Clinical trials: Lenvatinib
Carcinoma, Hepatocellular
A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma
This study is a post-marketing observational study of lenvatinib in participants with unresectable hepatocellular carcinoma. The primary objective of this study is assessment of risk factors for hepatic encephalopathy.
- Trial name
- NCT03663114
- Testing
- Lenvatinib
- Where
- 2 sites in Japan
- Volunteers
- 713 people
- Sponsor
- Eisai Inc.
Hepatic Impairment; Renal Impairment
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants.
- Trial name
- NCT02998775
- Testing
- Plasma Sampling
- Where
- 3 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Solid Tumors
Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials
This study will be conducted to assess the long-term safety of study drug(s) in participants who are enrolled in Eisai-sponsored lenvatinib studies.
- Trial name
- NCT03477175
- Testing
- E7080, Comparator Drug, Comparator Drug: Sorafenib
- Where
- 28 sites in United States, Australia and 9 more
- Volunteers
- 40 people
- Sponsor
- Eisai Inc.
Colorectal Neoplasms
Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)
The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer.
- Trial name
- NCT04776148
- Testing
- pembrolizumab, lenvatinib, regorafenib
- Where
- 95 sites in United States, Argentina and 13 more
- Volunteers
- 563 people
- Sponsor
- Merck Sharp & Dohme LLC
Endometrial Neoplasms
Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])
This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer.
- Trial name
- NCT03517449
- Testing
- Pembrolizumab, Lenvatinib, Paclitaxel
- Where
- 169 sites in United States, Argentina and 19 more
- Volunteers
- 827 people
- Sponsor
- Eisai Inc.
Non-small-cell Lung Cancer
E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with…
- Trial name
- NCT00832819
- Testing
- E7080, Paclitaxel, Carboplatin
- Where
- 3 sites in Japan
- Volunteers
- 28 people
- Sponsor
- Eisai Co., Ltd.
Endometrial Neoplasms
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma.
- Trial name
- LEAP-001 (NCT03884101)
- Testing
- Lenvatinib, Pembrolizumab, Paclitaxel
- Where
- 195 sites in United States, Argentina and 20 more
- Volunteers
- 842 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatocellular Carcinoma
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
- Trial name
- EMERALD-3 (NCT05301842)
- Testing
- Tremelimumab, Durvalumab, Transarterial Chemoembolization (TACE)
- Where
- 171 sites in United States, Belgium and 20 more
- Volunteers
- 760 people
- Sponsor
- AstraZeneca
Non Clear Cell Renal Cell Carcinoma (nccRCC)
A Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease
This is a single-arm, multicenter, Phase 2 study of lenvatinib in combination with everolimus in participants with unresectable advanced or metastatic non clear cell renal cell carcinoma (nccRCC) who have not received any…
- Trial name
- NCT02915783
- Testing
- lenvatinib, everolimus
- Where
- 8 sites in United States
- Volunteers
- 41 people
- Sponsor
- Eisai Inc.
Renal Impairment, Disease Severity
A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects
The purpose of this multicenter, open-label, non-randomized, single, oral dose, sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg) administered to healthy subjects and to subjects with…
- Trial name
- NCT02199379
- Testing
- Lenvatinib
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Head and Neck Squamous Cell Carcinoma
A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010/LEAP-010)-China Extension
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell…
- Trial name
- NCT05523323
- Testing
- Lenvatinib, Pembrolizumab
- Where
- 28 sites in China
- Volunteers
- 112 people
- Sponsor
- Merck Sharp & Dohme LLC
Endometrial Neoplasms
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study
The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma.
- Trial name
- LEAP-001 (NCT04865289)
- Testing
- Lenvatinib, Pembrolizumab, Paclitaxel
- Where
- 22 sites in China
- Volunteers
- 130 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteers
A Pharmacokinetic Study to Assess the Influence of Simultaneous CYP3A4 and P-glycoprotein Inhibition on E7080 Pharmacokinetics Following Single Dose Oral Administration of 5 mg E7080 to Healthy Volunteers
The purpose of this study is to assess the influence of simultaneous CYP3A4 and p-glycoprotein inhibition on lenvatinib pharmacokinetics following a single oral dose of 5 mg lenvatinib.
- Trial name
- NCT02198170
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Solid Tumors
Efficacy and Safety Study of F520 Combined With Lenvatinib in the Treatment of Patients With Advanced Solid Tumors
This is a multicenter, open-label, phase Ib/II study on the efficacy and safety of F520 combined with lenvatinib in the treatment of patients with advanced solid tumors.
- Trial name
- NCT05740215
- Testing
- F520, Lenvatinib
- Where
- China
- Volunteers
- 158 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Thyroid Cancer
Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
The purpose of this study is to determine the safety and efficacy of oral lenvatinib in participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC)…
- Trial name
- NCT00784303
- Testing
- Lenvatinib (DTC Cohort), Lenvatinib (MTC Cohort)
- Where
- 42 sites in United States, Australia and 4 more
- Volunteers
- 117 people
- Sponsor
- Eisai Inc.
Carcinoma, Hepatocellular
Real-World Lenvatinib Sequencing in Unresectable Hepatocellular Carcinoma (uHCC)
This observational study will use existing real-world data from routine clinical care to describe patients with uHCC who received lenvatinib.
- Trial name
- NCT07849660
- Testing
- Lenvatinib
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Eisai Inc.
Urothelial Carcinoma
Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)
The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand…
- Trial name
- NCT03898180
- Testing
- Pembrolizumab, Lenvatinib
- Where
- 194 sites in United States, Argentina and 18 more
- Volunteers
- 505 people
- Sponsor
- Merck Sharp & Dohme LLC
Neoplasm Malignant
Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)
The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC)…
- Trial name
- NCT04976634
- Testing
- Pembrolizumab, Belzutifan, Lenvatinib
- Where
- 57 sites in United States, Australia and 8 more
- Volunteers
- 730 people
- Sponsor
- Merck Sharp & Dohme LLC
Solid Tumors
Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Participants With Selected Solid Tumors
This is an open-label Phase 1b study designed to confirm the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with selected solid tumors (non-small cell lung cancer, predominantly clear cell…
- Trial name
- NCT03006887
- Testing
- lenvatinib, pembrolizumab
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Eisai Co., Ltd.
Cancer
A Study of E7080 in Subjects With Solid Tumor
The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors
- Trial name
- NCT01268293
- Testing
- E7080
- Where
- Japan
- Volunteers
- 9 people
- Sponsor
- Eisai Co., Ltd.