Study on a New Combination Treatment for Metastatic Melanoma (TRINITY)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06683755

Provider View

This clinical trial is testing a new combination of three drugs—Relatlimab, Ipilimumab, and Nivolumab—to find the best dose and see if it is safe and effective for treating metastatic melanoma, a type of skin cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this study is to determine the best dose and evaluate the safety and effectiveness of a new combination of three drugs—Relatlimab, Ipilimumab, and Nivolumab—in treating patients with metastatic melanoma. The study will assess how well the treatment works in shrinking tumors and improving patient outcomes.

Description

This study is divided into two phases: Phase I and Phase IIa.

In Phase I, the main goal is to find the best dose of the drug Ipilimumab when used with Nivolumab and Relatlimab for treating metastatic melanoma. Researchers will also look at how well the treatment works in shrinking tumors.

In Phase IIa, the focus is on evaluating how effective the treatment is at the best dose found in Phase I. Researchers will measure the overall response rate, which indicates how much the tumors shrink.

Secondary goals include assessing the safety and tolerability of the treatment, monitoring how long patients live without the disease getting worse, and evaluating the overall survival rates. The study will also explore changes in the tumor and immune system before and after treatment.

Participants will need to provide tumor samples for research purposes and undergo various tests and evaluations throughout the study to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a good overall health status, with an ECOG performance score of 0 or 1.
  • Have a confirmed diagnosis of unresectable stage III or stage IV melanoma.
  • Have at least one measurable tumor that has not been treated before.
  • Provide a tumor sample for research purposes.
  • Have not received any prior systemic treatment for metastatic melanoma.
  • Have adequate organ function based on specific blood tests.
  • Women of childbearing potential must not be pregnant or breastfeeding and must agree to use effective birth control during the study and for five months after treatment.
  • Have resolved any side effects from previous cancer treatments to a mild level.
  • Have known BRAF V600 mutation status or agree to testing.
  • Participants with asymptomatic brain metastases are eligible if they do not require high doses of steroids.

Exclusion Criteria

  • Have ocular melanoma.
  • Have symptomatic brain metastases or require steroid treatment for them.
  • Have a history of certain severe immune-related side effects from previous treatments.
  • Have active autoimmune diseases, except for certain stable conditions.
  • Have major medical, neurological, or psychiatric conditions that could interfere with the study.
  • Have a history of another cancer unless it was successfully treated and there is no evidence of disease for at least two years.
  • Have active hepatitis B or C, or HIV infection.
  • Have used corticosteroids or other immunosuppressive medications recently, except for certain low-dose or specific types.
  • Have had major surgery or significant injury recently.
  • Have uncontrolled illnesses or conditions that could interfere with the study.
  • Have significant heart disease or recent heart problems.
  • Have used investigational drugs or herbal supplements recently.
  • Have a history of lung inflammation that required steroids.

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