Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM

Running, not enrolling · Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID: NCT04195139
Run by: University of Sydney
People needed: 103
Starts: 2018-02-22
Expected to finish: 2025-12-31
Last updated by the study team: 2024-12-11

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Tissue available for MGMT testing
ECOG 0-2
Life expectancy of >12 weeks
Adequate bone marrow function (platelets > 100 x 10\^9/L, ANC > 1.5 x 10\^9/L)
Adequate liver function (ALT/AST < 1.5 x ULN)
Adequate renal function (creatinine clearance > 30 ml/min measured using Cockcroft-Gault
Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments including MRI
Signed, written informed consent

You may not qualify if…

Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may impact with the administration of study related treatments or procedures
Other co-morbidities or conditions that may compromise assessment of key outcomes
Prior chemotherapy or cranial radiation within the last 5 years. Prior or concomitant therapies for GBM (except surgery).
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.
Significant infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated
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.
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.
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.

Where it is running

Duke University Medical Center — Durham, North Carolina, United States
Campbelltown Hospital — Campbelltown, New South Wales, Australia
Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
Gosford Hospital — Gosford, New South Wales, Australia
Newcastle Private Hospital — New Lambton Heights, New South Wales, Australia
Port Macquarie Hospital — Port Macquarie, New South Wales, Australia
Prince of Wales Hospital — Randwick, New South Wales, Australia
Royal North Shore Hospital — Saint Leonards, New South Wales, Australia
Wollongong Hospital — Wollongong, New South Wales, Australia
Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
Icon Cancer Centre — South Brisbane, Queensland, Australia
Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
Royal Adelaide Hospital — Adelaide, South Australia, Australia
Flinders Medical Centre — Bedford Park, South Australia, Australia
Royal Hobart Hospital — Hobart, Tasmania, Australia
Monash Medical Centre — Clayton, Victoria, Australia
Austin Hospital — Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
Epworth Healthcare — Richmond, Victoria, Australia
Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia

Full record on ClinicalTrials.gov

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