Concurrent intrathecal and intravenous nivolumab in leptomeningeal disease: phase 1 trial interim results.
Isabella C Glitza Oliva, Sherise D Ferguson, Roland Bassett...
https://pubmed.ncbi.nlm.nih.gov/36997799Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID03025256
Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Melanoma and Lung Cancer Patients With Leptomeningeal Disease
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
75
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety, best dose, and effects of intrathecal (IT) nivolumab combined with intravenous (IV) nivolumab in treating patients with leptomeningeal disease (LMD) caused by melanoma or lung cancer. This phase I/Ib trial aims to understand how this immunotherapy may help the immune system fight cancer cells in the brain and spinal fluid, and to assess overall survival and immune responses during treatment. Patients receive nivolumab injected into the cerebrospinal fluid over 5 minutes on day 1 of each cycle. Starting from cycle 2, they also receive nivolumab intravenously 4 hours after the IT dose. Treatment cycles repeat every 14 days for up to 18 cycles, then every 28 days if the disease does not progress or side effects are manageable. During treatment, cerebrospinal fluid and blood samples are collected on days 1, 2, and 8 of each cycle and at the end of treatment. Imaging scans including CT, PET, and MRI are done at scheduled intervals to monitor disease. Participants undergo regular clinical and laboratory evaluations, imaging scans, and sample collections throughout the study. After finishing treatment, follow-up visits occur within 4 weeks and then every 12 weeks to monitor health and survival. The main measures include monitoring side effects, determining the recommended dose of combined IT and IV nivolumab, and assessing overall survival for up to 2 years.
CONDITIONS
Brief Title
Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Radiographic or cerebrospinal fluid evidence of leptomeningeal disease
- Confirmed diagnosis of melanoma or non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Steroid use of 4 mg dexamethasone or less per day (physiologic replacement allowed)
- Completed brain or spine radiation at least 7 days before treatment start
- Specific washout periods from prior therapies as detailed in protocol
- Age 18 years or older
- Ability to provide written informed consent
- Adequate blood counts and organ function as specified
- No contraindications for Ommaya reservoir placement
- Women must meet specific criteria regarding childbearing potential and contraception
- Men sexually active with women of childbearing potential must use contraception
You will not qualify if you...
- Active autoimmune disease requiring systemic treatment in past 2 years
- Need for systemic corticosteroids over 4 mg dexamethasone equivalents daily within 14 days before treatment
- Ongoing grade 3 or higher side effects from prior PD-1 or CTLA-4 therapy
- Currently receiving cancer therapy other than approved targeted therapies
- Pregnant or breastfeeding women
- Major medical, neurologic, or psychiatric conditions preventing study participation
- History of pneumonitis
- Active infections within 7 days prior to treatment
- Use of live virus vaccines within 12 weeks before treatment
- Positive test for hepatitis B or C infection
- Known HIV infection
- Allergy to study drug components or severe hypersensitivity to monoclonal antibodies
- Prisoners or involuntarily incarcerated individuals
- Patients compulsorily detained for psychiatric or physical illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 18 months or longer depending on treatment continuation
Participants receive intrathecal nivolumab on day 1 of every cycle. Starting from cycle 2, participants also receive intravenous nivolumab on day 1, 4 hours after the intrathecal dose. Treatment cycles repeat every 14 days for 18 cycles and then every 28 days thereafter in the absence of disease progression or unacceptable toxicity.
Biweekly visits for up to 18 cycles, then monthly visits thereafter
Follow-up
Duration - Up to 2 years
After completing study treatment, participants are followed up within 4 weeks and then every 12 weeks to monitor overall survival and safety.
Follow-up visits within 4 weeks after treatment and then every 12 weeks
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
I
Isabella Glitza, MD
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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