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Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015) (LEAP-015)

Primary Purpose

Advanced/Metastatic Gastroesophageal Adenocarcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Lenvatinib
Oxaliplatin
Capecitabine
Leucovorin (or Levoleucovorin)
5-FU
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced/Metastatic Gastroesophageal Adenocarcinoma focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has histologically and/or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma
  • Is not expected to require tumor resection during the treatment course
  • Has gastroesophageal adenocarcinoma that is not HER-2/neu positive
  • Has measurable disease as defined by RECIST 1.1 by scan with IV contrast as determined by the local site investigator
  • Male participants agree to refrain from donating sperm and agree to either remain abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for ≥7 days after last dose of lenvatinib or 90 days after last dose of chemotherapy-whichever comes last
  • Female participants not pregnant or breastfeeding are eligible to participate if not a women of childbearing potential (WOCBP), or if a WOCBP they either use a contraceptive method that is highly effective OR remain abstinent from heterosexual intercourse as their preferred and usual lifestyle, and do not donate eggs (ova, oocytes) to others or freeze/store for their own use, and abstain from breastfeeding during the intervention period through 120 days after last dose of pembrolizumab, 30 days after last dose of lenvatinib, or 180 days after last dose of chemotherapy-whichever occurs last
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of study treatment
  • Has adequately controlled blood pressure with or without antihypertensive medications
  • Has adequate organ function

Exclusion Criteria:

  • Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ) esophageal adenocarcinoma
  • Has had major surgery within 28 days prior to first dose of study interventions
  • Has had radiotherapy within 14 days of randomization
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has known CNS metastases and/or carcinomatous meningitis
  • Has severe hypersensitivity (≥Grade 3) to treatment with an monoclonal antibody (mAb) or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products
  • Has had an allogeneic tissue/solid organ transplant
  • Has perforation risks or significant gastrointestinal (GI) bleeding
  • Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants)
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
  • Has received prior therapy with anti- vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
  • Has inadequate cardiac function
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has poorly controlled diarrhea
  • Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment.
  • Has peripheral neuropathy ≥Grade 2
  • Has a known history of human immunodeficiency virus (HIV) or HIV 1/2 antibodies
  • Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
  • Has weight loss of >20% within the last 3 months

Sites / Locations

  • UCLA Hematology/Oncology - Santa Monica ( Site 0003)
  • Georgetown University Medical Center ( Site 0009)
  • James Graham Brown Cancer Center ( Site 0017)
  • Johns Hopkins University ( Site 0052)
  • Dana Farber Cancer Center ( Site 0019)
  • UMASS Memorial Medical Center ( Site 0020)
  • Henry Ford Health System ( Site 0023)
  • Cancer and Hematology Centers of Western Michigan ( Site 0025)
  • Washington University School of Medicine ( Site 0027)
  • Mount Sinai Hospital ( Site 0051)
  • Memorial Sloan Kettering Cancer Center ( Site 0032)
  • AHN West Penn Hospital-AHN Esophageal and Lung Institute ( Site 0058)
  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)
  • Instituto Medico Alexander Fleming ( Site 0208)
  • Fundacion Favaloro ( Site 0201)
  • Hospital Aleman ( Site 0210)
  • Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0207)
  • CEMIC ( Site 0209)
  • Hospital Privado de Cordoba ( Site 0204)
  • Nepean Hospital ( Site 2305)
  • Wollongong Hospital ( Site 2307)
  • Royal Brisbane and Women s Hospital ( Site 2304)
  • Hollywood Private Hospital-Medical Oncology ( Site 2308)
  • CHU UCL Namur Site de Godinne ( Site 1005)
  • UZ Gent ( Site 1002)
  • UZ Leuven ( Site 1004)
  • AZ Delta ( Site 1006)
  • Queen Elizabeth II Health Sciences Centre ( Site 0101)
  • Hamilton Health Sciences - Juravinski Site ( Site 0106)
  • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
  • Centro Investigación del Cáncer James Lind ( Site 0414)
  • IC La Serena Research ( Site 0410)
  • Clinica Universidad Catolica del Maule ( Site 0411)
  • Fundacion Arturo Lopez Perez FALP ( Site 0403)
  • Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)
  • Bradfordhill ( Site 0404)
  • Anhui Provincial Hospital ( Site 2415)
  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 2403)
  • Beijing Cancer Hospital ( Site 2453)
  • Fujian Provincial Cancer Hospital ( Site 2408)
  • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si
  • The First Affiliated Hospital of Xiamen University ( Site 2420)
  • The First Affiliated Hospital of Xiamen University ( Site 2446)
  • Zhongshan Hospital Affiliated to Xiamen University ( Site 2421)
  • First Hospital of Lanzhou University ( Site 2417)
  • Nanfang Hospital ( Site 2456)
  • The Affiliated Hospital Of Hainan Medical University-Cancer rehabilitation and palliative treatment
  • Fourth Hospital Of Hebei Medical University ( Site 2441)
  • Harbin Medical University Cancer Hospital ( Site 2410)
  • Henan Cancer Hospital ( Site 2443)
  • Hubei Cancer Hospital ( Site 2429)
  • Hunan Cancer Hospital ( Site 2440)
  • Changzhou Cancer Hospital-Department of Oncology ( Site 2458)
  • Nanjing Drum Tower Hospital ( Site 2419)
  • Nantong Tumor Hospital-Digestive Oncology ( Site 2464)
  • Jilin Cancer Hospital ( Site 2438)
  • Tang Du Hospital ( Site 2432)
  • LinYi Cancer Hospital-Gastrology department ( Site 2463)
  • Shanghai General Hospital ( Site 2424)
  • Shanghai East Hospital ( Site 2455)
  • Tianjin Medical University Cancer Institute & Hospital ( Site 2447)
  • Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2428)
  • The First Affiliated Hospital of Zhejiang University ( Site 2414)
  • Sir Run Run Shaw Hospital ( Site 2412)
  • Clinica de la Costa S.A.S. ( Site 0502)
  • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0508)
  • Oncomedica S.A. ( Site 0507)
  • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0501)
  • Instituto Cancerologico de Narino Ltda ( Site 0504)
  • Oncologos del Occidente S.A. ( Site 0525)
  • CIMCA-Hemato-Oncology ( Site 0601)
  • Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0602)
  • Centre Francois Baclesse ( Site 1107)
  • Centre Georges Francois Leclerc ( Site 1106)
  • CHU Bordeaux Haut-Leveque ( Site 1110)
  • Centre Hospitalier Annecy Genevois ( Site 1117)
  • CHU Hotel Dieu Nantes ( Site 1101)
  • Hôpital Edouard Herriot ( Site 1116)
  • Hopital Henri Mondor ( Site 1105)
  • Institut du Cancer Avignon-Provence ( Site 1103)
  • Hopital Saint Louis ( Site 1100)
  • CHU Hopital Saint Antoine ( Site 1102)
  • Klinikum Rechts der Isar der TU Muenchen ( Site 1200)
  • Universitaetsklinikum Regensburg ( Site 1203)
  • Krankenhaus Nordwest ( Site 1205)
  • Medizinische Hochschule Hannover ( Site 1210)
  • Universitaetsklinikum Leipzig ( Site 1211)
  • Charite Berlin Campus Virchow-Klinikum ( Site 1202)
  • Facharztzentrum Eppendorf ( Site 1201)
  • Clinica Privada Dr Rixci Ramirez Fallas ( Site 0702)
  • Oncologika S.A. ( Site 0704)
  • Oncomedica ( Site 0701)
  • Soluciones Gastrointestinales S.A. ( Site 0706)
  • Sanatorio Nuestra Senora del Pilar ( Site 0705)
  • Medi-K Cayala ( Site 0700)
  • Prince of Wales Hospital ( Site 2503)
  • Princess Margaret Hospital. ( Site 2502)
  • Queen Mary Hospital ( Site 2501)
  • St James Hospital ( Site 1400)
  • Beaumont Hospital ( Site 1402)
  • Soroka Medical Center ( Site 1507)
  • Hillel Yaffe Medical Center ( Site 1503)
  • Rambam Health Care Campus-Oncology Division ( Site 1502)
  • Hadassah Ein Kerem Medical Center ( Site 1501)
  • Meir Medical Center ( Site 1504)
  • Rabin Medical Center ( Site 1506)
  • Sourasky Medical Center ( Site 1500)
  • Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1608)
  • Presidio Ospedaliero Universitario Santa Maria della Misericordia ( Site 1609)
  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1610)
  • Humanitas Research Hospital ( Site 1600)
  • AULSS8 Berica-Ospedale S.Bortolo ( Site 1607)
  • Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1611)
  • IRCCS Ospedale San Raffaele di Milano ( Site 1603)
  • A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1604)
  • Aichi Cancer Center Hospital ( Site 2603)
  • National Cancer Center Hospital East ( Site 2601)
  • National Hospital Organization Shikoku Cancer Center ( Site 2610)
  • Hyogo Cancer Center ( Site 2621)
  • Kobe City Medical Center General Hospital ( Site 2606)
  • Ibaraki Prefectural Central Hospital ( Site 2618)
  • Kagawa University Hospital ( Site 2611)
  • Kanagawa Cancer Center ( Site 2608)
  • Kansai Medical University Hospital ( Site 2622)
  • Kindai University Hospital ( Site 2600)
  • Saitama Cancer Center ( Site 2604)
  • National Hospital Organization Kyushu Cancer Center ( Site 2609)
  • Hiroshima City Hiroshima Citizens Hospital ( Site 2612)
  • Osaka International Cancer Institute ( Site 2607)
  • National Cancer Center Hospital ( Site 2602)
  • The Cancer Institute Hospital of JFCR ( Site 2605)
  • Hallym University Sacred Heart Hospital ( Site 2806)
  • Seoul National University Bundang Hospital ( Site 2804)
  • Asan Medical Center ( Site 2802)
  • Konyang University ( Site 2807)
  • Seoul National University Hospital ( Site 2803)
  • Severance Hospital Yonsei University Health System ( Site 2800)
  • Gangnam Severance Hospital ( Site 2805)
  • Samsung Medical Center ( Site 2801)
  • Korea University Guro Hospital ( Site 2808)
  • Dolnoslaskie Centrum Onkologii. ( Site 1712)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1704)
  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1702)
  • Przychodnia Lekarska KOMED ( Site 1701)
  • Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 1703)
  • Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1816)
  • National Medical and Surgical Center n.a.N.I.Pirogov ( Site 1805)
  • Blokhin National Medical Oncology ( Site 1800)
  • Central Clinical Hospital with Polyclinic ( Site 1801)
  • Medical University REAVIZ ( Site 1814)
  • St Petersburg City Clinical Oncology Dispensary ( Site 1808)
  • Leningrad Regional Oncology Center ( Site 1810)
  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1809)
  • Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1821)
  • Hospital Universitario General de Asturias ( Site 1901)
  • Hospital Universitario Marques de Valdecilla ( Site 1902)
  • Hospital General Universitari Vall d Hebron ( Site 1907)
  • Hospital General Gregorio Maranon de Madrid ( Site 1904)
  • China Medical University Hospital ( Site 2903)
  • National Cheng Kung University Hospital ( Site 2904)
  • National Taiwan University Hospital ( Site 2901)
  • Chang Gung Medical Foundation. Linkou ( Site 2902)
  • Sakarya Universitesi Tip Fakultesi ( Site 2007)
  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2003)
  • Memorial Ankara Hastanesi ( Site 2004)
  • Trakya Universitesi Tip Fakultesi ( Site 2000)
  • Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2005)
  • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2002)
  • Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)
  • Addenbrooke's Hospital ( Site 2200)
  • Ninewells Hospital and Medical School ( Site 2207)
  • The Beatson West of Scotland Cancer Centre ( Site 2204)
  • University College London Hospitals NHS Foundation Trust ( Site 2201)
  • Royal Marsden NHS Foundation Trust ( Site 2202)
  • Royal Marsden NHS Trust ( Site 2203)
  • University Hospital Coventry and Warwickshire NHS Trust ( Site 2205)
  • The Christie NHS Foundation Trust ( Site 2209)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lenvatinib + Pembrolizumab + Chemotherapy

Chemotherapy

Arm Description

Participants receive lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab (400 mg Q6W) plus chemotherapy (CAPOX or mFOLFOX6) will be administered for 2 cycles (approximately 12 weeks), followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab (400 mg Q6W) for 16 cycles. A cycle is 6 weeks (42 days).

Participants receive chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W. A cycle is 6 weeks (42 days).

Outcomes

Primary Outcome Measures

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Hematologic DLTs were 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 included 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, or any grade thromboembolic event. The number of participants in Part 1 with DLTs will be reported by treatment arm.
Part 1: Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 1 with AEs will be reported by treatment arm.
Part 1: Number of Participants who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 1 that discontinued study due to an AE will be reported by treatment arm.
Part 2: Overall Survival (OS) in Participants with Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
OS is defined as the time from randomization to death due to any cause. OS will be reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Part 2: OS in All Participants
OS is defined as the time from randomization to death due to any cause. OS will be reported by treatment arm for all participants in Part 2.
Part 2: 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 Participants with PD-L1 CPS ≥1
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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. PFS will be reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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. PFS will be reported by treatment arm for all participants in Part 2.

Secondary Outcome Measures

Part 2: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥1
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and assessed by BICR. ORR will be reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Part 2: ORR Per RECIST 1.1 as Assessed by BICR in All Participants
ORR is defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and assessed by BICR. ORR will be reported by treatment arm for all participants in Part 2.
Part 2: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥1
For participants who demonstrated confirmed CR or PR, DOR is defined as the time from the first CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) to subsequent PD or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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. DOR will be reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Part 2: DOR Per RECIST 1.1 as Assessed by BICR in All Participants
For participants who demonstrated confirmed CR or PR, DOR is defined as the time from the first CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) to subsequent PD or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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. DOR will be reported by treatment arm for all participants in Part 2.
Part 2: Number of Participants with AEs
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 2 with AEs will be reported by treatment arm.
Part 2: Number of Participants who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 2 that discontinued study due to an AE will be reported by treatment arm.

Full Information

First Posted
December 4, 2020
Last Updated
September 5, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04662710
Brief Title
Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)
Acronym
LEAP-015
Official Title
Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy Compared With Standard of Care Therapy as First-line Intervention in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
February 2, 2026 (Anticipated)
Study Completion Date
February 2, 2026 (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 lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and 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 participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.
Detailed Description
There will be 2 parts to the study: a Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (Safety Run-in), approximately 12 participants will be treated with lenvatinib in combination with pembrolizumab and chemotherapy with either capecitabine and oxaliplatin (CAPOX), or 5-fluorouracil (5-FU), Leucovorin, and oxaliplatin (mFOLFOX6). Participants will be closely followed for dose-limiting toxicities for 21 days after the first dose of study intervention. In Part 2, up to 878 eligible participants (not including those participating in Part 1) will be randomly assigned in a 1:1 ratio to either lenvatinib plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) or Chemotherapy alone (CAPOX or mFOLFOX6). Participants can receive up to 18 infusions (up to 2 years) of pembrolizumab in the first course. Participants may be eligible to receive a second course of pembrolizumab (approximately 1 year) at the investigator's discretion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced/Metastatic Gastroesophageal Adenocarcinoma
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
890 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lenvatinib + Pembrolizumab + Chemotherapy
Arm Type
Experimental
Arm Description
Participants receive lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab (400 mg Q6W) plus chemotherapy (CAPOX or mFOLFOX6) will be administered for 2 cycles (approximately 12 weeks), followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab (400 mg Q6W) for 16 cycles. A cycle is 6 weeks (42 days).
Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
Participants receive chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W. A cycle is 6 weeks (42 days).
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, Keytruda®
Intervention Description
400 mg Q6W by IV infusion
Intervention Type
Biological
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
MK-7902, E7080
Intervention Description
Administered PO QD, 8 mg induction/20 mg consolidation.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg/m^2 administered by IV infusion on Day 1 of Weeks 1 and 4 of each Q6W cycle as part of CAPOX chemotherapy, or 85 mg/m^2 administered by IV infusion on Day 1 and Week 1, 3 and 5 of each Q6W cycle as part of mFOLFOX6 chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1000 mg/m^2 administered PO twice daily (BID) on Days 1-14, 22-35 of each Q6W cycle as part of CAPOX chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Leucovorin (or Levoleucovorin)
Intervention Description
Administered by IV infusion at 400 mg/m^2 (leucovorin) or 200 mg/m^2 (levoleucovorin) on Day 1, and Week 1, 3 and 5 of each Q6W cycle as part of mFOLFOX6 chemotherapy.
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous IV infusion administered on Day 1, and Week 1, 3, 5, of each Q2W cycle as part of mFOLFOX6 chemotherapy.
Primary Outcome Measure Information:
Title
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Description
Hematologic DLTs were 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 included 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, or any grade thromboembolic event. The number of participants in Part 1 with DLTs will be reported by treatment arm.
Time Frame
Up to ~21 days
Title
Part 1: Number of Participants with Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 1 with AEs will be reported by treatment arm.
Time Frame
Up to ~28 months
Title
Part 1: Number of Participants who Discontinued Study Treatment Due to an AE
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 1 that discontinued study due to an AE will be reported by treatment arm.
Time Frame
Up to ~25 months
Title
Part 2: Overall Survival (OS) in Participants with Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
Description
OS is defined as the time from randomization to death due to any cause. OS will be reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Time Frame
Up to ~41 months
Title
Part 2: OS in All Participants
Description
OS is defined as the time from randomization to death due to any cause. OS will be reported by treatment arm for all participants in Part 2.
Time Frame
Up to ~41 months
Title
Part 2: 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 Participants with PD-L1 CPS ≥1
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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. PFS will be reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Time Frame
Up to ~31 months
Title
Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants
Description
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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. PFS will be reported by treatment arm for all participants in Part 2.
Time Frame
Up to ~31 months
Secondary Outcome Measure Information:
Title
Part 2: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥1
Description
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and assessed by BICR. ORR will be reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Time Frame
Up to ~31 months
Title
Part 2: ORR Per RECIST 1.1 as Assessed by BICR in All Participants
Description
ORR is defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and assessed by BICR. ORR will be reported by treatment arm for all participants in Part 2.
Time Frame
Up to ~31 months
Title
Part 2: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥1
Description
For participants who demonstrated confirmed CR or PR, DOR is defined as the time from the first CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) to subsequent PD or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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. DOR will be reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Time Frame
Up to ~31 months
Title
Part 2: DOR Per RECIST 1.1 as Assessed by BICR in All Participants
Description
For participants who demonstrated confirmed CR or PR, DOR is defined as the time from the first CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) to subsequent PD or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, 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. DOR will be reported by treatment arm for all participants in Part 2.
Time Frame
Up to ~31 months
Title
Part 2: Number of Participants with AEs
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 2 with AEs will be reported by treatment arm.
Time Frame
Up to ~28 months
Title
Part 2: Number of Participants who Discontinued Study Treatment Due to an AE
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 2 that discontinued study due to an AE will be reported by treatment arm.
Time Frame
Up to ~25 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has histologically and/or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma Is not expected to require tumor resection during the treatment course Has gastroesophageal adenocarcinoma that is not HER-2/neu positive Has measurable disease as defined by RECIST 1.1 by scan with IV contrast as determined by the local site investigator Male participants agree to refrain from donating sperm and agree to either remain abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for ≥7 days after last dose of lenvatinib or 90 days after last dose of chemotherapy-whichever comes last Female participants not pregnant or breastfeeding are eligible to participate if not a women of childbearing potential (WOCBP), or if a WOCBP they either use a contraceptive method that is highly effective OR remain abstinent from heterosexual intercourse as their preferred and usual lifestyle, and do not donate eggs (ova, oocytes) to others or freeze/store for their own use, and abstain from breastfeeding during the intervention period through 120 days after last dose of pembrolizumab, 30 days after last dose of lenvatinib, or 180 days after last dose of chemotherapy-whichever occurs last Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of study treatment Has adequately controlled blood pressure with or without antihypertensive medications Has adequate organ function Exclusion Criteria: Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ) esophageal adenocarcinoma Has had major surgery within 28 days prior to first dose of study interventions Has had radiotherapy within 14 days of randomization Has a known additional malignancy that is progressing or has required active treatment within the past 5 years Has known CNS metastases and/or carcinomatous meningitis Has severe hypersensitivity (≥Grade 3) to treatment with an monoclonal antibody (mAb) or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products Has had an allogeneic tissue/solid organ transplant Has perforation risks or significant gastrointestinal (GI) bleeding Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants) Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor Has received prior therapy with anti- vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation Has inadequate cardiac function Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease Has poorly controlled diarrhea Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment. Has peripheral neuropathy ≥Grade 2 Has a known history of human immunodeficiency virus (HIV) or HIV 1/2 antibodies Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection Has weight loss of >20% within the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Hematology/Oncology - Santa Monica ( Site 0003)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Georgetown University Medical Center ( Site 0009)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
James Graham Brown Cancer Center ( Site 0017)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Johns Hopkins University ( Site 0052)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Dana Farber Cancer Center ( Site 0019)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UMASS Memorial Medical Center ( Site 0020)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Health System ( Site 0023)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan ( Site 0025)
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Washington University School of Medicine ( Site 0027)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mount Sinai Hospital ( Site 0051)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center ( Site 0032)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
AHN West Penn Hospital-AHN Esophageal and Lung Institute ( Site 0058)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Instituto Medico Alexander Fleming ( Site 0208)
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Fundacion Favaloro ( Site 0201)
City
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Hospital Aleman ( Site 0210)
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0207)
City
Buenos Aires
ZIP/Postal Code
C1264AAA
Country
Argentina
Facility Name
CEMIC ( Site 0209)
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Hospital Privado de Cordoba ( Site 0204)
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Nepean Hospital ( Site 2305)
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Wollongong Hospital ( Site 2307)
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Royal Brisbane and Women s Hospital ( Site 2304)
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Hollywood Private Hospital-Medical Oncology ( Site 2308)
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
CHU UCL Namur Site de Godinne ( Site 1005)
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
UZ Gent ( Site 1002)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven ( Site 1004)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Delta ( Site 1006)
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Queen Elizabeth II Health Sciences Centre ( Site 0101)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Hamilton Health Sciences - Juravinski Site ( Site 0106)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Centro Investigación del Cáncer James Lind ( Site 0414)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
Temuco
Country
Chile
Facility Name
IC La Serena Research ( Site 0410)
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Facility Name
Clinica Universidad Catolica del Maule ( Site 0411)
City
Talca
State/Province
Maule
ZIP/Postal Code
3460000
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez FALP ( Site 0403)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500836
Country
Chile
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
Facility Name
Bradfordhill ( Site 0404)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Anhui Provincial Hospital ( Site 2415)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2403)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Cancer Hospital ( Site 2453)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100035
Country
China
Facility Name
Fujian Provincial Cancer Hospital ( Site 2408)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University ( Site 2420)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University ( Site 2446)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Zhongshan Hospital Affiliated to Xiamen University ( Site 2421)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
First Hospital of Lanzhou University ( Site 2417)
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
Nanfang Hospital ( Site 2456)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The Affiliated Hospital Of Hainan Medical University-Cancer rehabilitation and palliative treatment
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570102
Country
China
Facility Name
Fourth Hospital Of Hebei Medical University ( Site 2441)
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Facility Name
Harbin Medical University Cancer Hospital ( Site 2410)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital ( Site 2443)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Hubei Cancer Hospital ( Site 2429)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital ( Site 2440)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
Changzhou Cancer Hospital-Department of Oncology ( Site 2458)
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Facility Name
Nanjing Drum Tower Hospital ( Site 2419)
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Nantong Tumor Hospital-Digestive Oncology ( Site 2464)
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226361
Country
China
Facility Name
Jilin Cancer Hospital ( Site 2438)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Tang Du Hospital ( Site 2432)
City
XI An
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Facility Name
LinYi Cancer Hospital-Gastrology department ( Site 2463)
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Facility Name
Shanghai General Hospital ( Site 2424)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Shanghai East Hospital ( Site 2455)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital ( Site 2447)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2428)
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University ( Site 2414)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital ( Site 2412)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Clinica de la Costa S.A.S. ( Site 0502)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0508)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Facility Name
Oncomedica S.A. ( Site 0507)
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0501)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111321
Country
Colombia
Facility Name
Instituto Cancerologico de Narino Ltda ( Site 0504)
City
Pasto
State/Province
Narino
ZIP/Postal Code
520001
Country
Colombia
Facility Name
Oncologos del Occidente S.A. ( Site 0525)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660001
Country
Colombia
Facility Name
CIMCA-Hemato-Oncology ( Site 0601)
City
San José
State/Province
San Jose
ZIP/Postal Code
10103
Country
Costa Rica
Facility Name
Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0602)
City
Santa Ana
State/Province
San Jose
ZIP/Postal Code
10903
Country
Costa Rica
Facility Name
Centre Francois Baclesse ( Site 1107)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Georges Francois Leclerc ( Site 1106)
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21079
Country
France
Facility Name
CHU Bordeaux Haut-Leveque ( Site 1110)
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Annecy Genevois ( Site 1117)
City
Epagny Metz-Tessy
State/Province
Haute-Savoie
ZIP/Postal Code
74370
Country
France
Facility Name
CHU Hotel Dieu Nantes ( Site 1101)
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Edouard Herriot ( Site 1116)
City
Lyon
State/Province
Rhone-Alpes
ZIP/Postal Code
69003
Country
France
Facility Name
Hopital Henri Mondor ( Site 1105)
City
Creteil
State/Province
Val-de-Marne
ZIP/Postal Code
94010
Country
France
Facility Name
Institut du Cancer Avignon-Provence ( Site 1103)
City
Avignon
State/Province
Vaucluse
ZIP/Postal Code
84918
Country
France
Facility Name
Hopital Saint Louis ( Site 1100)
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU Hopital Saint Antoine ( Site 1102)
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Klinikum Rechts der Isar der TU Muenchen ( Site 1200)
City
Muechen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Regensburg ( Site 1203)
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Krankenhaus Nordwest ( Site 1205)
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60488
Country
Germany
Facility Name
Medizinische Hochschule Hannover ( Site 1210)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Leipzig ( Site 1211)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Charite Berlin Campus Virchow-Klinikum ( Site 1202)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Facharztzentrum Eppendorf ( Site 1201)
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Clinica Privada Dr Rixci Ramirez Fallas ( Site 0702)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Oncologika S.A. ( Site 0704)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Oncomedica ( Site 0701)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Soluciones Gastrointestinales S.A. ( Site 0706)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Sanatorio Nuestra Senora del Pilar ( Site 0705)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Medi-K Cayala ( Site 0700)
City
Guatemala
ZIP/Postal Code
01016
Country
Guatemala
Facility Name
Prince of Wales Hospital ( Site 2503)
City
Hong Kong
Country
Hong Kong
Facility Name
Princess Margaret Hospital. ( Site 2502)
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital ( Site 2501)
City
Hong Kong
Country
Hong Kong
Facility Name
St James Hospital ( Site 1400)
City
Dublin
State/Province
Leinster
ZIP/Postal Code
Dublin 8
Country
Ireland
Facility Name
Beaumont Hospital ( Site 1402)
City
Dublin
ZIP/Postal Code
Dublin 9
Country
Ireland
Facility Name
Soroka Medical Center ( Site 1507)
City
Be'er Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Hillel Yaffe Medical Center ( Site 1503)
City
Hadera
ZIP/Postal Code
3810004
Country
Israel
Facility Name
Rambam Health Care Campus-Oncology Division ( Site 1502)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Ein Kerem Medical Center ( Site 1501)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center ( Site 1504)
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center ( Site 1506)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sourasky Medical Center ( Site 1500)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1608)
City
Meldola
State/Province
Abruzzo
ZIP/Postal Code
47014
Country
Italy
Facility Name
Presidio Ospedaliero Universitario Santa Maria della Misericordia ( Site 1609)
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1610)
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Humanitas Research Hospital ( Site 1600)
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
AULSS8 Berica-Ospedale S.Bortolo ( Site 1607)
City
Vicenza
State/Province
Veneto
ZIP/Postal Code
36100
Country
Italy
Facility Name
Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1611)
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele di Milano ( Site 1603)
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1604)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Aichi Cancer Center Hospital ( Site 2603)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 2601)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 2610)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Hyogo Cancer Center ( Site 2621)
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kobe City Medical Center General Hospital ( Site 2606)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Ibaraki Prefectural Central Hospital ( Site 2618)
City
Kasama
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Kagawa University Hospital ( Site 2611)
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kanagawa Cancer Center ( Site 2608)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Kansai Medical University Hospital ( Site 2622)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Kindai University Hospital ( Site 2600)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Saitama Cancer Center ( Site 2604)
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 2609)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital ( Site 2612)
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 2607)
City
Osaka
ZIP/Postal Code
5418567
Country
Japan
Facility Name
National Cancer Center Hospital ( Site 2602)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR ( Site 2605)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Hallym University Sacred Heart Hospital ( Site 2806)
City
Anyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
14068
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 2804)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 2802)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Konyang University ( Site 2807)
City
Daejeon
State/Province
Taejon-Kwangyokshi
ZIP/Postal Code
35365
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 2803)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 2800)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital ( Site 2805)
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 2801)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital ( Site 2808)
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Dolnoslaskie Centrum Onkologii. ( Site 1712)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1704)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1702)
City
Przemysl
State/Province
Podkarpackie
ZIP/Postal Code
37-700
Country
Poland
Facility Name
Przychodnia Lekarska KOMED ( Site 1701)
City
Konin
State/Province
Wielkopolskie
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 1703)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-780
Country
Poland
Facility Name
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1816)
City
Chelyabinsk
State/Province
Chelyabinskaya Oblast
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
National Medical and Surgical Center n.a.N.I.Pirogov ( Site 1805)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
105203
Country
Russian Federation
Facility Name
Blokhin National Medical Oncology ( Site 1800)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Central Clinical Hospital with Polyclinic ( Site 1801)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Medical University REAVIZ ( Site 1814)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
St Petersburg City Clinical Oncology Dispensary ( Site 1808)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Center ( Site 1810)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1809)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1821)
City
Yaroslavl
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Hospital Universitario General de Asturias ( Site 1901)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla ( Site 1902)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital General Universitari Vall d Hebron ( Site 1907)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Gregorio Maranon de Madrid ( Site 1904)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
China Medical University Hospital ( Site 2903)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 2904)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 2901)
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Linkou ( Site 2902)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Sakarya Universitesi Tip Fakultesi ( Site 2007)
City
Sakarya
State/Province
Istanbul
ZIP/Postal Code
54290
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2003)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Memorial Ankara Hastanesi ( Site 2004)
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi ( Site 2000)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2005)
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2002)
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Addenbrooke's Hospital ( Site 2200)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School ( Site 2207)
City
Dundee
State/Province
Dundee City
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre ( Site 2204)
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust ( Site 2201)
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust ( Site 2202)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Royal Marsden NHS Trust ( Site 2203)
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
University Hospital Coventry and Warwickshire NHS Trust ( Site 2205)
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust ( Site 2209)
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)

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