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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03797326
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : October 14, 2021
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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
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


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
Hide Hide 88 study locations
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United States, California
City of Hope ( Site 0002) Active, not recruiting
Duarte, California, United States, 91010
Cedars Sinai Medical Center ( Site 0003) Active, not recruiting
Los Angeles, California, United States, 90048
University of California Davis Comprehensive Cancer Center ( Site 0005) Recruiting
Sacramento, California, United States, 95817
Contact: Study Coordinator    916-734-3772      
United States, Colorado
University of Colorado, Anschutz Cancer Pavilion ( Site 0007) Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida-Health Cancer Center-Orlando ( Site 0015) Recruiting
Orlando, Florida, United States, 32806
Contact: Study Coordinator    321-841-6626      
United States, New Jersey
Rutgers Cancer Institute of New Jersey ( Site 0009) Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Study Coordinator    732-235-8991      
United States, New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023) Recruiting
New York, New York, United States, 10016
Contact: Study Coordinator    212-731-5076      
United States, North Dakota
Sanford Fargo Medical Center ( Site 0059) Recruiting
Fargo, North Dakota, United States, 58102
Contact: Study Coordinator    605-376-4905      
United States, Pennsylvania
Lehigh Valley Hospital- Cedar Crest ( Site 0047) Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Study Coordinator    610-402-9543      
United States, South Dakota
Sanford Cancer Center ( Site 0058) Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Study Coordinator    605-376-4905      
United States, Tennessee
West Cancer Center - East Campus ( Site 0018) Recruiting
Germantown, Tennessee, United States, 38138
Contact: Study Coordinator    901683005561236      
United States, Texas
Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049) Recruiting
Dallas, Texas, United States, 75230
Contact: Study Coordinator    972-566-3000      
United States, Washington
Swedish Medical Center ( Site 0021) Completed
Seattle, Washington, United States, 98104
United States, Wisconsin
University of Wisconsin Carbone Cancer Center ( Site 0017) Recruiting
Madison, Wisconsin, United States, 53792
Contact: Study Coordinator    800-622-8922      
Argentina
Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106) Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1078AAI
Contact: Study Coordinator    +541143781200 ext 1145      
Hospital Aleman ( Site 2100) Recruiting
Buenos Aires, Caba, Argentina, 1118
Contact: Study Coordinator    +541148277000      
Hospital Britanico de Buenos Aires ( Site 2109) Recruiting
Ciudad de Buenos Aires, Caba, Argentina, C1280AEB
Contact: Study Coordinator    +541121571056      
Instituto de Oncologia de Rosario ( Site 2105) Recruiting
Rosario, Santa Fe, Argentina, S2000KZE
Contact: Study Coordinator    543414218909      
CEMIC ( Site 2104) Recruiting
Buenos Aires, Argentina, C1431FWO
Contact: Study Coordinator    +54 11 52990100 ext 2746/2543      
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101) Recruiting
Caba, Argentina, C1012AAR
Contact: Study Coordinator    +541150319700      
Australia, Queensland
Royal Brisbane and Women s Hospital ( Site 0901) Recruiting
Herston, Queensland, Australia, 4029
Contact: Study Coordinator    +61736468111      
Australia, Victoria
Alfred Health ( Site 0902) Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Study Coordinator    +61390763129      
Australia, Western Australia
Sir Charles Gairdner Hospital ( Site 0903) Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Study Coordinator    +61893464265 +      
Canada, British Columbia
BC Cancer - Abbotsford ( Site 0200) Completed
Abbotsford, British Columbia, Canada, V2S 0C2
Canada, Manitoba
CancerCare Manitoba ( Site 0201) Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Study Coordinator    2047874156      
Canada, Ontario
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208) Completed
Hamilton, Ontario, Canada, L8V5C2
Sunnybrook Research Institute ( Site 0207) Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Study Coordinator    4164804662      
Princess Margaret Cancer Centre ( Site 0202) Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Study Coordinator    4169464501x3527      
Canada, Quebec
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210) Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Study Coordinator    5148908000      
Canada
CHU de Quebec Universite de Laval ( Site 0206) Recruiting
Quebec, Canada, G1R 2J6
Contact: Study Coordinator    4185254444x22644      
Chile
Centro Investigación del Cáncer James Lind ( Site 1203) Active, not recruiting
Temuco, Araucania, Chile, Temuco
Fundacion Arturo Lopez Perez ( Site 1201) Active, not recruiting
Santiago, Region M. De Santiago, Chile, 7500921
Pontificia Universidad Catolica de Chile ( Site 1202) Active, not recruiting
Santiago, Region M. De Santiago, Chile, 8330024
Hospital Clinico Universidad de Chile ( Site 1200) Active, not recruiting
Santiago, Region M. De Santiago, Chile, 8380456
Colombia
Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105) Recruiting
Medellin, Antioquia, Colombia, 050030
Contact: Study Coordinator    573134336816      
Instituto Nacional de Cancerologia E.S.E ( Site 1102) Active, not recruiting
Bogota, Distrito Capital De Bogota, Colombia, 110321
Oncologos del Occidente S.A. ( Site 1106) Recruiting
Pereira, Risaralda, Colombia, 660001
Contact: Study Coordinator    57 3155313926      
Fundacion Valle del Lili ( Site 1101) Recruiting
Cali, Valle Del Cauca, Colombia, 760032
Contact: Study Coordinator    57 3012895296      
France
Centre Antoine Lacassagne ( Site 0404) Recruiting
Nice, Alpes-Maritimes, France, 06189
Contact: Study Coordinator    +33492031514      
Centre Leon Berard ( Site 0405) Recruiting
Lyon, Auvergne, France, 69373
Contact: Study Coordinator    +33478782935      
Institut Claudius Regaud IUCT Oncopole ( Site 0403) Recruiting
Toulouse, Haute-Garonne, France, 31059
Contact: Study Coordinator    +33531155101      
Centre Oscar Lambret ( Site 0401) Active, not recruiting
Lille, Nord, France, 59000
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402) Recruiting
Saint-Herblain, Val-de-Marne, France, 44805
Contact: Study Coordinator    +33240679900      
Institut Gustave Roussy ( Site 0400) Active, not recruiting
Villejuif, Val-de-Marne, France, 94800
Germany
Robert Bosch GmbH ( Site 0307) Recruiting
Stuttgart, Baden-Wurttemberg, Germany, 70376
Contact: Study Coordinator    +4971562037757      
Universitaetsklinikum Regensburg ( Site 0304) Recruiting
Regensburg, Bayern, Germany, 93053
Contact: Study Coordinator    +4994194414800      
Universitaetsklinikum Frankfurt ( Site 0306) Recruiting
Frankfurt am Main, Hessen, Germany, 60528
Contact: Study Coordinator    +4969630184488      
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301) Completed
Wiesbaden, Hessen, Germany, 65199
SRH Wald-Klinikum Gera GmbH ( Site 0309) Recruiting
Gera, Thuringen, Germany, 07548
Contact: Study Coordinator    +49 3658287758      
Universitaetsklinikum Jena ( Site 0302) Recruiting
Jena, Thuringen, Germany, 07740
Contact: Study Coordinator    +4936419396675      
Israel
Soroka Medical Center ( Site 0601) Recruiting
Beer Sheva, Israel, 8457108
Contact: Study Coordinator    +97286244127      
Rambam Medical Center ( Site 0602) Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator    +97247773003      
Hadassah Ein Kerem Medical Center ( Site 0604) Recruiting
Jerusalem, Israel, 9112001
Contact: Study Coordinator    +97257874799      
Chaim Sheba Medical Center ( Site 0600) Recruiting
Ramat Gan, Israel, 5262000
Contact: Study Coordinator    +97235302243      
Sourasky Medical Center ( Site 0603) Recruiting
Tel Aviv, Israel, 6423906
Contact: Study Coordinator    +97236973082      
Italy
Istituto Clinico Humanitas Research Hospital ( Site 1402) Recruiting
Rozzano, Milano, Italy, 20089
Contact: Study Coordinator    +390282244080      
Istituto Nazionale Tumori Fondazione Pascale ( Site 1400) Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +390815903431      
Fondazione Policlinico Universitario A. Gemelli ( Site 1403) Recruiting
Roma, Italy, 00168
Contact: Study Coordinator    +390696734844      
Policlinico Le Scotte - A.O. Senese ( Site 1401) Recruiting
Siena, Italy, 53100
Contact: Study Coordinator    +390577586322      
Korea, Republic of
Asan Medical Center ( Site 1002) Active, not recruiting
Songpagu, Seoul, Korea, Republic of, 05505
Seoul National University Hospital ( Site 1000) Active, not recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital Yonsei University Health System ( Site 1001) Active, not recruiting
Seoul, Korea, Republic of, 03722
Russian Federation
Arkhangelsk Clinical Oncological Dispensary ( Site 1600) Recruiting
Arkhangelsk, Arkhangel Skaya Oblast, Russian Federation, 163045
Contact: Study Coordinator    79212469153      
Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604) Recruiting
Moscow, Moskva, Russian Federation, 115478
Contact: Study Coordinator    +79037103422      
Leningrad Regional Oncology Center ( Site 1609) Recruiting
Saint-Petersburg, Sankt-Peterburg, Russian Federation, 188663
Contact: Study Coordinator    +79052075653      
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610) Recruiting
Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197758
Contact: Study Coordinator    79219437168      
City Clinical Oncology Center ( Site 1608) Recruiting
Saint-Petersburg, Sankt-Peterburg, Russian Federation, 198255
Contact: Study Coordinator    79111019156      
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603) Recruiting
Kazan, Tatarstan, Respublika, Russian Federation, 420029
Contact: Study Coordinator    +79172662851      
Spain
Hospital Clinic i Provincial ( Site 0703) Recruiting
Barcelona, Spain, 08036
Contact: Study Coordinator    +34932279214      
Hospital Universitario Gregorio Maranon ( Site 0701) Recruiting
Madrid, Spain, 28009
Contact: Study Coordinator    +34914269393      
Clinica Universitaria de Navarra ( Site 0704) Recruiting
Madrid, Spain, 28027
Contact: Study Coordinator    +34948255400      
Hospital Ramon y Cajal ( Site 0702) Recruiting
Madrid, Spain, 28034
Contact: Study Coordinator    +34913368263      
Switzerland
Inselspital Universitaetsspital Bern ( Site 1705) Recruiting
Bern, Berne, Switzerland, 3010
Contact: Study Coordinator    +41316320840      
Kantonsspital Graubuenden ( Site 1704) Recruiting
Chur, Grisons, Switzerland, 7000
Contact: Study Coordinator    +41812566884      
Kantonsspital St. Gallen ( Site 1702) Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Contact: Study Coordinator    +41714949701      
Ospedale Regionale di Bellinzona e Valli ( Site 1703) Recruiting
Bellinzona, Ticino, Switzerland, 6500
Contact: Study Coordinator    +41918118931      
Hopitaux Universitaires de Geneve HUG ( Site 1701) Recruiting
Geneve, Switzerland, 1211
Contact: Study Coordinator    +41223729881      
Universitaetsspital Zurich ( Site 1700) Recruiting
Zurich, Switzerland, 8091
Contact: Study Coordinator    +41442554874      
Taiwan
National Cheng Kung University Hospital ( Site 3003) Recruiting
Tainan, Taiwan, 704
Contact: Study Coordinator    +88662353535x4559      
National Taiwan University Hospital ( Site 3000) Recruiting
Taipei, Taiwan, 10002
Contact: Study Coordinator    +886-2-2312-3456 ext. 67680      
Thailand
Chulalongkorn University ( Site 5001) Recruiting
Bangkok, Krung Thep Maha Nakhon, Thailand, 10330
Contact: Study Coordinator    +6622564533      
Ramathibodi Hospital. ( Site 5002) Recruiting
Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
Contact: Study Coordinator    +6622011671      
Siriraj Hospital ( Site 5003) Recruiting
Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
Contact: Study Coordinator    +6624194488      
United Kingdom
Cambridge University Hospitals NHS Trust ( Site 0803) Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Study Coordinator    +441223769310      
Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804) Recruiting
Leicester, Leicestershire, United Kingdom, LE1 5WW
Contact: Study Coordinator    +443003031573      
Guy's Hospital ( Site 0806) Recruiting
London, London, City Of, United Kingdom, SE1 9RT
Contact: Study Coordinator    +442032994849      
Royal Marsden Hospital (Sutton) ( Site 0800) Active, not recruiting
London, Sutton, United Kingdom, SM2 5PT
Christie NHS Foundation Trust ( Site 0805) Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Study Coordinator    +441619187672      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Eisai Inc.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
Additional Information:
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Responsible Party: Merck Sharp & Dohme Corp.
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: October 14, 2021
Last Verified: October 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 Corp.:
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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Triple Negative Breast Neoplasms
Biliary Tract Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Breast Neoplasms
Glioblastoma
Digestive System Diseases
Astrocytoma
Glioma
Breast Diseases
Skin Diseases
Biliary Tract Diseases
Pembrolizumab
Lenvatinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action