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Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

Primary Purpose

Advanced Solid Tumors, Triple Negative Breast Cancer, Ovarian Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Lenvatinib
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors focused on measuring programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1), programmed cell death ligand 2 (PD-L2, PDL2), tyrosine kinase inhibitor (TKI), multiple TKI, Vascular Endothelial Growth Factor Receptor (VEFG), Fibroblast Growth Factor (FGF), Platelet-Derived Growth Factor (PDGF)

Eligibility Criteria

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

Inclusion Criteria:

  • Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer
  • Must have progressed on or since the last treatment
  • Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR
  • Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period
  • Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of study treatment initiation
  • Has adequate organ function

For Triple Negative Breast Cancer Participants:

  • Has received one or 2 prior lines of therapy
  • Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)
  • Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses

For Ovarian Cancer Participants:

- Has primary ovarian cancer and has received 3 prior lines of therapy.

For Gastric Cancer Participants:

- Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible

For Colorectal Cancer Participants:

- Has received 2 prior lines of therapy

For GBM Participants:

  • Has failed initial systemic therapy for newly diagnosed GBM
  • Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines
  • Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable
  • Has histologically confirmed World Health Organization (WHO) Grade IV GBM
  • Has locally determined result for O^6-methylguanine-DNA methyltransferase (MGMT) analysis

For Biliary Tract Cancer Participants:

  • Has received 1 prior line of therapy
  • Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6

For Pancreatic Cancer Participants:

  • Has pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma that is metastatic at enrollment
  • Has received one or 2 prior lines of therapy
  • Has received prior therapy with at least 1 (platinum-containing regimen or gemcitabine-containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer

Exclusion Criteria:

  • Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
  • Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to all cohorts except the ovarian cancer cohort)
  • Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are not eligible for enrollment
  • Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment
  • Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability
  • Has a history of arterial thromboembolism within 12 months of start of study treatment
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has a serious nonhealing wound, ulcer or bone fracture
  • Has had major surgery within 3 weeks prior to first dose of study interventions
  • Has biologic response modifiers therapy (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry
  • Has preexisting ≥Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula
  • Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start
  • If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
  • Has received a live vaccine within 30 days prior to the first dose of study treatment
  • Has known intolerance to lenvatinib (and/or any of the excipients)
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
  • Has known active CNS metastases and/or carcinomatous meningitis
  • Has tumors involving the brain stem
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of hepatitis B or known active hepatitis C virus infection
  • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
  • Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection)

For GBM Participants:

  • Has carcinomatous meningitis
  • Has recurrent tumor greater than 6 cm in maximum diameter
  • Has tumor primarily localized to the brainstem or spinal cord
  • Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease
  • Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans
  • Has received Optune® TTFields within 2 weeks of study intervention

Sites / Locations

  • City of Hope ( Site 0002)
  • Cedars Sinai Medical Center ( Site 0003)
  • University of California Davis Comprehensive Cancer Center ( Site 0005)
  • University of Colorado, Anschutz Cancer Pavilion ( Site 0007)
  • University of Florida-Health Cancer Center-Orlando ( Site 0015)
  • Rutgers Cancer Institute of New Jersey ( Site 0009)
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)
  • Sanford Fargo Medical Center ( Site 0059)
  • Lehigh Valley Hospital- Cedar Crest ( Site 0047)
  • Sanford Cancer Center ( Site 0058)
  • West Cancer Center - East Campus ( Site 0018)
  • Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)
  • Swedish Medical Center ( Site 0021)
  • University of Wisconsin Carbone Cancer Center ( Site 0017)
  • Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106)
  • Hospital Aleman ( Site 2100)
  • Hospital Britanico de Buenos Aires ( Site 2109)
  • Instituto de Oncologia de Rosario ( Site 2105)
  • CEMIC ( Site 2104)
  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101)
  • Royal Brisbane and Women s Hospital ( Site 0901)
  • Alfred Health ( Site 0902)
  • Sir Charles Gairdner Hospital ( Site 0903)
  • BC Cancer - Abbotsford ( Site 0200)
  • CancerCare Manitoba ( Site 0201)
  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)
  • Sunnybrook Research Institute ( Site 0207)
  • Princess Margaret Cancer Centre ( Site 0202)
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210)
  • CHU de Quebec Universite de Laval ( Site 0206)
  • Centro Investigación del Cáncer James Lind ( Site 1203)
  • Fundacion Arturo Lopez Perez ( Site 1201)
  • Pontificia Universidad Catolica de Chile ( Site 1202)
  • Hospital Clinico Universidad de Chile ( Site 1200)
  • Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105)
  • Instituto Nacional de Cancerologia E.S.E ( Site 1102)
  • Oncologos del Occidente S.A. ( Site 1106)
  • Fundacion Valle del Lili ( Site 1101)
  • Centre Antoine Lacassagne ( Site 0404)
  • Centre Leon Berard ( Site 0405)
  • Institut Claudius Regaud IUCT Oncopole ( Site 0403)
  • Centre Oscar Lambret ( Site 0401)
  • Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402)
  • Institut Gustave Roussy ( Site 0400)
  • Robert Bosch GmbH ( Site 0307)
  • Universitaetsklinikum Regensburg ( Site 0304)
  • Universitaetsklinikum Frankfurt ( Site 0306)
  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301)
  • SRH Wald-Klinikum Gera GmbH ( Site 0309)
  • Universitaetsklinikum Jena ( Site 0302)
  • Soroka Medical Center ( Site 0601)
  • Rambam Medical Center ( Site 0602)
  • Hadassah Ein Kerem Medical Center ( Site 0604)
  • Chaim Sheba Medical Center ( Site 0600)
  • Sourasky Medical Center ( Site 0603)
  • Istituto Clinico Humanitas Research Hospital ( Site 1402)
  • Policlinico Le Scotte - A.O. Senese ( Site 1401)
  • Istituto Nazionale Tumori Fondazione Pascale ( Site 1400)
  • Fondazione Policlinico Universitario A. Gemelli ( Site 1403)
  • Asan Medical Center ( Site 1002)
  • Seoul National University Hospital ( Site 1000)
  • Severance Hospital Yonsei University Health System ( Site 1001)
  • Arkhangelsk Clinical Oncological Dispensary ( Site 1600)
  • Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604)
  • Leningrad Regional Oncology Center ( Site 1609)
  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610)
  • City Clinical Oncology Center ( Site 1608)
  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603)
  • Hospital Clinic i Provincial ( Site 0703)
  • Hospital Universitario Gregorio Maranon ( Site 0701)
  • Clinica Universitaria de Navarra ( Site 0704)
  • Hospital Ramon y Cajal ( Site 0702)
  • Inselspital Universitaetsspital Bern ( Site 1705)
  • Kantonsspital Graubuenden ( Site 1704)
  • Kantonsspital St. Gallen ( Site 1702)
  • Ospedale Regionale di Bellinzona e Valli ( Site 1703)
  • Hopitaux Universitaires de Geneve HUG ( Site 1701)
  • Universitaetsspital Zurich ( Site 1700)
  • National Cheng Kung University Hospital ( Site 3003)
  • National Taiwan University Hospital ( Site 3000)
  • Chulalongkorn University ( Site 5001)
  • Ramathibodi Hospital. ( Site 5002)
  • Siriraj Hospital ( Site 5003)
  • Cambridge University Hospitals NHS Trust ( Site 0803)
  • Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804)
  • Guy's Hospital ( Site 0806)
  • Royal Marsden Hospital (Sutton) ( Site 0800)
  • Christie NHS Foundation Trust ( Site 0805)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pembrolizumab + Lenvatinib (Arm 1)

Lenvatinib Monotherapy (Arm 2)

Arm Description

Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).

Participants receive lenvatinib 24 mg via oral capsule QD, to be administered until progressive disease or unacceptable toxicity (up to at least 2 years).

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Glioblastoma (GBM) by Investigator Assessment in Initial Cohorts
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. For participants with GBM, response will be assessed by the investigator based on RANO criteria (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value). For participants in the pancreatic cancer cohort, response will be assessed by blinded independent central review (BICR).
ORR per RECIST 1.1 or RANO (GBM) by Blinded Independent Central Review (BICR) in Expanded Cohorts (Combined with Initial Cohorts)
ORR is defined as the percentage of participants who have a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by BICR per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. For participants with GBM, response will be assessed based on RANO criteria (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value).
Percentage of Participants Receiving Pembrolizumab Plus Lenvatinib who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving pembrolizumab plus lenvatinib who experience at least one AE will be reported.
Percentage of Participants Receiving Pembrolizumab Plus Lenvatinib who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving pembrolizumab plus lenvatinib who discontinue study treatment due to an AE will be reported.
Percentage of Participants Receiving Lenvatinib Monotherapy who Experience an AE
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving lenvatinib monotherapy who experience at least one AE will be reported.
Percentage of Participants Receiving Lenvatinib Monotherapy who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving lenvatinib monotherapy who discontinue study treatment due to an AE will be reported.

Secondary Outcome Measures

Disease Control Rate (DCR) per RECIST 1.1 by Investigator Assessment in Initial Cohorts
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per RECIST 1.1. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DCR will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR.
Duration of Response (DOR) per RECIST 1.1 or RANO (GBM) by Investigator Assessment in Initial Cohorts
DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR.
Progression Free Survival (PFS) per RECIST 1.1 or RANO (GBM) by Investigator Assessment in Initial Cohorts
PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first. PFS will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR.
Overall Survival (OS) in Initial Cohorts
OS is defined as the time from the date of study treatment to the date of death due to any cause.
DCR per RECIST 1.1 by BICR in Expanded Cohorts (Combined with Initial Cohorts)
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or (SD) per RECIST 1.1. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure.
DOR per RECIST 1.1 or RANO (GBM) by BICR in Expanded Cohorts (Combined with Initial Cohorts)
DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure.
PFS per RECIST 1.1 or RANO (GBM) by BICR in Expanded Cohorts (Combined with Initial Cohorts)
PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first, as assessed by BICR.
OS in Expanded Cohorts (Combined with Initial Cohorts)
OS is defined as the time from the date of study treatment to the date of death due to any cause.
ORR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm
ORR is defined as the percentage of participants who have a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by BICR per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
DCR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or SD per RECIST 1.1. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure.
DOR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm
DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure.
PFS per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm
PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first, as assessed by BICR.
OS in Lenvatinib Monotherapy Arm
OS is defined as the time from the date of study treatment to the date of death due to any cause.
Plasma Concentration of Lenvatinib
Blood samples will be obtained on Day 1 and Day 15 of Cycle 1 (21-day cycle) and Day 1 of Cycle 2 (21-day cycle) for pharmacokinetic (PK) analysis to determine the plasma concentration of lenvatinib.

Full Information

First Posted
January 7, 2019
Last Updated
August 19, 2022
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03797326
Brief Title
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)
Official Title
A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (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
No

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Triple Negative Breast Cancer, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, Glioblastoma, Biliary Tract Cancers, Pancreatic Cancer
Keywords
programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1), programmed cell death ligand 2 (PD-L2, PDL2), tyrosine kinase inhibitor (TKI), multiple TKI, Vascular Endothelial Growth Factor Receptor (VEFG), Fibroblast Growth Factor (FGF), Platelet-Derived Growth Factor (PDGF)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
590 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Lenvatinib (Arm 1)
Arm Type
Experimental
Arm Description
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
Arm Title
Lenvatinib Monotherapy (Arm 2)
Arm Type
Experimental
Arm Description
Participants receive lenvatinib 24 mg via oral capsule QD, to be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, Keytruda®
Intervention Description
Administered as an IV infusion on Day 1 Q3W.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
MK-7902, E7080, LENVIMA™
Intervention Description
Administered orally once a day during each 21-day cycle.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Glioblastoma (GBM) by Investigator Assessment in Initial Cohorts
Description
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) as assessed by the investigator per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. For participants with GBM, response will be assessed by the investigator based on RANO criteria (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value). For participants in the pancreatic cancer cohort, response will be assessed by blinded independent central review (BICR).
Time Frame
Up to approximately 72 months
Title
ORR per RECIST 1.1 or RANO (GBM) by Blinded Independent Central Review (BICR) in Expanded Cohorts (Combined with Initial Cohorts)
Description
ORR is defined as the percentage of participants who have a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by BICR per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. For participants with GBM, response will be assessed based on RANO criteria (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value).
Time Frame
Up to approximately 72 months
Title
Percentage of Participants Receiving Pembrolizumab Plus Lenvatinib who Experience an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving pembrolizumab plus lenvatinib who experience at least one AE will be reported.
Time Frame
Up to approximately 72 months
Title
Percentage of Participants Receiving Pembrolizumab Plus Lenvatinib who Discontinue Study Treatment Due to an AE
Description
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving pembrolizumab plus lenvatinib who discontinue study treatment due to an AE will be reported.
Time Frame
Up to approximately 72 months
Title
Percentage of Participants Receiving Lenvatinib Monotherapy who Experience an AE
Description
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving lenvatinib monotherapy who experience at least one AE will be reported.
Time Frame
Up to approximately 72 months
Title
Percentage of Participants Receiving Lenvatinib Monotherapy who Discontinue Study Treatment Due to an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants receiving lenvatinib monotherapy who discontinue study treatment due to an AE will be reported.
Time Frame
Up to approximately 72 months
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR) per RECIST 1.1 by Investigator Assessment in Initial Cohorts
Description
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per RECIST 1.1. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DCR will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR.
Time Frame
Up to approximately 72 months
Title
Duration of Response (DOR) per RECIST 1.1 or RANO (GBM) by Investigator Assessment in Initial Cohorts
Description
DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. DOR will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR.
Time Frame
Up to approximately 72 months
Title
Progression Free Survival (PFS) per RECIST 1.1 or RANO (GBM) by Investigator Assessment in Initial Cohorts
Description
PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first. PFS will be assessed by the investigator for all initial cohorts except for the pancreatic cancer cohort, will be assessed by BICR.
Time Frame
Up to approximately 72 months
Title
Overall Survival (OS) in Initial Cohorts
Description
OS is defined as the time from the date of study treatment to the date of death due to any cause.
Time Frame
Up to approximately 72 months
Title
DCR per RECIST 1.1 by BICR in Expanded Cohorts (Combined with Initial Cohorts)
Description
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or (SD) per RECIST 1.1. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure.
Time Frame
Up to approximately 72 months
Title
DOR per RECIST 1.1 or RANO (GBM) by BICR in Expanded Cohorts (Combined with Initial Cohorts)
Description
DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure.
Time Frame
Up to approximately 72 months
Title
PFS per RECIST 1.1 or RANO (GBM) by BICR in Expanded Cohorts (Combined with Initial Cohorts)
Description
PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first, as assessed by BICR.
Time Frame
Up to approximately 72 months
Title
OS in Expanded Cohorts (Combined with Initial Cohorts)
Description
OS is defined as the time from the date of study treatment to the date of death due to any cause.
Time Frame
Up to approximately 72 months
Title
ORR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm
Description
ORR is defined as the percentage of participants who have a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) as assessed by BICR per RECIST 1.1, which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Time Frame
Up to approximately 72 months
Title
DCR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm
Description
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or SD per RECIST 1.1. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure.
Time Frame
Up to approximately 72 months
Title
DOR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm
Description
DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response until earliest date of disease progression or death from any cause, whichever comes first. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and will be assessed by BICR for this outcome measure.
Time Frame
Up to approximately 72 months
Title
PFS per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm
Description
PFS is defined as the time from date of study treatment to the first documented disease progression based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ (or RANO for GBM participants), or death due to any cause, whichever occurs first, as assessed by BICR.
Time Frame
Up to approximately 72 months
Title
OS in Lenvatinib Monotherapy Arm
Description
OS is defined as the time from the date of study treatment to the date of death due to any cause.
Time Frame
Up to approximately 72 months
Title
Plasma Concentration of Lenvatinib
Description
Blood samples will be obtained on Day 1 and Day 15 of Cycle 1 (21-day cycle) and Day 1 of Cycle 2 (21-day cycle) for pharmacokinetic (PK) analysis to determine the plasma concentration of lenvatinib.
Time Frame
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose and 2-12 hours post-dose; Cycle 2 Day 1: pre-dose, 0.5-4 hours, and 6-10 hours post-dose (up to approximately 23 days). Each cycle is 21 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer Must have progressed on or since the last treatment Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of study treatment initiation Has adequate organ function For Triple Negative Breast Cancer Participants: Has received one or 2 prior lines of therapy Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN) Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses For Ovarian Cancer Participants: - Has primary ovarian cancer and has received 3 prior lines of therapy. For Gastric Cancer Participants: - Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible For Colorectal Cancer Participants: - Has received 2 prior lines of therapy For GBM Participants: Has failed initial systemic therapy for newly diagnosed GBM Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable Has histologically confirmed World Health Organization (WHO) Grade IV GBM Has locally determined result for O^6-methylguanine-DNA methyltransferase (MGMT) analysis For Biliary Tract Cancer Participants: Has received 1 prior line of therapy Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6 For Pancreatic Cancer Participants: Has pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma that is metastatic at enrollment Has received one or 2 prior lines of therapy Has received prior therapy with at least 1 (platinum-containing regimen or gemcitabine-containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer Exclusion Criteria: Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to all cohorts except the ovarian cancer cohort) Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are not eligible for enrollment Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability Has a history of arterial thromboembolism within 12 months of start of study treatment Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Has a serious nonhealing wound, ulcer or bone fracture Has had major surgery within 3 weeks prior to first dose of study interventions Has biologic response modifiers therapy (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry Has preexisting ≥Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]) Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease Has received a live vaccine within 30 days prior to the first dose of study treatment Has known intolerance to lenvatinib (and/or any of the excipients) Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment Has known active CNS metastases and/or carcinomatous meningitis Has tumors involving the brain stem Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients Has an active autoimmune disease that has required systemic treatment in past 2 years Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of human immunodeficiency virus (HIV) infection Has a known history of hepatitis B or known active hepatitis C virus infection Has a known history of active tuberculosis (TB; Bacillus tuberculosis) Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection) For GBM Participants: Has carcinomatous meningitis Has recurrent tumor greater than 6 cm in maximum diameter Has tumor primarily localized to the brainstem or spinal cord Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans Has received Optune® TTFields within 2 weeks of study intervention
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 0002)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Cedars Sinai Medical Center ( Site 0003)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center ( Site 0005)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado, Anschutz Cancer Pavilion ( Site 0007)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida-Health Cancer Center-Orlando ( Site 0015)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 0009)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Sanford Fargo Medical Center ( Site 0059)
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
Lehigh Valley Hospital- Cedar Crest ( Site 0047)
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Sanford Cancer Center ( Site 0058)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
West Cancer Center - East Campus ( Site 0018)
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Swedish Medical Center ( Site 0021)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center ( Site 0017)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106)
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1078AAI
Country
Argentina
Facility Name
Hospital Aleman ( Site 2100)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
1118
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires ( Site 2109)
City
Ciudad de Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Instituto de Oncologia de Rosario ( Site 2105)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
CEMIC ( Site 2104)
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101)
City
Caba
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Royal Brisbane and Women s Hospital ( Site 0901)
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Alfred Health ( Site 0902)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Sir Charles Gairdner Hospital ( Site 0903)
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
BC Cancer - Abbotsford ( Site 0200)
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 0C2
Country
Canada
Facility Name
CancerCare Manitoba ( Site 0201)
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 4X2
Country
Canada
Facility Name
Sunnybrook Research Institute ( Site 0207)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre ( Site 0202)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
CHU de Quebec Universite de Laval ( Site 0206)
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centro Investigación del Cáncer James Lind ( Site 1203)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez ( Site 1201)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 1202)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330024
Country
Chile
Facility Name
Hospital Clinico Universidad de Chile ( Site 1200)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050030
Country
Colombia
Facility Name
Instituto Nacional de Cancerologia E.S.E ( Site 1102)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110321
Country
Colombia
Facility Name
Oncologos del Occidente S.A. ( Site 1106)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660001
Country
Colombia
Facility Name
Fundacion Valle del Lili ( Site 1101)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Centre Antoine Lacassagne ( Site 0404)
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06189
Country
France
Facility Name
Centre Leon Berard ( Site 0405)
City
Lyon
State/Province
Auvergne
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Claudius Regaud IUCT Oncopole ( Site 0403)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Oscar Lambret ( Site 0401)
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Facility Name
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402)
City
Saint-Herblain
State/Province
Val-de-Marne
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Gustave Roussy ( Site 0400)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Robert Bosch GmbH ( Site 0307)
City
Stuttgart
State/Province
Baden-Wurttemberg
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitaetsklinikum Regensburg ( Site 0304)
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt ( Site 0306)
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60528
Country
Germany
Facility Name
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301)
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65199
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH ( Site 0309)
City
Gera
State/Province
Thuringen
ZIP/Postal Code
07548
Country
Germany
Facility Name
Universitaetsklinikum Jena ( Site 0302)
City
Jena
State/Province
Thuringen
ZIP/Postal Code
07740
Country
Germany
Facility Name
Soroka Medical Center ( Site 0601)
City
Beer Sheva
ZIP/Postal Code
8457108
Country
Israel
Facility Name
Rambam Medical Center ( Site 0602)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Ein Kerem Medical Center ( Site 0604)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Chaim Sheba Medical Center ( Site 0600)
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Sourasky Medical Center ( Site 0603)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Istituto Clinico Humanitas Research Hospital ( Site 1402)
City
Rozzano
State/Province
Milano
Country
Italy
Facility Name
Policlinico Le Scotte - A.O. Senese ( Site 1401)
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione Pascale ( Site 1400)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli ( Site 1403)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Asan Medical Center ( Site 1002)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 1000)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 1001)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Arkhangelsk Clinical Oncological Dispensary ( Site 1600)
City
Arkhangelsk
State/Province
Arkhangel Skaya Oblast
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Center ( Site 1609)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
City Clinical Oncology Center ( Site 1608)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Hospital Clinic i Provincial ( Site 0703)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Gregorio Maranon ( Site 0701)
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Clinica Universitaria de Navarra ( Site 0704)
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Ramon y Cajal ( Site 0702)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Inselspital Universitaetsspital Bern ( Site 1705)
City
Bern
State/Province
Berne
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kantonsspital Graubuenden ( Site 1704)
City
Chur
State/Province
Grisons
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Kantonsspital St. Gallen ( Site 1702)
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Ospedale Regionale di Bellinzona e Valli ( Site 1703)
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve HUG ( Site 1701)
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Universitaetsspital Zurich ( Site 1700)
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
National Cheng Kung University Hospital ( Site 3003)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 3000)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Chulalongkorn University ( Site 5001)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Ramathibodi Hospital. ( Site 5002)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital ( Site 5003)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Cambridge University Hospitals NHS Trust ( Site 0803)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804)
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Guy's Hospital ( Site 0806)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden Hospital (Sutton) ( Site 0800)
City
London
State/Province
Surrey
ZIP/Postal Code
SM3 5PT
Country
United Kingdom
Facility Name
Christie NHS Foundation Trust ( Site 0805)
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
Links:
URL
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trial Information

Learn more about this trial

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

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