Study on Lenvatinib and Pembrolizumab for Patients with Untreated Metastatic Uveal Melanoma

Sponsor: Providence Health & Services

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05308901

Provider View

This clinical trial is testing the effectiveness of combining two drugs, lenvatinib and pembrolizumab, to treat patients with metastatic uveal melanoma who have not previously received immune checkpoint inhibitors.

Patient Parameters

Program Overview

The aim of this study is to see how well the combination of lenvatinib and pembrolizumab works in treating metastatic uveal melanoma, a type of eye cancer that has spread to other parts of the body. Participants will receive lenvatinib daily and pembrolizumab every three weeks for up to two years.

Description

This is a Phase II clinical trial conducted at a single institution. It involves adults aged 18 and older who have metastatic uveal melanoma and have not been treated with immune checkpoint inhibitors before. Participants will take lenvatinib orally every day and receive pembrolizumab through an IV every three weeks, for a maximum of two years. The study will evaluate how effective this treatment is in controlling the cancer.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a confirmed diagnosis of metastatic uveal melanoma.
  • Male participants must agree to use contraception during the study and for 120 days after the last dose of lenvatinib.
  • Female participants must not be pregnant or breastfeeding and must agree to use contraception during the study and for 120 days after the last dose of treatment.
  • Participants must provide written informed consent.
  • Must have measurable disease based on specific criteria.
  • Must provide a tumor tissue sample for analysis.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have adequate organ function as determined by specific tests.
  • Must agree to undergo tumor biopsies before treatment and on day 15, unless medically unable to do so.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Previous treatment with certain immune therapies, except Tebentafusp.
  • Recent live vaccine within 30 days before starting the study.
  • Current or recent use of high-dose steroids or other immunosuppressive drugs.
  • Other active cancers requiring treatment in the past 3 years, except certain skin cancers or early-stage cancers.
  • Active brain metastases or meningitis.
  • Severe allergy to pembrolizumab or its ingredients.
  • Active autoimmune disease requiring treatment in the past 2 years.
  • History of lung disease requiring steroids.
  • Active infection needing treatment.
  • Uncontrolled high blood pressure.
  • Significant heart problems or recent heart attack or stroke.
  • Risk of severe bleeding or blood clotting disorders.
  • Severe kidney problems or protein in urine.
  • Not fully recovered from previous cancer treatments or surgery.
  • Severe allergy to lenvatinib or its ingredients.

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