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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04195139
Registration number
NCT04195139
Ethics application status
Date submitted
18/11/2019
Date registered
11/12/2019
Titles & IDs
Public title
Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM
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Scientific title
A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide Alone in Newly Diagnosed Elderly Patients With Glioblastoma (NUTMEG)
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Secondary ID [1]
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ACTRN12617000267358
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Secondary ID [2]
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COGNO 16/01, CTC 0156
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Universal Trial Number (UTN)
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Trial acronym
NUTMEG
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glioblastoma Multiforme
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Condition category
Condition code
Cancer
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Treatment: Drugs - Temozolomide
Experimental: Nivolumab and Temozolomide - After radiotherapy and 4 week break, participants who are assigned to this arm will receive Nivolumab with concurrent adjuvant temozolomide treatment
Active comparator: Temozolomide - After radiotherapy and 4 week break, participants who are assigned to this arm will receive the standard treatment of adjuvant temozolomide treatment
Treatment: Drugs: Nivolumab
Participants will receive Nivolumab intravenous infusions (240 mg days 1 and 15 every 28 days for cycles 1-4; then 480 mg day 1 every 28 days for cycles 5-6).
Treatment: Drugs: Temozolomide
Participants will receive temozolomide (TMZ) tablets days 1-5, every 28 days for 6 cycles. TMZ will be dosed at 150mg/m2 for the first cycle. If well tolerated TMZ is then given at 200mg/m2 for cycles 2 - 6.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival outcomes
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Assessment method [1]
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Overall survival is defined as the interval from the date of randomisation to date of death from any cause, or date of last known follow-up alive. This will be calculated using the Kaplan-Meier method.
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Timepoint [1]
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24 months post randomisation of first participant
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Secondary outcome [1]
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Progression Free Survival
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Assessment method [1]
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Progression free survival (PFS) is defined as the interval from date of randomisation to the date of first evidence of disease progression or death from any cause, whichever occurs first. The PFS will be calculated using the Kaplan-Meier method and disease progression is defined according to modified Response Assessment in Neuro-Oncology (RANO) criteria.
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Timepoint [1]
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6 months post randomisation
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Secondary outcome [2]
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Number and severity of adverse events
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Assessment method [2]
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The NCI Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) will be used to classify and grade the intensity of adverse events.
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Timepoint [2]
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Through study completion, up to 24 months
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Secondary outcome [3]
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Health related quality of life of participants (QLQ C-30)
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Assessment method [3]
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Health related quality of life will be reported directly by the participants using the EORTC core quality of life questionnaire QLQ C-30. The QLQ-C30 is a 30-item questionnaire with 5 functional scales (physical, role, cognitive, emotional, and social), global health status, 3 symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher score=better level of physical functioning.
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Timepoint [3]
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Through study completion, up to 24 months
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Secondary outcome [4]
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Health related quality of life of participants (QLQ-BN20)
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Assessment method [4]
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Health related quality of life will be reported directly by the participants using the EORTC core quality of life questionnaire brain cancer specific module (QLQ-BN20). The QLQ-BN20 consisted of 20 items assessing visual disorders, motor dysfunction, communication deficit, various disease symptoms (e.g. headaches and seizures), treatment toxicities (e.g. hair loss) and future uncertainty. All of the 20 items are rated on a 4 point scale (1=not at all, 4=very much), and were linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.
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Timepoint [4]
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Through study completion, up to 24 months
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Secondary outcome [5]
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Health related quality of life of participants (EuroQoL EQ-5D-5L)
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Assessment method [5]
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Health related quality of life will be reported directly by the participants using the EORTC core quality of life questionnaire EuroQol EQ-5D-5L. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health).
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Timepoint [5]
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Through study completion, up to 24 months
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Secondary outcome [6]
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Neurologic function of participants
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Assessment method [6]
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Cognitive function will be assessed by the Neurologic Assessment in Neuro-Oncology (NANO) scales. The NANO is a quantifiable evaluation of nine major domains for subjects with brain tumours. The domains include: gait, strength, ataxia, sensation, visual field, facial strength, language, level of consciousness, behaviour and overall. Each domain is rated on a scale of 0 to 3 where 0 represents normal and 3 represents the worst severity. The evaluation is based on direct observation/testing performed during routine office visits.
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Timepoint [6]
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Through study completion, up to 24 months
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Secondary outcome [7]
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Correlating modified RANO and immune related RANO in the experimental arm
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Assessment method [7]
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Site investigators will assess disease progression using modified RANO criteria for clinical decision making. The study team will coordinate image analysis and central review of MRI including modified RANO (both experimental and comparator arms) and iRANO (in the experimental arm).
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Timepoint [7]
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Through study completion, up to 24 months
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Eligibility
Key inclusion criteria
1. Adults, aged greater than or equal to 70 years, or aged 65-69 years if long course RT is inappropriate, with newly diagnosed histologically confirmed GBM (WHO grade IV glioma including gliosarcoma) following surgery
2. Tissue available for MGMT testing
3. ECOG 0-2
4. Life expectancy of >12 weeks
5. Adequate bone marrow function (platelets > 100 x 10^9/L, ANC > 1.5 x 10^9/L)
6. Adequate liver function (ALT/AST < 1.5 x ULN)
7. Adequate renal function (creatinine clearance > 30 ml/min measured using Cockcroft-Gault
8. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments including MRI
9. Signed, written informed consent
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may impact with the administration of study related treatments or procedures
2. Other co-morbidities or conditions that may compromise assessment of key outcomes
3. Prior chemotherapy or cranial radiation within the last 5 years. Prior or concomitant therapies for GBM (except surgery).
4. History of another malignancy within 2 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years after definitive primary treatment.
5. Significant infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated
6. Active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
7. 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.
8. For a condition other than GBM, the need for >2 mg/day of dexamethasone or >10 mg/day prednisone (or equivalent) or other immunosuppressive medications within 14 days prior to randomisation. Exceptions to this include the use of inhaled or topical steroids >10 mg/day prednisone (or equivalent), which are permitted in the absence of active autoimmune disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/02/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
103
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [2]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [3]
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Gosford Hospital - Gosford
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Recruitment hospital [4]
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Newcastle Private Hospital - New Lambton Heights
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Recruitment hospital [5]
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Port Macquarie Hospital - Port Macquarie
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Recruitment hospital [6]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [7]
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Royal North Shore Hospital - Saint Leonards
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Recruitment hospital [8]
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Wollongong Hospital - Wollongong
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Recruitment hospital [9]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [10]
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Icon Cancer Centre - South Brisbane
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Recruitment hospital [11]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [12]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [13]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [14]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [15]
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Monash Medical Centre - Clayton
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Recruitment hospital [16]
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Austin Hospital - Heidelberg
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Recruitment hospital [17]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [18]
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Epworth Healthcare - Richmond
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Recruitment hospital [19]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2250 - Gosford
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Recruitment postcode(s) [4]
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2305 - New Lambton Heights
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Recruitment postcode(s) [5]
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2444 - Port Macquarie
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Recruitment postcode(s) [6]
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2031 - Randwick
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Recruitment postcode(s) [7]
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2065 - Saint Leonards
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Recruitment postcode(s) [8]
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2500 - Wollongong
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Recruitment postcode(s) [9]
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4029 - Herston
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Recruitment postcode(s) [10]
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4101 - South Brisbane
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Recruitment postcode(s) [11]
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4102 - Woolloongabba
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Recruitment postcode(s) [12]
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5000 - Adelaide
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Recruitment postcode(s) [13]
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5042 - Bedford Park
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Recruitment postcode(s) [14]
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7000 - Hobart
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Recruitment postcode(s) [15]
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3168 - Clayton
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Recruitment postcode(s) [16]
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3084 - Heidelberg
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Recruitment postcode(s) [17]
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3000 - Melbourne
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Recruitment postcode(s) [18]
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3121 - Richmond
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Recruitment postcode(s) [19]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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North Carolina
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Cooperative Trials Group for Neuro-Oncology
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study aims to investigate effect of Nivolumab and Temozolomide vs Temozolomide alone on overall survival in newly diagnosed elderly patients with glioblastoma. Who is it for? You may be eligible to join this study if you are aged 65 years or above, with newly diagnosed histologically confirmed GBM (WHO grade IV glioma including gliosarcoma) following surgery. The study aims to evaluate whether the combination of adjuvant nivolumab with temozolomide improves overall survival outcomes for this patient population. The outcome of the study will help determine the most effective treatment for patients with glioblastoma in the future.
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Trial website
https://clinicaltrials.gov/study/NCT04195139
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mustafa Khasraw
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Address
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Duke University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04195139