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Checkpoint Inhibitor

Nivolumab for Brain Tumors

Phase 2

Waitlist Available

Research Sponsored by Fabio Iwamoto, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with pathologically confirmed grade 2, 3 or 4 gliomas with IDH mutation and progressive tumor with previous exposure to alkylating agents

Participants must have measurable disease with at least one enhancing tumor lesion ≥ 10mm x 10mm on brain MRI

Must not have

Prior use of specific inhibitors or exposure to checkpoint inhibitors

Prior exposure to bevacizumab or other VEGF/VEGFR inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up total treatment duration for 2 years or until pd, unacceptable toxicity, or withdrawal of consent.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing nivolumab for people with IDH-mutant gliomas who have progressed after treatment with alkylating agents.

Who is the study for?

This trial is for adults with recurrent or progressive brain tumors (IDH mutant gliomas grades 2, 3, or 4) who have previously been treated with alkylating agents. Participants must be able to perform daily activities at a reasonable level (KPS of 60+), have measurable disease on MRI, and provide tumor samples. They need normal organ function tests and must consent to study requirements.

What is being tested?

The trial is testing the effectiveness of Nivolumab in treating IDH mutant gliomas that are recurring or worsening despite prior treatment. The main goal is to see how many patients experience partial or complete shrinkage of their tumors after receiving this drug.

What are the potential side effects?

Nivolumab can potentially cause immune-related side effects such as inflammation in various organs like lungs and intestines, skin rash, hormone gland problems (like thyroid dysfunction), liver issues, fatigue, and infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain tumor is aggressive, has an IDH mutation, and has worsened despite previous treatments.

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I have a tumor in my brain that is visible and measures at least 10mm x 10mm on an MRI.

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I am a woman who can have children and have a negative pregnancy test.

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I am 18 years old or older.

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I can care for myself but may need occasional assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously used specific inhibitors or checkpoint inhibitors.

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I have been treated with bevacizumab or similar drugs before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ total treatment duration for 2 years or until pd, unacceptable toxicity, or withdrawal of consent.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~total treatment duration for 2 years or until pd, unacceptable toxicity, or withdrawal of consent.

This trial's timeline: 3 weeks for screening, Varies for treatment, and total treatment duration for 2 years or until pd, unacceptable toxicity, or withdrawal of consent. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

Duration of Response

Overall Survival (OS)

Progression-Free Survival (PFS)

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%

Tinnitus

10%

Cushingoid

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%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NivolumabExperimental Treatment1 Intervention

Nivolumab 240 mg will be given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

0 / 7Eligibility criteria met