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TRINITY Study: Relatlimab, Ipilimumab, and Nivolumab for Metastatic Melanoma

This study, called TRINITY, is testing a combination of three drugs – relatlimab, ipilimumab, and nivolumab – as a first treatment for metastatic melanoma (melanoma that has spread). The study aims to find the safest and most effective dose of these drugs when given together. Researchers will also look at how well the treatment shrinks tumors and how long patients live without their cancer getting worse. You may be able to join if you are 18 or older and have a good general health status. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional study that will enroll 30 participants. It aims to find the best dose of the drug combination and then test its effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be monitored throughout the study, which is expected to last an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06683755

Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY)

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~30 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:NivolumabRelatlimabIpilimumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Melanoma

Explore related trials

MelanomaBRAF Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Hussein Tawbi, MD,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Hussein Tawbi, MD,PHD
[email protected]
(713) 792-4185
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

For Phase I participants: Pretreatment tissue must be available through either an archival sample obtained within at most 6 months and submitted as an FFPE tissue block or 30 unstained tumor tissue slides or a fresh pretreatment biopsy. Subsequent tumor biopsies will be optional.
For Phase IIa participants: Either an archival sample submitted as an FFPE tissue block or unstained tumor tissue slides or a fresh pretreatment biopsy from safely biopsiable lesion. Note that if the patient has archival tissue available from a biopsy within 90 days of C1D1 and there has been no systemic treatment since that time then that tissue can be used in place of a fresh pre-treatment biopsy. Patients must also agree to undergo post treatment, cycle 2, tumor biopsies for research purposes. Subsequent biopsies will be optional. 7. No prior systemic lines of treatment for metastatic melanoma. Prior adjuvant or neo-adjuvant therapy will be permitted as long as it did not contain ipilimumab and the last dose has been \>6 months. 8. Prior radiation is allowed with a two week wash out period prior to initiation of treatment. 9. Adequate organ function as described below.
1.5 ×ULN OR direct bilirubin ≤ULN Total bilirubin for participants with total bilirubin levels AST (SGOT) and ALT (SGPT) ≤3.0 × ULN (≤5 × ULN for participants with liver metastases) Coagulation International normalized ratio (INR) OR ≤1.5 × ULN unless participant is receiving prothrombin time (PTT) anticoagulant therapy as long as PT or Activated partial thromboplastin time aPTT wi withing therapeutic range of intended use of anticoagulants (aPTT) ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0