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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

Must not have

Prior use of immunotherapy such as vaccine therapy, dendritic cell vaccine, other checkpoint inhibitors, or intracavitary or convectional enhanced delivery of chemotherapy

Active connective tissue disorders or autoimmune diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after end of treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My diagnosis is one of the listed brain or central nervous system tumors.

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My cancer has grown despite treatment.

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I am 18 years old or older.

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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.

Exclusion Criteria

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

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I have previously received immunotherapy or specific cancer vaccines.

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I have an active autoimmune or connective tissue disorder.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after end of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

objective response

progression free survival rate

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: 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

2015

Completed Phase 3

~4010

0 / 7Eligibility criteria met