Lenvatinib

Generic Name
Lenvatinib
Brand Names
Lenvima 10, Kisplyx, Lenvima
Drug Type
Small Molecule
Chemical Formula
C21H19ClN4O4
CAS Number
417716-92-8
Unique Ingredient Identifier
EE083865G2
Background

Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. These receptor tyrosine kinases (RTKs) located in the cell membrane play a central role in the activation of signal transduction pathways involved in the normal regulation of cellular processes, such as cell proliferation, migration, apoptosis and differentiation, and in pathogenic angiogenesis, lymphogenesis, tumour growth and cancer progression. In particular, VEGF has been identified as a crucial regulator of both physiologic and pathologic angiogenesis and increased expression of VEGF is associated with a poor prognosis in many types of cancers.

Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer. Most patients with thyroid cancer have a very good prognosis with treatment (98% 5 year survival rate) involving surgery and hormone therapy. However, for patients with RAI-refractory thyroid cancer, treatment options are limited and the prognosis is poor, leading to a push for the development of more targeted therapies such as lenvatinib.

Indication

Lenvatinib is indicated for the treatment of the following cancerous conditions:

Differentiated Thyroid Cancer (DTC)

Renal Cell Carcinoma (RCC)

Hepatocellular Carcinoma (HCC)

Endometrial Carcinoma

Associated Conditions
Advanced Renal Cell Carcinoma, Endometrial Carcinoma, Unresectable Hepatocellular Carcinoma (HCC), Progressive, locally advanced radioactive iodine-refractory Differentiated Thyroid Cancer (DTC), Progressive, metastatic radioactive iodine-refractory Differentiated Thyroid Cancer (DTC)
Associated Therapies
-

Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004)

First Posted Date
2021-02-05
Last Posted Date
2023-11-13
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
110
Registration Number
NCT04740307
Locations
🇺🇸

Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 0013), Baltimore, Maryland, United States

🇨🇭

CHUV (centre hospitalier universitaire vaudois) ( Site 0333), Lausanne, Vaud, Switzerland

🇪🇸

Hospital Universitario Central de Asturias-Hepatology ( Site 0309), Oviedo, Asturias, Spain

and more 37 locations

Study of HX008 in Combination With Bevacizumab or Lenvatinib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)

First Posted Date
2021-02-05
Last Posted Date
2021-02-05
Lead Sponsor
Taizhou Hanzhong biomedical co. LTD
Target Recruit Count
72
Registration Number
NCT04741165
Locations
🇨🇳

Tianjin Cancer Hospital, Tianjin, Tianjin, China

🇨🇳

Cancer Hospital Chinese Academy of Medical Sciences, shenzhen center, Shenzhen, Guangdong, China

🇨🇳

Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China

and more 10 locations

A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)

First Posted Date
2021-02-03
Last Posted Date
2024-11-18
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
1653
Registration Number
NCT04736706
Locations
🇺🇸

Hartford Hospital ( Site 0024), Hartford, Connecticut, United States

🇺🇸

Cedars Sinai Medical Center ( Site 0027), Los Angeles, California, United States

🇺🇸

New England Cancer Specialists ( Site 0082), Scarborough, Maine, United States

and more 259 locations

Pembrolizumab and Lenvatinib/Chemotherapy for Poorly Differentiated/Anaplastic Thyroid Cancer

First Posted Date
2021-02-01
Last Posted Date
2024-03-25
Lead Sponsor
Saint Petersburg State University, Russia
Registration Number
NCT04731740
Locations
🇷🇺

Saint-Petersburg State University (SPSU) N.I.Pirogov Clinic of High Medical Technologies, Saint Petersburg, Russian Federation

Pembrolizumab And Lenvatinib In Leptomeningeal Metastases

First Posted Date
2021-01-28
Last Posted Date
2024-03-15
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
10
Registration Number
NCT04729348
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)-China Extension Study

First Posted Date
2021-01-20
Last Posted Date
2024-10-04
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
201
Registration Number
NCT04716933
Locations
🇨🇳

Fujian Provincial Cancer Hospital ( Site 0102), Fuzhou, Fujian, China

🇨🇳

Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0110), Urumuqi, Xinjiang, China

🇨🇳

The First Affiliated Hospital of Wenzhou Medical University ( Site 0124), Wen Zhou, Zhejiang, China

and more 16 locations

Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-01-11
Last Posted Date
2024-11-28
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
152
Registration Number
NCT04704219
Locations
🇺🇸

Comprehensive Cancer Centers of Nevada ( Site 0010), Las Vegas, Nevada, United States

🇺🇦

Chernihiv Medical Center of Modern Oncology ( Site 0509), Chernihiv, Chernihivska Oblast, Ukraine

🇷🇺

Russian Scientific Center of Radiology-Russian Scientific Center of Radiology ( Site 0602), Moscow, Moskva, Russian Federation

and more 53 locations

Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02)

First Posted Date
2021-01-07
Last Posted Date
2024-11-19
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
300
Registration Number
NCT04700072
Locations
🇺🇸

The Angeles Clinic and Research Institute ( Site 4009), Los Angeles, California, United States

🇺🇸

UCLA Hematology & Oncology ( Site 4004), Los Angeles, California, United States

🇺🇸

Martha Morehouse Tower ( Site 4020), Columbus, Ohio, United States

and more 33 locations

Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) [MK-7902-007/E7080-G000-314/LEAP-007] - China Extension Study

First Posted Date
2020-12-21
Last Posted Date
2024-08-01
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
27
Registration Number
NCT04676412
Locations
🇨🇳

The First Affiliated Hospital of Anhui Medical University ( Site 0113), Hefei, Anhui, China

🇨🇳

Hunan Cancer Hospital ( Site 0104), Changsha, Hunan, China

🇨🇳

Anhui Provincial Hospital ( Site 0108), Hefei, Anhui, China

and more 14 locations

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)

First Posted Date
2020-12-10
Last Posted Date
2024-11-18
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
890
Registration Number
NCT04662710
Locations
🇺🇸

UCLA Hematology/Oncology - Santa Monica ( Site 0003), Los Angeles, California, United States

🇦🇺

Nepean Hospital ( Site 2305), Kingswood, New South Wales, Australia

🇺🇸

Mount Sinai Hospital ( Site 0051), New York, New York, United States

and more 174 locations
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