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Checkpoint Inhibitor
Intravenous and Intrathecal Nivolumab for Leptomeningeal Disease
Phase 1
Waitlist Available
Led By Isabella C Glitza
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have radiographic and/or CSF cytological evidence of LMD
Patients with lung cancer must have non-small cell lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a combination of two immunotherapy drugs to see if they can better treat leptomeningeal disease with fewer side effects than current treatments.
Who is the study for?
This trial is for adults with leptomeningeal disease from melanoma or non-small cell lung cancer. Participants can have had prior treatments but must meet specific conditions, such as not having severe allergies to monoclonal antibodies, no active autoimmune diseases requiring treatment in the past 2 years, and no ongoing serious side effects from previous immunotherapy.Check my eligibility
What is being tested?
The trial tests intrathecal (into the spinal canal) and intravenous Nivolumab to see how well it works against leptomeningeal disease. It aims to find the best dose and assess side effects when using this form of immunotherapy that helps the immune system fight cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion, immune-related inflammation in various organs, fatigue, possible worsening of pre-existing autoimmune diseases, increased risk of infections due to immune system changes caused by Nivolumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tests show cancer cells in my brain or spinal fluid.
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My lung cancer is non-small cell type.
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I can take care of myself but might not be able to do heavy physical work.
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I have been diagnosed with melanoma in the brain or its metastasis.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Overall survival (OS) in patients treated with IT and IV nivolumab (dose expansion part)
Recommended dose of combined intrathecal (IT) and intravenous (IV) nivolumab defined as the highest dose for which the posterior probability of toxicity is closest to 30% (dose escalation part)
Secondary outcome measures
Immunological effects of nivolumab
OS
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab)Experimental Treatment6 Interventions
Patients receive nivolumab IT over 5 minutes on day 1 of every cycle. Beginning in cycle 2, patients also receive nivolumab IV over 30 minutes on day 1 (4 hours after the IT dose). Cycles repeat every 14 days for 18 cycles and then every 28 days (cycles 19 and beyond) in the absence of disease progression or unacceptable toxicity. Patients will have CSF and blood specimen collection on days 1, 2, 8 of each cycle and end of treatment. Patients undergo CT or PET at baseline, cycle 5 and then every 8 weeks. Patients undergo MRI at baseline, cycles 3, 5, and then every 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Lumbar Puncture
2016
Completed Phase 3
~510
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Nivolumab
FDA approved
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,752 Total Patients Enrolled
1 Trials studying Leptomeningeal Neoplasm
200 Patients Enrolled for Leptomeningeal Neoplasm
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,617 Total Patients Enrolled
1 Trials studying Leptomeningeal Neoplasm
85 Patients Enrolled for Leptomeningeal Neoplasm
Isabella C GlitzaPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
61 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tests show cancer cells in my brain or spinal fluid.I haven't needed treatment for an autoimmune disease in the last 2 years.I am experiencing significant side effects from my immunotherapy.I last received biologic therapy for my condition over 2 weeks ago.I last received immunotherapy at least 7 days before starting this treatment.I have not had any infections in the last week.You have had a serious allergic reaction to any monoclonal antibody in the past.My lung cancer is non-small cell type.I can take care of myself but might not be able to do heavy physical work.I finished any brain or spine radiation treatment over a week ago.You have a positive test for hepatitis B virus or hepatitis C virus, showing that you have an ongoing infection.I am taking 4 mg or less of dexamethasone daily for CNS symptoms.I am a man and will use birth control if I have sex with a woman who can get pregnant.I haven't had any live vaccines in the last 12 weeks.You are currently being held against your will for treatment of a mental or physical illness.I haven't taken steroids or immunosuppressants in the last 14 days.I have been diagnosed with melanoma in the brain or its metastasis.I am currently undergoing cancer treatment or participating in a drug trial.My last chemotherapy was over 2 weeks ago.I am currently on approved targeted therapy for my condition.I am 18 years old or older.You do not have any reasons that would make using an Ommaya reservoir unsafe for you.I have had pneumonitis before.Your blood test results need to be within certain ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are involved in this investigation?
"Affirmative. Clinical trials.gov details that this research project, initially posted on May 2nd 2018 and recently updated November 28th 2022, is actively recruiting patients at one location with a total enrolment of 50 participants."
Answered by AI
What risks have been observed in connection with Nivolumab treatments?
"While there is not a lot of data to support the efficacy or safety of Nivolumab, our Power team has assigned it a rating of 1 on their scale."
Answered by AI
Has this medical research ever been conducted before?
"Scientific exploration of nivolumab commenced in 2012 and was spearheaded by Ono Pharmaceutical Co. Ltd. Thanks to the successful Phase 1 & 2 trials involving 659 patients, it has since been approved for use as a medication. At current count 717 clinical studies are being conducted with nivolumab across 2356 cities within 49 countries worldwide."
Answered by AI
Would you be able to provide an overview of Nivolumab research projects conducted in the past?
"Presently, 717 studies are being conducted on Nivolumab, with 82 of those in their final phase. Although the majority of research for this therapeutic agent is located in Basel BE, there are 40281 worldwide locations participating in trials."
Answered by AI
Is participant recruitment ongoing for this investigation?
"Indeed, the information available on clinicaltrials.gov asserts that this investigation is actively searching for participants. This experiment was first published on May 2nd 2018 and has been modified as recently as November 28th 2022. As of now, 50 people are required to take part in the trial from one location."
Answered by AI
What health conditions can be treated with Nivolumab?
"Nivolumab is commonly used to help patients with malignant neoplasms, however it has also proven effective at treating various other life-threatening illnesses such as unresectable melanoma, metastatic esophageal adenocarcinoma and squamous cell carcinoma."
Answered by AI
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