Actively Recruiting
Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
75
Participants Needed
1
Research Sites
473 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/Ib trial studies the side effects and best dose of intrathecal nivolumab, and how well it works in combination with intravenous nivolumab in treating patients with leptomeningeal disease. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
CONDITIONS
Official Title
Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have radiographic and/or cerebrospinal fluid cytological evidence of leptomeningeal disease
- For melanoma patients: confirmed diagnosis of primary CNS melanoma, melanocytomas, or metastatic melanoma by histology
- For lung cancer patients: non-small cell lung cancer confirmed by histology
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Steroid use for CNS symptoms limited to 4 mg or less of dexamethasone daily or equivalent
- Completed brain or spine radiation treatment at least 7 days prior to treatment start
- Previous treatment with approved targeted therapies allowed with specific washout periods for other therapies
- Age 18 years or older
- Able to provide written informed consent
- Adequate blood counts and liver and kidney function as specified
- No contraindication for Ommaya reservoir placement
- Women must meet specific criteria regarding childbearing potential and contraception use
- Men sexually active with women of childbearing potential must use contraception as instructed
You will not qualify if you...
- Active autoimmune disease requiring systemic treatment within past 2 years
- Need for systemic corticosteroids above 4 mg dexamethasone daily or other immunosuppressive drugs within 14 days before study drug
- Ongoing grade 3 or higher side effects from prior anti-PD-1 or anti-CTLA-4 therapy
- Currently receiving other anticancer therapies except approved targeted therapies
- Pregnant or breastfeeding women
- Major medical, neurological, or psychiatric conditions preventing study compliance
- History of pneumonitis
- Active infections within 7 days before starting study drug
- Use of live virus vaccines within 12 weeks before study drug
- Positive tests for hepatitis B or C virus
- Known HIV infection
- History of allergy or severe reaction to study drug or monoclonal antibodies
- Prisoners or involuntarily incarcerated individuals
- Subjects detained for psychiatric or infectious disease treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
I
Isabella Glitza, MD
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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