Actively Recruiting
Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases
Led by M.D. Anderson Cancer Center · Updated on 2026-01-14
30
Participants Needed
1
Research Sites
283 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if giving nivolumab in combination with relatlimab can help to control melanoma that has spread to the brain (melanoma with brain metastases). The safety and side effects of the study drug combination will also be studied.
CONDITIONS
Official Title
Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Life expectancy greater than 12 weeks
- Signed informed consent and willingness to comply with study visits and procedures
- Histologically confirmed malignant melanoma with measurable brain metastases (at least one lesion 0.5 to 3 cm in size)
- No prior stereotactic radiosurgery (SRS) to the target brain lesion
- Availability of tumor tissue samples for testing or willingness to undergo biopsy
- Prior stereotactic radiotherapy or excision of up to 5 brain metastases allowed if fully recovered without neurological symptoms
- No neurological symptoms or corticosteroid use within 5 days before starting treatment
- ECOG performance status of 0 or 1
- Adequate organ function
- Women of child-bearing potential must have a negative pregnancy test and agree to contraceptive measures
- All prior cancer therapy side effects resolved to grade 1 or baseline except stable endocrinopathies
- Steroids allowed only for physiological replacement
You will not qualify if you...
- Known leptomeningeal involvement
- Stereotactic radiotherapy within 1 week before study dosing
- More than 5 brain lesions treated with stereotactic radiotherapy or prior whole brain radiation
- Brain lesions larger than 3 cm
- Prior checkpoint inhibitor therapy in metastatic setting (with exceptions requiring a 6-month washout)
- Active or suspected autoimmune disease requiring systemic treatment (some stable conditions allowed)
- Major medical, neurological, or psychiatric conditions limiting study compliance
- History of second malignancy unless disease-free for at least 2 years (exceptions apply)
- Positive for hepatitis B or C infection
- Known HIV infection
- Use of corticosteroids or immunosuppressive drugs within 10-14 days before study (except physiological replacement or allowed inhaled/topical steroids)
- Recent major surgery or traumatic injury within 14 days before treatment
- Non-healing wounds or fractures
- Pregnant or breastfeeding women
- Uncontrolled illness or infection
- Significant cardiac disease or recent heart problems
- Elevated troponin levels above institutional limits
- Use of investigational drugs within 14 days before study treatment
- History of pneumonitis requiring steroids or current pneumonitis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Hussein Tawbi, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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