Clinical trials: Lenvatinib
Renal Cell Carcinoma
Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)
This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated…
- Trial name
- KEYNOTE-B61 (NCT04704219)
- Testing
- Pembrolizumab, Lenvatinib
- Where
- 56 sites in United States, Australia and 12 more
- Volunteers
- 160 people
- Sponsor
- Merck Sharp & Dohme LLC
Cancer, Tumor, Solid
Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer
This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of subcutaneously administered JK08 in patients with unresectable locally, advanced…
- Conditions
- Cancer, Tumor, Solid, Advanced Solid Tumor, Metastatic Cancer
- Trial name
- NCT05620134
- Testing
- JK08, Pembrolizumab, Lenvatinib Pill
- Where
- 11 sites in Belgium, Spain
- Volunteers
- 263 people
- Sponsor
- Salubris Biotherapeutics Inc
P-glycoprotein, Healthy Volunteers
A Pharmacokinetic Study to Assess the Influence of P-glycoprotein Inhibition and Simultaneous CYP3A4 and P-glycoprotein Induction on E7080 Pharmacokinetics Following Single Dose Oral Administration of 24 mg E7080 to Healthy Volunteers
The purpose of this single-dose, open-label, sequential, three-period study in 15 healthy subjects was to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and P-glycoprotein induction on lenvatinib…
- Trial name
- NCT02199392
- Testing
- Lenvatinib
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Thyroid Carcinoma, Anaplastic
A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)
The primary purpose of the study is to evaluate objective response rate ([ORR]: complete response [CR] and partial response [PR]) by investigator review in participants with anaplastic thyroid cancer (ATC) treated with lenvatinib.
- Trial name
- NCT02657369
- Testing
- Lenvatinib 24 mg
- Where
- 30 sites in United States, Australia and 3 more
- Volunteers
- 34 people
- Sponsor
- Eisai Inc.
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.
Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma
A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
This is an open-label, multicentre dose escalation/expansion study to assess safety and tolerability of MIV 818 as either monotherapy or in combination with 1) lenvatinib, a tyrosine kinase inhibitor used as a standard of care…
- Conditions
- Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Liver Metastases
- Trial name
- NCT03781934
- Testing
- MIV-818 (fostroxacitabine bralpamide) + pembrolizumab, MIV-818 (fostroxacitabine bralpamide) + lenvatinib
- Where
- 18 sites in Belgium, South Korea and 2 more
- Volunteers
- 53 people
- Sponsor
- Medivir
Thyroid Cancer
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once…
- Trial name
- SELECT (NCT01321554)
- Testing
- Lenvatinib
- Where
- 155 sites in United States, Argentina and 21 more
- Volunteers
- 392 people
- Sponsor
- Eisai Inc.
Malignant Melanoma
Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults…
- Trial name
- NCT03820986
- Testing
- Pembrolizumab, Lenvatinib
- Where
- 119 sites in United States, Australia and 16 more
- Volunteers
- 674 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
Advanced Renal Cell Carcinoma (aRCC)
Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients
This observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab +…
- Trial name
- NCT06345183
- Testing
- Nivolumab + Ipilimumab combination therapy, Pembrolizumab + Lenvatinib combination therapy
- Where
- United States
- Volunteers
- 327 people
- Sponsor
- Bristol-Myers Squibb
Hepatocellular Carcinoma (HCC)
A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma
E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable…
- Trial name
- NCT01761266
- Testing
- Lenvatinib, Sorafenib
- Where
- 186 sites in United States, Australia and 19 more
- Volunteers
- 954 people
- Sponsor
- Eisai Limited
Unresectable, Non-metastatic Hepatocellular Carcinoma
A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic hepatocellular carcinoma
- Trial name
- NCT05319431
- Testing
- AK104, Lenvatinib, TACE
- Where
- 5 sites in China
- Volunteers
- 60 people
- Sponsor
- Akeso
Biliary Tract Cancer
Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy
This is a multicenter, single arm, open-label study in participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and…
- Trial name
- NCT02579616
- Testing
- Lenvatinib
- Where
- 7 sites in Japan
- Volunteers
- 29 people
- Sponsor
- Eisai Co., Ltd.
Carcinoma, Renal Cell
Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC)
Phase 1 study to investigate the tolerability and safety of lenvatinib in combination with Everolimus in participants with unresectable advanced or metastatic RCC.
- Trial name
- NCT02454478
- Testing
- Lenvatinib, Everolimus
- Where
- 3 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Eisai Co., Ltd.
Uterine Cervical Neoplasms, Endometrial Neoplasms
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected…
- Conditions
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck, Gallbladder Neoplasms
- Trial name
- NCT05007106
- Testing
- Pembrolizumab/Vibostolimab Co-Formulation, Pembrolizumab, Lenvatinib
- Where
- 73 sites in United States, Canada and 13 more
- Volunteers
- 611 people
- Sponsor
- Merck Sharp & Dohme LLC
Carcinoma, Hepatocellular
A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety…
- Trial name
- STELLAR (NCT04763408)
- Testing
- Lenvatinib, Sorafenib
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 335 people
- 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
Differentiated Thyroid Cancer (DTC)
A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in China
The primary purpose of this study is to compare the progression-free survival (PFS) of participants with radioiodine (131 I)-refractory differentiated thyroid cancer (DTC) and radiographic evidence of disease progression within…
- Trial name
- NCT02966093
- Testing
- Lenvatinib
- Where
- 24 sites in China
- Volunteers
- 151 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
Tumors
A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors
This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in participants with selected solid tumors. Phase 1b will determine and confirm the maximum tolerated dose (MTD) for lenvatinib in combination with…
- Trial name
- NCT02501096
- Testing
- Lenvatinib, Pembrolizumab
- Where
- 64 sites in United States, Norway and 1 more
- Volunteers
- 357 people
- Sponsor
- Eisai Inc.