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Tyrosine Kinase Inhibitor

Lenvatinib + Pembrolizumab + TACE for Liver Cancer

Q: Are there any other research institutes conducting this trial in Canada?

There are 23 locations enrolling patients for this trial, including Tampa General Hospital in <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>, UC Irvine Health in <a href="https://www.withpower.com/clinical-trials/california">California</a>, and UCLA Hematology/<a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> - Santa Monica in Los Angeles.

Q: What is the efficacy of Pembrolizumab in other medical trials?

Pembrolizumab was first studied in 2010 at City of Hope. Since then, there have been a total of 340 completed studies. At the moment, there are 1077 active trials recruiting participants. A large portion of these studies are based in Tampa, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>.

Q: Are there still positions available in this research program for volunteers?

The most recent information on clinicaltrials.gov suggests that this study is currently looking for patients. The original posting was on 5/22/2020, with the last edit happening on 11/7/2022.

Q: For what purpose is Pembrolizumab most often utilized?

Pembrolizumab is most often used as an oncologic drug, however it also has potential to treat unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, microsatellite instability high, and chemotherapy-resistant patients.

Q: Does Pembrolizumab have any dangerous side effects that patients should be aware of?

Pembrolizumab is a Phase 3 trial drug, which means that while there is some data supporting efficacy, multiple rounds of data have confirmed its safety. As such, our team has given it a score of 3.

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has HCC localized to the liver and not amenable to curative treatment

Has a diagnosis of HCC confirmed by radiology, histology, or cytology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~95 months

Awards & highlights

Study Summary

This trial is testing a combo of two drugs vs TACE (a cancer treatment) plus placebos to see if it prolongs PFS and OS in people with incurable HCC.

Who is the study for?

This trial is for adults with non-metastatic, incurable liver cancer (HCC) confirmed by radiology or pathology. Eligible participants may have had Hepatitis B or C if treated properly. They must have stable blood pressure and organ function, and their cancer should be limited to the liver but not suitable for curative treatment.Check my eligibility

What is being tested?

The study tests the effectiveness of lenvatinib plus pembrolizumab with TACE against placebo plus TACE in improving survival without cancer progression in patients with HCC. The goal is to see if combining these drugs with TACE leads to better outcomes than TACE alone.See study design

What are the potential side effects?

Possible side effects include high blood pressure, fatigue, loss of appetite, weight loss, nausea, inflammation of organs due to immune response from pembrolizumab and potential complications from the TACE procedure like abdominal pain or fever.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My liver cancer cannot be cured with surgery or other treatments.

Select...

My liver cancer diagnosis was confirmed through imaging or lab tests.

Select...

I have Hepatitis B.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~95 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~95 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~95 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Secondary outcome measures

DCR per RECIST 1.1

DOR per RECIST 1.1

Disease Control Rate (DCR) per mRECIST

+10 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Pneumothorax

Malnutrition, Hypercalcemia and Weakness

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lenvatinib plus Pembrolizumab plus TACEExperimental Treatment3 Interventions

Participants will receive a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib will be administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years [~35 cycles] or longer with Sponsor approval). Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).

Group II: Oral Placebo plus IV Placebo plus TACEActive Control3 Interventions

Participants will receive a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo will be administered once a day during each 21-day cycle for up to 2 years (~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TACE

2010

Completed Phase 3

~2190

Pembrolizumab

2017

Completed Phase 2

~2010

Lenvatinib

2005

Completed Phase 4

~2690

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,896 Previous Clinical Trials

5,062,268 Total Patients Enrolled

25 Trials studying Hepatocellular Carcinoma

5,743 Patients Enrolled for Hepatocellular Carcinoma

Eisai Inc.Industry Sponsor

516 Previous Clinical Trials

158,586 Total Patients Enrolled

5 Trials studying Hepatocellular Carcinoma

362 Patients Enrolled for Hepatocellular Carcinoma

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,582,156 Total Patients Enrolled

6 Trials studying Hepatocellular Carcinoma

2,707 Patients Enrolled for Hepatocellular Carcinoma

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04246177 — Phase 3

Hepatocellular Carcinoma Research Study Groups: Lenvatinib plus Pembrolizumab plus TACE, Oral Placebo plus IV Placebo plus TACE

Hepatocellular Carcinoma Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04246177 — Phase 3

Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04246177 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other research institutes conducting this trial in Canada?

"There are 23 locations enrolling patients for this trial, including Tampa General Hospital in Florida, UC Irvine Health in California, and UCLA Hematology/Oncology - Santa Monica in Los Angeles."

Answered by AI

What is the efficacy of Pembrolizumab in other medical trials?

"Pembrolizumab was first studied in 2010 at City of Hope. Since then, there have been a total of 340 completed studies. At the moment, there are 1077 active trials recruiting participants. A large portion of these studies are based in Tampa, Florida."

Answered by AI

Are there still positions available in this research program for volunteers?

"The most recent information on clinicaltrials.gov suggests that this study is currently looking for patients. The original posting was on 5/22/2020, with the last edit happening on 11/7/2022."

Answered by AI

For what purpose is Pembrolizumab most often utilized?

"Pembrolizumab is most often used as an oncologic drug, however it also has potential to treat unresectable melanoma, microsatellite instability high, and chemotherapy-resistant patients."

Answered by AI

Does Pembrolizumab have any dangerous side effects that patients should be aware of?

"Pembrolizumab is a Phase 3 trial drug, which means that while there is some data supporting efficacy, multiple rounds of data have confirmed its safety. As such, our team has given it a score of 3."

Answered by AI