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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
Scientific title
A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide Alone in Newly Diagnosed Elderly Patients With Glioblastoma (NUTMEG)
Secondary ID [1] 0 0
ACTRN12617000267358
Secondary ID [2] 0 0
COGNO 16/01, CTC 0156
Universal Trial Number (UTN)
Trial acronym
NUTMEG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma Multiforme 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival outcomes
Timepoint [1] 0 0
24 months post randomisation of first participant
Secondary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
6 months post randomisation
Secondary outcome [2] 0 0
Number and severity of adverse events
Timepoint [2] 0 0
Through study completion, up to 24 months
Secondary outcome [3] 0 0
Health related quality of life of participants (QLQ C-30)
Timepoint [3] 0 0
Through study completion, up to 24 months
Secondary outcome [4] 0 0
Health related quality of life of participants (QLQ-BN20)
Timepoint [4] 0 0
Through study completion, up to 24 months
Secondary outcome [5] 0 0
Health related quality of life of participants (EuroQoL EQ-5D-5L)
Timepoint [5] 0 0
Through study completion, up to 24 months
Secondary outcome [6] 0 0
Neurologic function of participants
Timepoint [6] 0 0
Through study completion, up to 24 months
Secondary outcome [7] 0 0
Correlating modified RANO and immune related RANO in the experimental arm
Timepoint [7] 0 0
Through study completion, up to 24 months

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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [5] 0 0
Port Macquarie Hospital - Port Macquarie
Recruitment hospital [6] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [7] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [8] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [9] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [10] 0 0
Icon Cancer Centre - South Brisbane
Recruitment hospital [11] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [12] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [14] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [15] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [16] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [17] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [18] 0 0
Epworth Healthcare - Richmond
Recruitment hospital [19] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [5] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [6] 0 0
2031 - Randwick
Recruitment postcode(s) [7] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [8] 0 0
2500 - Wollongong
Recruitment postcode(s) [9] 0 0
4029 - Herston
Recruitment postcode(s) [10] 0 0
4101 - South Brisbane
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [12] 0 0
5000 - Adelaide
Recruitment postcode(s) [13] 0 0
5042 - Bedford Park
Recruitment postcode(s) [14] 0 0
7000 - Hobart
Recruitment postcode(s) [15] 0 0
3168 - Clayton
Recruitment postcode(s) [16] 0 0
3084 - Heidelberg
Recruitment postcode(s) [17] 0 0
3000 - Melbourne
Recruitment postcode(s) [18] 0 0
3121 - Richmond
Recruitment postcode(s) [19] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cooperative Trials Group for Neuro-Oncology
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mustafa Khasraw
Address 0 0
Duke University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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