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Monoclonal Antibodies

Nivolumab + Temozolomide for Glioblastoma (NUTMEG Trial)

Port Macquarie, Australia
Phase 2
Waitlist Available
Research Sponsored by University of Sydney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate liver function (ALT/AST < 1.5 x ULN)
Tissue available for MGMT testing
Must not have
For symptoms related to GBM, the need for >4 mg/day of dexamethasone or >20 mg/day prednisone (or equivalent) at the time of screening.
Prior chemotherapy or cranial radiation within the last 5 years. Prior or concomitant therapies for GBM (except surgery).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is for elderly patients with newly diagnosed glioblastoma. It will compare the effectiveness of two treatments: temozolomide alone or in combination with nivolumab.

See full description
Who is the study for?
Elderly patients aged 65 or above with newly diagnosed glioblastoma (GBM) may qualify for this trial. They should have had surgery, a life expectancy over 12 weeks, and be able to undergo MRI scans. Excluded are those needing high doses of steroids, with certain autoimmune diseases or other serious health issues that could affect the study.Check my eligibility
What is being tested?
The trial is testing if adding Nivolumab to Temozolomide improves survival in elderly GBM patients compared to using Temozolomide alone after surgery. It's designed to find better treatments for GBM by measuring how long patients live with each therapy.See study design
What are the potential side effects?
Nivolumab can cause immune-related side effects like inflammation in various organs, skin rash, and fatigue. Temozolomide might lead to nausea, constipation, loss of appetite and lower blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver tests are within normal limits.
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I have tissue available for MGMT testing.
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My blood tests show my bone marrow is working well.
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I am 70 or older, or 65-69 and cannot have long course RT, with a new GBM diagnosis after surgery.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My kidneys work well (creatinine clearance over 30 ml/min).
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need more than 4 mg of dexamethasone or more than 20 mg of prednisone daily for my GBM symptoms.
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Select...
I have not had chemotherapy or brain radiation in the last 5 years.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 24 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
Overall survival outcomes
Secondary study objectives
Correlating modified RANO and immune related RANO in the experimental arm
Health related quality of life of participants (EuroQoL EQ-5D-5L)
Health related quality of life of participants (QLQ C-30)
+4 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
70%
Fatigue
50%
Headache
45%
Confusional state
45%
Cough
40%
Malignant neoplasm progression
35%
Hemiparesis
35%
Diarrhoea
30%
Gait disturbance
30%
Nausea
30%
Pruritus
25%
Urinary tract infection
25%
Fall
25%
Hyperglycaemia
25%
Muscular weakness
25%
Rash
20%
Constipation
20%
Vomiting
20%
Lethargy
20%
Memory impairment
20%
Urinary incontinence
20%
Dizziness
20%
Nasal congestion
15%
Abdominal pain
15%
Alanine aminotransferase increased
15%
Lymphocyte count decreased
15%
Platelet count decreased
15%
Decreased appetite
15%
Arthralgia
15%
Cognitive disorder
10%
Aspartate aminotransferase increased
10%
Oedema peripheral
10%
Facial paresis
10%
Pyrexia
10%
Candida infection
10%
Depressed level of consciousness
10%
Syncope
10%
Pulmonary embolism
10%
Anaemia
10%
Sinus tachycardia
10%
Anal incontinence
10%
Asthenia
10%
Tooth infection
10%
Upper respiratory tract infection
10%
Lipase increased
10%
Paraesthesia
10%
Psychomotor skills impaired
10%
Seizure
10%
Agitation
10%
Anxiety
10%
Disorientation
10%
Dehydration
10%
Hypoalbuminaemia
10%
Hypokalaemia
10%
Hyponatraemia
10%
Aphasia
10%
Dysarthria
10%
Dyspnoea
10%
Rash maculo-papular
5%
Dermatitis acneiform
5%
Dysphagia
5%
Oedema
5%
Pain
5%
Cardio-respiratory arrest
5%
Autoimmune thyroiditis
5%
Pneumonia
5%
Hip fracture
5%
White blood cell count decreased
5%
Enterocolitis infectious
5%
Tumour flare
5%
Brain oedema
5%
Cerebrovascular accident
5%
Ischaemic stroke
5%
Mental status changes
5%
Aspiration
5%
Herpes zoster
5%
Haemorrhage intracranial
5%
Hypoxia
5%
Pneumonitis
5%
Respiratory distress
5%
Atrial fibrillation
5%
Cushingoid
5%
Hyperthyroidism
5%
Hypothyroidism
5%
Dry eye
5%
Eyelid ptosis
5%
Visual field defect
5%
Visual impairment
5%
Dyspepsia
5%
Oral candidiasis
5%
Stomatitis
5%
Chills
5%
Amylase increased
5%
Blood alkaline phosphatase increased
5%
Blood bilirubin increased
5%
Weight decreased
5%
Weight increased
5%
Tremor
5%
Vasogenic cerebral oedema
5%
Depression
5%
Insomnia
5%
Pollakiuria
5%
Hypocalcaemia
5%
Proteinuria
5%
Back pain
5%
Myalgia
5%
Amnesia
5%
Ataxia
5%
Balance disorder
5%
Dysphonia
5%
Dry skin
5%
Deep vein thrombosis
5%
Hypertension
5%
Hypotension
5%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1b: Arm N3+I1
Cohort 1: Arm N3
Cohort 1: Arm N1+I3
Cohort 2: Arm N3
Part A Cohort 1c: Arm N3+RT+TMZ
Cohort 2: Arm B
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Part A Cohort 1d: Arm N3+RT

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab and TemozolomideExperimental Treatment2 Interventions
After radiotherapy and 4 week break, participants who are assigned to this arm will receive Nivolumab with concurrent adjuvant temozolomide treatment
Group II: TemozolomideActive Control1 Intervention
After radiotherapy and 4 week break, participants who are assigned to this arm will receive the standard treatment of adjuvant temozolomide treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~3880
Temozolomide
2010
Completed Phase 3
~1880

Find a Location

Closest Location:Duke University Medical Center· Durham, NC

Who is running the clinical trial?

University of SydneyLead Sponsor
207 Previous Clinical Trials
417,157 Total Patients Enrolled
1 Trials studying Glioblastoma
20 Patients Enrolled for Glioblastoma
Cooperative Trials Group for Neuro-OncologyUNKNOWN
1 Previous Clinical Trials
751 Total Patients Enrolled
Mustafa KhasrawStudy ChairDuke University

Media Library

Nivolumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04195139 — Phase 2
Glioblastoma Research Study Groups: Nivolumab and Temozolomide, Temozolomide
Glioblastoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04195139 — Phase 2
Nivolumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04195139 — Phase 2
~13 spots leftby Mar 2026
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