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PD-1 Inhibitor

Nivolumab for Brain Cancer

Phase 2
Recruiting
Led By Jing Wu, 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
Karnofsky greater than or equal to 60%
Patients must have tumor specific mutation burden tested at NIH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 12 months
Awards & highlights

Study Summary

This trial is testing nivolumab to see if it stops tumor growth and prolongs the time that the tumor is controlled in adults with IDH1 or IDH2 mutated gliomas.

Who is the study for?
Adults over 18 with IDH1 or IDH2 mutated gliomas are eligible for this trial. They must have adequate organ function, be able to undergo MRI scans, and not be pregnant or breastfeeding. Participants should not have a history of severe allergies to monoclonal antibodies, active infections, certain autoimmune diseases, or other cancers within the last three years.Check my eligibility
What is being tested?
The trial is testing Nivolumab's effectiveness on brain tumors with specific genetic mutations (IDH1/IDH2). It aims to see if it can stop tumor growth in patients with these mutations both with and without a high number of additional mutations known as HMP.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs, potential infusion reactions during administration, fatigue, skin issues like rash or itching, and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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My tumor mutation burden was tested at NIH.
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I am 18 years old or older.
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My glioma has come back and has an IDH mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6-month progression free survival rate
Secondary outcome measures
Correlation between neoantigen burden of tumor and proportion of subjects that survive after 6 and 12 months
Median amount of time subject survives after therapy and Proportion of patients that have progressive disease after 12 months
Proportion of patients that have improvement in quality of life

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
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%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Superior vena cava syndrome
1%
Syncope
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Lung cancer metastatic
1%
Cancer pain
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
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/NivolumabExperimental Treatment1 Intervention
IV nivolumab
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
13,627 Previous Clinical Trials
40,927,765 Total Patients Enrolled
Jing Wu, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
419 Total Patients Enrolled

Media Library

Nivolumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03718767 — Phase 2
Brain Tumor Research Study Groups: 1/Nivolumab
Brain Tumor Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03718767 — Phase 2
Nivolumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03718767 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety profile has been observed with Nivolumab usage?

"The safety of Nivolumab is rated at a 2 on the scale, as it has been tested for efficacy but not to its full extent. There is however some data available that corroborates its safety."

Answered by AI

In what medical circumstances is Nivolumab typically recommended?

"Nivolumab is regularly used to combat malignant neoplasms, but has also proven successful in treating forms of melanoma, squamous cell carcinoma, and esophageal adenocarcinomas which are not operable."

Answered by AI

Is this research the inaugural endeavor of its kind?

"Since 2012, Ono Pharmaceutical Co. Ltd has conducted 252 trials for Nivolumab across 49 countries and 2356 cities. Currently there are 718 active studies of this investigational drug, with the first trial completed in its Phase 1 & 2 approval stage involving 659 patients."

Answered by AI

Is recruitment still underway for this experiment?

"According to the clinicaltrials.gov database, this research study is currently accepting trial participants. The first posting of this medical project was on March 27th 2019, with its latest edit being in November 19th 2022."

Answered by AI

Has Nivolumab been the focus of previous research initiatives?

"Presently, there are 718 clinical trials exploring the efficacy of Nivolumab. Of those live studies, 82 have reached Phase 3 status. While Basel in BE is a major site for such research, 40285 different sites around the world are offering this treatment to their patients."

Answered by AI

How many participants are accepted in this research endeavor?

"Affirmative, according to clinicaltrials.gov the study is still recruiting participants since its initial posting on March 27th 2019 and last update of November 19th 2022. At present, 95 individuals are sought from a single centre."

Answered by AI
~16 spots leftby Sep 2025