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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 24 months
Awards & highlights

NUTMEG Trial 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.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.

NUTMEG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver tests are within normal limits.
Select...
I have tissue available for MGMT testing.
Select...
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.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
My kidneys work well (creatinine clearance over 30 ml/min).

NUTMEG Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival outcomes
Secondary outcome measures
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 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Chills
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Hypercalcaemia
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

NUTMEG 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
~4750
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

University of SydneyLead Sponsor
190 Previous Clinical Trials
214,629 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Nivolumab been accepted by the FDA?

"Nivolumab's safety was scored as a 2 because, while there is some data supporting its safety, none of it indicates that the medication is effective."

Answered by AI

What indications is Nivolumab approved to treat?

"Nivolumab is a medication used to treat various forms of cancer. Some other examples of conditions it can be taken for include unresectable melanoma, squamous cell carcinoma, and high risk of recurrence."

Answered by AI

Are people with the medical condition currently being accepted into this trial?

"This specific clinical trial is no longer recruiting patients. The original posting date was February 22nd, 2018 and the most recent edit was made on July 14th, 2022. For other trials, there are 458 studies actively looking for patients with glioblastoma multiforme (gbm) and 955 trials for Nivolumab that have open recruitment at this time."

Answered by AI

How many people have been included in this clinical trial thus far?

"Unfortunately, this study is not presently looking for new patients. The clinical trial was initially posted on February 22nd, 2018 and was last updated on July 14th, 2022. However, there are 458 other studies actively searching for patients with glioblastoma multiforme (gbm) and 955 trials for Nivolumab that are admitting participants."

Answered by AI

What are the most recent findings on Nivolumab's efficacy?

"At the moment, 955 clinical trials involving Nivolumab are ongoing with 106 of them being Phase 3 trials. The majority of these studies originate from Houston, Texas; however, there are a total of 44852 research sites for Nivolumab worldwide."

Answered by AI

Has this particular clinical trial been conducted before?

"To date, there are 955 ongoing clinical trials worldwide for the drug Nivolumab. The first trial was back in 2002 and involved 60 patients that completed Phase 2 of the study. 543 more trials have been conducted in the years since."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
65+
What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM
2018. "Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04195139.
All > Gbm
~10 spots leftby Dec 2024
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