NUTMEG : A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide alone in newly diagnosed Elderly patients with Glioblastoma (NUTMEG) to analyse overall survival.

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

TwoPhase Two

65+Age Over 65

Brain and Spinal<br/>CancersCancer LocationBrain and Spinal
Cancers

Multiple treatment types,Radiotherapy,Systemic therapy | Brain and spinal cordBrain,Glioblastoma (GBM)

Trial Overview Read MoreRead more

This phase II trial is comparing the effect of a chemotherapy drug (Temozolomide) alone and in combination with an immunotherapy drug (Nivolumab) for the treatment of elderly patients with a newly diagnosed glioblastoma.
 

This trial is treating patients with Glioblastoma.

This is a systemic and radiotherapy trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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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) to analyse overall survival.

Other Non-Commercial Sponsor

National Health & Medical Research Council (NHMRC)

Summary

All patients will receive radiotherapy (40Gy/ 15 fractions, weekdays over 21 days) concurrently with temozolomide (TMZ) tablets 75mg/m2 daily for 21 days. After a 4 week break the experimental group 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) with concurrent adjuvant temozolomide 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. The intervention will not be personalised.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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