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Duration: Up to 104 weeks

6 Participants Needed

Lenvatinib + Pembrolizumab for Uveal Melanoma

Overseen ByChris Fountain, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Providence Health & Services

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pregnancy, Active infection, CNS metastases, others

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

What is the purpose of this trial?

This trial is testing a combination of two drugs, lenvatinib and pembrolizumab, to treat adults with metastatic uveal melanoma. Lenvatinib is taken as a daily pill, and pembrolizumab is given through an IV periodically. The goal is to see if these drugs can stop cancer growth and help the immune system fight the cancer. Pembrolizumab is an immune checkpoint inhibitor that has shown promise in treating various cancers, including melanoma, by enhancing the immune system's ability to fight cancer.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or certain steroids, you may need to stop them before starting the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug pembrolizumab for treating uveal melanoma?

Some studies show that pembrolizumab, a drug used for treating other types of melanoma, can help some patients with uveal melanoma by slowing disease progression or stabilizing the condition, especially in those without large liver tumors. However, the overall response rate is low, and the benefits vary among patients.¹ ² ³ ⁴ ⁵

Is the combination of Lenvatinib and Pembrolizumab generally safe for humans?

The combination of Lenvatinib and Pembrolizumab has been studied for safety in various conditions. Common side effects include high blood pressure, low thyroid function, diarrhea, nausea, vomiting, loss of appetite, fatigue, and weight loss. There is also a rare but serious risk of toxic epidermal necrolysis, a severe skin reaction.⁶ ⁷ ⁸ ⁹ ¹⁰

How is the drug combination of Lenvatinib and Pembrolizumab unique for treating uveal melanoma?

The combination of Lenvatinib and Pembrolizumab is unique for treating uveal melanoma because it pairs a multikinase inhibitor (Lenvatinib) with an immune checkpoint inhibitor (Pembrolizumab), offering a novel approach by targeting both tumor growth and the immune system, whereas existing treatments have limited efficacy.² ⁷ ¹¹ ¹² ¹³

Research Team

Matthew Taylor, MD

Principal Investigator

Providence Health & Services

Eligibility Criteria

This trial is for adults with a confirmed diagnosis of metastatic uveal melanoma who haven't been treated with certain immune therapies before. Participants must have measurable disease, provide tissue samples, and have good organ function and performance status. They should agree to use contraception and not be pregnant or breastfeeding.

Inclusion Criteria

The participant (or legally acceptable representative if applicable) provides written informed consent for the trial

I have provided a sample of my tumor that has not been treated with radiation.

I am fully active or can carry out light work.

See 7 more

Exclusion Criteria

You have uncorrected problems with the minerals in your body.

I have no health issues that could affect the study's results.

You have high levels of protein in your urine.

See 21 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lenvatinib 20 mg daily and Pembrolizumab 200 mg IV every 3 weeks for up to 2 years

Up to 104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Safety Monitoring

Evaluate the safety and tolerability of treatment with lenvatinib plus pembrolizumab

30 days

Treatment Details

Interventions

Lenvatinib
Pembrolizumab

Trial OverviewThe study tests the effectiveness of combining lenvatinib with pembrolizumab in treating metastatic uveal melanoma. It aims to see how well these drugs work together for patients who haven't received similar treatments previously.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions

Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.

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?

Providence Health & Services

Lead Sponsor

Trials

131

Recruited

827,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Findings from Research

Uveal melanoma, the most common eye cancer in adults, has a significant risk of metastasis, with up to 50% of patients developing metastases within 15 years after treatment of the primary tumor.

Current systemic therapies for uveal melanoma have limited efficacy, but ongoing research is exploring new candidate drugs, including bortezomib and MEK inhibitors, to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New therapeutic agents in uveal melanoma.Velho, TR., Kapiteijn, E., Jager, MJ.[2012]

In a study of 64 patients with metastatic uveal melanoma treated with a combination of CTLA-4 and PD-1 inhibitors, the overall response rate was 15.6%, with a median overall survival of 16.1 months, indicating that this combination therapy may be the most effective option currently available for this difficult-to-treat cancer.

Despite a significant number of patients experiencing severe treatment-related adverse events (39.1%), the tolerability of this combined therapy appears to be better than that seen in trials for cutaneous melanoma, suggesting a potentially safer profile for patients with uveal melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined immune checkpoint blockade for metastatic uveal melanoma: a retrospective, multi-center study.Heppt, MV., Amaral, T., Kähler, KC., et al.[2023]

The combination of lenvatinib and pembrolizumab shows significant clinical benefits for patients with endometrial carcinoma, with a safety profile consistent with each drug's individual use, primarily involving manageable side effects like hypertension and hypothyroidism.

Effective management of lenvatinib's common adverse events is crucial to maximize its efficacy, as most side effects can be prevented or mitigated through proactive monitoring and intervention during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the use of lenvatinib in combination with pembrolizumab in patients with advanced endometrial carcinoma.Lorusso, D., Danesi, R., Locati, LD., et al.[2023]

References

1.United Statespubmed.ncbi.nlm.nih.gov

Response to Anti-PD-1 in Uveal Melanoma Without High-Volume Liver Metastasis. [2023]

2.Greecepubmed.ncbi.nlm.nih.gov

New therapeutic agents in uveal melanoma. [2012]

3.Englandpubmed.ncbi.nlm.nih.gov

Combined immune checkpoint blockade for metastatic uveal melanoma: a retrospective, multi-center study. [2023]

4.Englandpubmed.ncbi.nlm.nih.gov

The use of pembrolizumab for the treatment of metastatic uveal melanoma. [2022]

5.Englandpubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of uveal melanoma: A case series. [2020]

6.Switzerlandpubmed.ncbi.nlm.nih.gov

Optimizing the use of lenvatinib in combination with pembrolizumab in patients with advanced endometrial carcinoma. [2023]

7.United Statespubmed.ncbi.nlm.nih.gov

Phase II LEAP-004 Study of Lenvatinib Plus Pembrolizumab for Melanoma With Confirmed Progression on a Programmed Cell Death Protein-1 or Programmed Death Ligand 1 Inhibitor Given as Monotherapy or in Combination. [2023]

8.Englandpubmed.ncbi.nlm.nih.gov

Combined use of pembrolizumab and lenvatinib: A review. [2023]

9.United Statespubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]

10.United Statespubmed.ncbi.nlm.nih.gov

Combination therapy (toripalimab and lenvatinib)-associated toxic epidermal necrolysis in a patient with metastatic liver cancer: A case report. [2022]

11.United Statespubmed.ncbi.nlm.nih.gov

Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. [2022]

12.Germanypubmed.ncbi.nlm.nih.gov

A feasibility study of lenvatinib plus pembrolizumab in Japanese patients with advanced solid tumors. [2022]

13.Englandpubmed.ncbi.nlm.nih.gov

Pembrolizumab plus lenvatinib in second-line and third-line patients with pleural mesothelioma (PEMMELA): a single-arm phase 2 study. [2023]

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Lenvatinib + Pembrolizumab for Uveal Melanoma

Trial Summary

Research Team

Eligibility Criteria

Timeline

Treatment Details

Find a Clinic Near You

Who Is Running the Clinical Trial?

Findings from Research

References

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