Actively Recruiting
Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases
Led by Stanford University · Updated on 2025-09-08
60
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-uveal melanoma with brain metastases and at least one measurable untreated brain lesion (5-40 mm)
- Age 18 years or older
- ECOG performance status 0-1 for asymptomatic patients (Cohort A), 0-2 for symptomatic patients (Cohort B)
- No prior anti-CTLA-4, anti-PD-1, or anti-LAG-3 therapy for unresectable stage III/IV melanoma; prior such therapy allowed if completed over 6 months ago
- Adequate organ function including liver enzymes, creatinine clearance, and bilirubin levels within specified limits
- Recovery from prior anti-cancer therapy side effects to Grade 1 or less (exceptions apply)
- For asymptomatic patients, no neurologic symptoms or systemic corticosteroid use above physiologic replacement in past 10 days; symptomatic patients may use low-dose stable or tapering steroids
- HIV-infected patients on effective therapy with undetectable viral load are eligible
- Treated and cured hepatitis B or C infection, or undetectable viral load if currently treated
- Provide tumor tissue samples suitable for PD-L1 testing; biopsy allowed if no archival tissue available
- Any prior radiation or surgery to non-target brain lesions completed at least 1 week before treatment start
- Radiation to non-brain lesions allowed if toxicity recovered to Grade 1 or less
- Women of child-bearing potential must not be breastfeeding, have a negative pregnancy test, and agree to use effective contraception during and for 12 months after treatment
- Ability to understand and agree to study requirements and provide written informed consent
You will not qualify if you...
- Another primary cancer within the past 3 years except certain treated localized cancers
- Active medical illnesses including infections, coagulation disorders, or major cardiovascular, respiratory, or immune diseases
- Active autoimmune disease requiring systemic corticosteroids or immunosuppressive therapy in past 3 years (except certain immune-related adverse events)
- Implanted devices incompatible with MRI
- Previous Grade 4 immune checkpoint inhibitor side effects
- History of leptomeningeal metastasis
- Prior whole brain radiation therapy
- Pregnant or breastfeeding women
- Significant heart disease or congestive heart failure worse than NYHA class 2, recent unstable angina or heart attack, or myocarditis
- Elevated troponin levels above specified limits without cardiologist clearance
- Use of investigational drugs within 14 days before starting study treatment
- Use of dexamethasone above 4 mg/day or equivalent prior to treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
A
Allison Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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