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Monoclonal Antibodies

Nivolumab + Temozolomide for Glioblastoma (NUTMEG Trial)

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.

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.
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.
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.
Select...
I have tissue available for MGMT testing.
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My blood tests show my bone marrow is working well.
Select...
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).

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.
Select...
I have not had chemotherapy or brain radiation in the last 5 years.

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
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%
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

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
2015
Completed Phase 3
~4010
Temozolomide
2010
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

University of SydneyLead Sponsor
198 Previous Clinical Trials
335,903 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
~1 spots leftby Dec 2024
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