drug or tumor bleeding within 2 weeks prior to the first dose of study intervention
Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
Has GI obstruction, poor oral intake, difficulty in taking oral medication, or existing esophageal stent
Has had major surgery, open biopsy, or significant traumatic injury within 3 weeks prior to first dose of study interventions
Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis
Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention, or has a history of organ transplant, including allogeneic stem cell transplant
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment and is allowed
Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
Has poorly controlled diarrhea
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
Has peripheral neuropathy ≥Grade 2
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B or know active Hepatitis C virus infection
Has a weight loss of >20% within the last 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
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
City of Hope ( Site 0102)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Completed
Facility Name
MedStar Washington Hospital Center ( Site 0186)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
408-334-6772
Facility Name
James Graham Brown Cancer Center ( Site 0117)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
502-314-0369
Facility Name
Norton Cancer Institute ( Site 0116)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
502-636-7845
Facility Name
Johns Hopkins Bayview Medical Center ( Site 0152)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
410-550-5358
Facility Name
UMASS Memorial Medical Center ( Site 0120)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
508-856-3216
Facility Name
Hematology-Oncology Associates of CNY ( Site 0173)
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
315-472-7504
Facility Name
Memorial Sloan Kettering Cancer Center ( Site 0132)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
646-888-4588
Facility Name
Weill Cornell Medical College ( Site 0133)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
646-962-6200
Facility Name
AHN Allegheny General Hospital ( Site 0164)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
412-359-6391
Facility Name
VCU Health Adult Outpatient Pavillion ( Site 0160)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
412-327-7343
Facility Name
Seattle Cancer Care Alliance ( Site 0145)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
810-423-3800
Facility Name
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203)
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541142262013
Facility Name
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+54115031-9779
Facility Name
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZO
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5492235937663
Facility Name
Fundacion Estudios Clinicos-Oncology ( Site 0215)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5493469699922
Facility Name
Sanatorio Parque ( Site 0206)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+543414200250
Facility Name
Hospital Provincial del Centenario ( Site 0217)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002KDS
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5493415717551
Facility Name
Fundacion Favaloro ( Site 0201)
City
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
549 1150523121
Facility Name
Fundación Respirar ( Site 0216)
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+541151082017
Facility Name
Hospital Italiano de Córdoba ( Site 0218)
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+54 9 3517 58-5670
Facility Name
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+54 9 443 6443
Facility Name
Instituto San Marcos ( Site 0213)
City
San Juan
ZIP/Postal Code
J5400EBB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+549-264-507141
Facility Name
Princess Margaret Cancer Centre ( Site 0004)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4169464501 ext 6508
Facility Name
Hotel-Dieu de Levis ( Site 0013)
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4186915225
Facility Name
James Lind Centro de Investigación del Cáncer ( Site 0412)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56994443272
Facility Name
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810218
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56452657374
Facility Name
Fundacion Arturo Lopez Perez FALP ( Site 0403)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500836
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
569981369487
Facility Name
Oncovida ( Site 0413)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56225992980
Facility Name
Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7550000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56227548924
Facility Name
Bradford Hill Centro de Investigaciones Clinicas ( Site 0404)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56229490970
Facility Name
Anhui Cancer Hospital ( Site 8058)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0551-65327666
Facility Name
The Second Affiliated Hospital of Anhui Medical University ( Site 8026)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0551-63869420
Facility Name
Beijing Cancer Hospital ( Site 8001)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613911219511
Facility Name
Fujian Provincial Cancer Hospital ( Site 8029)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613809500871
Facility Name
The First Affiliated Hospital of Xiamen University ( Site 8003)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613860458889
Facility Name
Zhongshan Hospital Affiliated to Xiamen University ( Site 8055)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8615880277305
Facility Name
The First Affiliated Hospital.Sun Yat-sen University ( Site 8047)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020-87755766
Facility Name
Southern Medical University Nanfang Hospital ( Site 8031)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18820408460
Facility Name
The Third Xiangya Hospital of Central South University ( Site 8046)
City
Changsha
State/Province
Hainan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+861378731809
Facility Name
The First Affiliated Hospital of Hainan Medical University ( Site 8042)
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 898 66737967
Facility Name
Affiliated Hospital of Chengde Medical Univeristy ( Site 8053)
City
Chengde
State/Province
Hebei
ZIP/Postal Code
067055
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8615633142750
Facility Name
Harbin Medical University Cancer Hospital ( Site 8009)
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613845120210
Facility Name
Anyang Cancer Hospital ( Site 8006)
City
Anyang
State/Province
Henan
ZIP/Postal Code
455000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13503723589
Facility Name
The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036)
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0379-64820110
Facility Name
The First Affiliated Hospital of Xinxiang Medical University ( Site 8018)
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13663030446
Facility Name
Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+862783662688
Facility Name
Hubei Cancer Hospital ( Site 8014)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
027-87670003
Facility Name
Affiliated hospital of Jiangnan university ( Site 8049)
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214122
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613506198192
Facility Name
The Affiliated Hospital of Xuzhou Medical University ( Site 8015)
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0516-85609999
Facility Name
Jilin Cancer Hospital ( Site 8016)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13943012851
Facility Name
Jinan Central Hospital ( Site 8052)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86053155863107
Facility Name
Shandong Cancer Hospital ( Site 8060)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 (0531) 67626073
Facility Name
Affiliated Hospital of Jining Medical University ( Site 8017)
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8605372903595
Facility Name
Linyi Cancer Hospital- Medical Oncology Department ( Site 8051)
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8605398122693
Facility Name
Shanxi Provincial Cancer Hospital ( Site 8019)
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13834646436
Facility Name
West China Hospital of Sichuan University ( Site 8048)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18980606593
Facility Name
Tianjin Medical University Cancer Institute & Hospital ( Site 8035)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8615321420806
Facility Name
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 8041)
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18160627936
Facility Name
Sir Run Run Shaw Hospital ( Site 8021)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0571-86090073
Facility Name
ICIMED-Oncology Research Unit ( Site 0903)
City
San José
State/Province
San Jose
ZIP/Postal Code
10108
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
50688360236
Facility Name
PROCLINICAL Pharma ( Site 0904)
City
San José
State/Province
San Jose
ZIP/Postal Code
11303
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
50683778387
Facility Name
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902)
City
San Jose
ZIP/Postal Code
10103
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50683893636
Facility Name
Onco Tech S A ( Site 0901)
City
San Jose
ZIP/Postal Code
10103
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50688886626
Facility Name
Rigshospitalet ( Site 2102)
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
35455072
Facility Name
Odense University Hospital ( Site 2101)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4566113333
Facility Name
Institut De Cancerologie De Lorraine ( Site 1010)
City
Vandoeuvre les Nancy
State/Province
Ain
ZIP/Postal Code
54519
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33 3 83 59 85 64
Facility Name
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1014)
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33388252456
Facility Name
Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33298223428
Facility Name
Centre François Baclesse ( Site 1009)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0033231455016
Facility Name
Centre Georges Francois Leclerc ( Site 1008)
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
03 45 34 80 68
Facility Name
CHU Besançon ( Site 1015)
City
Besançon
State/Province
Franche-Comte
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33370632403
Facility Name
CHU Bordeaux Haut-Leveque ( Site 1012)
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33556795679
Facility Name
Institut du Cancer de Montpellier ( Site 1002)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33467613136
Facility Name
CHRU de Tours - Hopital Bretonneau ( Site 1018)
City
Tours
State/Province
Indre-et-Loire
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33147475900
Facility Name
Institut De Cancerologie De L Ouest ( Site 1003)
City
Saint Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33240679900
Facility Name
Hôpital Claude Huriez ( Site 1030)
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33320445461
Facility Name
Hopital Henri Mondor ( Site 1007)
City
Creteil
State/Province
Val-de-Marne
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33149812567
Facility Name
Hopital Saint Louis ( Site 1029)
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33142499597
Facility Name
Centro Regional de Sub Especialidades Medicas SA ( Site 0604)
City
Guatemala
State/Province
Quetzaltenango
ZIP/Postal Code
09001
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50259450559
Facility Name
Oncomedica ( Site 0602)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50222781269
Facility Name
Soluciones Gastrointestinales S.A. ( Site 0607)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Completed
Facility Name
Medi-K Cayala ( Site 0601)
City
Guatemala
ZIP/Postal Code
01016
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50255505555
Facility Name
Queen Mary Hospital ( Site 4001)
City
Hong Kong
ZIP/Postal Code
000000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+85222554352
Facility Name
Queen Elizabeth Hospital. ( Site 4004)
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+85235062851
Facility Name
Pecsi Tudomanyegyetem AOK ( Site 1204)
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3672536000
Facility Name
Petz Aladar Egyetemi Oktato Korhaz ( Site 1210)
City
Gyor
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
36964182446104
Facility Name
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1203)
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
36209323256
Facility Name
Orszagos Onkologiai Intezet ( Site 1207)
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
36122486003209
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1313)
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390543739100
Facility Name
A.O.U. Santa Maria della Misericordia di Udine ( Site 1302)
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390432559304
Facility Name
IRCCS Ospedale San Raffaele di Milano ( Site 1304)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390226437624
Facility Name
Humanitas Research Hospital ( Site 1309)
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390282244080
Facility Name
Azienda Ospedaliera Universitaria Pisana ( Site 1312)
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39050992070
Facility Name
Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1314)
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3909613647921
Facility Name
Azienda Ospedaliero Universitaria Careggi ( Site 1301)
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390552751818
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390223903835
Facility Name
A.O. Universitaria di Modena ( Site 1307)
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390594224383
Facility Name
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390815666713
Facility Name
Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390630154953
Facility Name
Aichi Cancer Center Hospital ( Site 9006)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-52-762-6111
Facility Name
Chiba cancer center ( Site 9023)
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81432645431
Facility Name
National Cancer Center Hospital East ( Site 9002)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-4-7133-1111
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 9019)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-89-999-1111
Facility Name
Hyogo Cancer Center ( Site 9014)
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
＋81-78-929-1151
Facility Name
Ibaraki Prefectural Central Hospital ( Site 9007)
City
Kasama
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-296-77-1121
Facility Name
Kagawa University Hospital ( Site 9015)
City
Kita
State/Province
Kagawa
ZIP/Postal Code
761-0701
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-87-898-5111
Facility Name
Kanagawa Cancer Center ( Site 9004)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-45-520-2222
Facility Name
Tohoku University Hospital ( Site 9013)
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-22-717-7000
Facility Name
Kindai University Hospital- Osakasayama Campus ( Site 9017)
City
Osaka-sayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-72-366-0221
Facility Name
Osaka University Hospital ( Site 9021)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81668795111
Facility Name
Osaka Medical and Pharmaceutical University Hospital ( Site 9008)
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-72-683-1221
Facility Name
Saitama Cancer Center ( Site 9003)
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-48-722-1111
Facility Name
Shizuoka Cancer Center ( Site 9016)
City
Nagaizumi
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-55-989-5222
Facility Name
Showa University Hospital ( Site 9025)
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3784-8000
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 9010)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-92-541-3231
Facility Name
Kyoto University Hospital ( Site 9011)
City
Kyoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-75-751-3111
Facility Name
Okayama University Hospital ( Site 9024)
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0862357257
Facility Name
Osaka International Cancer Institute ( Site 9009)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-6-6945-1181
Facility Name
Osaka General Medical Center ( Site 9018)
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-6-6692-1201
Facility Name
National Cancer Center Hospital ( Site 9001)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3542-2511
Facility Name
The Cancer Institute Hospital of JFCR ( Site 9005)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3520-0111
Facility Name
Keio university hospital ( Site 9020)
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-3353-1211
Facility Name
Seoul National University Bundang Hospital ( Site 5006)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13605
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82317877003
Facility Name
Asan Medical Center ( Site 5002)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82230103217
Facility Name
Severance Hospital ( Site 5003)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82222284190
Facility Name
Samsung Medical Center ( Site 5005)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82-2-3410-6518
Facility Name
Korea University Guro Hospital ( Site 5001)
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82226263060
Facility Name
University Malaya Medical Centre ( Site 9101)
City
Lembah Pantai
State/Province
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
60379492120
Facility Name
SC Radiotherapy Center Cluj SRL ( Site 2202)
City
Comuna Floresti
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0040 742 206 212
Facility Name
Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 2203)
City
Ovidiu
State/Province
Constanta
ZIP/Postal Code
905900
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40241503485
Facility Name
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2204)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40727 774 974
Facility Name
Policlinica Oncomed SRL ( Site 2206)
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40 256 495 403
Facility Name
S.C.Focus Lab Plus S.R.L ( Site 2201)
City
Bucuresti
ZIP/Postal Code
022548
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+40 721298677
Facility Name
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450054
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SBHI Leningrad Regional Oncology Dispensary ( Site 1502)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
188663
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SAIH of Tyumen reg "Multifield clinical medical center "Medical city" ( Site 1520)
City
Tyumen
State/Province
Tyumenskaya Oblast
ZIP/Postal Code
625041
Country
Russian Federation
Individual Site Status
Completed
Facility Name
National Cancer Centre Singapore ( Site 9201)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6597434358
Facility Name
The Oncology Centre ( Site 9505)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27312099030
Facility Name
Hospital Universitario General de Asturias ( Site 1601)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34985106100
Facility Name
Hospital Universitario Marques de Valdecilla ( Site 1602)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34942202525
Facility Name
Complexo Hospitalario Universitario de Ourense-MEDICAL ONCOLOGY ( Site 1609)
City
Ourense
State/Province
Orense
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0034616360974
Facility Name
Hospital General Universitari Vall d Hebron ( Site 1607)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34932746085
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 1604)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34914269393
Facility Name
Hospital Virgen del Rocio ( Site 1606)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34955012000
Facility Name
Chi Mei Hospital - Liouying Branch-Clinical Trial Center ( Site 6007)
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
73657
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8866622699973132
Facility Name
Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005)
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+88677317123
Facility Name
China Medical University Hospital ( Site 6003)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886422052121
Facility Name
National Cheng Kung University Hospital ( Site 6004)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886623535354620
Facility Name
National Taiwan University Hospital ( Site 6001)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8862231234567680
Facility Name
Taipei Veterans General Hospital ( Site 6006)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8862287121212573
Facility Name
Medeniyet Universitesi Tip Fakultesi ( Site 1703)
City
Istambul
State/Province
Istanbul
ZIP/Postal Code
34732
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00905063509061
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
903123052910
Facility Name
Memorial Ankara Hastanesi ( Site 1702)
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+9003122536666/1209
Facility Name
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 1712)
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905072864555
Facility Name
Istanbul Okmeydanı Egitim ve Arastirma Hastanesi ( Site 1711)
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
Individual Site Status
Completed
Facility Name
Chernihiv Medical Center of Modern Oncology ( Site 1811)
City
Chernihiv
State/Province
Chernihivska Oblast
ZIP/Postal Code
14029
Country
Ukraine
Individual Site Status
Completed
Facility Name
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804)
City
Kryviy Rih
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
50048
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Kharkiv Regional Clinical Oncology Center ( Site 1812)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61000
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61103
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
City
Antonivka Village
State/Province
Khersonska Oblast
ZIP/Postal Code
73000
Country
Ukraine
Individual Site Status
Completed
Facility Name
National Cancer Institute of the MoH of Ukraine ( Site 1806)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Individual Site Status
Completed
Facility Name
Podillya Regional Center of Oncology ( Site 1809)
City
Vinnytsia
State/Province
Vinnytska Oblast
ZIP/Postal Code
21029
Country
Ukraine
Individual Site Status
Completed
Facility Name
Volyn Regional Oncological Dispensary ( Site 1816)
City
Lutsk
State/Province
Volynska Oblast
ZIP/Postal Code
43018
Country
Ukraine
Individual Site Status
Completed
Facility Name
Cambridge University Hospitals NHSFT ( Site 1908)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44(0)1223 216083
Facility Name
Ninewells Hospital and Medical School ( Site 1907)
City
Dundee
State/Province
Dundee City
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
01382 660111 x 5363
Facility Name
Nottingham University Hospital NHS Trust ( Site 1910)
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44 (0)115 969 1169
Facility Name
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
07985955179
Facility Name
University College London Hospitals NHS Foundation Trust ( Site 1901)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442034577126
Facility Name
Royal Marsden NHS Foundation Trust ( Site 1905)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44(0)208 642 6011
Facility Name
Royal Marsden NHS Trust. ( Site 1906)
City
Sutton
State/Province
London, City Of
ZIP/Postal Code
SM25PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44(0)208 642 6011
Facility Name
Western General Hospital ( Site 1912)
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH42XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0131 537 1000
Facility Name
The Christie NHS Foundation Trust ( Site 1909)
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441614468342
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
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7902-014&kw=7902-014
Description
Plain Language Summary
Learn more about this trial
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
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