110 Participants Needed

Pembrolizumab/Quavonlimab + Lenvatinib for Liver Cancer

Recruiting at 40 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Merck Sharp & Dohme Corp.
Must be taking: Antivirals, Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

Research shows that combining lenvatinib with pembrolizumab has shown promising results in treating liver cancer that cannot be surgically removed, with studies indicating potential benefits in improving survival rates and tumor response.12345

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

MD

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

My organs are functioning well.
You are expected to live for more than 3 months.
My blood pressure is under control, with or without medication.
See 6 more

Exclusion Criteria

I have a condition that affects how my body absorbs medication.
You have recently taken part in a study testing a new medication or device within the past month.
I have a serious wound or fracture that is not healing.
See 28 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

Up to 5 years
IV infusion every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 28 months

Treatment Details

Interventions

  • Lenvatinib
  • Pembrolizumab/Quavonlimab
Trial Overview The trial tests a combination of two drugs: Pembrolizumab/Quavonlimab and Lenvatinib in patients with first-line Hepatocellular Carcinoma. It aims to see how safe this combo is and how well it works against this type of liver cancer without comparing it to another treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab/Quavonlimab + LenvatinibExperimental Treatment3 Interventions
Participants receive pembrolizumab/quavonlimab via intravenous (IV) infusion every 6 weeks (Q6W) for up to 2 years, plus lenvatinib orally (based on actual body weight at screening) until progressive disease or unacceptable toxicity for up to 5 years. In the event of discontinuation of pembrolizumab/quavonlimab due to intolerable toxicity, re-initiation of treatment with pembrolizumab may be considered.

Lenvatinib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Lenvima for:
  • Differentiated Thyroid Cancer
  • Renal Cell Carcinoma
  • Hepatocellular Carcinoma
  • Endometrial Cancer
🇪🇺
Approved in European Union as Lenvima for:
  • Thyroid Cancer
  • Renal Cell Carcinoma
  • Hepatocellular Carcinoma
  • Endometrial Cancer
🇪🇺
Approved in European Union as Kisplyx for:
  • Renal Cell Carcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials
2,287
Recruited
4,582,000+
Chirfi Guindo profile image

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 profile image

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

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Findings from Research

In a study of 71 patients with unresectable hepatocellular carcinoma (uHCC), the combination of lenvatinib and pembrolizumab demonstrated a high disease control rate of 84.1% for first-line treatment, indicating its efficacy in managing this condition.
The treatment did not adversely affect liver function, as measured by the Albumin-Bilirubin (ALBI) score, and factors such as prior nivolumab failure and Child-Pugh class B were associated with poorer progression-free and overall survival, highlighting the need for further investigation in these subgroups.
Lenvatinib plus pembrolizumab for systemic therapy-naïve and -experienced unresectable hepatocellular carcinoma.Wu, CJ., Lee, PC., Hung, YW., et al.[2022]
In a phase Ib study involving 104 patients with unresectable hepatocellular carcinoma (uHCC), the combination of lenvatinib and pembrolizumab demonstrated significant antitumor activity, with an objective response rate of 46% according to modified RECIST criteria.
The treatment was well-tolerated, with manageable toxicities and no new safety signals identified, indicating that this combination could be a viable option for patients with uHCC.
Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma.Finn, RS., Ikeda, M., Zhu, AX., et al.[2022]
In a phase 3 study involving 794 patients with unresectable hepatocellular carcinoma, the combination of pembrolizumab and lenvatinib showed a median overall survival of 21.2 months, compared to 19.0 months for lenvatinib plus placebo, indicating a potential benefit in survival.
Despite the observed improvement in overall survival, the combination therapy did not meet the predefined significance thresholds for overall survival and progression-free survival, suggesting that it may not warrant a change in current treatment practices.
Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma (LEAP-002): a randomised, double-blind, phase 3 trial.Llovet, JM., Kudo, M., Merle, P., et al.[2023]

References

Lenvatinib plus pembrolizumab for systemic therapy-naïve and -experienced unresectable hepatocellular carcinoma. [2022]
Immunomodulatory Effects of Lenvatinib Plus Anti-Programmed Cell Death Protein 1 in Mice and Rationale for Patient Enrichment in Hepatocellular Carcinoma. [2022]
Pembrolizumab plus lenvatinib with or without hepatic arterial infusion chemotherapy in selected populations of patients with treatment-naive unresectable hepatocellular carcinoma exhibiting PD-L1 staining: a multicenter retrospective study. [2022]
Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. [2022]
Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma (LEAP-002): a randomised, double-blind, phase 3 trial. [2023]
Optimizing the use of lenvatinib in combination with pembrolizumab in patients with advanced endometrial carcinoma. [2023]
Adverse events and oncologic outcomes with combination lenvatinib and pembrolizumab for the treatment of recurrent endometrial cancer. [2023]
Characterization and Management of Adverse Reactions From the CLEAR Study in Advanced Renal Cell Carcinoma Treated With Lenvatinib Plus Pembrolizumab. [2023]
Characterization and Management of Adverse Reactions in Patients With Advanced Endometrial Cancer Receiving Lenvatinib Plus Pembrolizumab. [2023]
Lenvatinib Plus Immune Checkpoint Inhibitors Improve Survival in Advanced Hepatocellular Carcinoma: A Retrospective Study. [2022]
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