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A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010) (LEAP-10)

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenvatinib
Pembrolizumab
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring head and neck squamous cell carcinoma, pembrolizumab, lenvatinib, PD-L1

Eligibility Criteria

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

Inclusion Criteria:

  • Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.

Note: Participants with newly-diagnosed HNSCC must be M1/Stage IV.

  • Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.

Note: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.

Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.

  • Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, 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/placebo, whichever occurs last
  • Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions.
  • Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
  • Has adequately controlled blood pressure with or without antihypertensive medications.
  • Has adequate organ function.

Exclusion Criteria:

  • Has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (≥Grade 3) or lenvatinib.
  • Has pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
  • Has a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption.
  • Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident/transient ischemic attack (TIA)/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability.
  • Has disease that is suitable for local therapy administered with curative intent.
  • Had PD within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
  • Has had major surgery within 3 weeks before to first dose of study interventions.
  • Has difficulty swallowing capsules or ingesting a suspension orally or by a feeding tube.
  • Has received prior therapy with lenvatinib or pembrolizumab.
  • Received last dose of systemic therapy for locoregionally advanced disease less than 6 months before signing consent.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
  • Has received prior radiotherapy within 2 weeks of start of study intervention.
  • Has received a live vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention-administration.
  • 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 intervention.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.

Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.

  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.).
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection.
  • 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 intervention.
  • Has had an allogenic tissue/solid organ transplant.
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.

Sites / Locations

  • California Cancer Associates for Research & Excellence ( Site 0025)
  • California Cancer Associates for Research & Excellence ( Site 0059)
  • University of Colorado Cancer Center ( Site 0023)
  • University of Connecticut Health Center ( Site 0020)
  • Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069)
  • Georgia Cancer Center at Augusta University ( Site 0013)
  • Northwest Georgia Oncology Centers PC ( Site 0028)
  • University of Kansas Cancer Center ( Site 0033)
  • University of Louisville, James Graham Brown Cancer Center ( Site 0045)
  • Dana Farber Cancer Institute ( Site 0019)
  • University of Michigan ( Site 0064)
  • Karmanos Cancer Institute ( Site 0054)
  • Henry Ford Health System ( Site 0001)
  • Washington University School of Medicine ( Site 0060)
  • St. Vincent Frontier Cancer Center ( Site 0008)
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053)
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002)
  • Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040)
  • SUNY Upstate Medical University ( Site 0051)
  • University of North Carolina- Chapel Hill ( Site 0056)
  • Duke Cancer Center ( Site 0044)
  • Providence Portland Medical Center ( Site 0048)
  • Blue Ridge Cancer Care ( Site 0015)
  • Inova Schar Cancer Institute ( Site 0009)
  • Cancer Care Northwest ( Site 0017)
  • University of Wisconsin- Madison Carbone Cancer Center ( Site 0006)
  • Chris OBrien Lifehouse ( Site 1002)
  • St George Hospital ( Site 1001)
  • Royal Adelaide Hospital ( Site 1004)
  • Oncocentro Ceara ( Site 0412)
  • Fundacao Sao Francisco Xavier ( Site 0409)
  • ELO Pesquisa Clinica ( Site 0405)
  • Hospital de Passo Fundo ( Site 0401)
  • Clinica LACKS ( Site 0402)
  • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0414)
  • A.C. Camargo Cancer Center ( Site 0407)
  • Princess Margaret Cancer Centre ( Site 0200)
  • McGill University Health Centre ( Site 0206)
  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
  • Beijing Cancer Hospital ( Site 3314)
  • Peking Union Medical College Hospital ( Site 3304)
  • Chongqing Cancer Hospital ( Site 3327)
  • Fujian Provincial Cancer Hospital ( Site 3326)
  • Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)
  • Guizhou Cancer Hospital ( Site 3330)
  • The Third Affiliated Hospital of Harbin Medical University ( Site 3302)
  • Henan Cancer Hospital ( Site 3309)
  • Wuhan Union hospital Cancer Center ( Site 3307)
  • Tongji Hospital Tongji Medical,Science & Technology ( Site 3316)
  • Hunan Cancer Hospital ( Site 3311)
  • Xiangya Hospital of Central South University ( Site 3305)
  • Jiangxi Cancer Hospital ( Site 3313)
  • Jilin Cancer Hospital ( Site 3310)
  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328)
  • Fudan University Shanghai Cancer Center ( Site 3324)
  • Shanghai East Hospital ( Site 3300)
  • West China Hospital of Sichuan University ( Site 3308)
  • Tianjin Medical University Cancer Hospital ( Site 3312)
  • Zhejiang Cancer Hospital ( Site 3303)
  • Centre Leon Berard ( Site 1901)
  • Hopital de la Timone ( Site 1903)
  • Hopital Foch ( Site 1905)
  • Centre Henri Becquerel ( Site 1904)
  • Gustave Roussy ( Site 1906)
  • Universitaetsklinikum Tuebingen ( Site 2108)
  • Universitaetsklinikum Ulm ( Site 2102)
  • Universitaetsklinikum Regensburg ( Site 2100)
  • Universitaetsklinikum Frankfurt ( Site 2107)
  • KRH Klinikum Siloah ( Site 2103)
  • Universitaetsklinikum Koeln ( Site 2111)
  • Universitätsklinikum Leipzig-Department for ENT ( Site 2106)
  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112)
  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
  • Szegedi Egyetem Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2207)
  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 2200)
  • Uzsoki Utcai Korhaz ( Site 2201)
  • Orszagos Onkologiai Intezet ( Site 2202)
  • Debreceni Egyetem Klinikai Kozpont ( Site 2206)
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 2402)
  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2400)
  • IEO Istituto Europeo di Oncologia ( Site 2406)
  • ASST Santi Paolo e Carlo - Presidio Ospedaliero San Paolo ( Site 2405)
  • Istituto Oncologico Veneto ( Site 2404)
  • ASL Liguria 2 - Ospedale San Paolo ( Site 2401)
  • Aichi Cancer Center Hospital ( Site 1113)
  • Nagoya University Hospital ( Site 1106)
  • Chiba cancer center ( Site 1110)
  • National Cancer Center Hospital East ( Site 1100)
  • Hyogo Cancer Center ( Site 1112)
  • Kagawa University Hospital ( Site 1108)
  • Yokohama City University Hospital ( Site 1104)
  • Kindai University Hospital ( Site 1107)
  • Shizuoka Cancer Center Hospital and Research Institute ( Site 1105)
  • National Hospital Organization Kyushu Medical Center ( Site 1111)
  • Hiroshima University Hospital ( Site 1109)
  • National Cancer Center Hospital ( Site 1102)
  • The Cancer Institute Hospital of JFCR ( Site 1103)
  • Tokyo Medical and Dental University Hospital ( Site 1101)
  • Chonnam National University Hwasun Hospital ( Site 1202)
  • Seoul National University Bundang Hospital ( Site 1205)
  • Ajou University Hospital ( Site 1200)
  • Asan Medical Center ( Site 1201)
  • Keimyung University Dongsan Hospital ( Site 1203)
  • The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1204)
  • Cryptex Investigación Clínica S.A. de C.V. ( Site 0608)
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0602)
  • Christus Muguerza Clinica Vidriera ( Site 0607)
  • Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0604)
  • Oaxaca Site Management Organization S.C. ( Site 0603)
  • Instituto Nacional de Enfermedades Neoplasicas ( Site 0701)
  • Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700)
  • Hospital Nacional Edgardo Rebagliati Martins ( Site 0702)
  • Hospital Nacional Arzobispo Loayza ( Site 0703)
  • Hospital Nacional Cayetano Heredia ( Site 0704)
  • Dolnoslaskie Centrum Onkologii. ( Site 2507)
  • Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508)
  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2502)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Glowy i Szyi ( Site
  • Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2504)
  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506)
  • Przychodnia Lekarska Komed ( Site 2500)
  • Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 2509)
  • Altay Regional Oncology Dispensary ( Site 2611)
  • FSCC FMBA of Russia ( Site 2603)
  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609)
  • Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605)
  • Hospital Duran i Reynals ( Site 2701)
  • H.U. Vall de Hebron ( Site 2700)
  • Hospital Universitario 12 de Octubre ( Site 2702)
  • Hospital Universitario La Paz ( Site 2706)
  • Hospital de Valme ( Site 2705)
  • Hospital Clinico Universitario Lozano Blesa ( Site 2703)
  • National Cheng Kung University Hospital ( Site 1603)
  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604)
  • National Taiwan University Hospital ( Site 1600)
  • MacKay Memorial Hospital ( Site 1602)
  • Taipei Veterans General Hospital ( Site 1601)
  • Hacettepe Universitesi Tip Fakultesi ( Site 2805)
  • Ankara Sehir Hastanesi ( Site 2802)
  • Trakya Universitesi Tip Fakultesi ( Site 2801)
  • Medipol Universite Hastanesi ( Site 2800)
  • Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804)
  • Medical Park Izmir Hospital ( Site 2807)
  • Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803)
  • Aberdeen Royal Infirmary ( Site 2905)
  • Guy's Hospital in London ( Site 2908)
  • Royal Marsden NHS Foundation Trust ( Site 2910)
  • Mount Vernon Cancer Centre ( Site 2902)
  • Royal Marsden Hospital ( Site 2904)
  • Nottingham City Hospital ( Site 2907)
  • Taunton and Somerset Hospital ( Site 2900)
  • Christie NHS Foundation Trust ( Site 2903)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab with Lenvatinib

Pembrolizumab with Placebo

Arm Description

Participants receive lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.

Participants receive lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months).

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experience a CR or PR based on modified RECIST 1.1 will be presented.
Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥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 ≥5 mm. Note: The appearance of one or more new lesions is also considered PD.
Overall Survival (OS)
OS is the time from randomization to death due to any cause.

Secondary Outcome Measures

Duration of Response (DOR)
For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death.
Number of Participants Who Experienced an Adverse Event (AE)
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Who Discontinued Study Drug Due to an AE
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Full Information

First Posted
December 12, 2019
Last Updated
September 13, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04199104
Brief Title
A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010)
Acronym
LEAP-10
Official Title
A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
April 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
head and neck squamous cell carcinoma, pembrolizumab, lenvatinib, PD-L1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
511 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab with Lenvatinib
Arm Type
Experimental
Arm Description
Participants receive lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.
Arm Title
Pembrolizumab with Placebo
Arm Type
Active Comparator
Arm Description
Participants receive lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months).
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
E7080, MK-7902, LENVIMA®
Intervention Description
Lenvatinib, 20 mg (two 10-mg oral capsules) administered QD
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, Keytruda®
Intervention Description
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up to 35 3-week cycles
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lenvatinib-matching placebo, oral capsules, administered once daily (QD)
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).
Description
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experience a CR or PR based on modified RECIST 1.1 will be presented.
Time Frame
Up to approximately 24 months
Title
Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥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 ≥5 mm. Note: The appearance of one or more new lesions is also considered PD.
Time Frame
Up to approximately 30 months
Title
Overall Survival (OS)
Description
OS is the time from randomization to death due to any cause.
Time Frame
Up to approximately 44 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death.
Time Frame
Up to approximately 44 months
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame
Up to approximately 44 months
Title
Number of Participants Who Discontinued Study Drug Due to an AE
Description
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame
Up to approximately 44 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies. Note: Participants with newly-diagnosed HNSCC must be M1/Stage IV. Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx. Note: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed. Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, 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/placebo, whichever occurs last Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions. Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status. Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1. Has adequately controlled blood pressure with or without antihypertensive medications. Has adequate organ function. Exclusion Criteria: Has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (≥Grade 3) or lenvatinib. Has pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula. Has a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption. Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident/transient ischemic attack (TIA)/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability. Has disease that is suitable for local therapy administered with curative intent. Had PD within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC. Has had major surgery within 3 weeks before to first dose of study interventions. Has difficulty swallowing capsules or ingesting a suspension orally or by a feeding tube. Has received prior therapy with lenvatinib or pembrolizumab. Received last dose of systemic therapy for locoregionally advanced disease less than 6 months before signing consent. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137). Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Has received prior radiotherapy within 2 weeks of start of study intervention. Has received a live vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention-administration. 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 intervention. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.). Has a known history of human immunodeficiency virus (HIV) infection. Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection. 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 intervention. Has had an allogenic tissue/solid organ transplant. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, MD
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
California Cancer Associates for Research & Excellence ( Site 0025)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
California Cancer Associates for Research & Excellence ( Site 0059)
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
Facility Name
University of Colorado Cancer Center ( Site 0023)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Connecticut Health Center ( Site 0020)
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Georgia Cancer Center at Augusta University ( Site 0013)
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC ( Site 0028)
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Kansas Cancer Center ( Site 0033)
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Louisville, James Graham Brown Cancer Center ( Site 0045)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Dana Farber Cancer Institute ( Site 0019)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan ( Site 0064)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5936
Country
United States
Facility Name
Karmanos Cancer Institute ( Site 0054)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System ( Site 0001)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School of Medicine ( Site 0060)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Vincent Frontier Cancer Center ( Site 0008)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002)
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
SUNY Upstate Medical University ( Site 0051)
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
University of North Carolina- Chapel Hill ( Site 0056)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke Cancer Center ( Site 0044)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Providence Portland Medical Center ( Site 0048)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Blue Ridge Cancer Care ( Site 0015)
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
Inova Schar Cancer Institute ( Site 0009)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Cancer Care Northwest ( Site 0017)
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
University of Wisconsin- Madison Carbone Cancer Center ( Site 0006)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Chris OBrien Lifehouse ( Site 1002)
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
St George Hospital ( Site 1001)
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Royal Adelaide Hospital ( Site 1004)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Oncocentro Ceara ( Site 0412)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60135-237
Country
Brazil
Facility Name
Fundacao Sao Francisco Xavier ( Site 0409)
City
Ipatinga
State/Province
Minas Gerais
ZIP/Postal Code
35162-189
Country
Brazil
Facility Name
ELO Pesquisa Clinica ( Site 0405)
City
Maringa
State/Province
Parana
ZIP/Postal Code
87015-200
Country
Brazil
Facility Name
Hospital de Passo Fundo ( Site 0401)
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
Clinica LACKS ( Site 0402)
City
Pelotas
State/Province
Rio Grande Do Sul
ZIP/Postal Code
96020-080
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0414)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
A.C. Camargo Cancer Center ( Site 0407)
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Princess Margaret Cancer Centre ( Site 0200)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Facility Name
McGill University Health Centre ( Site 0206)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Beijing Cancer Hospital ( Site 3314)
City
Beining
State/Province
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Peking Union Medical College Hospital ( Site 3304)
City
Bejiing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Chongqing Cancer Hospital ( Site 3327)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Fujian Provincial Cancer Hospital ( Site 3326)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Facility Name
Guizhou Cancer Hospital ( Site 3330)
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550003
Country
China
Facility Name
The Third Affiliated Hospital of Harbin Medical University ( Site 3302)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital ( Site 3309)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Wuhan Union hospital Cancer Center ( Site 3307)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Tongji Hospital Tongji Medical,Science & Technology ( Site 3316)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Hunan Cancer Hospital ( Site 3311)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Xiangya Hospital of Central South University ( Site 3305)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Jiangxi Cancer Hospital ( Site 3313)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Facility Name
Jilin Cancer Hospital ( Site 3310)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328)
City
XI An
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Fudan University Shanghai Cancer Center ( Site 3324)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai East Hospital ( Site 3300)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
West China Hospital of Sichuan University ( Site 3308)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610047
Country
China
Facility Name
Tianjin Medical University Cancer Hospital ( Site 3312)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Zhejiang Cancer Hospital ( Site 3303)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Centre Leon Berard ( Site 1901)
City
Lyon
State/Province
Auvergne
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital de la Timone ( Site 1903)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13005
Country
France
Facility Name
Hopital Foch ( Site 1905)
City
Suresnes
State/Province
Hauts-de-Seine
ZIP/Postal Code
92151
Country
France
Facility Name
Centre Henri Becquerel ( Site 1904)
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76038
Country
France
Facility Name
Gustave Roussy ( Site 1906)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Universitaetsklinikum Tuebingen ( Site 2108)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm ( Site 2102)
City
Ulm
State/Province
Baden-Wurttemberg
ZIP/Postal Code
89075
Country
Germany
Facility Name
Universitaetsklinikum Regensburg ( Site 2100)
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt ( Site 2107)
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
KRH Klinikum Siloah ( Site 2103)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30459
Country
Germany
Facility Name
Universitaetsklinikum Koeln ( Site 2111)
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Leipzig-Department for ENT ( Site 2106)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szegedi Egyetem Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2207)
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 2200)
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz ( Site 2201)
City
Budapest
State/Province
Vas
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet ( Site 2202)
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont ( Site 2206)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 2402)
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2400)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
IEO Istituto Europeo di Oncologia ( Site 2406)
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
ASST Santi Paolo e Carlo - Presidio Ospedaliero San Paolo ( Site 2405)
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Istituto Oncologico Veneto ( Site 2404)
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
ASL Liguria 2 - Ospedale San Paolo ( Site 2401)
City
Savona
ZIP/Postal Code
17100
Country
Italy
Facility Name
Aichi Cancer Center Hospital ( Site 1113)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4648681
Country
Japan
Facility Name
Nagoya University Hospital ( Site 1106)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Chiba cancer center ( Site 1110)
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 1100)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Hyogo Cancer Center ( Site 1112)
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kagawa University Hospital ( Site 1108)
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Yokohama City University Hospital ( Site 1104)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2360064
Country
Japan
Facility Name
Kindai University Hospital ( Site 1107)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Shizuoka Cancer Center Hospital and Research Institute ( Site 1105)
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center ( Site 1111)
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Hiroshima University Hospital ( Site 1109)
City
Hiroshima
ZIP/Postal Code
7348551
Country
Japan
Facility Name
National Cancer Center Hospital ( Site 1102)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR ( Site 1103)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital ( Site 1101)
City
Tokyo
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital ( Site 1202)
City
Hwasun-gun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 1205)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Ajou University Hospital ( Site 1200)
City
Suwon-si
State/Province
Kyonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 1201)
City
Songpa-gu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital ( Site 1203)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1204)
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
Cryptex Investigación Clínica S.A. de C.V. ( Site 0608)
City
Cuauhtémoc, Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06100
Country
Mexico
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0602)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Christus Muguerza Clinica Vidriera ( Site 0607)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64570
Country
Mexico
Facility Name
Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0604)
City
Cancun
State/Province
Quintana Roo
ZIP/Postal Code
77500
Country
Mexico
Facility Name
Oaxaca Site Management Organization S.C. ( Site 0603)
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Instituto Nacional de Enfermedades Neoplasicas ( Site 0701)
City
Lima
State/Province
Muni Metro De Lima
ZIP/Postal Code
Lima 34
Country
Peru
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700)
City
Lima
ZIP/Postal Code
15033
Country
Peru
Facility Name
Hospital Nacional Edgardo Rebagliati Martins ( Site 0702)
City
Lima
ZIP/Postal Code
15072
Country
Peru
Facility Name
Hospital Nacional Arzobispo Loayza ( Site 0703)
City
Lima
ZIP/Postal Code
15082
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia ( Site 0704)
City
Lima
ZIP/Postal Code
15102
Country
Peru
Facility Name
Dolnoslaskie Centrum Onkologii. ( Site 2507)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2502)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Glowy i Szyi ( Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2504)
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506)
City
Gliwice
State/Province
Slaskie
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Przychodnia Lekarska Komed ( Site 2500)
City
Konin
State/Province
Wielkopolskie
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 2509)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-780
Country
Poland
Facility Name
Altay Regional Oncology Dispensary ( Site 2611)
City
Barnaul
State/Province
Altayskiy Kray
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
FSCC FMBA of Russia ( Site 2603)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605)
City
Yaroslavl
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Hospital Duran i Reynals ( Site 2701)
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
H.U. Vall de Hebron ( Site 2700)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre ( Site 2702)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz ( Site 2706)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital de Valme ( Site 2705)
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa ( Site 2703)
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
National Cheng Kung University Hospital ( Site 1603)
City
Taiwan
State/Province
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604)
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 1600)
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
MacKay Memorial Hospital ( Site 1602)
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Taipei Veterans General Hospital ( Site 1601)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Hacettepe Universitesi Tip Fakultesi ( Site 2805)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Ankara Sehir Hastanesi ( Site 2802)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi ( Site 2801)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Medipol Universite Hastanesi ( Site 2800)
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804)
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Medical Park Izmir Hospital ( Site 2807)
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Facility Name
Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803)
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Aberdeen Royal Infirmary ( Site 2905)
City
Aberdeen
State/Province
Aberdeen City
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Guy's Hospital in London ( Site 2908)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust ( Site 2910)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre ( Site 2902)
City
Northwood
State/Province
London, City Of
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Royal Marsden Hospital ( Site 2904)
City
Sutton
State/Province
London, City Of
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Nottingham City Hospital ( Site 2907)
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Taunton and Somerset Hospital ( Site 2900)
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Christie NHS Foundation Trust ( Site 2903)
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
33300372
Citation
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.
Results Reference
derived
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010)

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