Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002)

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified November 2025 by Merck Sharp & Dohme LLC
Sponsor
Merck Sharp & Dohme LLC
Information Provided by (Responsible Party)
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
NCT03713593
Other Study ID Numbers:
7902-002
First Submitted
October 17, 2018
First Posted
October 21, 2018
Results First Posted
June 7, 2023
Last Update Posted
February 4, 2026
Last Verified
November 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Carcinoma, Hepatocellular
Drug: lenvatinibDrug: lenvatinib

Study Design

Study TypeInterventional
Actual Enrollment794 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)
Study Start DateDecember 30, 2018
Actual Primary Completion DateJune 20, 2022
Actual Study Completion DateSeptember 23, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
lenvatinib plus pembrolizumab
Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.
Drug: lenvatinib
Administered orally once a day
lenvatinib plus placebo
Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally QD plus saline placebo by IV infusion on Day 1 Q3W. Saline placebo will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.
Drug: lenvatinib
Administered orally once a day

Outcome Measures

Primary Outcome Measures
  1. Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
    PFS was defined as the time from the date of the first documentation of disease progression, as determined by blinded independent central review (BICR) per RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.
  2. Overall Survival (OS)
    OS was defined as the time from randomization until death from any cause
Secondary Outcome Measures
  1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
    ORR was defined as the percentage of participants who have a confirmed 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, taking as reference the baseline sum diameters) per RECIST 1.1 as assessed by BICR. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
  2. Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
    DOR was determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR, per RECIST 1.1 as assessed by BICR, until the first documented disease progression or death due to any cause, whichever occurred first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
  3. Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
    DCR was defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per RECIST 1.1 as assessed by BICR. SD must be achieved at &ge;6 weeks after randomization to be considered best overall response. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
  4. Time to Disease Progression (TTP) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
    TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR. RECIST 1.1 was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed.
  5. Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
    PFS was defined as the time from the first dose of study intervention to the first documented progressive disease (PD) per mRECIST by BICR or death due to any cause, whichever occurred first. mRECIST for HCC allowed evaluation of treatment effects that were not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the sum of diameters (SODs) of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started.
  6. Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
    ORR wass defined as the percentage of participants who have a confirmed complete response (CR: disappearance of any intratumoral arterial enhancement in all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of viable \[enhancement in the arterial phase\] target lesions, taking as reference the baseline sum of the diameters of target lesions) per mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed.
  7. Duration of Response (DOR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
    DOR was determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR, per mRECIST as assessed by BICR, until the first documented disease progression or death due to any cause, whichever occurs first. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed.
  8. Disease Control Rate (DCR) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
    DCR was defined as the percentage of participants who have a best overall response of CR, PR, or SD per mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. SD must be achieved at &ge;6 weeks after randomization to be considered best overall response. A maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed.
  9. Time to Disease Progression (TTP) Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
    TTP was defined as the time from randomization to the first documented disease progression per mRECIST as assessed by BICR. mRECIST for hepatocellular carcinoma evaluates lesions within the liver parenchyma showing increased contrast enhancement in the arterial phase. A maximum of 10 target lesions and a maximum of 5 target lesions per organ were followed.
  10. Number of Participants Who Experienced an Adverse Event (AE)
    Number of participants who experienced an AE defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study treatment
  11. Number of Participants Who Experienced an Serious Adverse Event (SAE)
    Number of participants who experienced a SAE defined as an AE that resulted in death, was life threatening, resulting in persistent or significant disability or incapacity, resulting in or prolonged a hospitalization, was a congenital anomaly or birth defect, was a cancer, was associated with an overdose, or was another important medical event
  12. Number of Participants Who Experienced an Immune-related Adverse Event (irAE) of Clinical Interest
    Number of participants who experienced an AE representing an immunologic etiology and considered to be causally related to drug exposure
  13. Number of Participants Who Experienced an Hepatic Event of Clinical Interest (HECI)
    Number of participants who experienced a hepatic ECI not due to disease progression as judged by the investigator.
  14. Number of Participants Who Discontinued Study Drug Due to an Adverse Event
    Number of participants who discontinued study treatment due to an AE

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Is male or female and ≥18 years of age at the time of signing the informed consent
Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
Has a Child-Pugh class A liver score
Has a predicted life expectancy of \>3 months
Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1 as confirmed by BICR
Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
Participants with hepatitis B will be eligible as long as their virus is well controlled
Exclusion Criteria
Has had esophageal or gastric variceal bleeding within the last 6 months
Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
Has a preexisting Grade ≥3 gastrointestinal or non-gastrointestinal fistula
Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior to the first dose of study intervention
Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident stroke, or cardiac arrhythmia associated with hemodynamic instability
Has had major surgery to the liver within 4 weeks prior to the first dose of study intervention
Has had a minor surgery (ie, simple excision) within 7 days prior to the first dose of study intervention
Has serious non-healing wound, ulcer, or bone fracture
Has received any systemic chemotherapy for HCC or chemotherapy for any malignancy in the past 3 years
Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, or CD137)
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exceptions of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that has undergone potentially curative therapy
Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis as assessed by local site investigator
Has severe hypersensitivity (≥Grade 3) to study intervention and/or any of their excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has urine protein ≥1 grams/24 hours
Prolongation of corrected QT (QTc) interval to \>480 milliseconds (corrected by Fridericia Formula)
Has left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO)
Has an active infection requiring systemic therapy with the exceptions of hepatitis B virus (HBV) or hepatitis C virus (HCV)
Has a known history of human immunodeficiency virus (HIV) infection
Has known active tuberculosis (Bacillus tuberculosis)
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention
Has had an allogenic tissue/solid organ transplant

Contacts and Locations

Sponsors and CollaboratorsMerck Sharp & Dohme LLC
Locations
The University of Arizona Cancer Center - North Campus ( Site 0621) | Tucson Arizona, United States, 85721City of Hope Comprehensive Cancer Center ( Site 0587) | Duarte California, United States, 91010Scripps Health ( Site 0644) | La Jolla California, United States, 92037Pacific Hematology Oncology Associates ( Site 0588) | San Francisco California, United States, 94115UCLA ( Site 0589) | Santa Monica California, United States, 90404Georgetown University ( Site 0594) | Washington D.C. District of Columbia, United States, 20007University of Miami, Sylvester Comprehensive Cancer Center ( Site 0596) | Miami Florida, United States, 33136Advent Health ( Site 0595) | Orlando Florida, United States, 32804Tampa General Medical Group ( Site 0629) | Tampa Florida, United States, 33606Emory University Winship Cancer Institute ( Site 0639) | Atlanta Georgia, United States, 30322University of Kansas Cancer Center ( Site 0600) | Westwood Kansas, United States, 66205Massachusetts General Hospital ( Site 0603) | Boston Massachusetts, United States, 02114Beth Israel Deaconess Medical Center ( Site 0716) | Boston Massachusetts, United States, 02215Icahn School of Medicine at Mount Sinai ( Site 0611) | New York New York, United States, 10029University of Rochester ( Site 0613) | Rochester New York, United States, 14642Stony Brook University Medical Center - Cancer Center ( Site 0612) | Stony Brook New York, United States, 11794University of Oklahoma Health Science Center ( Site 0625) | Oklahoma City Oklahoma, United States, 73104Oregon Health & Science University ( Site 0645) | Portland Oregon, United States, 97239Eastern Regional Medical Center, Inc. ( Site 0626) | Philadelphia Pennsylvania, United States, 19124Central Texas Veterans Healthcare System ( Site 0617) | Temple Texas, United States, 76504Cancer Care Northwest ( Site 0636) | Spokane Washington, United States, 99218Royal Prince Alfred Hospital ( Site 0001) | Camperdown New South Wales, Australia, 2050Princess Alexandra Hospital ( Site 0007) | Wooloongabba Queensland, Australia, 4102Monash Health-Monash Medical Centre ( Site 0004) | Clayton Victoria, Australia, 3168St Vincents Hospital Melbourne ( Site 0003) | Fitzroy Victoria, Australia, 3065Liverpool Hospital. ( Site 0002) | Liverpool , Australia, 2170BC Cancer-Vancouver Center ( Site 0056) | Vancouver British Columbia, Canada, V5Z 4E6London Health Sciences Centre ( Site 0053) | London Ontario, Canada, N6A 5A5Sunnybrook Research Institute ( Site 0055) | Toronto Ontario, Canada, M4N 3M5Princess Margaret Cancer Centre ( Site 0050) | Toronto Ontario, Canada, M5G 2M9McGill University Health Centre ( Site 0052) | Montreal Quebec, Canada, H4A 3J1Clinica Universidad Catolica del Maule ( Site 0065) | Talca Maule Region, Chile, 3465584Fundacion Arturo Lopez Perez ( Site 0064) | Santiago Santiago Metropolitan, Chile, 7500921Pontificia Universidad Catolica de Chile ( Site 0070) | Santiago Santiago Metropolitan, Chile, 8330024Instituto Clinico Oncologico del Sur ( Site 0067) | Temuco , Chile, 4810469First Affiliated Hospital of Anhui Medical University ( Site 0095) | Hefei Anhui, China, 230088Cancer Hospital Chinese Academy of Medical Sciences ( Site 0100) | Beijing Beijing Municipality, China, 100021Beijing Cancer Hospital ( Site 0088) | Beijing Beijing Municipality, China, 100142900 Hospital of the Joint ( Site 0091) | Fuzhou Fujian, China, 350025Guangdong General Hospital ( Site 0092) | Guangzhou Guangdong, China, 510080Southern Medical University Nanfang Hospital ( Site 0102) | Guangzhou Guangdong, China, 510515Harbin Medical University Cancer Hospital ( Site 0089) | Harbin Heilongjiang, China, 610000Wuhan Union hospital Cancer Center ( Site 0105) | Wuhan Hubei, China, 430022Hunan Cancer Hospital ( Site 0094) | Changsha Hunan, China, 410006The Third Xiangya Hospital of Central South University ( Site 0093) | Changsha Hunan, China, 410013The 81st Hospital of PLA ( Site 0085) | Nanjing Jiangsu, China, 210031Fudan University Shanghai Cancer Center ( Site 0086) | Shanghai Shanghai Municipality, China, 200032The First Affiliated Hospital of Xi an Jiaotong University ( Site 0090) | Xi’an Shanxi, China, 710061West China Hospital of Sichuan University ( Site 0087) | Chengdu Sichuan, China, 610000Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0109) | Ürümqi Xinjiang, China, 830001The First Affiliated Hospital of Zhejiang University ( Site 0097) | Hangzhou Zhejiang, China, 310003Sir Run Run Shaw Hospital ( Site 0110) | Hangzhou Zhejiang, China, 310016Zhejiang Cancer Hospital ( Site 0101) | Hangzhou Zhejiang, China, 310022Zhongshan Hospital Fudan University ( Site 0096) | Shanghai , China, 200032Fundacion Centro de Investigacion Clinica CIC ( Site 0141) | Medellín Antioquia, Colombia, 050021Hospital Pablo Tobon Uribe ( Site 0144) | Medellín Antioquia, Colombia, 050034Hospital General de Medellin Luz Castro de Gutierrez ( Site 0137) | Medellín Antioquia, Colombia, 500515Biomelab S A S ( Site 0145) | Barranquilla Atlántico, Colombia, 080002Administradora Country SA - Clinica del Country ( Site 0146) | Bogotá Bogota D.C., Colombia, 110221Instituto Nacional de Cancerologia E.S.E ( Site 0142) | Bogotá Bogota D.C., Colombia, 111511Fundacion Valle del Lili ( Site 0140) | Cali Valle del Cauca Department, Colombia, 760032Centro Medico Imbanaco de Cali S.A ( Site 0139) | Cali Valle del Cauca Department, Colombia, 760042Institut Sainte Catherine ( Site 0167) | Avignon , France, 84918Hopital Beaujon ( Site 0160) | Clichy , France, 92110CHU Henri Mondor ( Site 0162) | Créteil , France, 94000CHRU de Lille - Hopital Claude Huriez ( Site 0159) | Lille , France, 59037Hopital de la Croix Rousse ( Site 0157) | Lyon , France, 69004Hopital Saint Joseph ( Site 0166) | Marseille , France, 13285Centre Hospitalier Regional du Orleans ( Site 0169) | Orléans , France, 45100Centre Eugene Marquis ( Site 0158) | Rennes , France, 35042CHU de Nancy Hopital Brabois Adultes ( Site 0164) | Vandœuvre-lès-Nancy , France, 54500Klinikum der Universitaet Aachen - RWTH ( Site 0185) | Aachen , Germany, 52074Universitaetsklinik Koeln ( Site 0189) | Cologne , Germany, 50937Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0178) | Dresden , Germany, 01307Universitaetsklinikum Essen ( Site 0188) | Essen , Germany, 45147Universitaetsklinikum Frankfurt ( Site 0180) | Frankfurt am Main , Germany, 60596Universitaetsklinikum Hamburg-Eppendorf ( Site 0184) | Hamburg , Germany, 20246Universitaetsklinikum Leipzig ( Site 0187) | Leipzig , Germany, 04103Otto-Von-Guericke-Universitaet Magdeburg ( Site 0182) | Magdeburg , Germany, 39120Universitaetsklinikum Tuebingen ( Site 0179) | Tübingen , Germany, 72076Universitaetsklinikum Wuerzburg ( Site 0186) | Würzburg , Germany, 97080St Vincents University Hospital ( Site 0242) | Dublin , Ireland, D04 T6F4Mater Misericordiae University Hospital ( Site 0241) | Dublin , Ireland, D07 R2WYOspedale Sacro Cuore - Don Calabria ( Site 0289) | Negrar VR, Italy, 37024Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 0292) | Aviano , Italy, 33081Policlinico S. Orsola-Malpighi ( Site 0286) | Bologna , Italy, 40138Istituto Oncologico Veneto ( Site 0287) | Padova , Italy, 35128Az Osp Univ Policlin Paolo Giaccone ( Site 0284) | Palermo , Italy, 90127Fondazione Salvatore Maugeri IRCCS. ( Site 0290) | Pavia , Italy, 27100Azienda Ospedaliero-Univers. Pisana Ospedale S. Chiara ( Site 0291) | Pisa , Italy, 56126Policlinico Universitario Campus Biomedico ( Site 0288) | Roma , Italy, 00128Aichi Cancer Center Hospital ( Site 0316) | Nagoya Aichi-ken, Japan, 464-8681National Cancer Center Hospital East ( Site 0306) | Kashiwa Chiba, Japan, 277-8577Kurume University Hospital ( Site 0322) | Kurume Fukuoka, Japan, 830-0011Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0304) | Sapporo Hokkaido, Japan, 060-0033Kanazawa University Hospital ( Site 0315) | Kanazawa Ishikawa-ken, Japan, 920-8641Kagawa University Hospital ( Site 0324) | Kita-gun Kagawa-ken, Japan, 761-0793Kagawa Prefectural Central Hospital ( Site 0325) | Takamatsu Kagawa-ken, Japan, 760-8557Toranomon Hospital Kajigaya ( Site 0312) | Kawasaki Kanagawa, Japan, 213-8587Yokohama City University Medical Center ( Site 0313) | Yokohama Kanagawa, Japan, 232-0024Kanagawa Cancer Center ( Site 0314) | Yokohama Kanagawa, Japan, 241-8515Kindai University Hospital ( Site 0319) | Sayama Osaka, Japan, 589-8511Kyorin University Hospital ( Site 0309) | Mitaka Tokyo, Japan, 181-8611Musashino Red Cross Hospital ( Site 0310) | Musashino Tokyo, Japan, 180-8610Chiba University Hospital ( Site 0305) | Chiba , Japan, 260-8677National Hospital Organization Kyushu Medical Center ( Site 0321) | Fukuoka , Japan, 810-8563Hiroshima University Hospital ( Site 0320) | Hiroshima , Japan, 734-8551Osaka Red Cross Hospital ( Site 0317) | Osaka , Japan, 543-8555Saga-Ken Medical Centre Koseikan ( Site 0323) | Saga , Japan, 840-8571National Cancer Center Hospital ( Site 0307) | Tokyo , Japan, 104-0045Toranomon Hospital ( Site 0311) | Tokyo , Japan, 105-8470The University of Tokyo Hospital ( Site 0308) | Tokyo , Japan, 113-8655Wakayama Medical University Hospital ( Site 0318) | Wakayama , Japan, 641-8510Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0365) | Guadalajara Jalisco, Mexico, 44280Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0363) | Mexico City Mexico City, Mexico, 14080Centro de Investigacion Medica Aguascalientes ( Site 0355) | Aguascalientes , Mexico, 20116CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 0362) | Mexico City , Mexico, 06100Medical Care and Research S.A. de C.V. ( Site 0359) | Mérida , Mexico, 97070Oaxaca Site Management Organization S.C. ( Site 0366) | Oaxaca City , Mexico, 68000Unidad Medica Oncologica ( Site 0369) | Puebla City , Mexico, 72530Auckland City Hospital ( Site 0376) | Auckland , New Zealand, 1023Christchurch Hospital ( Site 0377) | Christchurch , New Zealand, 8011Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 0419) | Bytom Silesian Voivodeship, Poland, 41-902Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0421) | Koszalin West Pomeranian Voivodeship, Poland, 75-581ID Clinic ( Site 0431) | Mysłowice , Poland, 41-400Ars Medical Sp. z o.o. ( Site 0433) | Piła , Poland, 64-920Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0418) | Warsaw , Poland, 02-034MTZ Clinical Research Sp. z o. o. ( Site 0427) | Warsaw , Poland, 02-106N.N. Blokhin NMRCO ( Site 0439) | Moscow Moscow, Russia, 115478First Moscow State Medical University n.a. I.M.Sechenov ( Site 0453) | Moscow Moscow, Russia, 119881Railway Hospital of OJSC ( Site 0447) | Saint Petersburg Sankt-Peterburg, Russia, 195271City Clinical Oncology Center ( Site 0446) | Saint Petersburg Sankt-Peterburg, Russia, 198255Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0450) | Krasnoyarsk , Russia, 660133Pyatigorsk Oncology Dispensary ( Site 0441) | Pyatigorsk , Russia, 357502Seoul National University Bundang Hospital ( Site 0464) | Seongnam-si Kyonggi-do, South Korea, 13620Seoul National University Hospital ( Site 0462) | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 03080Yonsei University Severance Hospital ( Site 0463) | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 03722Asan Medical Center ( Site 0460) | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 05505Samsung Medical Center ( Site 0461) | Seoul , South Korea, 06351Hospital Universitari Vall d Hebron ( Site 0508) | Barcelona Barcelona [Barcelona], Spain, 08035Hospital Universitario Puerta de Hierro ( Site 0513) | Majadahonda Madrid, Spain, 28222Hospital General Universitario Gregorio Maranon ( Site 0504) | Madrid , Spain, 28007Hospital Universitario Ramon y Cajal ( Site 0514) | Madrid , Spain, 28034Hospital Universitario La Paz ( Site 0510) | Madrid , Spain, 28046Complejo Hospitalario Universitario de Santiago ( Site 0506) | Santiago de Compostela , Spain, 15706Hospital Universitario Virgen del Rocio ( Site 0509) | Seville , Spain, 41013Hospital Universitario y Politecnico La Fe de Valencia ( Site 0505) | Valencia , Spain, 46026Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0529) | Kaoshiung , Taiwan, 807China Medical University Hospital ( Site 0527) | Taichung , Taiwan, 404Taichung Veterans General Hospital ( Site 0526) | Taichung , Taiwan, 407National Cheng Kung University Hospital ( Site 0528) | Tainan , Taiwan, 70457National Taiwan University Hospital ( Site 0523) | Taipei , Taiwan, 100Taipei Veterans General Hospital ( Site 0524) | Taipei , Taiwan, 112Chang Gung Medical Foundation. Linkou ( Site 0525) | Taoyuan , Taiwan, 333Siriraj Hospital. Mahidol Univerisity ( Site 0213) | Bangkok Noi Bangkok, Thailand, 10700Songklanagarind Hospital ( Site 0214) | Hat Yai Changwat Songkhla, Thailand, 90110Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 0211) | Chiang Mai , Thailand, 50200Adana Sehir Hastanesi ( Site 0549) | Adana , Turkey (Türkiye), 01250Hacettepe Uni. Tip Fakultesi ( Site 0553) | Ankara , Turkey (Türkiye), 06100Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0551) | Ankara , Turkey (Türkiye), 06200Akdeniz Universitesi Tip Fakultesi ( Site 0548) | Antalya , Turkey (Türkiye), 07070Trakya Universitesi Tip Fakultesi ( Site 0544) | Edirne , Turkey (Türkiye), 22030Erzurum Ataturk University Faculty of Medicine ( Site 0546) | Erzurum , Turkey (Türkiye), 25240Bezmi Alem Universitesi Tıp Fakultesi ( Site 0547) | Istanbul , Turkey (Türkiye), 34093Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0550) | Konya , Turkey (Türkiye), 42080Inonu Universitesi Medical Fakultesi ( Site 0545) | Malatya , Turkey (Türkiye), 44280Royal Free London NHS Foundation Trust ( Site 0567) | London London, City of, United Kingdom, NW3 2QGKings College Hospital NHS Foundation Trust ( Site 0565) | London London, City of, United Kingdom, SE5 9RSThe Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0573) | Birkenhead , United Kingdom, CH63 4JYThe Beatson West of Scotland Cancer Centre ( Site 0566) | Glasgow , United Kingdom, G12 0YNThe Christie NHS Foundation Trust ( Site 0575) | Manchester , United Kingdom, M20 4BXNottingham University Hospitals NHS Trust ( Site 0569) | Nottingham , United Kingdom, NG5 1PB
Investigators
Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full Text)
Documents provided by Merck Sharp & Dohme LLC: Study Protocol and Statistical Analysis Plan  August 6, 2023