AzTrials
AzTrials

Squamous Cell Carcinoma of Head and NeckPhase 2NCT04428151

Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

A Phase 2 study testing Lenvatinib, Pembrolizumab and Docetaxel in people with Squamous Cell Carcinoma of Head and Neck, run by Merck Sharp & Dohme LLC at 120 sites in 15 countries.

Completed

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

Official record
Search all trials

Trial summary

Researchers are looking for new ways to treat people with head and neck cancer whose cancer has come back after treatment (recurrent) or whose cancer has spread to other parts of the body (metastatic). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
Lenvatinib, Pembrolizumab and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
120 sitesin 15 countries
Study dates
6 Aug 2020to 30 Oct 2025
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

  • Pathologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx, and/or larynx that is considered incurable by local therapies
  • Disease progression at any time during or after treatment with a platinum-containing (e.g., carboplatin or cisplatin) regimen
  • Disease progression on or after treatment with a programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody (anti-PD-1/PD-L1 mAb)
  • Pre-study imaging that demonstrates evidence of disease progression based on investigator review of at least 2 pre-study images per RECIST 1.1, following initiation of treatment with a PD-1/PD-L1 inhibitor
  • Measurable disease by computed tomography scan (CT) or magnetic resonance imaging (MRI) based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as verified by blinded independent central review (BICR). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of the first dose of study intervention
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  • Male participants are eligible to participate if they agree to the following during the intervention period and for at least 1 week after the last dose of lenvatinib, 3 months after the last dose of capecitabine and paclitaxel, and 6 months after the last dose of docetaxel:
  • Refrain from donating sperm
  • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic
  • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  • Is not a woman of childbearing potential (WOCBP)
  • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days post pembrolizumab or 1 month post lenvatinib, whichever occurs last (Arms 1 and 3), or during the intervention period and for at least 6 months after the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last dose of cetuximab (Arm 2)
  • Female participants who randomize to Arm 2 must also agree not to donate or freeze/store eggs during the intervention period and for at least 6 months after the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last dose of cetuximab
  • Adequately controlled blood pressure (BP) with or without antihypertensive medications
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  • Adequate organ function

Who cannot join

  • Disease that is suitable for local therapy administered with curative intent
  • Life expectancy of less than 3 months and/or has rapidly progressing disease in the opinion of the treating investigator
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, or has current pneumonitis/interstitial lung disease
  • Active infection requiring systemic therapy
  • 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 to the first dose of study drug
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
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  • Known additional malignancy that is progressing or has required active systemic treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ that have undergone potentially curative therapy
  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • Had an allogeneic tissue/solid organ transplant
  • Known history of human immunodeficiency virus (HIV) infection
  • History of any contraindication or has a severe hypersensitivity to any components of pembrolizumab, lenvatinib or SOC chemotherapy.
  • Pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
  • History of a gastrointestinal malabsorption or any other condition or procedure that may affect oral study drug absorption
  • Had major surgery within 3 weeks prior to first dose of study interventions
  • Clinically significant cardiovascular impairment within 12 months of the first dose of study drug
  • Active tuberculosis
  • Has difficulty swallowing capsules or ingesting a suspension orally, or by a feeding tube
  • Prior treatment with lenvatinib
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Study Day 1 or has not recovered from adverse events (AEs) due to a previously administered agent. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible
  • Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Administration of killed vaccines is allowed
  • Previously treated with 4 or more systemic regimens given for recurrent/metastatic disease
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Trial locations and contacts

120 sites in 15 countries.

120 sites in 15 countries

United States55 sites

  • VA Ann Arbor Healthcare System ( Site 1584)

    Ann Arbor, Michigan, 48105

  • Georgia Cancer Center at Augusta University ( Site 1575)

    Augusta, Georgia, 30912

  • University of Maryland Greenebaum Cancer Center ( Site 1522)

    Baltimore, Maryland, 21201

  • Our Lady of the Lake RMC-Clinical Research ( Site 1624)

    Baton Rouge, Louisiana, 70808

  • Mary Bird Perkins Cancer Center Baton Rouge ( Site 1622)

    Baton Rouge, Louisiana, 70809

  • St. Vincent Frontier Cancer Center ( Site 1507)

    Billings, Montana, 59102

  • Boston Medical Center ( Site 1605)

    Boston, Massachusetts, 02118

  • Medical University of South Carolina ( Site 1579)

    Charleston, South Carolina, 29425

  • Levine Cancer Institute ( Site 1590)

    Charlotte, North Carolina, 28204

  • Rush University Medical Center ( Site 1560)

    Chicago, Illinois, 60607

  • University of Cincinnati Medical Center ( Site 1567)

    Cincinnati, Ohio, 45219

  • University Hospital Cleveland ( Site 1578)

    Cleveland, Ohio, 44106

  • Cleveland Clinic Main ( Site 1598)

    Cleveland, Ohio, 44195

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 1558)

    Columbus, Ohio, 43210

  • Barbara Ann Karmanos Cancer Institute ( Site 1566)

    Detroit, Michigan, 48201

  • Henry Ford Health System ( Site 1544)

    Detroit, Michigan, 48202

  • City of Hope ( Site 1519)

    Duarte, California, 91010

  • Duke Cancer Institute ( Site 1541)

    Durham, North Carolina, 27710

  • NorthShore University HealthSystem - Evanston Hospital ( Site 1614)

    Evanston, Illinois, 60201

  • Inova Schar Cancer Institute ( Site 1550)

    Fairfax, Virginia, 22031-4867

  • The Center For Cancer And Blood Disorders ( Site 1569)

    Fort Worth, Texas, 76104

  • Hematology Oncology Associates of Fredericksburg ( Site 1537)

    Fredericksburg, Virginia, 22408

  • UF Health ( Site 1554)

    Gainesville, Florida, 32608

  • Gettysburg Cancer Center ( Site 1594)

    Gettysburg, Pennsylvania, 17325

  • St Francis Cancer Center-Research Office ( Site 1607)

    Greenville, South Carolina, 29607

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1555)

    Hackensack, New Jersey, 07601

  • Hattiesburg Clinic ( Site 1515)

    Hattiesburg, Mississippi, 39401

  • Penn State Hershey Medical Center ( Site 1561)

    Hershey, Pennsylvania, 17033

  • University of Iowa ( Site 1572)

    Iowa City, Iowa, 52242

  • Jackson Oncology Associates, PLLC-Clinical Trials ( Site 1625)

    Jackson, Mississippi, 39202

  • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)

    Los Angeles, California, 90095

  • Norton Hospital-Norton Cancer Institute - Downtown ( Site 1601)

    Louisville, Kentucky, 40205

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521)

    Marietta, Georgia, 30060

  • Medical College of Wisconsin Clinical Cancer Center ( Site 1574)

    Milwaukee, Wisconsin, 53226

  • Perlmutter Cancer Center at Winthrop Oncology Hematology Associates NYU Langone Health ( Site 1597)

    Mineola, New York, 11501

  • IU Health Ball Memorial Hospital, Inc.-IU Health Ball Memorial Cancer Center ( Site 1612)

    Muncie, Indiana, 47303

  • Rutgers Cancer Institute of New Jersey ( Site 1523)

    New Brunswick, New Jersey, 08901

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 1505)

    New Haven, Connecticut, 06510

  • Laura and Isaac Perlmutter Cancer Center ( Site 1582)

    New York, New York, 10016

  • University Of Nebraska Medical Center ( Site 1570)

    Omaha, Nebraska, 68105

  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 1627)

    Omaha, Nebraska, 68130

  • Mid Florida Hematology and Oncology Center ( Site 1606)

    Orange City, Florida, 32763

  • Mercy Health-Paducah Cancer Center ( Site 1623)

    Paducah, Kentucky, 42003

  • Fox Chase Cancer Center ( Site 1502)

    Philadelphia, Pennsylvania, 19111

  • Beacon Cancer Care ( Site 1599)

    Post Falls, Idaho, 83854

  • Utah Cancer Specialists ( Site 1621)

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute ( Site 1532)

    Salt Lake City, Utah, 84112

  • Memorial Health University Medical Center ( Site 1626)

    Savannah, Georgia, 31404

  • Washington University School of Medicine ( Site 1500)

    St Louis, Missouri, 63110

  • MultiCare Health System-MultiCare Oncology - Puget Sound ( Site 1609)

    Tacoma, Washington, 98405

  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1508)

    Tulsa, Oklahoma, 74146

  • Georgetown University Medical Center ( Site 1520)

    Washington D.C., District of Columbia, 20007

  • Cleveland Clinic Florida ( Site 1596)

    Weston, Florida, 33331

  • University of Kansas Cancer Center ( Site 1538)

    Westwood, Kansas, 66205

  • University of Massachusetts Chan Medical School ( Site 1616)

    Worcester, Massachusetts, 01655

Other trials in United States

United Kingdom10 sites

  • Aberdeen Royal Infirmary ( Site 0911)

    Aberdeen, Aberdeen City, AB25 2ZN

  • Castle Hill Hospital ( Site 0910)

    Cottingham, East Riding Of Yorkshire, HU16 5JQ

  • The Beatson West of Scotland Cancer Centre ( Site 0909)

    Glasgow, Glasgow City, G12 0YN

  • Guy s and St Thomas Hospital NHS Foundation Trust ( Site 0903)

    London, Great Britain, SE1 9RT

  • Royal Marsden Hospital ( Site 0902)

    London, London, City of, SW3 6JJ

  • Charing Cross Hospital ( Site 0908)

    London, London, City of, W6 8RF

  • The Christie NHS Foundation Trust ( Site 0907)

    Manchester, m20 4bx

  • University Hospital Southampton NHS Foundation Trust ( Site 0905)

    Southampton, Hampshire, SO16 6YD

  • Royal Marsden Hospital. ( Site 0901)

    Sutton, Surrey, SM2 5PT

  • Musgrove Park Hospital ( Site 0904)

    Taunton, Somerset, TA1 5DA

Other trials in United Kingdom

Romania7 sites

  • MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 1703)

    Bucharest, Bucharest, 013823

  • Spitalul Clinic Colțea ( Site 1708)

    Bucharest, Bucharest, 030171

  • Cardiomed SRL Cluj-Napoca ( Site 1701)

    Cluj-Napoca, Cluj, 400015

  • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1702)

    Cluj-Napoca, Cluj, 400015

  • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1704)

    Craiova, Dolj, 200542

  • S.C. Radiotherapy Center Cluj S.R.L ( Site 1706)

    Floreşti, Cluj, 407280

  • Cabinet Medical Oncomed ( Site 1707)

    Timișoara, Timiș County, 300239

Other trials in Romania

Spain7 sites

  • Centro Oncologico de Galicia ( Site 0706)

    A Coruña, Galicia, 15009

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 0707)

    Barcelona, Catalonia, 08036

  • Hospital Universitari Vall d Hebron ( Site 0701)

    Barcelona, 08035

  • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0700)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Ramon y Cajal ( Site 0705)

    Madrid, 28034

  • Hospital Virgen de la Victoria ( Site 0702)

    Málaga, 29010

  • Hospital General de Valencia ( Site 0703)

    Valencia, Valenciana, Comunitat, 46014

Other trials in Spain

Taiwan7 sites

  • Chang Gung Medical Foundation - Kaohsiung ( Site 1204)

    Kaohsiung City, 83301

  • China Medical University Hospital ( Site 1205)

    Taichung, 404332

  • Taichung Veterans General Hospital ( Site 1206)

    Taichung, 407

  • National Cheng Kung University Hospital ( Site 1202)

    Tainan, 704

  • National Taiwan University Hospital ( Site 1200)

    Taipei, 10048

  • Taipei Veterans General Hospital ( Site 1201)

    Taipei, 11217

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 1203)

    Taoyuan, 333

Other trials in Taiwan

Australia6 sites

  • Royal Adelaide Hospital ( Site 0110)

    Adelaide, South Australia, 5000

  • Monash Health ( Site 0102)

    Clayton, Victoria, 3168

  • The Townsville Hospital ( Site 0107)

    Douglas, Queensland, 4814

  • Gallipoli Medical Research Ltd-GMRF CTU ( Site 0105)

    Greenslopes, Queensland, 4120

  • Mid North Coast Cancer Institute ( Site 0109)

    Port Macquarie, New South Wales, 2444

  • Blacktown Hospital ( Site 0101)

    Sydney, New South Wales, 2148

Other trials in Australia

France6 sites

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 0510)

    Clermont-Ferrand, Puy-de-Dome, 63003

  • Hopital La Timone ( Site 0503)

    Marseille, Bouches-du-Rhone, 13385

  • Centre de Cancerologie du Grand Montpellier ( Site 0508)

    Montpellier, Herault, 34070

  • Institut Curie ( Site 0500)

    Paris, 75005

  • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0509)

    Rouen, Seine-Maritime, 76038

  • Institut Gustave Roussy ( Site 0505)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Canada4 sites

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0304)

    Calgary, Alberta, T2N 5G2

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0307)

    Hamilton, Ontario, L8V 5C2

  • Sunnybrook Research Institute ( Site 0308)

    Toronto, Ontario, M4N 3M5

  • BC Cancer-Vancouver Center ( Site 0306)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Colombia4 sites

  • Administradora Country S.A.S - Clínica del Country ( Site 0407)

    Bogotá, Cundinamarca, 110221

  • Instituto de Cancerología ( Site 0408)

    Medellín, Antioquia, 50034

  • IMAT S.A.S ( Site 0409)

    Montería, Departamento de Córdoba, 230002

  • Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0404)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Israel4 sites

  • Soroka Medical Center-Oncology ( Site 0604)

    Beersheba, 8400000

  • Rambam Health Care Campus-Oncology Division ( Site 0602)

    Haifa, 3109601

  • Hadassah Medical Center. Ein Kerem ( Site 0601)

    Jerusalem, 9112001

  • Chaim Sheba Medical Center ( Site 0600)

    Ramat Gan, 5265601

Other trials in Israel

South Korea4 sites

  • Seoul National University Bundang Hospital ( Site 1801)

    Seongnam, Kyonggi-do, 13620

  • Severance Hospital Yonsei University Health System ( Site 1800)

    Seoul, 03722

  • Samsung Medical Center ( Site 1803)

    Seoul, 06351

  • Ajou University Hospital ( Site 1802)

    Suwon, Kyonggi-do, 16499

Other trials in South Korea

Brazil2 sites

  • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0806)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • A. C. Camargo Cancer Center ( Site 0809)

    São Paulo, 01509-010

Other trials in Brazil

Portugal2 sites

  • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1400)

    Porto, 4200-072

  • Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1401)

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Denmark1 site

  • Rigshospitalet University Hospital Copenhagen ( Site 1000)

    Copenhagen, Capital Region, 2100

Other trials in Denmark

Norway1 site

  • Oslo universitetssykehus, Radiumhospitalet ( Site 1102)

    Oslo, 0379

Other trials in Norway

About this study

Official title: A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors) (LEAP-009)

Researchers are looking for new ways to treat people with head and neck cancer whose cancer has come back after treatment (recurrent) or whose cancer has spread to other parts of the body (metastatic). Some people with recurrent or metastatic head and neck cancer are treated with chemotherapy and immunotherapy, but the cancer gets worse.

The goal of this study is to learn if more people who receive lenvatinib and pembrolizumab have a better overall survival rate than people who receive standard chemotherapy treatment.

Read the detailed description

With Amendment 7, participants will discontinue lenvatinib and pembrolizumab and lenvatinib monotherapy, unless discussed with the Sponsor.

A protocol-specified periodic safety review was completed with a data cut-off of 31-May-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 34 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.

Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, 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.

  • LenvatinibDrug

    Also called LENVIMA®, MK-7902, E7080

    20 mg once daily, taken as oral capsules

  • PembrolizumabBiological

    Also called KEYTRUDA®, MK-3475, SCH 900475

    200 mg 30-minute IV infusion on day 1 of each 21-day cycle

  • DocetaxelDrug

    Also called TAXOTERE®

    75 mg/m^2 administered as an IV infusion on day 1 of each 21-day cycle

  • CapecitabineDrug

    Also called Xeloda®

    1250 mg/m^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets

  • PaclitaxelDrug

    Also called Taxol

    80 mg/m^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle

  • CetuximabDrug

    Also called ERBITUX®

    400 mg/m^2 loading dose, followed by 250 mg/m^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle

  • LenvatinibDrug

    Also called LENVIMA®, MK-7902, E7080

    24 mg once daily, taken as oral capsules

Study groups in NCT04428151
Study groupRoleWhat they receive
Lenvatinib + PembrolizumabExperimentalParticipants will be treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met. Participants may receive up to an additional 17 cycles of pembrolizumab as Second Course treatment, with or without lenvatinib.
Receives: Drug: Lenvatinib; Biological: Pembrolizumab
SOC ChemotherapyActive comparatorParticipants will be treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.
Receives: Drug: Docetaxel; Drug: Capecitabine; Drug: Paclitaxel; Drug: Cetuximab
Lenvatinib MonotherapyActive comparatorParticipants will be treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.
Receives: Drug: Lenvatinib

What is being measured

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

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 45 months

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. 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. Note: The appearance of one or more new lesions was also considered PD.

    Measured: Up to approximately 45 months

  2. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants who had a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

    Measured: Up to approximately 45 months

  3. Duration of Response (DOR)

    DOR was defined as the time from the first documented evidence of complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Responses were according to modified RECIST 1.1 as assessed by BICR.

    Measured: Up to approximately 45 months

  4. Number of Participants Who Experienced One or More Adverse Events (AEs)

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE was presented.

    Measured: Up to approximately 5 years

  5. Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE was presented.

    Measured: Up to approximately 5 years

Timeline

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

  1. First posted11 Jun 2020
  2. Study start6 Aug 2020
  3. Primary completion31 May 2024
  4. Study completion30 Oct 2025

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04428151
Sponsor's protocol ID
7902-009
Other IDs
LEAP-009, E7080-G000-228, MK-7902-009, 2022-500820-31-00, U1111-1278-2707, 2019-000569-19, 2019
Status last verified
Nov 2025
First submitted
9 Jun 2020
Last updated
4 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

    PubMed 33300372

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib, Pembrolizumab and Docetaxel in people with Squamous Cell Carcinoma of Head and Neck, run by Merck Sharp & Dohme LLC at 120 sites in 15 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 18 inclusion and 23 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, United Kingdom, Romania, Spain, Taiwan and 10 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 25 May 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?

Overall Survival (OS) (time frame: Up to approximately 45 months). 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 NCT04428151, which also lists 1 linked publication.

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 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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