Study on Nivolumab and Relatlimab for Patients with Metastatic Uveal Melanoma

Sponsor: Jose Lutzky, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04552223

Provider View

This clinical trial is testing a combination of two drugs, nivolumab and relatlimab, to see if they can help shrink tumors in patients with metastatic uveal melanoma, a type of eye cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

The aim of this study is to determine if a combination of the drugs nivolumab and relatlimab can effectively reduce tumors in patients with metastatic uveal melanoma. This study involves 27 patients and will assess the treatment's effectiveness and safety over a period of up to two years.

Description

This study is designed to test the effectiveness of a combination of two drugs, nivolumab and relatlimab, in treating metastatic uveal melanoma. The study will include 27 patients and will be conducted in two stages. Patients will receive the drugs through an IV every four weeks until their cancer progresses or they experience intolerable side effects, for up to two years. The study will also involve analyzing tumor samples before and after treatment to understand how the drugs affect the cancer at a cellular level. Participants must not have received certain types of cancer treatments before joining this study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic uveal melanoma that has not been treated with specific immune therapies before.
  • Agree to have a tumor biopsy before and after treatment if it is safe and easy to do.
  • Completed any previous cancer treatments at least three weeks before starting the study treatment, with any side effects resolved.
  • Be 18 years or older.
  • Have measurable cancer based on specific medical criteria.
  • Be in good overall health with a performance status score between 0 and 2.
  • Have a heart function test showing at least 50% efficiency within six months before starting treatment.
  • Have adequate organ function based on blood tests.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study and for 24 weeks after.
  • Men must agree to use effective contraception during the study and for seven months after.

Exclusion Criteria

  • Currently participating in another study or have recently received an investigational treatment.
  • Have an immune system deficiency or are taking medications that suppress the immune system.
  • Have a history of active tuberculosis.
  • Have previously been treated with PD-1 or LAG-3 targeted therapies.
  • Have allergies to nivolumab, relatlimab, or their ingredients.
  • Have had recent treatment with certain cancer therapies and have not recovered from side effects.
  • Have another active cancer that requires treatment, with some exceptions.
  • Have active brain metastases or a history of significant brain hemorrhage.
  • Have an autoimmune disease requiring treatment in the past two years.
  • Have a history of lung inflammation or active infections requiring treatment.
  • Have any condition that might interfere with the study or is not in the best interest of the participant.
  • Are pregnant, breastfeeding, or planning to conceive during the study period.
  • Have a history of HIV, unless controlled with medication.
  • Have active hepatitis B or C.
  • Have received a live vaccine recently.
  • Have a history of heart inflammation or abnormal heart enzyme levels.
  • Have impaired decision-making capacity or are incarcerated.

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