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

NCT06712927 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-18

No results posted yet for this study

Summary

This is a multicenter, phase II trial of relatlimab (rela), nivolumab (nivo), and ipilimumab (ipi) in patients with asymptomatic and symptomatic melanoma brain metastases.

Conditions

Interventions

DRUG

Ipilimumab

1 mg/kg of Ipilimumab will be administered via IV every 8 weeks. Participants will be assigned to Cohort A or B as per eligibility criteria. No randomization or blinding will occur

DRUG

Nivolumab + Relatlimab FDC

Relatlimab 160mg + Nivo 480mg will be administered via IV every 4 weeks. Participants will be assigned to Cohort A or B as per eligibility criteria. No randomization or blinding will occur

Sponsors & Collaborators

Principal Investigators

  • Allison Betof, MD, PhD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2026-11-30
Completion
2030-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06712927 on ClinicalTrials.gov