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Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03797326
Recruitment Status : Active, not recruiting
First Posted : January 9, 2019
Last Update Posted : November 12, 2021
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:
The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Triple Negative Breast Cancer Ovarian Cancer Gastric Cancer Colorectal Cancer Glioblastoma Biliary Tract Cancers Pancreatic Cancer Biological: Pembrolizumab Drug: Lenvatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 590 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : December 22, 2023
Estimated Study Completion Date : December 22, 2023


Arm Intervention/treatment
Experimental: Pembrolizumab + Lenvatinib (Arm 1)
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
Biological: Pembrolizumab
Administered as an IV infusion on Day 1 Q3W.
Other Names:
  • MK-3475
  • Keytruda®

Drug: Lenvatinib
Administered orally once a day during each 21-day cycle.
Other Names:
  • MK-7902
  • E7080
  • LENVIMA™

Experimental: Lenvatinib Monotherapy (Arm 2)
Participants receive lenvatinib 24 mg via oral capsule QD, to be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
Drug: Lenvatinib
Administered orally once a day during each 21-day cycle.
Other Names:
  • MK-7902
  • E7080
  • LENVIMA™




Primary Outcome Measures :
  1. Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Glioblastoma (GBM) by Investigator Assessment in Initial Cohorts [ Time Frame: Up to approximately 72 months ]
    ORR is 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 [SOD] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. For participants with GBM, response will be assessed by the investigator based on RANO criteria (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value). For participants in the pancreatic cancer cohort, response will be assessed by blinded independent central review (BICR).

  2. ORR per RECIST 1.1 or RANO (GBM) by Blinded Independent Central Review (BICR) in Expanded Cohorts (Combined with Initial Cohorts) [ Time Frame: Up to approximately 72 months ]
    ORR is defined as the percentage of participants who have a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by BICR per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. For participants with GBM, response will be assessed based on RANO criteria (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value).

  3. Percentage of Participants Receiving Pembrolizumab Plus Lenvatinib who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 72 months ]
    An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving pembrolizumab plus lenvatinib who experience at least one AE will be reported.

  4. Percentage of Participants Receiving Pembrolizumab Plus Lenvatinib who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 72 months ]
    An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving pembrolizumab plus lenvatinib who discontinue study treatment due to an AE will be reported.

  5. Percentage of Participants Receiving Lenvatinib Monotherapy who Experience an AE [ Time Frame: Up to approximately 72 months ]
    An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving lenvatinib monotherapy who experience at least one AE will be reported.

  6. Percentage of Participants Receiving Lenvatinib Monotherapy who Discontinue Study Treatment Due to an Adverse Event (AE) [ Time Frame: Up to approximately 72 months ]
    An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving lenvatinib monotherapy who discontinue study treatment due to an AE will be reported.


Secondary Outcome Measures :
  1. Disease Control Rate (DCR) per RECIST 1.1 by Investigator Assessment in Initial Cohorts [ Time Frame: Up to approximately 72 months ]
    DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per RECIST 1.1. 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. DCR will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR.

  2. Duration of Response (DOR) per RECIST 1.1 or RANO (GBM) by Investigator Assessment in Initial Cohorts [ Time Frame: Up to approximately 72 months ]
    DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes 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. DOR will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR.

  3. Progression Free Survival (PFS) per RECIST 1.1 or RANO (GBM) by Investigator Assessment in Initial Cohorts [ Time Frame: Up to approximately 72 months ]
    PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first. PFS will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR.

  4. Overall Survival (OS) in Initial Cohorts [ Time Frame: Up to approximately 72 months ]
    OS is defined as the time from the date of study treatment to the date of death due to any cause.

  5. DCR per RECIST 1.1 by BICR in Expanded Cohorts (Combined with Initial Cohorts) [ Time Frame: Up to approximately 72 months ]
    DCR is defined as the percentage of participants who have a best overall response of CR, PR, or (SD) per RECIST 1.1. 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, and will be assessed by BICR for this outcome measure.

  6. DOR per RECIST 1.1 or RANO (GBM) by BICR in Expanded Cohorts (Combined with Initial Cohorts) [ Time Frame: Up to approximately 72 months ]
    DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes 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, and will be assessed by BICR for this outcome measure.

  7. PFS per RECIST 1.1 or RANO (GBM) by BICR in Expanded Cohorts (Combined with Initial Cohorts) [ Time Frame: Up to approximately 72 months ]
    PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first, as assessed by BICR.

  8. OS in Expanded Cohorts (Combined with Initial Cohorts) [ Time Frame: Up to approximately 72 months ]
    OS is defined as the time from the date of study treatment to the date of death due to any cause.

  9. ORR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm [ Time Frame: Up to approximately 72 months ]
    ORR is defined as the percentage of participants who have a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by BICR per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

  10. DCR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm [ Time Frame: Up to approximately 72 months ]
    DCR is defined as the percentage of participants who have a best overall response of CR, PR, or SD per RECIST 1.1. 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, and will be assessed by BICR for this outcome measure.

  11. DOR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm [ Time Frame: Up to approximately 72 months ]
    DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes 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, and will be assessed by BICR for this outcome measure.

  12. PFS per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm [ Time Frame: Up to approximately 72 months ]
    PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first, as assessed by BICR.

  13. OS in Lenvatinib Monotherapy Arm [ Time Frame: Up to approximately 72 months ]
    OS is defined as the time from the date of study treatment to the date of death due to any cause.

  14. Plasma Concentration of Lenvatinib [ Time Frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose and 2-12 hours post-dose; Cycle 2 Day 1: pre-dose, 0.5-4 hours, and 6-10 hours post-dose (up to approximately 23 days). Each cycle is 21 days. ]
    Blood samples will be obtained on Day 1 and Day 15 of Cycle 1 (21-day cycle) and Day 1 of Cycle 2 (21-day cycle) for pharmacokinetic (PK) analysis to determine the plasma concentration of lenvatinib.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer
  • Must have progressed on or since the last treatment
  • Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR
  • Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period
  • Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of study treatment initiation
  • Has adequate organ function

For Triple Negative Breast Cancer Participants:

  • Has received one or 2 prior lines of therapy
  • Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)
  • Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses

For Ovarian Cancer Participants:

- Has primary ovarian cancer and has received 3 prior lines of therapy.

For Gastric Cancer Participants:

- Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible

For Colorectal Cancer Participants:

- Has received 2 prior lines of therapy

For GBM Participants:

  • Has failed initial systemic therapy for newly diagnosed GBM
  • Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines
  • Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable
  • Has histologically confirmed World Health Organization (WHO) Grade IV GBM
  • Has locally determined result for O^6-methylguanine-DNA methyltransferase (MGMT) analysis

For Biliary Tract Cancer Participants:

  • Has received 1 prior line of therapy
  • Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6

For Pancreatic Cancer Participants:

  • Has pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma that is metastatic at enrollment
  • Has received one or 2 prior lines of therapy
  • Has received prior therapy with at least 1 (platinum-containing regimen or gemcitabine-containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer

Exclusion Criteria:

  • Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
  • Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to all cohorts except the ovarian cancer cohort)
  • Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are not eligible for enrollment
  • Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment
  • Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability
  • Has a history of arterial thromboembolism within 12 months of start of study treatment
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has a serious nonhealing wound, ulcer or bone fracture
  • Has had major surgery within 3 weeks prior to first dose of study interventions
  • Has biologic response modifiers therapy (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry
  • Has preexisting ≥Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula
  • Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start
  • If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
  • Has received a live vaccine within 30 days prior to the first dose of study treatment
  • Has known intolerance to lenvatinib (and/or any of the excipients)
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
  • Has known active CNS metastases and/or carcinomatous meningitis
  • Has tumors involving the brain stem
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of hepatitis B or known active hepatitis C virus infection
  • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
  • 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 treatment
  • Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection)

For GBM Participants:

  • Has carcinomatous meningitis
  • Has recurrent tumor greater than 6 cm in maximum diameter
  • Has tumor primarily localized to the brainstem or spinal cord
  • Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease
  • Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans
  • Has received Optune® TTFields within 2 weeks of study intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797326


Locations
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United States, California
City of Hope ( Site 0002)
Duarte, California, United States, 91010
Cedars Sinai Medical Center ( Site 0003)
Los Angeles, California, United States, 90048
University of California Davis Comprehensive Cancer Center ( Site 0005)
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado, Anschutz Cancer Pavilion ( Site 0007)
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida-Health Cancer Center-Orlando ( Site 0015)
Orlando, Florida, United States, 32806
United States, New Jersey
Rutgers Cancer Institute of New Jersey ( Site 0009)
New Brunswick, New Jersey, United States, 08901
United States, New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)
New York, New York, United States, 10016
United States, North Dakota
Sanford Fargo Medical Center ( Site 0059)
Fargo, North Dakota, United States, 58102
United States, Pennsylvania
Lehigh Valley Hospital- Cedar Crest ( Site 0047)
Allentown, Pennsylvania, United States, 18103
United States, South Dakota
Sanford Cancer Center ( Site 0058)
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
West Cancer Center - East Campus ( Site 0018)
Germantown, Tennessee, United States, 38138
United States, Texas
Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)
Dallas, Texas, United States, 75230
United States, Washington
Swedish Medical Center ( Site 0021)
Seattle, Washington, United States, 98104
United States, Wisconsin
University of Wisconsin Carbone Cancer Center ( Site 0017)
Madison, Wisconsin, United States, 53792-0001
Argentina
Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1078AAI
Hospital Aleman ( Site 2100)
Buenos Aires, Caba, Argentina, 1118
Hospital Britanico de Buenos Aires ( Site 2109)
Ciudad de Buenos Aires, Caba, Argentina, C1280AEB
Instituto de Oncologia de Rosario ( Site 2105)
Rosario, Santa Fe, Argentina, S2000KZE
CEMIC ( Site 2104)
Buenos Aires, Argentina, C1431FWO
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101)
Caba, Argentina, C1012AAR
Australia, Queensland
Royal Brisbane and Women s Hospital ( Site 0901)
Herston, Queensland, Australia, 4029
Australia, Victoria
Alfred Health ( Site 0902)
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Sir Charles Gairdner Hospital ( Site 0903)
Nedlands, Western Australia, Australia, 6009
Canada, British Columbia
BC Cancer - Abbotsford ( Site 0200)
Abbotsford, British Columbia, Canada, V2S 0C2
Canada, Manitoba
CancerCare Manitoba ( Site 0201)
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)
Hamilton, Ontario, Canada, L8V 4X2
Sunnybrook Research Institute ( Site 0207)
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210)
Montreal, Quebec, Canada, H2X 3E4
Canada
CHU de Quebec Universite de Laval ( Site 0206)
Quebec, Canada, G1R 2J6
Chile
Centro Investigación del Cáncer James Lind ( Site 1203)
Temuco, Araucania, Chile, 4780000
Fundacion Arturo Lopez Perez ( Site 1201)
Santiago, Region M. De Santiago, Chile, 7500921
Pontificia Universidad Catolica de Chile ( Site 1202)
Santiago, Region M. De Santiago, Chile, 8330024
Hospital Clinico Universidad de Chile ( Site 1200)
Santiago, Region M. De Santiago, Chile, 8380456
Colombia
Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105)
Medellin, Antioquia, Colombia, 050030
Instituto Nacional de Cancerologia E.S.E ( Site 1102)
Bogota, Distrito Capital De Bogota, Colombia, 110321
Oncologos del Occidente S.A. ( Site 1106)
Pereira, Risaralda, Colombia, 660001
Fundacion Valle del Lili ( Site 1101)
Cali, Valle Del Cauca, Colombia, 760032
France
Centre Antoine Lacassagne ( Site 0404)
Nice, Alpes-Maritimes, France, 06189
Centre Leon Berard ( Site 0405)
Lyon, Auvergne, France, 69373
Institut Claudius Regaud IUCT Oncopole ( Site 0403)
Toulouse, Haute-Garonne, France, 31059
Centre Oscar Lambret ( Site 0401)
Lille, Nord, France, 59000
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402)
Saint-Herblain, Val-de-Marne, France, 44805
Institut Gustave Roussy ( Site 0400)
Villejuif, Val-de-Marne, France, 94800
Germany
Robert Bosch GmbH ( Site 0307)
Stuttgart, Baden-Wurttemberg, Germany, 70376
Universitaetsklinikum Regensburg ( Site 0304)
Regensburg, Bayern, Germany, 93053
Universitaetsklinikum Frankfurt ( Site 0306)
Frankfurt am Main, Hessen, Germany, 60528
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301)
Wiesbaden, Hessen, Germany, 65199
SRH Wald-Klinikum Gera GmbH ( Site 0309)
Gera, Thuringen, Germany, 07548
Universitaetsklinikum Jena ( Site 0302)
Jena, Thuringen, Germany, 07740
Israel
Soroka Medical Center ( Site 0601)
Beer Sheva, Israel, 8457108
Rambam Medical Center ( Site 0602)
Haifa, Israel, 3109601
Hadassah Ein Kerem Medical Center ( Site 0604)
Jerusalem, Israel, 9112001
Chaim Sheba Medical Center ( Site 0600)
Ramat Gan, Israel, 5262000
Sourasky Medical Center ( Site 0603)
Tel Aviv, Israel, 6423906
Italy
Istituto Clinico Humanitas Research Hospital ( Site 1402)
Rozzano, Milano, Italy
Policlinico Le Scotte - A.O. Senese ( Site 1401)
Siena, Toscana, Italy, 53100
Istituto Nazionale Tumori Fondazione Pascale ( Site 1400)
Napoli, Italy, 80131
Fondazione Policlinico Universitario A. Gemelli ( Site 1403)
Roma, Italy, 00168
Korea, Republic of
Asan Medical Center ( Site 1002)
Songpagu, Seoul, Korea, Republic of, 05505
Seoul National University Hospital ( Site 1000)
Seoul, Korea, Republic of, 03080
Severance Hospital Yonsei University Health System ( Site 1001)
Seoul, Korea, Republic of, 03722
Russian Federation
Arkhangelsk Clinical Oncological Dispensary ( Site 1600)
Arkhangelsk, Arkhangel Skaya Oblast, Russian Federation, 163045
Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604)
Moscow, Moskva, Russian Federation, 115478
Leningrad Regional Oncology Center ( Site 1609)
Saint-Petersburg, Sankt-Peterburg, Russian Federation, 188663
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610)
Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197758
City Clinical Oncology Center ( Site 1608)
Saint-Petersburg, Sankt-Peterburg, Russian Federation, 198255
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603)
Kazan, Tatarstan, Respublika, Russian Federation, 420029
Spain
Hospital Clinic i Provincial ( Site 0703)
Barcelona, Spain, 08036
Hospital Universitario Gregorio Maranon ( Site 0701)
Madrid, Spain, 28009
Clinica Universitaria de Navarra ( Site 0704)
Madrid, Spain, 28027
Hospital Ramon y Cajal ( Site 0702)
Madrid, Spain, 28034
Switzerland
Inselspital Universitaetsspital Bern ( Site 1705)
Bern, Berne, Switzerland, 3010
Kantonsspital Graubuenden ( Site 1704)
Chur, Grisons, Switzerland, 7000
Kantonsspital St. Gallen ( Site 1702)
St. Gallen, Sankt Gallen, Switzerland, 9007
Ospedale Regionale di Bellinzona e Valli ( Site 1703)
Bellinzona, Ticino, Switzerland, 6500
Hopitaux Universitaires de Geneve HUG ( Site 1701)
Geneve, Switzerland, 1211
Universitaetsspital Zurich ( Site 1700)
Zurich, Switzerland, 8091
Taiwan
National Cheng Kung University Hospital ( Site 3003)
Tainan, Taiwan, 704
National Taiwan University Hospital ( Site 3000)
Taipei, Taiwan, 10002
Thailand
Chulalongkorn University ( Site 5001)
Bangkok, Krung Thep Maha Nakhon, Thailand, 10330
Ramathibodi Hospital. ( Site 5002)
Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
Siriraj Hospital ( Site 5003)
Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
United Kingdom
Cambridge University Hospitals NHS Trust ( Site 0803)
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804)
Leicester, Leicestershire, United Kingdom, LE1 5WW
Guy's Hospital ( Site 0806)
London, London, City Of, United Kingdom, SE1 9RT
Royal Marsden Hospital (Sutton) ( Site 0800)
London, Surrey, United Kingdom, SM3 5PT
Christie NHS Foundation Trust ( Site 0805)
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Eisai Inc.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
Additional Information:
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT03797326    
Other Study ID Numbers: 7902-005
2018-003747-37 ( EudraCT Number )
MK-7902-005 ( Other Identifier: Merck Protocol Number )
E7080-G000-224 ( Other Identifier: Eisai Protocol Number )
LEAP-005 ( Other Identifier: Merck )
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: November 12, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme LLC:
programmed cell death 1 (PD-1, PD1)
programmed cell death ligand 1 (PD-L1, PDL1)
programmed cell death ligand 2 (PD-L2, PDL2)
tyrosine kinase inhibitor (TKI)
multiple TKI
Vascular Endothelial Growth Factor Receptor (VEFG)
Fibroblast Growth Factor (FGF)
Platelet-Derived Growth Factor (PDGF)
Additional relevant MeSH terms:
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Glioblastoma
Triple Negative Breast Neoplasms
Biliary Tract Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Breast Neoplasms
Breast Diseases
Skin Diseases
Biliary Tract Diseases
Pembrolizumab
Lenvatinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action