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Checkpoint Inhibitor
Nivolumab for Brain Cancer
Phase 2
Recruiting
Led By Marta Penas-Prado, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histopathologically proven diagnosis of Ependymoma, Medulloblastoma, Parenchymal Pineal Region Tumors, Choroid Plexus Tumors, Histone Mutated Gliomas, Gliomatosis Cerebri, ATRT, Malignant/Atypical Meningioma, Gliosarcoma, Primary CNS Sarcoma, Pleomorphic Xanthoastrocytoma, Anaplastic Pleomorphic Xanthoastrocytoma, and tumors formerly known as Primitive Neuro-Ectodermal Tumors prior to registration
Participants must have progressive tumor growth after receiving standard of care or other treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after end of treatment
Awards & highlights
Study Summary
This trial will test whether the immunotherapy drug nivolumab is an effective treatment for people with rare CNS tumors by measuring the shrinkage of tumors or the amount of time it takes for the tumors to grow or spread.
Who is the study for?
Adults with certain rare brain or spine tumors that have come back can join this trial. They must be over 18, in good health, and not on high steroid doses. Participants need to have had all COVID-19 shots, agree to use birth control if needed, and provide a tumor tissue sample. People who've had other cancers or severe illnesses, are pregnant or breastfeeding, allergic to the drug's ingredients, unable to get MRIs or vaccinated against COVID-19 can't join.Check my eligibility
What is being tested?
The trial is testing Nivolumab—an immunotherapy drug—given every two weeks through an IV for up to 64 weeks. It aims to see if it shrinks these rare CNS tumors or slows their growth. The study includes regular blood tests, MRIs every two months along with neurological function tests and quality of life surveys.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects like inflammation in various organs (lungs, intestines), skin rashes, hormone gland problems (thyroid), liver issues; also fatigue and infusion reactions are possible.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis is one of the listed brain or central nervous system tumors.
Select...
My cancer has grown despite treatment.
Select...
I am 18 years old or older.
Select...
I can care for myself but may not be able to do active work.
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I am not taking high doses of corticosteroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
objective response
progression free survival rate
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%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
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%
Malaise
5%
Pain
5%
Musculoskeletal chest 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%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
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: 1/Experimental TherapyExperimental Treatment1 Intervention
Patients will receive nivolumab at standard dose of 240 mg IV every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,674 Total Patients Enrolled
89 Trials studying Medulloblastoma
10,161 Patients Enrolled for Medulloblastoma
Marta Penas-Prado, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Medulloblastoma
120 Patients Enrolled for Medulloblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis is one of the listed brain or central nervous system tumors.My cancer has grown despite treatment.I am 18 years old or older.I have previously received immunotherapy or specific cancer vaccines.I do not have another cancer that could affect this treatment's safety or results.I have an active autoimmune or connective tissue disorder.I can care for myself but may not be able to do active work.My kidney function is good as tested within the last 14 days.My liver is functioning well, as tested within the last 2 weeks.I am not taking high doses of corticosteroids.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Experimental Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is this an unprecedented scientific investigation?
"Nivolumab has been subject to scientific scrutiny since 2012 thanks to a study conducted by Ono Pharmaceutical Co. Ltd, which included 659 participants. Following the successful Phase 1 & 2 trials, 718 active experiments are now being held in 2354 cities and 49 nations worldwide."
Answered by AI
What is the current regulatory status of Nivolumab?
"Nivolumab's safety has been supported by data from Phase 2, so our team rated it with a score of two. Unfortunately, no evidence exists yet to support the efficacy of this treatment."
Answered by AI
Are there any vacancies available to participate in this trial?
"Affirmative. According to the records on clinicaltrials.gov, enrollment for this research is currently open and began on July 13th 2017 with updates as recent as October 4th 2022. 180 participants are needed across 12 sites."
Answered by AI
How many participants have been recruited for this medical trial?
"This research requires 180 eligible patients to take part. Individuals can join the study from NorthShore University HealthSystem, Evanston Hospital in Illinois and UC Irvine in California."
Answered by AI
In what ways is Nivolumab typically employed?
"Nivolumab is a viable treatment option for malignant neoplasms, irresectable melanoma, and squamous cell carcinoma."
Answered by AI
How many healthcare facilities are overseeing this clinical trial?
"The current list of sites for this trial includes 12 locations, including Evanston, Orange and La Jolla. To ensure the best experience for yourself if you enroll in the study, it is recommended to select a nearby medical centre."
Answered by AI
Has Nivolumab been tested in any previous clinical research studies?
"Nivolumab's initial exploration was conducted at Local Institution in 2012, which has since been followed by 252 successful trials. Currently, there are 718 studies ongoing, with a considerable portion of these being done from Evanston, Illinois."
Answered by AI
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