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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
Must not have
Uncontrolled intercurrent illness
Patients with a history of receiving immune therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 12 months
Awards & highlights

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any uncontrolled illnesses.
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I have received immune therapy in the past.
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I am taking more than 1 mg of dexamethasone or its equivalent daily.
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I have been cancer-free for at least 3 years from a previous cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
6-month progression free survival rate
Secondary study objectives
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 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Cushingoid
10%
Tinnitus
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

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
~5220

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,930 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
~11 spots leftby Sep 2025
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