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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)

Primary Purpose

Squamous Cell Carcinoma of Head and Neck

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Lenvatinib

Pembrolizumab

Docetaxel

Capecitabine

Paclitaxel

Cetuximab

Lenvatinib

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

Eligibility Criteria

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

Inclusion Criteria:

Pathologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) 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 an anti-PD-1/PD-L1 mAb (programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody)
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 CT or 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
ECOG performance status of 0 or 1 assessed within 7 days of the first dose of study intervention
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 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

Exclusion Criteria:

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
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

Sites / Locations

City of Hope ( Site 1519)Recruiting
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)Recruiting
Yale-New Haven Hospital-Yale Cancer Center ( Site 1505)Recruiting
UF Health ( Site 1554)Recruiting
Mid Florida Hematology and Oncology Center ( Site 1606)Recruiting
Cleveland Clinic Florida ( Site 1596)Recruiting
Georgia Cancer Center at Augusta University ( Site 1575)
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521)Recruiting
Beacon Cancer Care ( Site 1599)Recruiting
Rush University Medical Center ( Site 1560)Recruiting
NorthShore University HealthSystem - Evanston Hospital ( Site 1614)Recruiting
IU Health Ball Memorial Hospital, Inc.-IU Health Ball Memorial Cancer Center ( Site 1612)Recruiting
University of Iowa ( Site 1572)Recruiting
University of Kansas Cancer Center ( Site 1538)Recruiting
Norton Hospital-Norton Cancer Institute - Downtown ( Site 1601)Recruiting
Mercy Health-Paducah Medical Oncology and Hematology ( Site 1623)Recruiting
Our Lady of the Lake RMC-Clinical Research ( Site 1624)Recruiting
Mary Bird Perkins Cancer Center Baton Rouge ( Site 1622)Recruiting
University of Maryland Greenebaum Cancer Center ( Site 1522)Recruiting
Boston Medical Center ( Site 1605)Recruiting
University of Massachusetts Chan Medical School ( Site 1616)Recruiting
VA Ann Arbor Healthcare System ( Site 1584)Recruiting
Barbara Ann Karmanos Cancer Institute ( Site 1566)Recruiting
Henry Ford Health System ( Site 1544)Recruiting
Hattiesburg Clinic ( Site 1515)
Jackson Oncology Associates, PLLC-Clinical Trials ( Site 1625)Recruiting
Washington University School of Medicine ( Site 1500)
St. Vincent Frontier Cancer Center ( Site 1507)Recruiting
University Of Nebraska Medical Center ( Site 1570)
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1555)
Rutgers Cancer Institute of New Jersey ( Site 1523)Recruiting
Perlmutter Cancer Center at Winthrop Oncology Hematology Associates NYU Langone Health ( Site 1597)
Laura and Isaac Perlmutter Cancer Center ( Site 1582)
Levine Cancer Institute ( Site 1590)
Duke Cancer Institute ( Site 1541)Recruiting
University of Cincinnati ( Site 1567)Recruiting
University Hospital Cleveland ( Site 1578)Recruiting
Cleveland Clinic ( Site 1598)Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1508)
Gettysburg Cancer Center ( Site 1594)
Penn State Hershey Medical Center ( Site 1561)Recruiting
Fox Chase Cancer Center ( Site 1502)Recruiting
Medical University of South Carolina ( Site 1579)Recruiting
St Francis Cancer Center-Research Office ( Site 1607)Recruiting
The Center For Cancer And Blood Disorders ( Site 1569)
Utah Cancer Specialists ( Site 1621)Recruiting
Huntsman Cancer Institute ( Site 1532)Recruiting
Inova Schar Cancer Institute ( Site 1550)Recruiting
Hematology Oncology Associates of Fredericksburg ( Site 1537)Recruiting
MultiCare Health System-MultiCare Oncology - Puget Sound ( Site 1609)Recruiting
Medical College of Wisconsin Clinical Cancer Center ( Site 1574)Recruiting
Blacktown Hospital ( Site 0101)Recruiting
Mid North Coast Cancer Institute ( Site 0109)
Gallipoli Medical Research Foundation-GMRF CTU ( Site 0105)Recruiting
The Townsville Hospital ( Site 0107)Recruiting
Royal Adelaide Hospital ( Site 0110)Recruiting
Monash Health ( Site 0102)Recruiting
Tom Baker Cancer Centre ( Site 0304)Recruiting
BC Cancer-Vancouver Center ( Site 0306)
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0307)Recruiting
Instituto de Cancerología ( Site 0408)Recruiting
Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0404)Recruiting
Oncomédica S.A.S ( Site 0409)Recruiting
Administradora Country S.A.S - Clínica del Country ( Site 0407)Recruiting
Rigshospitalet University Hospital Copenhagen ( Site 1000)Recruiting
Hopital La Timone ( Site 0503)Recruiting
Centre de Cancerologie du Grand Montpellier ( Site 0508)Recruiting
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 0510)Recruiting
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0509)Recruiting
Institut Gustave Roussy ( Site 0505)Recruiting
Institut Curie ( Site 0500)Recruiting
Soroka Medical Center-Oncology ( Site 0604)Recruiting
Rambam Health Care Campus-Oncology Division ( Site 0602)Recruiting
Hadassah Medical Center. Ein Kerem ( Site 0601)Recruiting
Chaim Sheba Medical Center ( Site 0600)
Seoul National University Bundang Hospital ( Site 1801)Recruiting
Ajou University Hospital ( Site 1802)
Severance Hospital Yonsei University Health System ( Site 1800)Recruiting
Samsung Medical Center ( Site 1803)Recruiting
Oslo universitetssykehus, Radiumhospitalet ( Site 1102)Recruiting
Centro Hospitalar Vila Nova de Gaia. Espinho EPE ( Site 1401)Recruiting
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1400)Recruiting
Spitalul Clinic Colțea ( Site 1708)Recruiting
Cardiomed SRL Cluj-Napoca ( Site 1701)Recruiting
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1702)Recruiting
S.C. Radiotherapy Center Cluj S.R.L ( Site 1706)Recruiting
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1704)Recruiting
Cabinet Medical Oncomed ( Site 1707)Recruiting
S.C.Focus Lab Plus S.R.L ( Site 1703)Recruiting
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0700)Recruiting
HOSPITAL CLÍNIC DE BARCELONA ( Site 0707)Recruiting
Centro Oncologico de Galicia ( Site 0706)Recruiting
Hospital General de Valencia ( Site 0703)Recruiting
Hospital Universitari Vall d Hebron ( Site 0701)
Hospital Ramon y Cajal ( Site 0705)Recruiting
Hospital Virgen de la Victoria ( Site 0702)Recruiting
Chang Gung Memorial Hospital - Linkou Branch ( Site 1203)Recruiting
Chang Gung Medical Foundation - Kaohsiung ( Site 1204)Recruiting
China Medical University Hospital ( Site 1205)Recruiting
Taichung Veterans General Hospital ( Site 1206)Recruiting
National Cheng Kung University Hospital ( Site 1202)Recruiting
National Taiwan University Hospital ( Site 1200)Recruiting
Taipei Veterans General Hospital ( Site 1201)Recruiting
Aberdeen Royal Infirmary ( Site 0911)Recruiting
Castle Hill Hospital ( Site 0910)
The Beatson West of Scotland Cancer Centre ( Site 0909)Recruiting
Guy s and St Thomas Hospital NHS Foundation Trust ( Site 0903)Recruiting
University Hospital Southampton NHS Foundation Trust ( Site 0905)Recruiting
Royal Marsden Hospital ( Site 0902)Recruiting
Charing Cross Hospital ( Site 0908)
Musgrove Park Hospital ( Site 0904)Recruiting
Royal Marsden Hospital. ( Site 0901)Recruiting
The Christie NHS Foundation Trust ( Site 0907)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Lenvatinib + Pembrolizumab

SOC Chemotherapy

Lenvatinib Monotherapy

Arm Description

Participants 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.

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters 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 occurs first. Responses are according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).

Secondary Outcome Measures

Progression-Free Survival (PFS)

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).

Overall Survival (OS)

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

Duration of Response (DOR)

DOR is 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 occurs first. Responses are according to modified RECIST 1.1 as assessed by BICR.

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

An AE is 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 will be presented.

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

Full Information

NCT ID

NCT04428151

First Posted

June 9, 2020

Last Updated

October 18, 2023

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04428151

Brief Title

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)

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 6, 2020 (Actual)

Primary Completion Date

August 18, 2024 (Anticipated)

Study Completion Date

August 18, 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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of Head and Neck

Keywords

Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lenvatinib + Pembrolizumab

Arm Type

Experimental

Arm Description

Arm Title

SOC Chemotherapy

Arm Type

Active Comparator

Arm Description

Arm Title

Lenvatinib Monotherapy

Arm Type

Active Comparator

Arm Description

Participants 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.

Intervention Type

Drug

Intervention Name(s)

Lenvatinib

Other Intervention Name(s)

LENVIMA®, MK-7902, E7080

Intervention Description

20 mg once daily, taken as oral capsules

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

KEYTRUDA®, MK-3475, SCH 900475

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

TAXOTERE®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Taxol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

ERBITUX®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lenvatinib

Other Intervention Name(s)

LENVIMA®, MK-7902, E7080

Intervention Description

24 mg once daily, taken as oral capsules

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Time Frame

Up to approximately 4 years

Secondary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

Time Frame

Up to approximately 4 years

Title

Overall Survival (OS)

Description

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

Time Frame

Up to approximately 4 years

Title

Duration of Response (DOR)

Description

Time Frame

Up to approximately 4 years

Title

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

Description

Time Frame

Up to approximately 4 years

Title

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

Description

Time Frame

Up to approximately 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) 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 an anti-PD-1/PD-L1 mAb (programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody) 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 CT or 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 ECOG performance status of 0 or 1 assessed within 7 days of the first dose of study intervention 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 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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Toll Free Number

Phone

1-888-577-8839

Trialsites@merck.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

City of Hope ( Site 1519)

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

626-256-4673

Facility Name

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

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

310-794-4955

Facility Name

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

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

203-737-7981

Facility Name

UF Health ( Site 1554)

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

352-265-0725

Facility Name

Mid Florida Hematology and Oncology Center ( Site 1606)

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

386-774-1223

Facility Name

Cleveland Clinic Florida ( Site 1596)

City

Weston

State/Province

Florida

ZIP/Postal Code

33331

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

786-413-9673

Facility Name

Georgia Cancer Center at Augusta University ( Site 1575)

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Individual Site Status

Completed

Facility Name

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

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

770-812-1928

Facility Name

Beacon Cancer Care ( Site 1599)

City

Post Falls

State/Province

Idaho

ZIP/Postal Code

83854

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

208-755-2408

Facility Name

Rush University Medical Center ( Site 1560)

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

312-563-8756

Facility Name

NorthShore University HealthSystem - Evanston Hospital ( Site 1614)

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

847-570-2515

Facility Name

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

City

Muncie

State/Province

Indiana

ZIP/Postal Code

47303

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

765-751-5850

Facility Name

University of Iowa ( Site 1572)

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

319-335-3500

Facility Name

University of Kansas Cancer Center ( Site 1538)

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

913-588-1227

Facility Name

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

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

502-394-6350

Facility Name

Mercy Health-Paducah Medical Oncology and Hematology ( Site 1623)

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

248-632-0743

Facility Name

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

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

225-765-3344

Facility Name

Mary Bird Perkins Cancer Center Baton Rouge ( Site 1622)

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

225-215-1185

Facility Name

University of Maryland Greenebaum Cancer Center ( Site 1522)

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

410-328-2703

Facility Name

Boston Medical Center ( Site 1605)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

617-638-8265

Facility Name

University of Massachusetts Chan Medical School ( Site 1616)

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

508-856-3216

Facility Name

VA Ann Arbor Healthcare System ( Site 1584)

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

734-769-7100

Facility Name

Barbara Ann Karmanos Cancer Institute ( Site 1566)

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

313-576-8778

Facility Name

Henry Ford Health System ( Site 1544)

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

313-916-2600

Facility Name

Hattiesburg Clinic ( Site 1515)

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39401

Country

United States

Individual Site Status

Completed

Facility Name

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

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

601-355-2485

Facility Name

Washington University School of Medicine ( Site 1500)

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

St. Vincent Frontier Cancer Center ( Site 1507)

City

Billings

State/Province

Montana

ZIP/Postal Code

59102

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

406-238-6290

Facility Name

University Of Nebraska Medical Center ( Site 1570)

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Individual Site Status

Completed

Facility Name

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

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Individual Site Status

Completed

Facility Name

Rutgers Cancer Institute of New Jersey ( Site 1523)

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

732-427-7394

Facility Name

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

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Individual Site Status

Completed

Facility Name

Laura and Isaac Perlmutter Cancer Center ( Site 1582)

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Completed

Facility Name

Levine Cancer Institute ( Site 1590)

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Individual Site Status

Completed

Facility Name

Duke Cancer Institute ( Site 1541)

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

919-681-4768

Facility Name

University of Cincinnati ( Site 1567)

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

513-584-7698

Facility Name

University Hospital Cleveland ( Site 1578)

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

216-844-3951

Facility Name

Cleveland Clinic ( Site 1598)

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

866-223-8100

Facility Name

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

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

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74146

Country

United States

Individual Site Status

Completed

Facility Name

Gettysburg Cancer Center ( Site 1594)

City

Gettysburg

State/Province

Pennsylvania

ZIP/Postal Code

17325

Country

United States

Individual Site Status

Completed

Facility Name

Penn State Hershey Medical Center ( Site 1561)

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

717-531-5471

Facility Name

Fox Chase Cancer Center ( Site 1502)

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

215-214-1515

Facility Name

Medical University of South Carolina ( Site 1579)

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

843-792-9321

Facility Name

St Francis Cancer Center-Research Office ( Site 1607)

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

864-603-6300

Facility Name

The Center For Cancer And Blood Disorders ( Site 1569)

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Individual Site Status

Completed

Facility Name

Utah Cancer Specialists ( Site 1621)

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

801-462-1053

Facility Name

Huntsman Cancer Institute ( Site 1532)

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

801-581-2121

Facility Name

Inova Schar Cancer Institute ( Site 1550)

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031-4867

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

571-472-0624

Facility Name

Hematology Oncology Associates of Fredericksburg ( Site 1537)

City

Fredericksburg

State/Province

Virginia

ZIP/Postal Code

22408

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

540-371-0079 X360

Facility Name

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

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

253-403-0791

Facility Name

Medical College of Wisconsin Clinical Cancer Center ( Site 1574)

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

414-805-4600

Facility Name

Blacktown Hospital ( Site 0101)

City

Blacktown

State/Province

New South Wales

ZIP/Postal Code

2148

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+61402348016

Facility Name

Mid North Coast Cancer Institute ( Site 0109)

City

Port Macquarie

State/Province

New South Wales

ZIP/Postal Code

2444

Country

Australia

Individual Site Status

Completed

Facility Name

Gallipoli Medical Research Foundation-GMRF CTU ( Site 0105)

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4120

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+61733947284

Facility Name

The Townsville Hospital ( Site 0107)

City

Douglas

State/Province

Queensland

ZIP/Postal Code

4814

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+61744331111

Facility Name

Royal Adelaide Hospital ( Site 0110)

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

(08) 70742342

Facility Name

Monash Health ( Site 0102)

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+61385722392

Facility Name

Tom Baker Cancer Centre ( Site 0304)

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

4035213093

Facility Name

BC Cancer-Vancouver Center ( Site 0306)

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Individual Site Status

Completed

Facility Name

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0307)

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V5C2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

9053879495

Facility Name

Instituto de Cancerología ( Site 0408)

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050025

Country

Colombia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

3409393 EXT 5414

Facility Name

Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0404)

City

Valledupar

State/Province

Cesar

ZIP/Postal Code

200001

Country

Colombia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

57 3157411877

Facility Name

Oncomédica S.A.S ( Site 0409)

City

Montería

State/Province

Cordoba

ZIP/Postal Code

230002

Country

Colombia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

3105394868

Facility Name

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

City

Bogotá

State/Province

Cundinamarca

ZIP/Postal Code

110221

Country

Colombia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

3005725172

Facility Name

Rigshospitalet University Hospital Copenhagen ( Site 1000)

City

Copenhagen

State/Province

Hovedstaden

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+4535453545

Facility Name

Hopital La Timone ( Site 0503)

City

Marseille

State/Province

Bouches-du-Rhone

ZIP/Postal Code

13385

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+33491385708

Facility Name

Centre de Cancerologie du Grand Montpellier ( Site 0508)

City

Montpellier

State/Province

Herault

ZIP/Postal Code

34070

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+33467926155

Facility Name

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

City

Clermont-Ferrand

State/Province

Puy-de-Dome

ZIP/Postal Code

63011

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

33473278141

Facility Name

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

City

Rouen

State/Province

Seine-Maritime

ZIP/Postal Code

76000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

33146252410

Facility Name

Institut Gustave Roussy ( Site 0505)

City

Villejuif

State/Province

Val-de-Marne

ZIP/Postal Code

94805

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+33142114637

Facility Name

Institut Curie ( Site 0500)

City

Paris

ZIP/Postal Code

75005

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

33144324086

Facility Name

Soroka Medical Center-Oncology ( Site 0604)

City

Be'er Sheva

ZIP/Postal Code

8400000

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

97286400189

Facility Name

Rambam Health Care Campus-Oncology Division ( Site 0602)

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+972502061161

Facility Name

Hadassah Medical Center. Ein Kerem ( Site 0601)

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+972508946244

Facility Name

Chaim Sheba Medical Center ( Site 0600)

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Individual Site Status

Completed

Facility Name

Seoul National University Bundang Hospital ( Site 1801)

City

Seongnam

State/Province

Kyonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+82317877084

Facility Name

Ajou University Hospital ( Site 1802)

City

Suwon

State/Province

Kyonggi-do

ZIP/Postal Code

16499

Country

Korea, Republic of

Individual Site Status

Completed

Facility Name

Severance Hospital Yonsei University Health System ( Site 1800)

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+8215991004

Facility Name

Samsung Medical Center ( Site 1803)

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+82234106489

Facility Name

Oslo universitetssykehus, Radiumhospitalet ( Site 1102)

City

Oslo

ZIP/Postal Code

0379

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+4722934000

Facility Name

Centro Hospitalar Vila Nova de Gaia. Espinho EPE ( Site 1401)

City

Vila Nova de Gaia

State/Province

Porto

ZIP/Postal Code

4434-502

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+351227865100

Facility Name

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

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+351225084000

Facility Name

Spitalul Clinic Colțea ( Site 1708)

City

București

State/Province

Bucuresti

ZIP/Postal Code

030171

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

40722559551

Facility Name

Cardiomed SRL Cluj-Napoca ( Site 1701)

City

Cluj Napoca

State/Province

Cluj

ZIP/Postal Code

400015

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+40721254415

Facility Name

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

City

Cluj Napoca

State/Province

Cluj

ZIP/Postal Code

400015

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+4026459831

Facility Name

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

City

Floresti

State/Province

Cluj

ZIP/Postal Code

407280

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

40742206212

Facility Name

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

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200542

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+40727774974

Facility Name

Cabinet Medical Oncomed ( Site 1707)

City

Timișoara

State/Province

Timis

ZIP/Postal Code

300239

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+40745100495

Facility Name

S.C.Focus Lab Plus S.R.L ( Site 1703)

City

Bucuresti

ZIP/Postal Code

022548

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+40721298677

Facility Name

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

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08908

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+34934014105

Facility Name

HOSPITAL CLÍNIC DE BARCELONA ( Site 0707)

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+34 93 227 54 02

Facility Name

Centro Oncologico de Galicia ( Site 0706)

City

A Coruna

State/Province

Galicia

ZIP/Postal Code

15009

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

981287499

Facility Name

Hospital General de Valencia ( Site 0703)

City

Valencia

State/Province

Valenciana, Comunitat

ZIP/Postal Code

46014

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+34963187527

Facility Name

Hospital Universitari Vall d Hebron ( Site 0701)

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Hospital Ramon y Cajal ( Site 0705)

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+34913368263

Facility Name

Hospital Virgen de la Victoria ( Site 0702)

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+34952270497

Facility Name

Chang Gung Memorial Hospital - Linkou Branch ( Site 1203)

City

Taoyuan County

State/Province

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+88633281200

Facility Name

Chang Gung Medical Foundation - Kaohsiung ( Site 1204)

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+88677317123

Facility Name

China Medical University Hospital ( Site 1205)

City

Taichung

ZIP/Postal Code

404332

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

8864220521215050

Facility Name

Taichung Veterans General Hospital ( Site 1206)

City

Taichung

ZIP/Postal Code

407

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

886-4-23592525

Facility Name

National Cheng Kung University Hospital ( Site 1202)

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+8866235-3535

Facility Name

National Taiwan University Hospital ( Site 1200)

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

886-2-23123456#67510

Facility Name

Taipei Veterans General Hospital ( Site 1201)

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

886-2-28267000 #7911

Facility Name

Aberdeen Royal Infirmary ( Site 0911)

City

Aberdeen

State/Province

Aberdeen City

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

01224 553876

Facility Name

Castle Hill Hospital ( Site 0910)

City

Cottingham

State/Province

East Riding Of Yorkshire

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Individual Site Status

Completed

Facility Name

The Beatson West of Scotland Cancer Centre ( Site 0909)

City

Glasgow

State/Province

Glasgow City

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+441413017070

Facility Name

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

City

London

State/Province

Great Britain

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+442071882018

Facility Name

University Hospital Southampton NHS Foundation Trust ( Site 0905)

City

Southampton

State/Province

Hampshire

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

02380777222

Facility Name

Royal Marsden Hospital ( Site 0902)

City

London

State/Province

London, City Of

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

00441227866393

Facility Name

Charing Cross Hospital ( Site 0908)

City

London

State/Province

London, City Of

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Individual Site Status

Completed

Facility Name

Musgrove Park Hospital ( Site 0904)

City

Taunton

State/Province

Somerset

ZIP/Postal Code

TA1 5DA

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

01823333444

Facility Name

Royal Marsden Hospital. ( Site 0901)

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

00441227866393

Facility Name

The Christie NHS Foundation Trust ( Site 0907)

City

Manchester

ZIP/Postal Code

m20 4bx

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Phone

+441614463317

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

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