๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-12-05

Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM (NCT04195139)

A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide Alone in Newly Diagnosed Elderly Patients With Glioblastoma (NUTMEG)

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: University of Sydney

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Duke University Medical Center โ€” Durham, North Carolina

Age range: 65 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (20 Sites)

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

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—