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Checkpoint Inhibitor
Immunotherapy Before and After Surgery for Brain Tumor
Phase 1
Recruiting
Research Sponsored by Sabine Mueller, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have evidence of recurrence or progression of disease by MRI scan
Age: Participants must be > 6 months and < 25 years of age at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects of two immunotherapy drugs before and after surgery in children and young adults with high grade glioma.
Who is the study for?
This trial is for children and young adults aged 6 months to less than 22 years with high-grade gliomas (brain tumors) that have recurred or progressed. They must have recovered from previous cancer treatments, meet specific blood count and organ function criteria, be candidates for surgical tumor removal, and not be on certain medications or have conditions like active TB or autoimmune diseases.Check my eligibility
What is being tested?
The trial tests the safety of nivolumab and ipilimumab immunotherapies before and after surgery in patients with aggressive brain tumors. These drugs are designed to help the immune system fight cancer by blocking pathways that allow tumor cells to evade an immune response.See study design
What are the potential side effects?
Potential side effects include inflammation in various organs, infusion reactions similar to allergic responses, fatigue, digestive issues such as diarrhea or constipation, skin rash, hormone gland problems (like thyroid dysfunction), liver inflammation, and potential worsening of pre-existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My MRI shows my disease is getting worse.
Select...
I am between 6 months and 25 years old.
Select...
My surgery aims to remove as much of the tumor as possible, not just to diagnose.
Select...
I have had high-grade brain cancer treated with radiation or chemotherapy.
Select...
I agree to only use the study's treatment and no other cancer-killing therapies while participating.
Select...
I have a high-grade brain tumor and am eligible for surgery to remove it.
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
Percentage change in cell cycle-related genetic signature
Therapeutic procedure
Secondary outcome measures
Overall survival
Progression-free survival (PFS)
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%
Chills
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
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%
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%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Small intestinal haemorrhage
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Circulatory collapse
1%
Hypercalcaemia
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: Neoadjuvant nivolumab and adjuvant nivolumabExperimental Treatment3 Interventions
NEOADJUVANT: Patients receive nivolumab IV over 30 minutes 14 days before undergoing standard of care surgical resection.
ADJUVANT MAINTENANCE: After completion of neoadjuvant infusion, patients receive nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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?
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,012 Total Patients Enrolled
Sabine Mueller, MD, PhDLead Sponsor
8 Previous Clinical Trials
463 Total Patients Enrolled
Pacific Pediatric Neuro-Oncology ConsortiumOTHER
14 Previous Clinical Trials
717 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My MRI shows my disease is getting worse.My neurological condition has been stable for at least a week, and I have a recent detailed exam report.All medical tests and evaluations must be completed within 14 days before enrolling in the study. You and your parent or legal guardian will be fully informed about the study and its requirements. You must sign a written consent form before being enrolled.I am currently being treated for an infection with medication.My neurological condition has been stable for at least a week.I am between 6 months and 25 years old.I have or had lung inflammation not caused by an infection.I have another cancer that is getting worse or needs treatment.I have an autoimmune disease treated with medication in the last 2 years.I am a good candidate for surgery to remove part of my tumor for study and treatment.I have had a stem cell transplant from a donor.I have an active tuberculosis infection.My cancer has spread widely in my brain or body.I have recovered from all side effects of my previous cancer treatments.My tumor is mainly in my brainstem or spinal cord.My surgery aims to remove as much of the tumor as possible, not just to diagnose.I have had high-grade brain cancer treated with radiation or chemotherapy.I agree to only use the study's treatment and no other cancer-killing therapies while participating.I have not taken drugs that weaken my immune system in the last 6 months.I haven't taken steroids or immunosuppressants in the last 14 days.I can do most activities myself, even if I use a wheelchair.I have been diagnosed with an immune system disorder.I have a high-grade brain tumor and am eligible for surgery to remove it.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant nivolumab and adjuvant nivolumab
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 the age limitation for this trial set at 40 or older?
"This clinical trial's parameters stipulate that suitable participants must be between 6 months and 22 years of age. The database currently features 319 studies catered to children, as well as 2145 for individuals over the retirement-age."
Answered by AI
Have there been any other experimental studies conducted with Nivolumab?
"In 2009, the initial studies of nivolumab were conducted at Texas Children's Hospital. As of today, there have been 605 completed trials and 764 that are currently in progress, many based out of Saint Louis Missouri."
Answered by AI
What is the total enrollment for this clinical experimentation?
"Unfortunately, recruitment for this trial has been suspended. It was first posted on October 2nd 2020 and last edited on the 14th of October 2022. If you are seeking alternative studies in glioblastoma or nivolumab treatment, there are currently 1610 and 764 trials open to participants respectively."
Answered by AI
Who is able to register for participation in this research study?
"In order to join this investigation, individuals must possess glioblastoma and be between 6 Months of age and 22 years old. This clinical trial has the capacity for 5 participants in total."
Answered by AI
How widely disseminated is this trial's implementation?
"This clinical trial has 13 sites recruiting patients. Washington University St. Louis in Saint Louis, University of Florida in Gainesville and Doernbecher Children's Hospital Oregon Health & Science University in Portland are a few examples."
Answered by AI
To what ailments is Nivolumab commonly administered?
"Nivolumab is typically used as a follow-up to anti-angiogenic therapy, and can be employed to target malignant neoplasms, inoperable melanoma, and squamous cell carcinoma."
Answered by AI
Are participants being actively sought for this investigation?
"Based on the information displayed on clinicaltrials.gov, this research endeavour is not currently seeking to include additional participants in their trial. It was first published October 2nd 2020 and last updated October 14th 2022; however, there are still 2374 studies actively recruiting patients at present."
Answered by AI
Has Nivolumab achieved certification from the FDA?
"Currently, the available data is limited in regards to nivolumab's safety and efficacy; therefore, it has been assessed with a score of 1."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
How old are they?
< 18
What site did they apply to?
Children's National Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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