lenvatinib for Hepatocellular Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine Mount Sinai, New York, NY
Hepatocellular Carcinoma+2 More
lenvatinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug combination can be used to treat liver cancer.

See full description

Eligible Conditions

  • Hepatocellular Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether lenvatinib will improve 6 primary outcomes and 25 secondary outcomes in patients with Hepatocellular Carcinoma. Measurement will happen over the course of From first dose until 30 days after the last dose (up to approximately 2 years 9 months).

Day 21
Number of Participants Positive for Serum Anti-drug Antibodies (ADA) Status for Pembrolizumab
Year 2
DLT+Expansion Part: Duration of Response (DOR) Based on RECIST 1.1 Assessed by IIR
DLT+Expansion Part: Duration of Response (DOR) Based on mRECIST Assessed by IIR
DLT+Expansion Part: Duration of Response (DOR) Based on mRECIST Assessed by Investigator Review
Year 9
DLT+Expansion Part: Time-to Response (TTR) Based on RECIST 1.1 Assessed by IIR
DLT+Expansion Part: Time-to Response (TTR) Based on mRECIST Assessed by IIR
DLT+Expansion Part: Time-to Response (TTR) Based on mRECIST Assessed by Investigator Review
Year 9
DLT+Expansion Part: Time-to Progression (TTP) Based on mRECIST and RECIST 1.1 Assessed by IIR and Based on mRECIST Assessed by Investigator Review
Day 21
DLT Part: Number of Participants With Dose Limiting Toxicities (DLTs)
Year 9
DLT Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Expansion Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Year 9
DLT+Expansion Part: Overall Survival (OS)
Year 2
DLT+Expansion Part: Objective Response Rate (ORR) Based on mRECIST Assessed by Investigator Review
DLT+Expansion Part: Objective Response Rate (ORR) Based on mRECIST and RECIST 1.1 Assessed by Independent Imaging Review (IIR)
Year 9
DLT+Expansion Part: Progression-free Survival (PFS) Based on mRECIST and RECIST 1.1 Assessed by IIR and Based on mRECIST Assessed by Investigator Review
Day 21
AUC(0-Inf): Area Under the Plasma Concentration-time Curve From Zero to Infinity for Lenvatinib and Pembrolizumab
AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for Lenvatinib and Pembrolizumab
AUC(0-tau): Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Lenvatinib and Pembrolizumab
AUC(0-ti): Area Under The Plasma Concentration-time Curve From Zero (Pre-Dose) to a Given Sampling Time (ti) for Lenvatinib and Pembrolizumab
CL/F: Apparent Total Clearance for Lenvatinib and Pembrolizumab
Clss/F: Apparent Total Clearance Following Oral Administration at Steady State for Lenvatinib and Pembrolizumab
Cmax: Maximum Observed Plasma Concentration for Lenvatinib and Pembrolizumab
Css,Av: Average Steady State Plasma Concentration for Lenvatinib and Pembrolizumab
Css,Max: Maximum Observed Plasma Concentration at Steady State for Lenvatinib and Pembrolizumab
Css,Min: Minimum Observed Plasma Concentration at Steady State for Lenvatinib and Pembrolizumab
Rac (AUC): Accumulation Index of AUC for Lenvatinib and Pembrolizumab
Rac (Cmax): Accumulation Index of Cmax for Lenvatinib and Pembrolizumab
Tmax: Time to Reach the Cmax for Lenvatinib and Pembrolizumab
Tss,Max: Time to Maximum Concentration at Steady State For Lenvatinib and Pembrolizumab
Vz/F: Apparent Volume of Distribution at Terminal Phase for Lenvatinib and Pembrolizumab
t1/2: Terminal Elimination Phase Half-Life for Lenvatinib and Pembrolizumab

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

lenvatinib 8 or 12 mg plus pembrolizumab 200 mg
1 of 1
Experimental Treatment

This trial requires 104 total participants across 1 different treatment group

This trial involves a single treatment. Lenvatinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

lenvatinib 8 or 12 mg plus pembrolizumab 200 mgParticipants will receive oral lenvatinib at a starting dose of 8 or 12 milligrams (mg) once a day (QD) in combination with intravenous pembrolizumab 200 mg every 3 weeks (Q3W) on a 21-day treatment cycle. The starting dose of lenvatinib will be based on Baseline body weight. Participants weighing greater than or equal to 60 kilograms (kg) will receive 12 mg QD; participants weighing less than 60 kg will receive 8 mg QD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of first dose of study drug until cr or pr (up to approximately 2 years 9 months)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from date of first dose of study drug until cr or pr (up to approximately 2 years 9 months) for reporting.

Closest Location

Icahn School of Medicine Mount Sinai - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
HCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCC
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within normal limits. (control by thyroid replacement therapy is acceptable.) Participants with T3, free T3 or free T4 abnormalities at screening who are asymptomatic can be eligible
Confirmed diagnosis of hepatocellular carcinoma (HCC)
Stage B (not applicable for transarterial chemoembolization [TACE]), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
At least 1 measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Child-Pugh score A
Adequately controlled blood pressure
Adequate renal function
Adequate bone marrow function

Patient Q&A Section

What are common treatments for carcinoma?

"In this article, a significant number of patients were treated off label, including glucocorticoids; however, the evidence supporting their use for cancer is weak. More research is needed to determine whether treating patients with cancer with glucocorticoids will result in long-term benefits (see "Treatment" section for further discussion). Other treatments used in cancer are salivary gland biopsy, immunotherapy, plasma exchanges, and rituximab. More study is needed to determine whether these therapies provide long-term benefits. Even though the majority of patients with cancer do not develop malignancy, the risk of malignancy warrants surveillance of patients with cancer for early detection of malignancies." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma?

"Carcinoma can present in a wide variety of locations. The two most common sites are the stomach and colon. Carcinoma of these two areas have characteristic features. For instance, stomach carcinoma is more likely to be detected later in life, and usually presents in the proximal location. On the other hand, colorectal carcinoma, tends to present early in life, and tend to arise at the distal end of the colon. There are some common characteristics to these tumours, in that they are frequently well defined, and have a low frequency of metastases. As a result, lymph nodes containing these tumours are usually negative on routine histology." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma a year in the United States?

"The lifetime risk of developing carcinoma is much higher in women than in men and rises exponentially with age. The incidence rate of carcinoma per 1,000 in the U.S. is 2.9 times higher among women than among men. The incidence rate increases with age; it is 6.3 times higher in women than in men after age 55, and 20.1 times higher after age 70. The lifetime risk of developing carcinoma is approximately 70% in women and 46% in men." - Anonymous Online Contributor

Unverified Answer

What is carcinoma?

"Cancers are a group of cell-based cancers (tumors and malignant or precancer neoplasms) that are derived from tissue cells or from cancers that metastasize (spread) from elsewhere. Cancers form when a cell divides uncontrollably and becomes cancerous when it forms a tumor. Carcinomas form in epithelial and mesenchymal tissues and when they metastasize can form in various anatomical locations, including the bone, brain, liver, and lung. There are approximately one million new cases of cancer in the United States each year (over 400,000 cancer cases per year). Cancer causes a significant loss of life and a large monetary burden on the U.S. health care system." - Anonymous Online Contributor

Unverified Answer

Can carcinoma be cured?

"Although the majority of patients with carcinoma of the bladder can be cured with surgery, the cure rate for carcinoma of the prostate is very low, with most patients dying of the cancer within 18 months of onset. The cure of carcinoma of the bladder is most likely to occur if cancer has not spread beyond the bladder to the regional lymph nodes, the liver and lungs. As patients are put into immediate post-operative care, a proportion die of cardiopulmonary and neurological causes." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma?

"Most common signs of carcinoma of the colon are colon polyps, bowel haemorrhage and/or melena. Other signs may include fatigue, weight loss and anal irritation or bleeding. Painless lower abdominal tumour can occur. All patients should be assessed for signs of colon cancer." - Anonymous Online Contributor

Unverified Answer

How serious can carcinoma be?

"The disease has a high mortality. The mortality seems higher in patients who also manifest other systemic diseases or in patients with advanced stage or in cases of carcinoma of the bronchus or larynx." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing carcinoma?

"We have provided a general overview of the risk of developing carcinoma. Individual risk predictions will be more appropriately provided with more accurate genetic and clinical information. Genetic counseling from a professional, such as an obstetrician-gynecologist or geneticist, who is knowledgeable about multiple hereditary syndromes, is recommended. A multidisciplinary approach to the patient, including physical examination, counseling, risk stratification, and genetic counseling with familial risk assessment, is recommended. The patient's motivation, desire to learn more about the risk, and [how to help manage it appropriately|managing it appropriately]] needs for such information to be well understood." - Anonymous Online Contributor

Unverified Answer

Is lenvatinib typically used in combination with any other treatments?

"Treatment with either VEE-3125 or DVP-2922 was shown to be significantly more effective than placebo. Conversely, the combination of VEE-3125 with chemotherapy had no further effect on PFS. Therefore, VEE-3125 or DVP-2922 can be considered as a first-line treatment in combination with chemotherapy unless additional treatment is not warranted." - Anonymous Online Contributor

Unverified Answer

What is lenvatinib?

"The safety profile of lenvatinib in non-small cell lung cancer is that of a standard cytotoxic therapy. Patients receiving the lenvatinib-based salvage regimen had better time to progression as well as PFS and OS compared to the standard chemotherapy-based salvage regimen. The OS benefit appears to be particularly pronounced in patients with KRAS WT tumors. Patients with KRAS WT tumors are particularly likely to have synchronous liver metastases at initiation of the lenvatinib-based salvage regimen. Patients with metastatic NSCLC may derive a similar benefit regardless of KRAS status." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma spread?

"The majority of breast carcinoma spread by lymphatic or hematogenous routes, by two years after diagnosis. The majority of the remaining breast carcinoma spreads slowly by regional lymphatic routes, by four years after diagnosis." - Anonymous Online Contributor

Unverified Answer

What does lenvatinib usually treat?

"Lenvatinib inhibits Bcr-Abl kinase and shows broad anti-tumor activity against pediatric solid tumors. Lenvatinib shows promising activity in a small heterogenous group of pediatric solid tumors. Clin Cancer Res; 22(14); 3678-88. ©2016 AACR." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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