Trial of Relatlimab, Nivolumab, and Ipilimumab for Melanoma Brain Metastases

This study is testing a combination of three drugs – relatlimab, nivolumab, and ipilimumab – for people with melanoma that has spread to the brain (brain metastases). These drugs work by targeting specific pathways in the body, such as CTLA-4, LAG-3, and PD-1, to help the immune system fight cancer. You would receive either ipilimumab every 8 weeks, or a combination of relatlimab and nivolumab every 4 weeks, given through an IV. To join, you must be at least 18 years old and have melanoma that has spread to the brain, with at least one measurable tumor in the brain that hasn't been treated locally before. The main goal is to see how many participants experience a benefit in their brain tumors after 6 months. This study plans to enroll 60 participants.

Study design
This is a Phase II, multicenter study. Participants will be assigned to one of two groups (Cohort A or B) to receive specific drug combinations; there is no randomization or blinding.
What's involved
Participants will receive IV infusions of either Ipilimumab every 8 weeks, or Relatlimab and Nivolumab every 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures clinical benefit at 6 months, suggesting follow-up for at least this duration.

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

NCT06712927

Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases

Recruiting
PHASE2Ages 18+InterventionalTreatment
Stanford University
~60 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:IpilimumabNivolumab + Relatlimab FDC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intracranial clinical benefit rate
Measured over 6 months
Melanoma
Brain Metastases
1 sites across 1 states
California1
  • Allison Betof, MD, PhD · PRINCIPAL_INVESTIGATOR · Stanford University

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  • Intracranial clinical benefit rate6 months

    Intracranial clinical benefit rate, defined as the percentage of patients who had a complete response (CR), partial response (PR), or stable disease for at least 6 months per modified RECIST 1.1 criteria.