AzTrials
AzTrials

Advanced Solid TumorsPhase 2NCT03797326

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)

A Phase 2 study testing Pembrolizumab and Lenvatinib in people with Advanced Solid Tumors and Triple Negative Breast Cancer, run by Merck Sharp & Dohme LLC at 88 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
611 participants
Where
88 sitesin 17 countries
Study dates
12 Feb 2019to 28 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

88 sites in 17 countries.

88 sites in 17 countries

United States14 sites

  • Lehigh Valley Hospital- Cedar Crest ( Site 0047)

    Allentown, Pennsylvania, 18103

  • University of Colorado, Anschutz Cancer Pavilion ( Site 0007)

    Aurora, Colorado, 80045

  • Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)

    Dallas, Texas, 75230

  • City of Hope ( Site 0002)

    Duarte, California, 91010

  • Sanford Fargo Medical Center ( Site 0059)

    Fargo, North Dakota, 58102

  • West Cancer Center - East Campus ( Site 0018)

    Germantown, Tennessee, 38138

  • Cedars Sinai Medical Center ( Site 0003)

    Los Angeles, California, 90048

  • University of Wisconsin Carbone Cancer Center ( Site 0017)

    Madison, Wisconsin, 53792-0001

  • Rutgers Cancer Institute of New Jersey ( Site 0009)

    New Brunswick, New Jersey, 08901

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)

    New York, New York, 10016

  • University of Florida-Health Cancer Center-Orlando ( Site 0015)

    Orlando, Florida, 32806

  • University of California Davis Comprehensive Cancer Center ( Site 0005)

    Sacramento, California, 95817

  • Swedish Medical Center ( Site 0021)

    Seattle, Washington, 98104

  • Sanford Cancer Center ( Site 0058)

    Sioux Falls, South Dakota, 57104

Other trials in United States

Canada7 sites

  • BC Cancer - Abbotsford ( Site 0200)

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)

    Hamilton, Ontario, L8V 4X2

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210)

    Montreal, Quebec, H2X 3E4

  • CHU de Quebec Universite de Laval ( Site 0206)

    Québec, Quebec, G1R 2J6

  • Sunnybrook Research Institute ( Site 0207)

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre ( Site 0202)

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba ( Site 0201)

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Argentina6 sites

  • Hospital Aleman ( Site 2100)

    Buenos Aires, Buenos Aires F.D., 1118

  • CEMIC ( Site 2104)

    Buenos Aires, C1431FWO

  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101)

    Caba, C1012AAR

  • Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1078AAI

  • Hospital Britanico de Buenos Aires ( Site 2109)

    Ciudad de Buenos Aires, Buenos Aires F.D., C1280AEB

  • Instituto de Oncologia de Rosario ( Site 2105)

    Rosario, Santa Fe Province, S2000KZE

Other trials in Argentina

France6 sites

  • Centre Oscar Lambret ( Site 0401)

    Lille, Nord, 59000

  • Centre Leon Berard ( Site 0405)

    Lyon, Auvergne, 69373

  • Centre Antoine Lacassagne ( Site 0404)

    Nice, Alpes-Maritimes, 06189

  • Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402)

    Saint-Herblain, Val-de-Marne, 44805

  • Institut Claudius Regaud IUCT Oncopole ( Site 0403)

    Toulouse, Haute-Garonne, 31059

  • Institut Gustave Roussy ( Site 0400)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Germany6 sites

  • Universitaetsklinikum Frankfurt ( Site 0306)

    Frankfurt am Main, Hesse, 60528

  • SRH Wald-Klinikum Gera GmbH ( Site 0309)

    Gera, Thuringia, 07548

  • Universitaetsklinikum Jena ( Site 0302)

    Jena, Thuringia, 07740

  • Universitaetsklinikum Regensburg ( Site 0304)

    Regensburg, Bavaria, 93053

  • Robert Bosch GmbH ( Site 0307)

    Stuttgart, Baden-Wurttemberg, 70376

  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301)

    Wiesbaden, Hesse, 65199

Other trials in Germany

Russia6 sites

  • Arkhangelsk Clinical Oncological Dispensary ( Site 1600)

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603)

    Kazan', Tatarstan, Respublika, 420029

  • Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604)

    Moscow, Moscow, 115478

  • Leningrad Regional Oncology Center ( Site 1609)

    Saint Petersburg, Sankt-Peterburg, 188663

  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610)

    Saint Petersburg, Sankt-Peterburg, 197758

  • City Clinical Oncology Center ( Site 1608)

    Saint Petersburg, Sankt-Peterburg, 198255

Other trials in Russia

Switzerland6 sites

  • Ospedale Regionale di Bellinzona e Valli ( Site 1703)

    Bellinzona, Canton Ticino, 6500

  • Inselspital Universitaetsspital Bern ( Site 1705)

    Bern, Canton of Bern, 3010

  • Kantonsspital Graubuenden ( Site 1704)

    Chur, Kanton Graubünden, 7000

  • Hopitaux Universitaires de Geneve HUG ( Site 1701)

    Geneva, 1211

  • Kantonsspital St. Gallen ( Site 1702)

    Sankt Gallen, Canton of St. Gallen, 9007

  • Universitaetsspital Zurich ( Site 1700)

    Zurich, 8091

Other trials in Switzerland

Israel5 sites

  • Soroka Medical Center ( Site 0601)

    Beersheba, 8457108

  • Rambam Medical Center ( Site 0602)

    Haifa, 3109601

  • Hadassah Ein Kerem Medical Center ( Site 0604)

    Jerusalem, 9112001

  • Chaim Sheba Medical Center ( Site 0600)

    Ramat Gan, 5262000

  • Sourasky Medical Center ( Site 0603)

    Tel Aviv, 6423906

Other trials in Israel

United Kingdom5 sites

  • Cambridge University Hospitals NHS Trust ( Site 0803)

    Cambridge, Cambridgeshire, CB2 0QQ

  • Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804)

    Leicester, Leicestershire, LE1 5WW

  • Guy's Hospital ( Site 0806)

    London, London, City of, SE1 9RT

  • Royal Marsden Hospital (Sutton) ( Site 0800)

    London, Surrey, SM3 5PT

  • Christie NHS Foundation Trust ( Site 0805)

    Manchester, M20 4BX

Other trials in United Kingdom

Chile4 sites

  • Fundacion Arturo Lopez Perez ( Site 1201)

    Santiago, Region M. de Santiago, 7500921

  • Pontificia Universidad Catolica de Chile ( Site 1202)

    Santiago, Region M. de Santiago, 8330024

  • Hospital Clinico Universidad de Chile ( Site 1200)

    Santiago, Region M. de Santiago, 8380456

  • Centro Investigación del Cáncer James Lind ( Site 1203)

    Temuco, Araucania, 4780000

Other trials in Chile

Colombia4 sites

  • Instituto Nacional de Cancerologia E.S.E ( Site 1102)

    Bogotá, Bogota D.C., 110321

  • Fundacion Valle del Lili ( Site 1101)

    Cali, Valle del Cauca Department, 760032

  • Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105)

    Medellín, Antioquia, 050030

  • Oncologos del Occidente S.A. ( Site 1106)

    Pereira, Risaralda Department, 660001

Other trials in Colombia

Italy4 sites

  • Istituto Nazionale Tumori Fondazione Pascale ( Site 1400)

    Naples, 80131

  • Fondazione Policlinico Universitario A. Gemelli ( Site 1403)

    Roma, 00168

  • Istituto Clinico Humanitas Research Hospital ( Site 1402)

    Rozzano, Milano

  • Policlinico Le Scotte - A.O. Senese ( Site 1401)

    Siena, Tuscany, 53100

Other trials in Italy

Spain4 sites

  • Hospital Clinic i Provincial ( Site 0703)

    Barcelona, 08036

  • Hospital Universitario Gregorio Maranon ( Site 0701)

    Madrid, 28009

  • Clinica Universitaria de Navarra ( Site 0704)

    Madrid, 28027

  • Hospital Ramon y Cajal ( Site 0702)

    Madrid, 28034

Other trials in Spain

Australia3 sites

  • Royal Brisbane and Women s Hospital ( Site 0901)

    Herston, Queensland, 4029

  • Alfred Health ( Site 0902)

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital ( Site 0903)

    Nedlands, Western Australia, 6009

Other trials in Australia

South Korea3 sites

  • Seoul National University Hospital ( Site 1000)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 1001)

    Seoul, 03722

  • Asan Medical Center ( Site 1002)

    Songpagu, Seoul, 05505

Other trials in South Korea

Thailand3 sites

  • Chulalongkorn University ( Site 5001)

    Bangkok, Bangkok, 10330

  • Ramathibodi Hospital. ( Site 5002)

    Bangkok, Bangkok, 10400

  • Siriraj Hospital ( Site 5003)

    Bangkok, Bangkok, 10700

Other trials in Thailand

Taiwan2 sites

  • National Cheng Kung University Hospital ( Site 3003)

    Tainan, 704

  • National Taiwan University Hospital ( Site 3000)

    Taipei, 10002

Other trials in Taiwan

About this study

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)

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.

Keywords
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)
Medical subject headings
Triple Negative Breast Neoplasms, Ovarian Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Glioblastoma, Biliary Tract Neoplasms, Pancreatic Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475, Keytruda®

    Administered as an IV infusion on Day 1 Q3W.

  • LenvatinibDrug

    Also called MK-7902, E7080, LENVIMA™

    Administered orally once a day during each 21-day cycle.

Study groups in NCT03797326
Study groupRoleWhat they receive
Pembrolizumab + Lenvatinib (Arm 1)ExperimentalParticipants 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).
Receives: Biological: Pembrolizumab; Drug: Lenvatinib
Lenvatinib Monotherapy (Arm 2)ExperimentalParticipants receive lenvatinib 24 mg via oral capsule QD, to be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
Receives: Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment

    ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 by investigator assessment was presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

    Measured: Up to approximately 66 months

  2. 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 Multiforma [GBM] Only), by Blinded Independent Central Review (BICR)

    ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. For participants with GBM, response was assessed according to RANO criteria whereby ORR was defined as the percentage of participants who had a best overall response of either Complete response (CR): Disappearance of all target lesions or Partial response (PR): sum of products of diameters decreased by ≥50% from baseline value. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 or RANO by BICR was presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.

    Measured: Up to approximately 66 months

  3. Number of Participants With One or More Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one or more AE is presented.

    Measured: Up to approximately 66 months

  4. Number of Participants Who Discontinued From Study Treatment Due to an AE

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued from study treatment due to an AE is presented.

    Measured: Up to approximately 62 months

Secondary outcomes (8)

  1. Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment

    DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]). Disease Control rate per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

    Measured: Up to approximately 66 months

  2. Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

    DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm]). The appearance of one or more new lesions is also considered PD.]). For participants with GBM, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information. The DCR as assessed by BICR is presented.

    Measured: Up to approximately 66 months

  3. Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. Duration of response per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

    Measured: Up to approximately 66 months

  4. Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. For participants with GBM, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. DOR assessments were based on blinded central imaging review with confirmation.

    Measured: Up to approximately 66 months

  5. Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment

    PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who experienced PFS per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.

    Measured: Up to approximately 66 months

  6. Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR

    PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1 (or RANO for GBM participants), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. For participants with GBM, either radiological progression or clinical deterioration (not attributable to a nontumor-related cause) qualifies as PD. The percentage of participants who experienced PFS per RECIST 1.1 or RANO by BICR is presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.

    Measured: Up to approximately 66 months

  7. Overall Survival (OS)

    OS was defined as the time from the date of study treatment to the date of death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for all participants is presented.

    Measured: Up to approximately 66 months

  8. Area Under the Concentration Curve at Steady State (AUCss) of Lenvatinib

    Blood samples were collected at pre-specified timepoints to determine the AUCss in participants receiving Lenvatinib (Lenva) co-administered with Pembrolizumab (Pembro). AUCss was defined as a measure of drug exposure that was calculated as the product of plasma drug concentration and time after drug administration at steady state. AUCss determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Noncompartmental analysis was used to calculate AUC0ss for each participant. Mean and standard deviation of AUCss were calculated for each cohort. As specified in the protocol, pharmacokinetic analysis was not planned or conducted in Cohorts D2 and G.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2019
  2. Study start12 Feb 2019
  3. Primary completion28 Oct 2024
  4. Study completion28 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
611 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03797326
Sponsor's protocol ID
7902-005
Other IDs
MK-7902-005, E7080-G000-224, LEAP-005, 2018-003747-37, 2018
Status last verified
Apr 2026
First submitted
7 Jan 2019
Last updated
4 May 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Gonzalez-Martin A, Chung HC, Saada-Bouzid E, Yanez E, Senellart H, Cassier PA, Basu B, Corr BR, Girda E, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Lwin Z. Lenvatinib plus pembrolizumab for patients with previously treated advanced ovarian cancer: Results from the phase 2 multicohort LEAP-005 study. Gynecol Oncol. 2024 Jul;186:182-190. doi: 10.1016/j.ygyno.2024.04.011. Epub 2024 May 7.

    PubMed 38718741

  • Chung HC, Saada-Bouzid E, Longo F, Yanez E, Im SA, Castanon E, Desautels DN, Graham DM, Garcia-Corbacho J, Lopez J, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Korakis I. Lenvatinib plus pembrolizumab for patients with previously treated, advanced, triple-negative breast cancer: Results from the triple-negative breast cancer cohort of the phase 2 LEAP-005 Study. Cancer. 2024 Oct 1;130(19):3278-3288. doi: 10.1002/cncr.35387. Epub 2024 Jun 21.

    PubMed 39031824

  • Ponz-Sarvise M, Rha SY, Gomez-Roca CA, Ortega Moran L, Gill S, Tortora G, Geva R, Saada-Bouzid E, Santoro A, Kim TW, Heudobler D, Dutcus CE, Okpara CE, Ghori R, Zhang Y, Vajdi A, Dettman EJ, Jin F, Groisberg R, Shapira-Frommer R. Lenvatinib plus Pembrolizumab for Patients with Previously Treated Advanced Gastric, Biliary Tract, or Pancreatic Cancer: Results from the Phase II LEAP-005 Study. Cancer Res Commun. 2026 Mar 1;6(3):673-686. doi: 10.1158/2767-9764.CRC-26-0018.

    PubMed 41747221

  • Victoria Ruiz I, Uboha NV, Jamal R, Mejia FC, Ahumada M, Im SA, Gomez-Roca C, Shapira-Frommer R, Perets R, Yanez E, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Castanon E. Lenvatinib Plus Pembrolizumab for Patients With Previously Treated Advanced Colorectal Cancer: Results From the Phase II LEAP-005 Study. Clin Colorectal Cancer. 2026 Jun;25(2):225-238.e2. doi: 10.1016/j.clcc.2026.01.003. Epub 2026 Jan 22.

    PubMed 41763955

  • Rha SY, Castanon E, Gill S, Senellart H, Lopez J, Marquez-Rodas I, Victoria I, Kim TM, Lwin Z, Burger MC, Simonelli M, Cassier PA, Hendifar AE, Ascierto PA, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Villanueva L. Lenvatinib plus pembrolizumab for patients with previously treated select solid tumors: Results from the phase 2 LEAP-005 study recurrent glioblastoma cohort. Cancer. 2025 Aug 15;131(16):e70015. doi: 10.1002/cncr.70015.

    PubMed 40808295

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Lenvatinib in people with Advanced Solid Tumors and Triple Negative Breast Cancer, run by Merck Sharp & Dohme LLC at 88 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Canada, Argentina, France, Germany and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment (time frame: Up to approximately 66 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03797326, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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