Pembrolizumab/Quavonlimab + Lenvatinib for Liver Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants must have adequately controlled blood pressure, which can be managed with or without medications. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination of pembrolizumab/quavonlimab and lenvatinib for liver cancer?
What is known about the safety of the combination treatment of Lenvatinib and Pembrolizumab?
The combination of Lenvatinib and Pembrolizumab has been studied for various cancers, including endometrial and renal cell carcinoma. Common side effects include high blood pressure, low thyroid function, diarrhea, nausea, vomiting, loss of appetite, fatigue, and weight loss. These side effects are consistent with what is known about each drug when used alone.16789
What makes the drug combination of Pembrolizumab/Quavonlimab and Lenvatinib unique for liver cancer?
This drug combination is unique because it combines Lenvatinib, which targets cancer growth, with Pembrolizumab/Quavonlimab, an immune checkpoint inhibitor that helps the immune system attack cancer cells. This approach aims to improve survival in patients with advanced liver cancer, especially those who have not responded to other treatments.123510
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and efficacy of fixed dose coformulated pembrolizumab/quavonlimab (MK-1308A) plus lenvatinib in a first line (1L) hepatocellular carcinoma (HCC) setting. No hypothesis testing will be performed.
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
This trial is for adults with advanced liver cancer (Hepatocellular Carcinoma) who haven't had certain treatments. They should have a specific stage of the disease, good liver function, controlled blood pressure, and no major health issues like brain metastases or recent surgeries. People with HIV, active infections besides hepatitis B/C, severe allergies to study drugs, or other cancers aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab/quavonlimab via IV infusion every 6 weeks for up to 2 years, plus lenvatinib orally until progressive disease or unacceptable toxicity for up to 5 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lenvatinib
- Pembrolizumab/Quavonlimab
Lenvatinib is already approved in United States, European Union for the following indications:
- Differentiated Thyroid Cancer
- Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Endometrial Cancer
- Thyroid Cancer
- Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Endometrial Cancer
- Renal Cell Carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University